Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)
Alembic Pharmaceuticals Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol maleate ophthalmic gel forming solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease [see WARNINGS, Obstructive Pulmonary Disease ]; (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure [see WARNINGS, Cardiac Failure ]; (7) cardiogenic shock; or (8) hypersensitivity to any component of this product. Timolol Maleate Ophthalmic Gel Forming Solution 0.25% and 0.5% Read this Instructions for Use that comes with Timolol maleate ophthalmic gel forming solution before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Important information about Timolol malea
Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent and slightly viscous solution. Timolol maleate ophthalmic gel forming solution 0.25% timolol equivalent, is supplied in a white low density polyethylene (LDPE) screw neck bottle with a white low density polyethylene (LDPE) nozzle and high density polyethylene (HDPE) yellow screw cap as follows: NDC 62332-545-05, 5 mL in a 5 mL capacity bottle. Timolol maleate ophthalmic gel forming solution 0.5% timolol equivalent, is supplied in a white low density polyethylene (LDPE) screw neck bottle with a white low density polyethylene (LDPE) nozzle and high density polyethylene (HDPE) yellow screw cap as follows: NDC 62332-546-05, 5 mL in a 5 mL capacity bottle. Storage Store at 15° to 25°C (59° to 77°F). Avoid Freezing. Protect from light. TIMOPTIC is trademark of Bausch & Lomb Incorporated or its affiliates. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA. Made in India. Manufactured by: Gland Pharma Limited Hyderabad-500 043, INDIA. Revised: 06/2021.
Abbreviated New Drug Application
TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% - TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% SOLUTION/ DROPS TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% - TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% SOLUTION/ DROPS ALEMBIC PHARMACEUTICALS INC. ---------- TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% AND 0.5% DESCRIPTION Timolol maleate ophthalmic gel forming solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(_tert_-butylamino)-3 [(4-morpholino- 1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 25° [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm Its molecular formula is C H N O S•C H O and its structural formula is: Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate ophthalmic gel forming solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Timolol maleate is a Lees het volledige document