Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
BRIMONIDINE TARTRATE
ABBVIE PTE. LTD.
S01EA05
0.15% w/v
SOLUTION
BRIMONIDINE TARTRATE 0.15% w/v
OPHTHALMIC
Prescription Only
ALLERGAN SALES LLC
ACTIVE
2003-06-26
* ARTWORK IS ACTUAL SIZE * DROP NOTES AND TEMPLATE BEFORE PROCESSING * IF REQUIRED, BARCODE AND CONTROL BAR(S) WILL BE ADDED BY SUPPLIER * PERFORATION REQUIRED: NO PART NUMBER: 71816SN12 DRAWING NUMBER: 0196601 V-CODE 128C BARCODE: 4465 PAGE: 1 OF 2 DESCRIPTION ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.15% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo- 6- (2-imidazolidinylideneamino) quinoxaline L-tartrate. It is an off-white to pale yellow powder. It has a molecular weight of 442.24 as the tartrate salt, and is both soluble in water (1.5 mg/mL) and in the product vehicle (3.0 mg/mL) at pH 7.2. The structural formula is: Formula: C 11 H 10 BrN 5 •C 4 H 6 O 6 CAS Number: 59803-98-4 In solution, ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.15% has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 6.6-7.4. Each mL of ALPHAGAN® P contains: ACTIVE INGREDIENT: brimonidine tartrate 0.15% (1.5 mg/mL) PRESERVATIVE: PURITE® 0.005% (0.05mg/mL) CLINICAL PHARMACOLOGY MECHANISM OF ACTION: ALPHAGAN® P is an alpha adrenergic receptor 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. CLINICAL EVALUATIONS: Elevated IOP presents a major risk factor in glaucomatous fiel Přečtěte si celý dokument