Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BRIMONIDINE TARTRATE
UNIMED SDN BHD
BRIMONIDINE TARTRATE
5ml mL
FDC LIMITED
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory I OBRIM EYE DROPS (Brimonidine Tartrate 0.2% w/v) COMPOSITION Brominodine Tartrate ….. 0.2% w/v (2 mg/ml) Benzalkonium Chloride Ph Eur ………0.005% w/v (0.05 mg/ml) (as preservative) DESCRIPTION Clear, greenish yellow solution. PHARMACODYNAMICS MECHANISM OF ACTION Brimonidine tartrate ophthalmic solution is an alpha-2 adrenergic agonist. It has 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 humor 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 metabolized primarily by the liver. Urinary excretion is the major route of elimination of the drug and its metabolites. Approximately 87% of an orally administered radioactive dose was eliminated within 120 hours, with 74% found in the urine. INDICATION Brimonidine Eye Drops are effective for lowering intraocular pressure in patients with chronic open- angle glaucoma or ocular hypertension. Brimonidine Eye Drops may also be used as adjunctive therapy when intraocular pressure (IOP) is not adequately controlled by a topical beta-blocking agent. There is no known cure for glaucoma. Treatment with Brimonidine Eye Drops (as with any other therapy) aims to preserve visual field through decrease of IOP. RECOMMENDED DOSE The recommended dose is one drop of Brimonidine tartrate ophthalmic solution 0.2% in the affected eye(s) two times daily. For those patients whose IOP peaks in the afternoon or need additional IOP control, an additional drop of brimonidine in the afternoon can be added. ROUTE OF ADMINISTRATION For Ocular use only. CONTRAINDICATIONS Brimonidine is contraindicated in Baca dokumen lengkap