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BRIMONIDINE OMNIVISION 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.
Posology Recommended dosage in adults (including the elderly) The recommended dose is one drop of Brimonidine OmniVision 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.
Method of administration 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.
If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart.
Summary of the safety profile The most commonly reported ADRs for preserved brimonidine containing eye drops 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).
Tabulated list of adverse reactions The following undesirable effects have been reported for preserved brimonidine containing eye drops and may also occur with the unpreserved Brimonidine OmniVision: 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 Not known* - iridocyclitis (anterior uveitis) - eyelid pruritus 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 Skin and subcutaneous tissue disorders Not known* skin reaction including erythema, face oedema, pruritus, rash and vasodilatation 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 *These adverse reactions have been identified during post-marketing use of preserved brimonidine containing eye drops in clinical practice.
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 OmniVision should be discontinued. Delayed ocular hypersensitivity reactions have been reported with a preserved multi- dose formulation of brimonidine eye drops, with some reported to be associated with an increase in IOP.
Brimonidine OmniVision should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans. Brimonidine OmniVision has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
8).
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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Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. 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 a preserved multi-dose formulation of brimonidine eye drops 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.
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