Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)
REMEDYREPACK INC.
OPHTHALMIC
PRESCRIPTION DRUG
Timolol maleate ophthalmic solution USP 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. The DROP-TAINER® bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER bottle, read the complete instructions carefully. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after Timolol Maleate Ophthalmic Solution. 2. Wash hands before each use. 3. Before using the medication for the first time, be sure the Safety Seal on th
Sterile timolol maleate ophthalmic solution USP is a clear, colorless solution. Timolol maleate ophthalmic solution, 0.25% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-226-05 5 mL NDC 61314-226-10 10 mL NDC 61314-226-15 15 mL Timolol maleate ophthalmic solution, 0.5% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-227-05 5 mL NDC 61314-227-10 10 mL NDC 61314-227-15 15 mL Storage : Store at room temperature 15° - 30°C (59° - 86°F). Protect from freezing. Protect from light. * BLOCADREN is a registered trademark of Merck & Co., Inc. Rx Only 340048-0604 Revised: June 2004
Abbreviated New Drug Application
TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION REMEDYREPACK INC. ---------- TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 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 optical rotation of timolol maleate is: [α] 25° 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 solution USP is stable at room temperature. Timolol maleate ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two do sage strengths: Each mL of timolol maleate ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of timolol maleate ophthalmic solution 0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH (6.5 to 7.5), 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. Beta-adrenergic receptor blockade reduces cardiac output in both healthy subjects and patients with 13 24 4 3 4 4 4 1 2 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-adrenergic receptor blockad Прочетете целия документ