[vc_row][vc_column width="1/3"][vc_single_image image="2045" img_size="300x510" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]

Atana®

50 μg/ml Latanoprost

2,5 ml Ophthalmic Solution

S4 Reg. No. 47/15.4/0116

Package Insert

[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml of ATANA Ophthalmic Solution contains latanoprost 50 μg, Other ingredients are: Disodium phosphate anhydrous, Sodium chloride
Sodium dihydrogen phosphate monohydrate, Sodium Hydroxide / Hydrochloric acid, water for injection
Preservative: Benzalkonium chloride 0,02 % m/v[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15.4 Ophthalmic Preparations. Other[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][vc_column_text]Latanoprost is a prostanoid selective prostaglandin F2 (FP) receptor agonist.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Latanoprost is believed to reduce intraocular pressure by increasing the outflow of aqueous humor. Studies in man and animals indicate increased uveoscleral outflow as the main mechanism of action.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Absorption:
Latanoprost is absorbed through the cornea following topical ocular administration. The peak concentration in the aqueous humor is reached about 2 hours after topical administration as indicated in studies conducted in man.
Biotransformation:
Latanoprost is an isopropyl ester prodrug and is hydrolysed by esterases in the cornea to the biologically active acid. The active acid of latanoprost that reaches the systemic circulation is primarily metabolised by the liver to the 1,2-dinor- and 1,2,3,4-tetranor-metabolites via fatty acid β-oxidation.
Elimination:
Following both intravenous and topical administration, the elimination of the latanoprost acid from human plasma is rapid (t½ = 17 minutes).
The systemic clearance is approximately 7 ml/min/kg. Metabolites are mainly eliminated via the kidneys, following hepatic β-oxidation.
Approximately 88 % and 98 % of the administered dose is recovered in the urine following topical and intravenous dosing respectively.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]ATANA ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma, ocular hypertension and chronic angle closure glaucoma.[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]• Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredient in the formulation of ATANA.
• Pregnancy and lactation (See “Pregnancy and Lactation”).
• ATANA contains a high concentration of the preservative, benzalkonium chloride, which may be absorbed by all contact lenses (See “Dosage and directions for use” and “Warnings and special precautions”).[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]• It is recommended that ATANA be used with caution in aphakic or pseudophakic patients with torn posterior capsules or in patients with known risk factors for cystoid macular oedema (See “Side-effects”).
• ATANA may result in a gradual change in eye colour, by increasing the amount of brown pigment in the iris (See “Side effects”). This colour change is not due to an increase in the number of melanocytes, but rather to the increased melanin content in the stromal melanocytes of the iris.
• The change in iris colour occurs gradually and may not be noticeable for several months to years. Patients should be made aware of the possibility of iris colour change, before treatment is instituted. It is necessary to inform patients who are expected to receive treatment in only one eye, about the potential for increased brown pigmentation in the treated eye and thus heterochromia between the eyes. The resultant pigmentation is irreversible.
• The change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e. grey-brown, green-brown, blue-brown and yellow-brown. The onset of the eye colour change is usually within the first 8 months of treatment but may occur at a later stage in a small number of patients. Based on evidence from consecutive photographs, this effect has been seen in 30 % of all patients during 4 years of treatment in clinical trials. The highest incidence was found in patients with yellow-brown and green-brown irides. The change
has only rarely been seen in patients with homogenously green, blue, grey or brown eyes.
• The brown pigmentation around the pupil spreads concentrically towards the periphery of the affected eyes, but the entire iris or parts of it may also become more brownish. No further increase in brown iris pigmentation has been observed once treatment is discontinued.
• Changes in eyelashes may occur (See “Side-effects”).

• Neither freckles nor naevi of the iris has been affected by the treatment.
• Pigment accumulation in the trabecular meshwork or elsewhere in the anterior chamber has not been observed in clinical trials.
• As the possibility of adverse effects on the corneal permeability, and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
• The safety and effectiveness of ATANA in children has not been established, therefore the use of ATANA in children is not recommended.
• ATANA has not been studied in patients with renal or hepatic impairment and should therefore be used with caution in patients with these conditions.
• Latanoprost is known to be hydrolysed in the cornea. The effect that may occur as a result of continued administration of ATANA in the corneal epithelium has not been fully evaluated.
• There is limited experience of ATANA in patients with asthma, but cases of asthma, acute asthma attack, asthma aggravation, dyspnoea and coughing have been reported (See “Side effects”).
• There is limited experience in inflammatory ocular conditions, inflammatory, angle closure, neovascular, congenital or pigmentary glaucoma and also in pseudophakic patients with open angle glaucoma.
• ATANA has no or little effect on the pupil, however there is no experience in acute attacks of closed angle glaucoma. Until more experience is obtained, it is recommended that ATANA be used with caution in these conditions.
• ATANA contains a high concentration of the preservative, benzalkonium chloride, which may be absorbed by all contact lenses (See “Contraindications” and “Dosage and directions for use”).
• Bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products, has been reported.
• Patients should be instructed to prevent the tip of the dispensing container to make contact with the eye or surrounding structures, as this could cause the tip to become contaminated by common bacteria known to cause common ocular infections. The use of contaminated solutions may result in serious damage to the eye and subsequent loss of vision.
• It is also important to advise patients that should they develop an intercurrent ocular condition (e.g. infection or trauma) they should
immediately seek their physician’s advice concerning the continued use of the multidose container they have been using.
• In addition, patients should be advised that if they develop any ocular reactions, particularly lid reactions and conjunctivitis, they should
seek their doctor’s advice.[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]Administration of eye drops may cause transient blurring of vision.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]In vitro studies have demonstrated the occurrence of precipitation when eye drops containing thiomersal are mixed with latanoprost. If such medicines are used, the eye drops should be administered with an interval of at least 5 minutes between applications.
Latanoprost is effective as monotherapy as demonstrated in pivotal studies.
Latanoprost’s intraocular reducing effect has been shown to be additive to that of beta-adrenergic antagonists (timolol).
In short term studies (up to 2 weeks) the effect of latanoprost was additive in combination with oral carbonic anhydrase inhibitors (acetazolamide) and adrenergic agonists (dipivefrin) and at least partly additive with cholinergic agonists (pilocarpine).
In the case of combination therapy the eye drops should be administered with an interval of at least 5 minutes between applications (See “Dosage and directions for use”).[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]The safety of ATANA for use in pregnancy has not been established. Since ATANA has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate, it should not be used in pregnancy (See “Contraindications”).
The safety of ATANA in lactation has not been established.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]ATANA contains a high concentration of the preservative, benzalkonium chloride, which may be absorbed by all contact lenses (See “Contraindications” and “Warnings and special precautions”). Patients wearing contact lenses should be instructed to remove their lenses prior to ATANA administration and to wait at least 15 minutes to reinsert them.[/vc_column_text][/vc_tta_section][vc_tta_section title="Recommended dosage for adults (including the elderly)" tab_id="1504698296730-b0688eef-6335"][vc_column_text]• Recommended therapy is one drop in the affected eye(s) once daily. The optimal effect is obtained if ATANA is administered in the evening.
• Dosage should not exceed more than once daily administration, since more frequent administration may decrease the intraocular pressure lowering effect of ATANA.
• If a dose is missed treatment should continue with the next dose as planned.
• Reduction of the intraocular pressure in man is initiated about 3 to 4 hours after administration and maximum effect is reached after 8 to 12 hours. Intraocular pressure reduction is maintained for at least 24 hours.
• ATANA may be used concomitantly with other topical ophthalmic preparations to lower intraocular pressure. If more than one topical
medicine is being used, the medicines should be administered at least 5 minutes apart (See “Interactions”).[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]The most undesirable side-effects relate to the ocular system.

Eye disorders:
Frequent:
An increase in brown pigmentation of the iris (See “Warnings and special precautions”); mild foreign body sensation; changes in the eyelashes (See “Warnings and special precautions”).
Transient punctate epithelial keratopathy, mostly without symptoms; mild to moderate conjunctival hyperaemia.
Less frequent:
Periorbital oedema; uveitis/iritis; symptomatic corneal oedema and erosions; darkening of the palpebral skin.
During treatment with ATANA eye drops, macular oedema including cystoid macular oedema was reported infrequently, mainly in patients with aphakia and pseudophakia with torn posterior lens capsule or anterior chamber lenses (See “Warnings and special precautions”).

Cardiac disorders:
Frequency unknown:
Chest pain and angina pectoris.

Respiratory, thoracic and mediastinal disorders:
Less frequent:
Dyspnoea; asthma and asthma aggravation (See “Warnings and special precautions”).
Frequency unknown:
Upper respiratory tract infection, colds and flu.

Skin and subcutaneous tissue disorders:
Less frequent:
Skin rash.

