Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
BRIMONIDINE TARTRATE
ABBVIE PTE. LTD.
S01EA05
0.20%
SOLUTION
BRIMONIDINE TARTRATE 0.2%
OPHTHALMIC
Prescription Only
ALLERGAN PHARMACEUTICALS IRELAND
ACTIVE
1998-05-27
ALPHAGAN ® BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% DESCRIPTION EACH ML CONTAINS: brimonidine tartrate 2 mg (equivalent to 1.32 mg as brimonidine free base) with: benzalkonium chloride 0.05 mg, polyvinyl alcohol 14 mg; sodium chloride; sodium citrate; citric acid and purified water. CLINICAL PHARMACOLOGY ALPHAGAN ® is a relatively selective 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. After ocular administration of a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and declined with a systemic half-life of approximately 3 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. Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. ALPHAGAN ® has the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters. In comparative clinical studies with timolol 0.5%, lasting up to one year, the IOP lowering effect of ALPHAGAN ® was approximately 4-6 mm Hg compared with approximately 6 mm Hg for timolol. Eight percent of subjects were discontinued from studies due to inadequately controlled intraocular pressure, which in 30% of these patients occurred during the first month of therapy. Approximately 20% were discontinued due to adverse experiences. INDICATIONS AND USAGE ALPHAGAN ® is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of ALPHAGAN ® ophthalmic soluti Đọc toàn bộ tài liệu