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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…
Verbatim from this product's MHRA label. Tap a section to expand.
Ocular use. Recommended dosage in adults (including elderly) The recommended dose is one drop of Brimonidine tartrate in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for the use in elderly patients.
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.
If more than one topical ophthalmic medicinal product is to be used, the different medicinal product should be instilled 5-15 minutes apart. 4). 9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of Brimonidine tartrate have not been established in children.
No clinical studies have been performed in adolescents (12-17 years).
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: abnormal taste, dizziness Very rare: syncope Eye disorders Very common: - ocular irritation including allergic reactions (hyperaemia, burning and stinging, pruritis, 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 (anterior uveitis) -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 tartrate in clinical practice.
8). Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular disease. 8 for details). If allergic reactions are observed, treatment with Brimonidine tartrate should be discontinued. Delayed ocular hypersensitivity reactions have been reported with brimonidine tartrate 2 mg/ml, with some reported to be associated with an increase in IOP.
Brimonidine tartrate should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans. Brimonidine tartrate has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Contact lenses should be removed before installation and may be reinserted 15 minutes following administration. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.
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. Neonates and infants. g. tricyclic antidepressants and mianserin).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made: Not known: Eye disorders - iridocyclitis (anterior uveitis) - eyelid pruritus Skin and subcutaneous tissue disorders skin reaction including erythema, face oedema, pruritus, rash and vasodilatation.
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 Reporting 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.