Musculoskeletal, connective tissue and bone disorders:
Frequency unknown:
Muscle, joint and back pain.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]Apart from conjunctival hyperaemia and ocular irritation, no other ocular side-effects are known in the event of overdosage.
The following information may be useful if ATANA is accidentally ingested:
One bottle of ATANA contains 125 micrograms latanoprost. More than 90 % of this is metabolised during the first pass through the liver.
Intravenous infusion of 3 micrograms/kg in healthy volunteers induced no symptoms, however, a dose of 5,5 to 10 micrograms/kg resulted in nausea, abdominal pain, fatigue, dizziness, hot flushes and sweating.
Latanoprost has been intravenously infused in monkeys, in doses of up to 500 micrograms/kg without major effects on the cardiovascular system.
Latanoprost has been associated with transient bronchoconstriction when administered intravenously in monkeys. Bronchoconstriction,
however, was not induced by latanoprost when applied topically to the eyes in a dose of seven times the clinical dose of ATANA, in patients with moderate bronchial asthma.
Treatment should be symptomatic, should overdosage with ATANA occur.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Clear, colourless aqueous solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]ATANA solution is supplied in a low density polyethylene 5 ml sterile white bottle containing 2,5 ml solution, with a sterile white high density polyethylene screw cap and a sterile white low density polyethylene under-cap dropper. The dropper bottle is contained in an outer
cardboard carton.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store in a refrigerator at 2 °C – 8 °C. Avoid freezing. Protect from light.
Keep the bottle in the carton until required for use.
Keep well closed after initial opening.
Once the container is opened store at or below 25 °C. The contents must be used within 30 days.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]47/15.4/0116[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]27 November 2014[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]

[vc_row][vc_column width="1/3"][vc_single_image image="2091" img_size="300x510" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]

CO-ATANA™

50 μg/ml Latanoprost and 5 mg/ml Timolol

2,5 ml Ophthalmic Solution
S4  Reg. No. 47/15.4/0528

Package Insert

[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]CO-ATANA Ophthalmic Solution contains: latanoprost 50 μg/ml and timolol maleate equivalent to 5 mg/ml timolol.

Other ingredients are: disodium phosphate anhydrous

sodium chloride

sodium dihydrogen phosphate monohydrate

water for injection

Preservative: benzalkonium chloride 0,02 % m/v[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15.4 Ophthalmic preparations, other.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text][/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1505995575796-77753bf0-965a"][vc_column_text]CO-ATANA consists of two components, latanoprost and timolol maleate, which decrease elevated intraocular pressure (IOP) by different mechanisms of action.

Latanoprost, a prostaglandin F2α analogue, is a prostanoid selective prostaglandin F2 (FP) receptor agonist that increases the outflow of aqueous humour, to reduce IOP. Increased uveoscleral outflow is the main mechanism of action. In addition, some increase in outflow activity (decrease to trabecular outflow resistance) has been reported in man.

Latanoprost has no significant effect on the production of aqueous humour, intraocular blood circulation or the blood-aqueous barrier. Latanoprost has not induced fluorescein leakage in the posterior segment of pseudophakic human eyes during short-term therapy.

Timolol is a non-selective beta-1 and beta-2 adrenergic receptor blocking agent. Timolol lowers IOP by reducing aqueous humour formation in the ciliary epithelium. The exact mechanism of action has not been clearly established.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Latanoprost:

Latanoprost is an inactive isopropyl ester prodrug, but following hydrolysis by esterases in the cornea to the acid of latanoprost, becomes biologically active. The prodrug is well absorbed through the cornea. All the prodrug that enters the aqueous humour is hydrolysed during the passage through the cornea. Studies in man indicate that the maximum concentration in the aqueous humour,approximately 30 ng/ml, is reached about 2 hours following topical administration of latanoprost alone.

The acid of latanoprost has a plasma clearance of 0,4 l/h/kg and a small volume of distribution of 0,16 l/kg, resulting in a rapid plasma half-life of 17 minutes.

Practically no metabolism of the acid of latanoprost occurs in the eye. Metabolism occurs mainly in the liver. The main metabolites, the 1,2,3,4-tetranor and 1,2-dinor metabolites, exert no or only weak biological activity in animal studies and are excreted primarily in the urine.

Timolol: The maximum concentration of timolol in the aqueous humour is achieved about one hour after topical administration of the eye drops. Part of the dose is absorbed systemically and a maximum plasma concentration of 1 ng/ml is reached 10 to 20 minutes following topical administration of one eye drop to each eye once daily (300 ìg/day). Half-life in plasma is about 4 hours. Timolol is extensively metabolised in the liver and the metabolites are excreted in the urine together with some unchanged timolol.

No pharmacokinetic interactions between latanoprost and timolol were observed, although there is a tendency for increased concentrations of the acid of latanoprost in aqueous humour 1 to 4 hours after administration of latanoprost and timolol compared to monotherapy. Onset of action is within one hour and maximal effect occurs within six to eight hours. The IOP reducing effect of

CO-ATANA has been shown to be present up to 24 hours post dosage after multiple treatments.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are not controlled on or are intolerant to monotherapy with compounds other than latanoprost and timolol.[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]

[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]Systemic effects:

Cardiovascular / respiratory reactions:

CO-ATANA may be absorbed systemically.Due to the beta-adrenergic component timolol, aggravation of Prinzmetal’s angina, aggravation of severe peripheral and central circulatory disorders, hypotension and bradycardia may occur.

Cardiac and respiratory reactions including death due to bronchospasm in patients with asthma and, less frequently, death associated with cardiac failure, have been reported following administration with timolol. Before treatment with CO-ATANA is initiated, cardiac failure should be adequately controlled (See CONTRAINDICATIONS).

Anaphylactic reactions:

Patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more responsive to repeated challenge with such allergens, while taking beta-blockers, either accidental, diagnostic or therapeutic. These patients may be unresponsive to the usual doses of epinephrine (adrenaline) used to treat anaphylactic reactions when using

CO-ATANA.

Concomitant therapy:

Timolol may have interactions with other medicines. (See INTERACTIONS).When CO-ATANA is given to patients already receiving an oral beta-blocking agent, the effect on intraocular pressure or the knowneffects of systemic beta-blockade may be exaggerated. The use of two local prostaglandins or two local beta-blockers is not recommended.

Additional effects of combination products, which contain a beta-blocker:

CO-ATANA should be administered with caution in patients subjected to spontaneous hypoglycaemia or to diabetic patients (especially those with labile diabetes) who are receiving oral hypoglycaemic agents or insulin. CO-ATANA may mask the signs and symptoms associated with acute hypoglycaemia.

Treatment with CO-ATANA may mask certain symptoms of hyperthyroidism and abrupt withdrawal of therapy may precipitate a worsening of symptoms.

Treatment with CO-ATANA may aggravate symptoms of myasthenia gravis.

Ocular effects:Latanoprost may gradually change the eye colour as a result of increasing the amount of brown pigment in the iris. This effect as predominantly been seen in patients with mixed colour irides, i.e. yellow-brown, green-brown, or blue/grey/brown and is due to the increased melanin content in the stromal melanocytes in the iris. Typically the brown pigmentation around the pupil spreads concentrically towards the periphery in the affected eyes, but parts of the iris or the entire iris may become more brownish.

The change in iris colour occurs gradually and may not be noticeable for several months to years. It has not been associated with any symptom or pathological changes.

Although no further increase in brown pigment has been observed after discontinuation of treatment, the resultant colour change may be permanent.

Neither freckles nor naevi of the iris have been affected by treatment.

Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed, however, patients should be examined regularly and, depending on the clinical situation, treatment may be stopped if increased iris pigmentation ensues.

Before treatment with CO-ATANA is instituted, patients should be made aware of the possibility of a change in eye colour. Unilateral treatment can lead to permanent heterochromia.

There is no or limited experience with latanoprost and CO-ATANA in neovascular, inflammatory, chronic angle closure or congenital glaucoma, in open angle glaucoma of pseudophakic patients and in pigmentary glaucoma.

Latanoprost has little or no effect on the pupil, however there is no experience in acute attacks of closed angle glaucoma. It is therefore recommended that CO-ATANA not be used in these conditions until more experience is obtained.

Macular oedema, including cystoid macular oedema, has been reported during therapy with latanoprost. These reports have mainly occurred in patients with known risk factors for macular oedema, aphakic patients or in pseudophakic patients with a torn posterior lens capsule. In such patients CO-ATANA should be used with caution.

Choroidal detachment following filtration procedures has been reported with the administration of ocular hypotensive agents.

As the possibility of adverse effects on corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

Use of contact lenses:

CO-ATANA contains the preservative benzalkonium chloride which may be absorbed by contact lenses. Contact lenses should therefore be removed before instillation of the eye drops and may be reinserted after 15 minutes.

Children:

As safety and efficacy in children has not been established, CO-ATANA is not recommended for use in children.

 

 

 

[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]Administration of eye drops may cause transient blurring of vision.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]No specific medicine interaction studies have been performed with CO-ATANA.
The potential exists for additive effects resulting in hypotension and/or marked bradycardia when eye drops containing timolol are administered with calcium-channel blockers, catecholamine-depleting medicines or beta-blocking agents, antidysrhythmics (including amiodarone and quinidine), parasympathomimetics, digoxin, monoamine oxidase (MAO) inhibitors and narcotics (See WARNINGS AND SPECIAL PRECAUTIONS).
Although CO-ATANA alone has little or no effect on pupil size, mydriasis has occasionally been reported when timolol is administered with epinephrine (adrenaline).
The hypoglycaemic affect of anti-diabetic agents may be increased by beta-blockers.

[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Pregnancy:

The safety of CO-ATANA in pregnancy has not been established (See CONTRAINDICATIONS).

Lactation:

CO-ATANA should not be used in women breast-feeding their infants, or breast-feeding should be stopped as latanoprost and its

metabolites may pass into breast milk, and timolol is excreted into breast milk (See CONTRAINDICATIONS).[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]The tamper evident overcap should be removed before use.

