INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ALPHAGAN® Purite® (Eye Drops) Ophthalmic solution

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME
(and dosage form):

ALPHAGAN® Purite® (Eye Drops) Ophthalmic solution

COMPOSITION:
Each mL contains:
Brimonidine tartrate 1,5 mg
Preservative: Purite® 0,005% m/v

PHARMACOLOGICAL CLASSIFICATION
A. 15.4 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION
Mechanism of action
Brimonidine tartrate is a selective alpha-2-adrenergic receptor agonist. Topical administration of brimonidine decreases intraocular pressure (IOP) in humans with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humour production and increasing uveoscleral outflow.
Pharmacokinetics
After ocular administration of either a 0,1% or 0,2% solution, plasma concentrations peaked within 0,5 to 2,5 hours and declined with a systemic half-life of approximately 2 hours. In humans, systemic metabolism of brimonidine is extensive. It is metabolised primarily by the liver. Urinary excretion is the major route of elimination of the medicine and its metabolites. Approximately 87% of an orally-administered radioactive dose was eliminated within 120 hours, with 74% found in the urine.

INDICATIONS
ALPHAGAN® Purite® is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

CONTRA-INDICATIONS
ALPHAGAN® Purite® is contra-indicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. It is also contra-indicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.

WARNINGS
None

INTERACTIONS
Although specific drug interaction studies have not been conducted with ALPHAGAN® Purite®, the possibility of an additive or potentiating effect with CNS-depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), anti-hypertensives and/or cardiac glycosides is advised.
Tricyclic antidepressants have been reported to blunt the hypotensive effects of systemic clonidine. It is not known whether the concurrent use of these agents with ALPHAGAN® Purite® ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. No data on the level of circulating catecholamines after ALPHAGAN® Purite®administration are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

PREGNANCY AND LACTATION
Pregnancy
There are no adequate and well-controlled studies in pregnant women. ALPHAGAN® Purite® should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Breastfeeding mothers
It is not known whether this medicine is excreted in human milk. A decision should be made whether to discontinue breastfeeding or to discontinue the medicine, taking into account the importance of the medicine to the mother.

DOSAGE AND DIRECTIONS FOR USE
The recommended dose is one drop of ALPHAGAN® Purite® in the affected eye(s) twice daily, approximately 12 hours apart.
ALPHAGAN® Purite® ophthalmic solution may be used concomitantly with other topical ophthalmic medicinalproducts to lower intraocular pressure. If more than one topical ophthalmic product is being used, the product should be administered at least 5 minutes apart.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
For each indication the frequency of adverse reactions arising from clinical experience is given as follows: Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1 000, <1/100); Rare (>1/10 000, <1/1 000); Very rare (<1/10 000).
Eye disorders
Very common (>1/10): Allergic conjunctivitis, conjunctival hyperemia, eye pruritus
Common (>1/100, <1/10): Blepharitis, burning sensation, conjunctival folliculosis, conjunctival oedema, conjunctival hemorrhage, conjunctivitis, epiphora, eye discharge, eye dryness, eye irritation, eye pain, follicular conjunctivitis, foreign body sensation, photophobia, stinging, superficial punctuate keratophy, visual disturbance, visual field defects, vitreous floaters, worsened visual acuity.
Uncommon (>1/1 000, <1/100): Corneal erosion
Nervous system disorders
Common (>1/100, <1/10): Dizziness, headache
Uncommon (>1/1 000, <1/100): Somnolence, taste perversion
Vascular disorders
Common (>1/100, <1/10): Hypertension
Psychiatric disorders
Uncommon (>1/1 000, <1/100): Insomnia
Respiratory, thoracic and mediastinal disorders
Common (>1/100, <1/10): Cough, dyspnoea
Uncommon (>1/1 000, <1/100): Nasal dryness
Gastrointestinal disorders
Common (>1/100, <1/10): Dyspepsia, oral dryness
Skin and subcutaneous tissue disorders
Common (>1/100, <1/10): Eyelid oedema, eyelid erythema, rash
Immune system disorders
Common (>1/100, <1/10): Allergic reaction
Infections and infestations
Common (>1/100, <1/10): Bronchitis, flu syndrome, pharyngitis, rhinitis, sinus infection, sinusitis
General disorders and administration site conditions
Common (>1/100, <1/10): Asthenia
The following events have been identified during post-marketing use of ALPHAGAN® Purite® ophthalmic solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ALPHAGAN® Purite®, or a combination of these factors, include: bradycardia, hypotension, iritis, miosis, skin reactions (including erythema, eyelid pruritus, rash and vasodilatation) and tachycardia. Apnoea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants receiving ALPHAGAN® Purite® ophthalmic solution.

Special precautions
General
Although ALPHAGAN® Purite® ophthalmic solution had minimal effects on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.
ALPHAGAN® Purite® has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
ALPHAGAN® Purite® should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans. Patients using IOP-lowering medication should be routinely monitored for IOP.

Information for patients
As with other alpha agonists, ALPHAGAN® Purite® may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.

Paediatric use
ALPHAGAN® Purite® is not recommended for use in paediatric patients.

Geriatric use
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
No information is available on overdosage in humans. Treatment of an oral overdose includes supportive and symptomatic therapy; a patient airway should be maintained.

IDENTIFICATION
Clear green-yellow solution, essentially free of any visible particulate matter.

PRESENTATION
ALPHAGAN® Purite®is supplied sterile in opaque teal LDPE plastic bottles and tips with purple high impact polystyrene (HIPS) caps, containing 5 mL, 10 mL or 15 mL of solution.

STORAGE INSTRUCTIONS
Store below 25ºC and protect from light. To avoid contamination of the solution keep container tightly closed. Do not touch dropper tip to any surface. Discard contents 30 days after opening the bottle. Contents are sterile if seal is intact.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER
A39/15.4/0202

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

DATE OF PUBLICATION OF THE PACKAGE INSERT
26 May 2006

Updated on this site: May 2008
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2012