البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)
Osmotica Pharmaceutical Corp.
OPHTHALMIC
PRESCRIPTION DRUG
Brimonidine Tartrate Ophthalmic Solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.2% diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored. Brimonidine Tartrate Ophthalmic Solution, 0.2% is contraindicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
Brimonidine Tartrate Ophthalmic Solution, 0.2% is supplied in white LDPE bottle with natural LDPE nozzle and purple HDPE cap. 5 mL in 5mL bottle NDC 42843-501-05 10 mL in 10 mL bottle NDC 42843-501-10 15 mL in 15 mL bottle NDC 42843-501-15. STORAGE: Store between 15°- 25°C (59°- 77°F). KEEP OUT OF THE REACH OF CHILDREN. Do not use if seal on the bottle is missing or broken. Rx only Manufactured by: Indoco Remedies Limited, L-32, 33, 34, Verna Industrial Area, Verna, Goa – 403722. India. Distributed by: Osmotica Pharmaceutical Corp. Wilmington, NC 28405 Revised:11/2014
Abbreviated New Drug Application
BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE SOLUTION/ DROPS OSMOTICA PHARMACEUTICAL CORP. ---------- BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.2% DESCRIPTION: Brimonidine Tartrate Ophthalmic Solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. In solution, Brimonidine Tartrate Ophthalmic Solution, 0.2% has a clear, greenish- yellow color. It has an osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6. The structural formula is C H BrN •C H O Mol. Wt. 442.24 (as the tartrate salt) Chemical Name: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. CAS Number: 59803-98-4 CONTAINS: ACTIVE: Brimonidine Tartrate 0.2% (2 mg/mL). INACTIVES: Citric Acid, Polyvinyl Alcohol, Sodium Chloride, Sodium Citrate, Water for injection, Hydrochloric acid and/or Sodium hydroxide may be added to adjust pH. PRESERVATIVES: Benzalkonium Chloride 0.005% (0.05 mg) CLINICAL PHARMACOLOGY: MECHANISM OF ACTION: Brimonidine Tartrate Ophthalmic Solution, 0.2% 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 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. 11 10 5 4 6 6 CLINICAL EVALUATIONS: 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. Brimonidine tartrate has the action of lowering intraocul اقرأ الوثيقة كاملة