Recommended dosage for adults (including the elderly):

Recommended therapy is one drop in the affected eye(s) once daily.

If one dose is missed, treatment should continue with the next dose as planned.

Administration:

If more than one topical ophthalmic medicine is being used, the medicines should be administered at least 5 minutes apart.[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]SIDE EFFECTS

The adverse effects of CO-ATANA are similar to those reported earlier for latanoprost and timolol.

Based on evidence from consecutive photographs, increased iris pigmentation was observed in 16 to 20 % of all patients who received CO-ATANA eye drops for up to one year.

The most frequent findings of increased iris pigmentation were in patients with yellow-brown, green-brown and blue/grey/brown irides. In patients with homogenously grey, green, blue, or brown eyes, the change was only less frequently seen. Thickening, lengthening and darkening of the eye lashes have been reported.

The most frequently reported undesirable effects in clinical trials were irritation of the eye including stinging, burning and itching, eye hyperaemia, blepharitis, corneal disorders, conjunctivitis, eye pain, headache and skin rash.

Additional adverse events that have been seen with one of the components and may occur during treatment with CO-ATANA:

Latanoprost:

Eye disorders:

Frequent: Foreign body sensation, punctate epithelial erosions.

Less frequent: Macular oedema/cystoid macular oedema, iritis/uveitis, corneal oedema and erosions.

Respiratory, thoracic and mediastinal disorders:

Less frequent: Dyspnoea, asthma and asthma exacerbation.

Skin and subcutaneous tissue disorders:

Less frequent: Darkening of the skin on eyelids.

Timolol:

Eye disorders:

Frequent: Signs and symptoms of ocular irritation, dry eyes, keratitis, decreased corneal sensitivity.

Less frequent: Visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases),

diplopia, ptosis and choroidal detachment (following filtration surgery).

Nervous system disorders:

Less frequent: Dizziness, insomnia, increase in signs and symptoms of myasthenia gravis, paraesthesia.

Psychiatric disorders:

Less frequent: Nightmares, depression, memory loss.

Ear and labyrinth disorders:

Less frequent: Tinnitus.

Cardiac disorders:

Less frequent: Dysrhythmia, heart block, congestive heart failure, palpitation, cardiac arrest.

Vascular disorders:

Less frequent: Bradycardia, hypotension, cold hands and feet, claudication, oedema, cerebral ischaemia, Raynaud’s

phenomenon, cerebrovascular accident, syncope.

Respiratory, thoracic and mediastinal disorders:

Less frequent: Respiratory failure, bronchospasm (predominantly in patients with pre-existing bronchospastic disease),

dyspnoea, cough.

Skin and subcutaneous tissue disorders:

Less frequent: Psoriasiform rash or exacerbation of psoriasis, alopecia.

Immune system disorders:

Less frequent: Symptoms of allergic reactions including angioedema, localised and generalised rash, urticaria, systemic

lupus erythematosus.

Reproductive system and breast disorders:

Less frequent: Peyronie’s disease, decreased libido.

General disorders and administrative site conditions:

Less frequent: Fatigue, chest pain, asthenia.

[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]

(See SIDE EFFECTS).

There is no data available in humans with respect to overdosage with CO-ATANA.

Apart from conjunctival hyperaemia and ocular irritation, no other ocular or systemic side effects are known should overdosage

with latanoprost occur. Symptoms of systemic timolol overdosage are hypotension, bradycardia, bronchospasm and cardiac arrest.

Should such symptoms occur, the treatment should be symptomatic and supportive. In studies performed, it was observed that

timolol does not dialyse readily. Should CO-ATANA be accidentally ingested, the following may be useful: during the first pass

through the liver, latanoprost is extensively metabolised.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Clear, colourless aqueous solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]CO-ATANA ophthalmic solution is supplied in a white sterile dropper bottle with a white sterile dropper and a white sterile cap. Each

bottle contains 2,5 ml ophthalmic solution. The dropper bottle is contained in an outer cardboard carton.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]

STORAGE INSTRUCTIONS

Store in a refrigerator (2 to 8 °C) in the original carton.

Once opened store at room temperature up to 25 °C.

After opening, the bottle must be stored in the original carton to protect it from light.

Do not use more than 30 days after opening.

KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]47/15.4/0528[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]28 April 2016[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]

[vc_row][vc_column width="1/3"][vc_single_image image="2052" img_size="300x510" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]

GLAUMIDE-CO

20 mg/ml Dorzolamide and 5 mg/ml Timolol

5 ml Ophthalmic Solution

S3 Reg. No. 46/15.4/0684

Package Insert

[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml of GLAUMIDE-CO Ophthalmic Solution contains 22,26 mg dorzolamide hydrochloride equivalent to 20 mg dorzolamide base and 6,83 mg timolol maleate equivalent to 5,0 mg timolol base.

Preservative : Benzalkonium chloride 0,0075 % m/v.

Other ingredients are: hydroxyethylcellulose, mannitol, sodium citrate dihydrate and water for injection.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A. 15.4 Ophthalmic Preparations, other.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][vc_column_text][/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]GLAUMIDE-CO contains dorzolamide hydrochloride and timolol maleate.
Dorzolamide hydrochloride and timolol maleate both decrease aqueous humour secretions and thus intraocular pressure, but do so by different modes of action.

Dorzolamide hydrochloride:
Dorzolamide hydrochloride is a carbonic anhydrase inhibitor used topically in the management of open-
angle glaucoma and ocular hypertension. Carbonic anhydrase is an enzyme which is widely
distributed throughout the body including the eyes. Carbonic anhydrase catalyses the rapid conversion
of carbon dioxide and water to hydrogen and carbonate ions. Carbonic anhydrase inhibitors thus
reduce the formation of hydrogen and bicarbonate ions from carbon dioxide and water by non-competitive,
reversible inhibition of carbonic anhydrase, thereby reducing the availability of these ions for active
transport into secretions.

In humans, carbonic anhydrase exists in several isoforms (isoenzymes).
Carbonic anhydrase ll (CA-ll) is the most active isoform of the enzyme, found primarily in erythrocytes (red blood cells) but also in other tissues including the secretory cells of the ciliary process, where its main function is to regulate the secretion of aqueous humour.

Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion, probably by slowing the formation of bicarbonate ions with a subsequent reduction in sodium and fluid transport and thus intra-ocular pressure.

Timolol maleate:
Timolol maleate, a non-selective beta-adrenergic receptor blocker, reduces intraocular pressure by decreasing the production of aqueous humour.

The combined effect of dorzolamide hydrochloride and timolol maleate results in additional intraocular pressure reduction compared to either component administered alone.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Dorzolamide hydrochloride:

Following topical application, dorzolamide hydrochloride reaches the systemic circulation.

During chronic dosing, dorzolamide hydrochloride accumulates in erythrocytes as a result of

selective binding to carbonic anhydrase II (CA-II), while a low concentration of free dorzolamide in the plasma is maintained.

Dorzolamide hydrochloride is metabolised in the liver by cytochrome P-450 isoenzymes to form

N-desethyldorzolamide hydrochloride, which inhibits CA-II less potently than the dorzolamide hydrochloride but also inhibits carbonic anhydrase I (CA-I). The metabolite also accumulates in erythrocytes where it binds primarily to CA-I.

Plasma protein binding of dorzolamide hydrochloride is approximately 33 %. While both dorzolamide and its metabolite are excreted in urine, it is excreted principally (about 80 %) unchanged.

Following discontinuation of the medicine, dorzolamide hydrochloride is eliminated from the erythrocytes

in a nonlinear manner with an initial rapid decline of dorzolamide concentration, followed by a slower elimination phase with a half-life of approximately 120 days.

 

Timolol maleate:

In a study of plasma timolol concentration, the systemic exposure to timolol was determined following a twice daily topical administration of timolol maleate ophthalmic solution 0,5 %. The mean peak plasma concentration following the morning dosing was 0,46 ng/ml and following the afternoon dosing was 0,35 ng/ml.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]GLAUMIDE-CO is indicated in the treatment of elevated intra-ocular pressure in patients with:

·         ocular hypertension.

·         open angle glaucoma.

·         pseudoexfoliative glaucoma and other secondary open-angle glaucomas when concurrent therapy is appropriate.[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]

·         Hypersensitivity to dorzolamide hydrochloride, timolol maleate or any of the ingredients of GLAUMIDE-CO.    

·         Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease.

·         Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.

·         Pregnancy and lactation.      

·         Safety and efficacy in children has not been established.

(See WARNINGS AND SPECIAL PRECAUTIONS)     

    

[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]  

As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

The preservative in GLAUMIDE-CO, benzalkonium chloride, may be absorbed by soft contact lenses.
GLAUMIDE-CO should therefore not be administered while wearing soft contact lenses.
Remove lenses before administration and re-insert 15 minutes after application of the drops.

Immunology and Hypersensitivity:
GLAUMIDE-CO contains dorzolamide hydrochloride which is a sulphonamide and topical administration can result in systemic absorption. Side-effects pertaining to sulphonamides may be experienced. These include Stevens-Johnson Syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia and other blood dyscrasis. If signs of serious reactions or hypersensitivity occur, discontinue the use of GLAUMIDE-CO.

