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BRIMONIDINE TARTRATE is a brand name for Brimonidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension - As monotherapy in patients in whom topical beta-blocker therapy is contraindicated. - As adjunctive therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a single…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Recommended dosage in adults (including the elderly) The recommended dose is one drop of Brimonidine tartrate 2 mg/ml, eye drops, solution in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients.
4). Paediatric population No clinical studies have been performed in adolescents (12 to 17 years). 9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of Brimonidine have not been established in children aged 2 to 12 years.
Method of administration:
Brimonidine tartrate 2 mg/ml, eye drops, solution administered for Ocular Use. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute.
This should be performed immediately following the instillation of each drop. This may result in a decrease of systematic side effects and an increase in locay activity. To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface.
If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart.
The most commonly reported ADRs are oral dryness, ocular hyperaemia and burning/stinging, all occurring in 22 to 25% of patients. They are usually transient and not commonly of a severity requiring discontinuation of treatment. 5% of subjects) in clinical trials with the onset between 3 and 9 months in the majority of patients.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), not known (cannot be estimated from the available data).
Cardiac disorders Uncommon: palpitations/arrhythmias (including bradycardia and tachycardia) Nervous system disorders Very common: headache, drowsiness Common: dizziness, abnormal taste Very rare: syncope Eye disorders Very common: - ocular irritation (hyperaemia, burning and stinging, pruritus, foreign body sensation, conjunctival follicles) - blurred vision - allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic - reaction, and follicular conjunctivitis Common: - local irritation (eyelid hyperaemia and oedema, blepharitis, conjunctival oedema and discharge, ocular pain and tearing) - photophobia - corneal erosion and staining - ocular dryness - conjunctival blanching - abnormal vision - conjunctivitis Very rare: - iritis - miosis Respiratory, thoracic and mediastinal disorders Common: upper respiratory symptoms Uncommon: nasal dryness Rare: dyspnoea Gastrointestinal disorders Very common: oral dryness Common: gastrointestinal symptoms Vascular disorders Very rare: hypertension, hypotension General disorders and administration site conditions Very common: fatigue Common: asthenia Immune system disorders Uncommon: systemic allergic reactions Psychiatric disorders Uncommon: depression Very rare: insomnia The following adverse reactions have been identified during post-marketing use of Brimonidine in clinical practice.
8). Cardiac disorders Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease. ) If allergic reactions are observed, treatment with Brimonidine should be discontinued. 2%, with some reported to be associated with an increase in IOP.
Vascular disorders:
Brimonidine should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
Hepatic and renal insufficiency:
Brimonidine has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients. Benzalkonium chloride: - Brimonidine contains the preservative benzalkonium chloride. May cause eye irritation, symptoms of dry eyes, and may affect the tear film and corneal surface.
Patients should remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Patients should avoid contact with soft contact lenses. Brimonidine tartrate 2 mg/ml, eye drops, solution should be used with caution in dry eye patients and in patients where the cornea may be compromised.
Patients should be monitored in case of prolonged use.
1. 8). g. tricyclic antidepressants and mianserin).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3). In a 3-month, phase 3 study in children aged 2-7 years with glaucoma, inadequately controlled by beta-blockers, a high prevalence of somnolence (55%) was reported with Brimonidine as adjunctive treatment. In 8% of children, this was severe and led to discontinuation of treatment in 13%.
4). Reporting of suspected adverse reactions RReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.