Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)
Pacific Pharma, Inc.
TIMOLOL MALEATE
TIMOLOL ANHYDROUS 2.5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Timolol Maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol Maleate is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.
Timolol Maleate ophthalmic solution, USP is a clear, colorless to light yellow solution. Timolol Maleate ophthalmic solution, 0.25% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: Timolol Maleate ophthalmic solution, 0.5% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 60758-801-05 10 mL in 15 mL bottle NDC 60758-801-10 Storage: Store at 15˚-25˚C (59˚-77˚F). Protect from freezing. Protect from light. Revised: 0 3 /2024 Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved. PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company. PHARMACIST - DETACH AND GIVE INSTRUCTIONS TO PATIENT Please detach at the perforation to separate the patient information.
Abbreviated New Drug Application
TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS PACIFIC PHARMA, INC. ---------- TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP 0.25% AND 0.5% STERILE DESCRIPTION Timolol Maleate ophthalmic 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 nominal optical rotation of Timolol Maleate is: 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 solution is stable at room temperature. Timolol Maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of Timolol Maleate in two dosage strengths: Each mL, for ophthalmic administration, of 0.25% solution contains 2.5 mg of timolol (3.4 mg of Timolol Maleate). The pH of the solution is approximately 7.0. Each mL, for ophthalmic administration, of 0.5% solution contains 5 mg of timolol (6.8 mg of Timolol Maleate). Inactive ingredients: monobasic and dibasic sodium phosphate; hydrochloric acid and/or sodium hydroxide to adjust pH; and purified water. Benzalkonium chloride 0.01% is added as preservative. CLINICAL PHARMACOLOGY Mechanism of Action: Timolol Maleate is a beta and beta (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. 13 24 4 3 4 4 4 1 2 Beta-adrenergic receptor blockade reduces cardiac output in both healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor blockade may inhibit the stimulatory effect of the sympathetic nervous system necessary to maintain adequate cardiac function. Beta- Pročitajte cijeli dokument