In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of ophthalmic solutions containing dorzolamide hydrochloride (as contained in GLAUMIDE-CO). Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of therapy. If such reactions occur, treatment with GLAUMIDE-CO should be discontinued and the patient evaluated before restarting the medicine.

While taking beta-blockers, including timolol (as contained in GLAUMIDE-CO), patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to accidental, diagnostic, or therapeutic repeated challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine (adrenaline) used to treat anaphylactic reactions.

Concomitant Therapy:
There is a potential for an additive effect on the systemic effects of the inhibition of carbonic anhydrase in patients taking an oral carbonic anhydrase inhibitor and GLAUMIDE-CO concomitantly.

The concomitant administration of GLAUMIDE-CO and oral carbonic anhydrase inhibitors has not been studied and is not recommended.

Patients who are currently receiving treatment with a beta-adrenergic blocker and who are given
GLAUMIDE-CO should be observed for a possible additive effect either on the intraocular pressure or on the known systemic effects of beta-blockade. The use of two topical beta-adrenergic blocking agents is not recommended.
(See INTERACTIONS)

Cardio-respiratory reactions:
GLAUMIDE-CO may be absorbed systemically. Timolol maleate is a beta-blocker and therefore the same types of adverse reactions found with systemic administration of beta-blockers may occur with GLAUMIDE-CO.
Because of the timolol maleate component, cardiac failure should be adequately controlled before beginning therapy with GLAUMIDE-CO. In patients with a history of severe cardiac disease, signs of cardiac failure should be watched for and pulse rates should be checked.

Respiratory and cardiac adverse effects, including death due to bronchospasm in patients with asthma and death in association with cardiac failure, have been reported following administration of ophthalmic solutions containing timolol maleate (as contained in GLAUMIDE-CO).

Renal and Hepatic Impairment:
GLAUMIDE-CO has not been studied in patients with severe renal impairment (CrCl less than
30 millimetre/min). Due to dorzolamide hydrochloride and its metabolite being excreted primarily by the kidney, GLAUMIDE-CO is not recommended in such patients. GLAUMIDE-CO has not been studied in patients with hepatic impairment.

Use in Elderly:
No differences in efficacy or safety were observed between older patients and younger patients, but greater sensitivity of some of the older individuals cannot be ruled out.

Other:
GLAUMIDE-CO has not been studied in patients with acute angle-closure glaucoma. The management of patients with acute angle-closure glaucoma requires therapeutic intervention in addition to ocular hypotensive agents. Choroidal detachment has been observed with the use of aqueous suppressant therapy (e.g. timolol, acetazolamide, dorzolamide hydrochloride) after filtration procedures

  [/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]GLAUMIDE-CO causes visual disturbances. Patients should be advised not to drive or operate machines until their vision is clear.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]Specific interaction studies with GLAUMIDE-CO have not been performed. However, in clinical studies dorzolamide-timolol ophthalmic solution was used concomitantly with the following medicines without evidence of adverse interactions: ACE-Inhibitors, calcium channel blockers, diuretics, non-steroidal anti-inflammatory drugs (including aspirin), hormones (e.g. oestrogen, insulin, thyroxine).

However there is a potential for additive effects and the development of hypotension and/or marked bradycardia when timolol maleate ophthalmic solution and oral calcium channel blockers, catecholamine-depleting medicines or beta-adrenergic blocking medicines are used concurrently.

 

Dorzolamide hydrochloride is a carbonic anhydrase inhibitor and although administered topically, is absorbed systemically. In clinical studies, dorzolamide hydrochloride ophthalmic solution was not associated with acid-base disturbances. However these disturbances have been reported with oral carbonic anhydrase inhibitors and have in some cases resulted in interactions (e.g. toxicity associated with high-dose salicylate therapy). Thus the potential for such interactions in patients using GLAUMIDE-CO should be considered.

 

Oral beta-adrenergic blocking agents (such as contained in GLAUMIDE-CO) may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.

 

Potentiated systemic beta-blockade (e.g. decreased heart rate) has been observed during concurrent treatment with quinidine and timolol (as contained in GLAUMIDE-CO), possibly as quinidine inhibits the metabolism of timolol via the P450 enzyme, CYP2D6.[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text](See CONTRA-INDICATIONS)
The safety of GLAUMIDE-CO in pregnant and lactating women has not been established.
There are no adequate and controlled studies in pregnant women.
According to studies timolol maleate is excreted into human milk.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]Benzalkonium chloride is known to cause eye irritation, discolour soft lenses and may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to remove their lenses prior to using GLAUMIDE-CO and to wait at least 15 minutes after instilling GLAUMIDE-CO to insert soft contact lenses (See WARNINGS AND SPECIAL PRECAUTIONS).[/vc_column_text][/vc_tta_section][vc_tta_section title="Recommended dosage for adults (including the elderly)" tab_id="1504698296730-b0688eef-6335"][vc_column_text]If more than one topical ophthalmic medication is being used, the medicines should be administered at least ten minutes apart.

The dose is one drop of GLAUMIDE-CO in the affected eye(s) two times a day.

When substituting GLAUMIDE-CO for another ophthalmic anti-glaucoma medicine, discontinue the other medicine after proper dosing on one day, and start GLAUMIDE-CO on the next day.[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]The following adverse reactions have been reported with GLAUMIDE-CO ophthalmic solution.
Adverse reactions marked with an asterisk (*) were also observed with dorzolamide-timolol ophthalmic
solution during post marketing experience.

Eye disorders:
GLAUMIDE-CO:
Frequent: Burning and stinging, conjunctival injection, blurred vision, tearing, corneal erosion, ocular itching.

Dorzolamide hydrochloride ophthalmic solution:
Frequent: Eyelid irritation, superficial punctuate keratitis, eyelid inflammation.
Less frequent: Iridocyclitis, transient myopia, eyelid crusting, signs and symptoms of local reactions including palpebral reaction, choroidal detachment (following filtration surgery).

Timolol maleate ophthalmic solution:
Frequent: Conjunctivitis, signs and symptoms of ocular irritation including blepharitis, keratitis, decreased corneal sensitivity, dry eyes.
Less frequent: Visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, choroidal detachment (following filtration surgery)*, ptosis.

Immune system disorders:
Dorzolamide hydrochloride ophthalmic solution:
Less frequent: Systemic allergic reactions including urticaria, angioedema, pruritus and bronchospasm.

Timolol maleate ophthalmic solution:
Less frequent: Systemic lupus erythematous, signs and symptoms of allergic reactions including anaphylaxis, localised and generalised rash, urticaria and angioedema.

Ear and labyrinth disorders:
Timolol maleate ophthalmic solution:
Less frequent: Tinnitus.

Nervous system disorders:
Dorzolamide hydrochloride ophthalmic solution:
Frequent: Headache.
Less frequent: Paraesthesia, dizziness.

Timolol maleate ophthalmic solution:
Frequent: Headache.
Less frequent: Depression, dizziness, syncope, nightmares, insomnia, paraesthesia, memory loss, increase in signs and symptoms of myasthenia gravis, cerebrovascular accident, decreased libido.

Cardiac disorders:
Timolol maleate ophthalmic solution:
Less frequent: Bradycardia*, palpitation, chest pain, congestive heart failure, dysrhythmia, heart block*, cerebral ischaemia, cold hands and feet, Raynaud’s phenomenon, claudication.

Vascular disorders:
Less frequent: Hypotension, oedema.

Respiratory, thoracic and mediastinal disorders:
GLAUMIDE-CO:
Less frequent: Respiratory failure.*

Dorzolamide hydrochloride ophthalmic solution:
Less frequent: Epistaxis.

Timolol maleate ophthalmic solution:
Less frequent: Dyspnoea*, cough, bronchospasm (predominantly in patients with pre-existing bronchospastic disease).

Gastro-intestinal disorders:
GLAUMIDE-CO:
Frequent: Taste perversion.

Dorzolamide hydrochloride ophthalmic solution:
Frequent: Nausea.*
Less Frequent: Dry mouth, throat irritation.

Timolol maleate ophthalmic solution:
Less frequent: Dyspepsia, nausea*, dry mouth, diarrhoea.

Skin and subcutaneous tissue disorders:
GLAUMIDE-CO:
Less frequent: Contact dermatitis.*

Dorzolamide hydrochloride ophthalmic solution:
Less frequent: Rash.

Timolol maleate ophthalmic solution:
Less frequent: Exacerbation of psoriasis or psoriasiform rash or, alopecia.

Renal and urinary disorders:
GLAUMIDE-CO:
Less frequent: Urolithiasis.

Reproductive system and breast disorders:
Timolol maleate ophthalmic solution:
Less frequent: Peyronie’s disease.

General disorders and administrative site disorders:
Dorzolamide hydrochloride ophthalmic solution:
Frequent: Fatigue/asthenia.

Timolol maleate ophthalmic solution:
Less frequent: Fatigue/asthenia.

Laboratory findings:
GLAUMIDE-CO was not associated with clinically meaningful electrolyte disturbances.

