Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)
STAT RX USA LLC
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 lOP 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 sterile in a plastic bottle with a controlled drop tip in the following sizes: 5 mL bottles – Prod. No. 41107 10 mL bottles – Prod. No. 41109 15 mL bottles – Prod. No. 41111 Storage: Store between 15° – 25°C (59° – 77°F). KEEP OUT OF THE REACH OF CHILDREN. DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW (mortar and pestle symbol) IS NOT INTACT. Revised July 2008 Bausch and Lomb Incorporated Tampa, FL 33637 ©Bausch and Lomb Incorporated 9104701 (Folded) 9104601 (Flat) Prod. No. 411
Abbreviated New Drug Application
BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE SOLUTION/ DROPS STAT RX USA LLC ---------- RX ONLY 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 EACH ML CONTAINS: ACTIVE: Brimonidine tartrate: 0.2% (2 mg/mL). INACTIVES: Citric Acid, Polyvinyl Alcohol, Sodium Chloride, Sodium Citrate, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH. PRESERVATIVE ADDED: Benzalkonium Chloride (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 11 10 5 4 6 6 dose was eliminated within 120 hours, with 74% found in the urine. CLINICAL EVALUATIONS: Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of lOP, the greater the likelihood of optic nerve damage and visual field loss. Brimonidine tartrate has the action of lowering intraocular pressure with minimal effect on cardiovascular and p Pročitajte cijeli dokument