[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text](See SIDE-EFFECTS)
Overdosage of dorzolamide hydrochloride can be expected to result in electrolyte imbalances, systemic acidosis and possibly central nervous system effects.
Incidents of accidental overdosage with timolol maleate ophthalmic solution have been reported resulting in systemic effects similar to those observed with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm and cardiac arrest.
Treatment is supportive and symptomatic.
Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Studies have shown that timolol maleate does not dialyse readily.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]GLAUMIDE-CO is a slightly opalescent, nearly colourless, slightly viscous solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]Cardboard carton containing a sterile, white, 10 ml, low density polyethylene container with a sterile, white low density polyethylene under-cap dropper and a sterile, white high density polyethylene cap.
Each container contains 5 ml of GLAUMIDE-CO ophthalmic solution[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store at or below 25 °C in a well closed container.
Protect from light.
Do not remove the container from the carton until required for use.
Do not use more than 28 days after opening.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]46/15.4/0684[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]16 September 2015[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]

[vc_row][vc_column width="1/3"][vc_single_image image="2041" img_size="300x510" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]

Glaucopress®

20 mg/ml Dorzolamide

5 ml Ophthalmic Solution

S3 Reg. No. 45/15.4/1035

Package Insert

[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml of GLAUCOPRESS Ophthalmic Solution contains: dorzolamide hydrochloride equivalent to 20 mg dorzolamide base and 0,0075 % m/v benzalkonium chloride as preservative.

Other ingredients are: sodium citrate, hydroxyethyl-cellulose, mannitol, sodium
hydroxide and purified water.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15.4 Ophthalmic Preparations, other.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][vc_column_text][/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Dorzolamide hydrochloride is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.

Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In humans, carbonic anhydrase exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II) found primarily in red blood cells (RBCs) but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction i n sodium and fluid transport. The result is a reduction in intraocular pressure (IOP).

Topically applied beta-adrenergic blocking agents also reduce IOP by decreasing aqueous humor secretion but by a different mechanism of action. When dorzolamide is added to a topical beta-blocker, there is an additional reduction in IOP. This is consistent with the reported additive effects of beta-blockers and oral carbonic anhydrase inhibitors.

When topically applied, dorzolamide reaches the systemic circulation. Dorzolamide accumulates in red blood cells (RBCs) during chronic dosing as a result of selective binding to CA-II while low concentrations of free dorzolamide in the plasma is maintained. Dorzolamide forms a single N-desethyl metabolite that inhibits CA-II less potently than dorzolamide but also inhibits a less active isoenzyme (CA-I). The m etabolite also accumulates in red blood cells (RBCs) where it binds primarily to CA-I.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Dorzolamide binds moderately to plasma proteins (approximately 33 %).
Dorzolamide is primarily excreted unchanged in the urine, the metabolite is also excreted in urine. After dosing ends, dorzolamide washes out of red blood cells (RBCs) nonlinearly, resulting in a rapid decline of agent concentration initially, followed by a slower elimination phase with a half life of about 4 months.

When dorzolamide was given orally to simulate the maximum systemic exposure after long term topical ocular administration, steady state was reached within 13 weeks. At steady state, there is virtually no free dorzolamide or metabolite in plasma.

CA inhibition in red blood cells (RBCs) is less than that anticipated to be necessary for a pharmacological effect on renal function or respiration. Similar pharmacokinetic results were observed after chronic topical administration of dorzolamide. However, some elderly patients with mild to moderate renal impairment (estimated CrCl 30 – 60 ml/min) had higher metabolite concentrations in red blood cells (RBCs), but no meaningful differences in carbonic anhydrase inhibition and no clinically significant systemic side effects were directly attributable to this finding.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]GLAUCOPRESS is indicated in the treatment of elevated intra-ocular pressure in
patients with:
• ocular hypertension
• open angle glaucoma
• pseudoexfoliative glaucoma and other secondary open-angle glaucomas[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]•Hypersensitivity to dorzolamide or any of the ingredients contained in GLAUCOPRESS.
• GLAUCOPRESS has not been evaluated in patients with moderate to severe
renal impairment (i.e. creatinine clearance less than 30 ml/minute). Due to
renal excretion of dorzolamide and N-desethyldorzolamide, topical ocular use of
GLAUCOPRESS in patients with severe renal impairment is not recommended.
• GLAUCOPRESS has not been evaluated in patients with hepatic impairment, and
GLAUCOPRESS should be used with caution in such patients.
• GLAUCOPRESS has not been evaluated in patients wearing contact lenses. The
preservative in GLAUCOPRESS, benzalkonium chloride, may be absorbed by soft
contact lenses.[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]GLAUCOPRESS is a sulphonamide and topical administration can result in systemic
absorption. Thus side-effects pertaining to sulphonamides may be experienced.
These include Stevens-Johnson Syndrome, toxic epidermal necrolysis, fulminant
hepatic necrosis, agranulocytosis, aplastic anaemia and other blood dyscrasis.
Sensitisation may recur when a sulphonamide is re-administered irrespective of
the route of administration.
If signs of serious reactions or hypersensitivity occur, discontinue the use of
GLAUCOPRESS and consult your doctor.
There is a potential for an additive effect on the systemic effects of the inhibition
of carbonic anhydrase in patients taking an oral carbonic anhydrase inhibitor and
GLAUCOPRESS concurrently. Thus concurrent administration of the GLAUCOPRESS
and oral carbonic anhydrase inhibitors is not recommended (See ‘’INTERACTIONS’’).
Safety and efficacy of dorzolamide ophthalmic solution in children younger than 16
years of age has not been established.
In patients 65 years of age or older compared with younger patients, safety and
efficacy of dorzolamide were similar however the possibility of greater sensitivity of
some older patients cannot be ruled out.
In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions,
were reported with chronic administration of GLAUCOPRESS ophthalmic solution.
Some of these reactions had the clinical appearance and course of an allergictype
reaction that resolved upon discontinuation of GLAUCOPRESS therapy. If such
reactions occur, treatment with GLAUCOPRESS should be discontinued, and the
patient evaluated before restarting GLAUCOPRESS is considered.
As the possibility of adverse effects on the corneal permeability, and the danger
of disruption of the corneal epithelium with prolonged or repeated usage of
benzalkonium chloride preserved ophthalmological preparations, cannot be
excluded, regular ophthalmological examination is required. Caution should
be exercised in the use of benzalkonium chloride preserved topical medication,
such as GLAUCOPRESS, over an extended period in patients with extensive ocular
surface disease.
The management of patients with acute angle-closure glaucoma requires
therapeutic intervention in addition to ocular hypotensive agents.
Incorrect handling of ophthalmic solutions can result in bacterial contamination of
the solution and subsequent ocular infections. Thus avoid allowing the tip of the
dispensing container to come in contact with the eye or surrounding areas.
Serious damage to the eye and subsequent loss of vision may result from using
contaminated ophthalmic solutions.
GLAUCOPRESS contains mannitol, which may have a mild laxative effect.[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]Administration of eye drops may cause transient blurring of vision.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]Specific interaction studies with GLAUCOPRESS have not been performed however,
in clinical studies dorzolamide was used concomitantly with the following medicines
without evidence of adverse interactions: timolol ophthalmic solution, betaxolol
ophthalmic solution and systemic medication including ACE-Inhibitors, calcium
channel blockers, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs) and
hormones (e.g. oestrogen, insulin, thyroxine).
GLAUCOPRESS is a carbonic anhydrase inhibitor and although administered
topically, is absorbed systemically.
Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors
and have in some cases resulted in interactions (e.g. toxicity associated with highdose
salicylate therapy). Thus the potential for such interactions in patients using
GLAUCOPRESS should be considered.
When GLAUCOPRESS is used in conjunction with beta adrenergic blocking agents,
the intraocular pressure lowering effect may be additive.
Concomitant administration with oral carbonic anhydrase inhibitors is not
recommended due to the potential for an additive effect on the known systemic
effects of carbonic anhydrase inhibition.[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Pregnancy:
There are no adequate and controlled studies in pregnant women, and
GLAUCOPRESS is not recommended during pregnancy.
In rabbits given maternotoxic doses associated with metabolic acidosis greater than
or equal to 2,5 mg/kg/day, malformation of the vertebral bodies were observed.
Lactation:
It is unknown whether dorzolamide is excreted into human milk. Due to the potential
for serious adverse reactions to dorzolamide in breastfed infants, a decision should
be made whether to discontinue breastfeeding the infant or the medicine, taking
into account the importance of GLAUCOPRESS to the women.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]Benzalkonium chloride may be absorbed by soft contact lenses. Patients wearing
soft contact lenses should be instructed to wait at least 15 minutes after
instilling GLAUCOPRESS to insert soft contact lenses (See “WARNINGS AND
SPECIAL PRECAUTIONS”).[/vc_column_text][/vc_tta_section][vc_tta_section title="Recommended dosage for adults (including the elderly)" tab_id="1504698296730-b0688eef-6335"][vc_column_text]If more than one topical ophthalmic medication is
being used, the medicines should be administered at least ten minutes apart.
When used as monotherapy, the dose is one drop of GLAUCOPRESS in the affected
eye(s) three times a day.
When used as adjunctive therapy with an ophthalmic ß-adrenergic blocker, the
dose is one drop of GLAUCOPRESS in the affected eye(s) twice daily.
When substituting GLAUCOPRESS for another ophthalmic antiglaucoma agent,
discontinue the other agent after completing the proper dosing on one day, and
start the GLAUCOPRESS the next day.[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]Eye disorders:
Frequent:
Burning and stinging, blurred vision, eye itching, tearing, conjunctivitis, eyelid
inflammation, eyelid irritation.
Less frequent:
Iridocyclitis, photophobia.
Frequency unknown:
Transient myopia, superficial punctuate keratitis, eye pain and redness.
General disorders and administrative site conditions:
Frequent:
Asthenia/fatigue.

Nervous system disorders:
Frequent:
Headache.
Frequency unknown:
Dizziness, paraesthesia.

Respiratory, thoracic and mediastinal disorders:
Less frequent:
Epistaxis.
Frequency unknown:
Bronchospasm.

Gastro-intestinal disorders:
Frequent:
Bitter taste, nausea.
Hepato-biliary disorders:
Less frequent:
Fulminant hepatic necrosis.
Blood and the lymphatic system disorders:
Less frequent:
Agranulocytosis, aplastic anaemia

Skin and subcutaneous tissue disorders:
Less frequent:
Rash, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Frequency unknown:
Urticaria, pruritus.

Immune system disorder:
Frequency unknown:
Angioedema.

Renal and urinary disorders:
Less frequent:
Urolithiasis.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]Limited data is available in regard to overdosage in humans. Overdosage of
GLAUCOPRESS can be expected to result in electrolyte imbalances, systemic
acidosis and possible central nervous system effects.
Serum electrolyte levels (particularly potassium) and blood pH levels should be
monitored.
Treatment is supportive and symptomatic.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Sterile clear colourless or slightly yellowish, slightly viscous solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]Sterile Opaque, white, low density polyethylene, 5 ml dropper bottle, with white low density polyethylene capillary plugs and blue polypropylene cap in cardboard carton.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store at or below 30 °C. Protect from light. Discard the product after 30 days of
being opened.
Keep well closed. For external use only.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]45/15.4/1035[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]27 November 2014[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]

[vc_row][vc_column width="1/3"][vc_single_image image="2381" img_size="full"][/vc_column][vc_column width="2/3"][vc_column_text]

Kelopt® Ophthalmic solution

Ketorolac Tromethamine 5,0 mg/ml.

5 ml Ophthalmic Solution

S3 Reg. No. 45/15.4/1033

Package Insert

[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]KELOPT Ophthalmic Solution contains: Ketorolac Tromethamine
5,0 mg/ml.
Other ingredients are:
Disodium Phosphate Anhydrous
Monosodium Phosphate Dihydrate
Sodium Chloride
Purified Water
Preservatives: Benzalkonium Chloride 0,01 % m/v
Disodium Edetate Dihydrate 0,05 % m/v

[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A 15.4 Ophthalmic preparations, others.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][/vc_tta_section][vc_tta_section title="Pharmacodynamic Properties" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Pharmacodynamic properties:
Ketorolac tromethamine is a non-steroidal anti-inflammatory agent, demonstrating both anti-inflammatory and analgesic activity.
The mechanism of action of ketorolac tromethamine is believed to
be due to its ability to inhibit the cyclo-oxygenase enzymes, which
are essential for the biosynthesis of certain prostaglandins in the
arachidonic acid pathway.
Ketorolac tromethamine has been shown to reduce aqueous
humour concentrations of these prostaglandins (PGE2) following
topical application to the eye. Ketorolac tromethamine has no
significant effect on intraocular pressure.
Systemic administration of ketorolac tromethamine does not cause
pupil constriction.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetic Properties:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Following topical administration of one drop (0,05 ml) of 0,5 %
ketorolac tromethamine ophthalmic solution into one eye and
one drop of vehicle into the other eye, 3 times a day in 26 normal
individuals, it was noted that only some of the individuals had
a detectable amount of ketorolac in their plasma (range: 10,7 to
22,5 ng/ml) at day 10. Steady state plasma levels of about
960 ng/ml is achieved when 10 mg of ketorolac tromethamine is
administered systemically every 6 hours.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATION" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]KELOPT is indicated for the relief of inflammation following ocular surgery.[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]KELOPT is contraindicated in patients who are hypersensitive to
ketorolac tromethamine, benzalkonium chloride or any ingredient in the formulation.
There is a potential for cross-sensitivity to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). KELOPT is contraindicated in individuals who have previously exhibited sensitivities to these components (See WARNINGS AND SPECIAL PRECAUTIONS).
Pregnancy and lactation.
Safety and effectiveness of KELOPT in children have not been established.
KELOPT should not be administered while wearing soft (hydrophilic)
contact lenses.[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]Since there is potential for cross-sensitivity between KELOPT and other NSAIDs [including aspirin (acetylsalicylic acid)], KELOPT should be used with caution in patients in whom asthma, rhinitis or urticaria is precipitated by aspirin or other NSAIDs.
KELOPT may mask the usual signs of infection.
KELOPT has the potential to increase bleeding time due to interference with thrombocyte aggregation and may cause increased bleeding of ocular tissue (including hyphemas) in conjunction with ocular surgery.
KELOPT should be used with caution in patients with a known history of peptic ulceration, in patients who have bleeding tendencies or who are receiving other medication which may prolong the bleeding time.
Keratitis may result from the use of KELOPT. Continued use of KELOPT may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or cornea perforation in some susceptible patients. These events may threaten vision.

KELOPT should be immediately discontinued in patients with evidence of
corneal epithelial breakdown and these patients should be closely monitored for corneal health.
Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time, may be at increased risk for corneal adverse events which may become sight threatening.
It is therefore recommended that KELOPT be used with caution in these patients.
The use of KELOPT for more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
KELOPT may slow or delay the healing process.
Benzalkonium chloride is known to cause eye irritation and discolour soft contact lenses. Patients that wear soft contact lenses should be instructed to remove their lenses prior to using KELOPT and to wait at least 15 minutes before reinserting them (See DOSAGE AND DIRECTIONS FOR USE).
In view of KELOPT’s inherent potential to cause fluid retention, heart
failure may be precipitated in some compromised patients.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.

Caution should be exercised in the use of benzalkonium chloride
preserved topical medication over an extended period in patients with extensive ocular surface disease.[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]KELOPT may cause transient burning on instillation. Patients should
be advised not to drive or use machines unless vision is clear.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]Concomitant use with medication containing anticoagulants, coumarin- or indandione-derivatives, heparin or platelet aggregation inhibitors may increase the risk of post-operative bleeding.
Since KELOPT and topical corticosteroids slow or delay healing, concomitant use of these agents may increase the potential for healing problems.
KELOPT has been safely administered with systemic and ophthalmic medication such as carbonic anhydrase inhibitors, cycloplegics, betablockers, antibiotics, miotics and mydriatrics.

 

[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Concomitant use with medication containing anticoagulants, coumarin- or indandione-derivatives, heparin or platelet aggregation inhibitors may increase the risk of post-operative bleeding.
Since KELOPT and topical corticosteroids slow or delay healing, concomitant use of these agents may increase the potential for healing problems.
KELOPT has been safely administered with systemic and ophthalmic medication such as carbonic anhydrase inhibitors, cycloplegics, betablockers, antibiotics, miotics and mydriatrics.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]Benzalkonium chloride is known to cause eye irritation and discolour soft contact lenses. Patients that wear soft contact lenses should be instructed to remove their lenses prior to using KELOPT and to wait at least 15 minutes before reinserting them (See WARNINGS AND SPECIAL PRECAUTIONS).
The recommended dose is one drop of KELOPT into the affected eye(s) four times daily starting 24 hours before surgery and continuing post-operatively.
Post marketing experience with topical NSAIDs such as KELOPT suggest that use of these medications for more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase the risk for the occurrence and severity of corneal adverse events (See WARNINGS AND SPECIAL PRECAUTIONS).[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]Eye disorders:
Frequent:
Stinging or burning upon instillation. Minor symptoms of ocular irritation.
Superficial ocular infections, corneal infiltrates, superficial keratitis, ocular irritation, conjunctival hyperaemia, ocular inflammation, ocular pain, ocular oedema, iritis, corneal oedema.
Less frequent:
Dry eyes, corneal ulceration.
Frequency unknown:
Blurring/visual disturbances.
Corneal perforation, corneal erosion, corneal thinning and epithelial breakdown.
Immune system disorders:
Frequent:
Allergic reactions such as rash, itching, redness or swelling of the skin.
Nervous system disorders:
Frequent:
Headache.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text](See SIDE EFFECTS, WARNINGS AND SPECIAL PRECAUTIONS).
In the event of topical overdosage, flush the eye with water.
Treatment is symptomatic and supportive.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Clear, transparent, yellowish solution without suspending particles.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]KELOPT ophthalmic solution is supplied in an opaque white sterile dropper bottle with a white sterile capillary plug and white sterile cap, containing 5 ml solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store at or below 30 °C. Do not use more than 28 days after opening.
Discard any unused portion. Protect from light. Keep the container in the outer carton.

Do not refrigerate or freeze.

KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]45/15.4/1033[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng

[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]25 August 2015

® - KELOPT is a registered trademark of Actor Pharma (Pty) Ltd
1 Company Registration number: 2008/008787/07[/vc_column_text][/vc_tta_section][vc_tta_section title="Section" tab_id="1523000451982-f9eed3dd-c529"][/vc_tta_section][/vc_tta_accordion][plethora_button button_text="Patient Info Leaflet" button_link="url:http%3A%2F%2Fgen-eye.webtestsite.co.za%2Fwp-content%2Fuploads%2F2016%2F12%2FBRIMOCT-Patient-leaflet-glaucoma-gen-eye-vision-care-medication-south-africa.pdf||target:%20_blank|" button_style="btn-secondary" button_with_icon="0"][/vc_column][/vc_row]

[vc_row][vc_column width="1/3"][vc_single_image image="2016" img_size="303x500" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]

Brimoct®

2 mg/ml Brimonidine Tartrate

5 ml Ophthalmic Solution

S3 Reg. No. 45/15.4/0688

Package Insert

[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml of BRIMOCT Ophthalmic Solution contains Brimonidine Tartrate 2,0 mg

Other ingredients are: Citric Acid Monohydrate

Polyvinyl Alcohol

Purified Water

Sodium Chloride

Sodium Citrate Dihydrate

Sodium Hydroxide

Preservative: Benzalkonium Chloride 0,005 % m/v

[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15.4 Ophthalmic Preparations. Other[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][vc_column_text]Brimonidine a selective alpha-2-adrenergic receptor agonist.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Following topical administration to the eye, brimonidine tartrate, a selective alpha-2-adrenergic receptor agonist, reduces intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Peak ocular hypotensive effect occurs at two hours post-dosing. Due to its selectivity brimonidine tartrate has minimal effect on cardiovascular and pulmonary parameters.

Brimonidine has a dual mechanism of action as suggested by fluorophotometric studies done in animals and humans. It lowers intraocular pressure by reducing aqueous humour production and by increasing uveoscleral outflow.

[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]Following topical ocular administration of 0,2 % brimonidine solution, plasma concentrations peaked within 0,5 to 2,5 hours and declined with a systemic half life of approximately 2 hours. Systemic metabolism of brimonidine in humans is extensive and occurs primarily by the liver. The major route of elimination of the medicine and its metabolites is by urinary excretion.[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]BRIMOCT ophthalmic solution is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]BRIMOCT is contraindicated in patients with hypersensitivity to brimonidine tartrate, benzalkonium chloride or any other ingredient in BRIMOCT. BRIMOCT is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.

Safety and efficacy of BRIMOCT in children younger than 2 years of age have not been established. However due to potentially serious adverse central nervous system effects, including apnoea and lethargy, reported in infants treated with topical brimonidine tartrate, the use of BRIMOCT is not recommended for use in paediatric patients under the age of two.

[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]As the possibility of adverse effects on the corneal permeability, and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations, cannot be excluded, regular ophthalmological examination is required.

Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

The use of BRIMOCT may result in dry eyes and therefore should be used with caution in patients with dry eye syndrome.

Patients that use intraocular lowering medication should be routinely monitored for intraocular pressure.

Brimonidine had minimal effects on the blood pressure of patients in clinical studies however caution should be exercised in treating patients with severe cardiovascular disease.

BRIMOCT should be used with caution in patients with Raynaud’s phenomenon, cerebral or coronary insufficiency, depression, orthostatic hypotension, or thromboangiitis obliterans.

BRIMOCT ophthalmic solution has not been studied in patients with renal or hepatic impairment and therefore caution should be exercised in treating such patients.

Benzalkonium chloride may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling BRIMOCT ophthalmic solution to insert soft contact lenses. The overall difference in safety and efficacy between the elderly and other adult patients has not been observed.

BRIMOCT may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should therefore be cautioned of the potential for a decrease in mental alertness.[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]BRIMOCT may sting, burn or cause itchiness and blurred vision just after instillation. Patients should be advised to not drive, use machinery or do any activity that requires clear vision, until they are sure that they can perform such activities safely.

[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]BRIMOCT has the possibility of an additive or potentiating effect when used with CNS depressants (alcohol, sedatives, barbiturates, opiates or anaesthetics).

Caution in using concomitant medicines such as beta blockers (ophthalmic and systemic), antihypertensive and/or cardiac glycosides is advised, since alpha agonists as a class, may reduce pulse and blood pressure.

The hypotensive effects of systemic clonidine have been reported to be blunted by tricyclic antidepressants. It is not known whether the concurrent use of these agents with BRIMOCT ophthalmic solution can lead to an interference with the IOP lowering effect.

There is no information available regarding the level of circulating catecholamines after BRIMOCT administration. However, since tricyclic antidepressants may affect the metabolism and uptake of circulating amines, caution is advised in patients using these antidepressants.

[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Pregnancy:

The safety and efficacy of BRIMOCT in pregnant women have not been established.

Lactation:

It has not been established whether BRIMOCT is excreted in human milk. A decision should be made on whether to discontinue BRIMOCT or discontinue breastfeeding, taking into account the importance of the medicine to the mother.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]

Benzalkonium chloride may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling BRIMOCT ophthalmic solution to insert soft contact lenses [See “Warnings and Special precautions”].

The recommended dose is one drop of BRIMOCT in the affected eye(s) twice daily, approximately 12 hours apart.

BRIMOCT may be used concomitantly with other topical ophthalmic medicinal products to lower ocular pressure. The topical ophthalmic products should be administered at least 5 minutes apart if more than one product is being used.[/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]The most undesirable side-effects relate to the ocular system and may include

Conjunctival hyperaemia, eye pruritus. Allergic conjunctivitis.

Frequent:

Burning sensation, stinging, foreign body sensation, follicular conjunctivitis, photophobia, eye pain, eye dryness, conjunctival oedema, blepharitis, eye irritation, eye discharge, conjunctival haemorrhage.

Conjunctival folliculosis, conjunctivitis, epiphora, visual field defects, visual disturbances, worsened visual acuity, superficial punctate keratopathy, vitreous floaters.

Less frequent:

Corneal erosion.

Frequency unknown:

Iritis, miosis.

 

Nervous system disorders:

Frequent:

Headache, dizziness.

Less Frequent:

Taste perversion, somnolence in adults and infants.

 

Psychiatric disorders:

Less frequent:

Insomnia, depression, anxiety, syncope.

 

 

Vascular disorders:

Frequent:

Hypertension.

Frequency unknown:

Hypotension in adults and infants.

 

Musculoskeletal disorders:

Frequency unknown:

Hypotonia in infants.

 

Cardiac disorders:

Less frequent:

Palpitations.

Frequency unknown:

Bradycardia in adults and infants, tachycardia.

 

Immune system disorders:

Frequent:

Allergic reactions.

 

Skin and subcutaneous tissue disorders:

Frequent:

Rash. Eyelid erythema, eyelid oedema.

Frequency unknown:

Eye pruritus, vasodilation.

 

Respiratory, thoracic and mediastinal disorders:

Frequent:

Cough, dyspnoea.

Less frequent:

Nasal dryness.

Frequency unknown:

Apnoea in infants.

 

Gastrointestinal disorders:

Frequent:

Oral dryness, dyspepsia.

 

 

 

Infections and infestations:

Frequent:

Sinusitis, sinus infection, flu syndrome, bronchitis, rhinitis, pharyngitis.

 

General disorders and administration site condition:

Frequent:

Asthenia.

Frequency unknown:

Hypothermia in infants.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]Treatment, in the event of an oral overdose, includes supportive and symptomatic therapy. A patent airway should be maintained.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]Clear, transparent, yellowish solution without suspending particles.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]BRIMOCT® ophthalmic solution is supplied in an opaque white sterile dropper bottle with a white sterile capillary plug and a purple sterile cap, containing 5 ml solution. The dropper bottle is contained in an outer cardboard carton.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]Store at or below 25 oC. Keep well closed. Protect from light. Do not refrigerate.

Do not use more than 30 days after opening.

KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]45/15.4/0688[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng

[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]11 December 2014[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]

[vc_row][vc_column width="1/3"][vc_single_image image="2023" img_size="300x520" alignment="center"][/vc_column][vc_column width="2/3"][vc_column_text]

Loxoptic®

5 mg/ml (0,5 % m/v) Betaxolol

5 ml Ophthalmic Solution

S3 Reg. No. 47/15.4/0526

Package Insert

[/vc_column_text][vc_tta_accordion][vc_tta_section title="COMPOSITION" tab_id="1504694888460-f282d4a8-c0c3"][vc_column_text]Each ml contains betaxolol hydrochloride equivalent to 5 mg (0,5 % m/v) betaxolol and  0,01% m/v benzalkonium chloride as the preservative.

The other ingredients are disodium edetate, sodium chloride and water for injection.[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL CLASSIFICATION" tab_id="1504696653492-dead5ed4-53ea"][vc_column_text]A.15. 4 Ophthalmic Preparations, other[/vc_column_text][/vc_tta_section][vc_tta_section title="PHARMACOLOGICAL ACTION" tab_id="1504696784236-399cdfd2-f45c"][/vc_tta_section][vc_tta_section title="Pharmacodynamics:" tab_id="1504696941473-15b39f01-f80e"][vc_column_text]Pharmacodynamic properties:

Betaxolol hydrochloride is a cardio-selective (beta-1-adrenergic) receptor blocking agent.

When administered to the eye, betaxolol reduces elevated and normal intraocular pressure.

The mechanism of ocular  hypotensive action appears to be a reduction of aqueous production.[/vc_column_text][/vc_tta_section][vc_tta_section title="Pharmacokinetics:" tab_id="1504696941330-da539579-c4e1"][vc_column_text]

Pharmacokinetic properties:

The onset of action of betaxolol is observed within 30 minutes with a duration of 12 to 24 hours.

The maximal effect is usually detected 2 hours after topical administration to the eye. A single dose results in a 12 hour reduction in intraocular pressure. No negative effect on the blood supply to the optic nerve has been observed while on treatment with betaxolol ophthalmic solution.  Betaxolol ophthalmic solution does not produce miosis and accommodative spasm.

[/vc_column_text][/vc_tta_section][vc_tta_section title="INDICATIONS" tab_id="1504696941138-eb436d2c-d9d2"][vc_column_text]LOXOPTIC has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of:

[/vc_column_text][/vc_tta_section][vc_tta_section title="CONTRAINDICATIONS" tab_id="1504696940964-6db7aa2a-ce57"][vc_column_text]

[/vc_column_text][/vc_tta_section][vc_tta_section title="WARNINGS AND SPECIAL PRECAUTIONS" tab_id="1504696940792-b2502b16-79d9"][vc_column_text]

[/vc_column_text][/vc_tta_section][vc_tta_section title="Effects on ability to drive and use machines" tab_id="1504696940622-1618a33d-4c35"][vc_column_text]LOXOPTIC may cause dizziness, fatigue, transient ocular irritation, blurred vision and lacrimation.

Patients should be advised to exercise caution until they know how LOXOPTIC affects them.[/vc_column_text][/vc_tta_section][vc_tta_section title="INTERACTIONS" tab_id="1504696940447-93197fdb-e240"][vc_column_text]

 

INTERACTIONS

·         LOXOPTIC used alone has little or no effect on pupil size; however concurrent therapy of LOXOPTIC and epinephrine (adrenaline) has resulted in mydriasis.

·         There is a potential for additive effects resulting in hypotension and/or marked bradycardia when LOXOPTIC is administered concomitantly with oral calcium channel blockers, beta adrenergic blocking agents, anti-dysrhythmics (including amiodarone, digoxin), parasympathomimetics and catecholamine-depleting agents such as reserpines (see WARNINGS AND SPECIAL PRECAUTIONS).

·         Caution should be exercised in patients using LOXOPTIC, hypoglycaemic agents and phenothiazines concurrently.

·         Caution should be exercised in patients using concomitant adrenergic psychotropic medicines.

[/vc_column_text][/vc_tta_section][vc_tta_section title="PREGNANCY AND LACTATION" tab_id="1504696940262-98475ac1-fe09"][vc_column_text]Pregnancy:

Safety in pregnancy has not yet been established. Infants of mothers administered beta-blockers shortly before giving birth, or during labour may be born hypotonic, collapsed and hypoglycaemic.

Lactation:

LOXOPTIC is secreted in human milk therefore caution should be exercised when administering LOXOPTIC to mothers breastfeeding their babies.[/vc_column_text][/vc_tta_section][vc_tta_section title="DOSAGE AND DIRECTIONS FOR USE" tab_id="1504696939902-865da232-1a1b"][vc_column_text]The usual dose is one drop of LOXOPTIC in the affected eye(s) twice daily.

In some patients, the intraocular pressure lowering response to LOXOPTIC may require a few weeks to stabilise.

A clinical follow up should include a determination of the intraocular pressure during the first month of treatment with LOXOPTIC.  Thereafter, intraocular pressure readings should be determined on an individual basis at the judgement of the medical practitioner.

 

When substituting LOXOPTIC for another ophthalmic anti-glaucoma agent, continue the agent already used and add one drop of LOXOPTIC in the affected eye(s) twice a day. On the following day, discontinue the previous anti-glaucoma agent completely and continue with LOXOPTIC.

Due to diurnal variations of intraocular pressure in individual patients, a satisfactory response to twice a day therapy is best determined by measuring intraocular pressure at different times during the day.

 

Therapy with LOXOPTIC should be individualised. If the intraocular pressure of the patient is poorly controlled on this regimen, concurrent therapy with pilocarpine, other miotics, epinephrine (adrenaline) or systemically administered carbonic anhydrase inhibitors can be initiated.

If more than one eye drop is being used, the eye drops should be administered at least 10 minutes apart.

 

When a patient is transferred from several concomitantly administered anti-glaucoma agents individualisation is needed. The adjustment should involve one agent at a time made at intervals of not less than one week. A recommended approach is to continue the agents being used and add one drop of LOXOPTIC in the affected eye(s) twice a day. On the following day, discontinue one of the other anti-glaucoma agents. The remaining anti-glaucoma agents may be decreased or discontinued according to the patient’s response to treatment.[/vc_column_text][/vc_tta_section][vc_tta_section title="Recommended dosage for adults (including the elderly)" tab_id="1504698296730-b0688eef-6335"][vc_column_text][/vc_column_text][/vc_tta_section][vc_tta_section title="SIDE-EFFECTS" tab_id="1504696939701-d619dd3e-19b6"][vc_column_text]LOXOPTIC is absorbed into the systemic circulation and may cause similar undesirable effects as seen with systemic beta-blockers.

 

Immune system disorders:

Frequency unknown: Systemic allergic reactions including angioedema, urticaria, localised and generalised rash, pruritus.

 

Eye disorders:

Frequent: Discomfort on instillation.

Less frequent: Tearing, instances of decreased corneal sensitivity, itching sensation, corneal punctuate staining, keratitis, anisocoria, photophobia, erythema.

Frequency unknown: Blepharitis, decreased tear production and dry eyes, blurred vision, conjunctivitis, soreness, ocular irritation (burning, stinging, redness), diplopia, ptosis, corneal erosion.

 

Psychiatric disorders:

Frequency unknown: Depressive neurosis, malaise, vivid dreams and nightmares, overt psychosis, hallucinations.

 

Nervous system disorders:

Frequent: Headache.

Less frequent: Depression.

Frequency unknown: Insomnia, confusion, memory loss, syncope, cerebrovascular accident, cerebral ischaemia, increase in signs and symptoms of myasthenia gravis, dizziness, paraesthesia.

 

Metabolism and nutrition disorders:

Frequency unknown: Hypoglycaemia.

 

Cardiac disorders:

Less frequent: Marked bradycardia.

Frequency unknown: Congestive cardiac failure, chest pain, palpitations, dysrhythmia, cardiac failure, atrioventricular block, cardiac arrest, a slowed AV-conduction or increase of an existing AV-block.

 

Vascular disorders:

Frequency unknown: Exacerbation of peripheral vascular disease, Raynaud’s phenomenon (due to unopposed arteriolar sympathetic activation), severe peripheral vascular disease, peripheral gangrene, hypotension, cold and cyanotic hands and feet, oedema, exacerbation of intermittent claudication.

 

Respiratory, thoracic and mediastinal disorders:

Less frequent: Dyspnoea, asthma.

Frequency unknown:  Bronchospasm, cough.

 

Gastro-intestinal disorders:

Frequency unknown: Nausea, vomiting, diarrhoea, constipation, abdominal cramping, dysgeusia, dyspepsia, dry mouth.

 

Skin and subcutaneous tissue disorders:

Less frequent: Alopecia.

Frequency unknown: Erythema, psoriasiform rash or exacerbation of psoriasis.

 

Musculoskeletal, connective tissue and bone disorders:

Frequency unknown: Skeletal muscle weakness, myalgia.

 

Reproductive system and breast disorders:

Frequency unknown: Sexual dysfunction, impotence, decreased libido.

 

Side-effects are frequent in patients with renal decomposition.[/vc_column_text][/vc_tta_section][vc_tta_section title="KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS" tab_id="1504697656865-f242e147-a927"][vc_column_text]KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

(see SIDE EFFECTS and WARNINGS AND SPECIAL PRECAUTIONS)

The symptoms which might be expected in an overdosage of a systemically administered beta-1-adrenergic receptor blocking agent are hypotension, bradycardia, and acute cardiac failure.

A topical overdose of LOXOPTIC may be flushed from the eye(s) with warm tap water.[/vc_column_text][/vc_tta_section][vc_tta_section title="IDENTIFICATION" tab_id="1504697656470-fa82922f-13cc"][vc_column_text]LOXOPTIC ophthalmic solution is a clear, colourless solution free from visible particulate matter.[/vc_column_text][/vc_tta_section][vc_tta_section title="PRESENTATION" tab_id="1504697656056-d141d0d1-b24c"][vc_column_text]Carton containing a colourless, translucent, LDPE bottle with a white to off-white polystyrene cap.

Each bottle contains 5 ml of LOXOPTIC ophthalmic solution.[/vc_column_text][/vc_tta_section][vc_tta_section title="STORAGE INSTRUCTIONS" tab_id="1504697655670-4d98e465-bd16"][vc_column_text]

STORAGE INSTRUCTIONS

Store at or below 30 °C. Protect from light.

Do not use more than 28 days after opening.
KEEP OUT OF REACH OF CHILDREN.[/vc_column_text][/vc_tta_section][vc_tta_section title="REGISTRATION NUMBER" tab_id="1504697655304-2efb71f5-a8e6"][vc_column_text]47/15.4/0526[/vc_column_text][/vc_tta_section][vc_tta_section title="NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION" tab_id="1504697653976-4fb20b42-ff45"][vc_column_text]Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng[/vc_column_text][/vc_tta_section][vc_tta_section title="DATE OF PUBLICATION OF THIS PACKAGE INSERT" tab_id="1504697953640-4b9e076c-b7e5"][vc_column_text]26 November 2015[/vc_column_text][/vc_tta_section][/vc_tta_accordion][/vc_column][/vc_row]

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