Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)
Amring Pharmaceuticals Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial 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.
Preservative-free Timolol Maleate Ophthalmic Solution USP is a clear, colorless to light yellow solution. Preservative-free Timolol Maleate Ophthalmic Solution USP, 0.25% timolol equivalent, is supplied in a clear low density polyethylene vial. Each individual unit contains 0.3 mL of solution, and is available in 2 blocks of 5 vials in a sealed aluminum pouch; six pouches per carton. NDC 69918-602-60; 0.3 mL Single-dose vials in a carton of 60. Preservative-free Timolol Maleate Ophthalmic Solution, 0.5% timolol equivalent, is supplied in a clear low density polyethylene vial. Each individual unit contains 0.3 mL of solution, and is available in 2 blocks of 5 vials in a sealed aluminum pouch; six pouches per carton. NDC 69918-601-60; 0.3 mL Single-dose vials in a carton of 60. Storage Store at room temperature, 15 to 30°C (59 to 86°F). Protect from freezing. Protect from light. Because evaporation can occur through the unprotected polyethylene unit dose vial and prolonged exposure to direct light can modify the product, the unit dose vial should be kept in the protective foil overwrap and used within one month after the foil package has been opened. Keep out of Reach of Children. Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312 www.amringusa.com The Amring Logo and the “A” Logo are trademarks of Amring Pharmaceuticals Inc. Manufactured by: Holopack Verpackungstechnik GmbH, Bahnhofstrasse 18, 74429 Sulzbach-Laufen, Germany Origin Germany Rev. 11/2021 006-00423
Abbreviated New Drug Application
TIMOPTIC IN OCUDOSE- TIMOLOL MALEATE SOLUTION AMRING PHARMACEUTICALS INC. ---------- TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP 0.25% AND 0.5% PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION in a Sterile Ophthalmic Single-Dose Vial DESCRIPTION Timolol maleate USP 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° 405 nm in 1.0N HCl (C = 5%) = -12.2° (-11.7° to - 12.5°) 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 is stable at room temperature. Timolol maleate ophthalmic solution is supplied in two formulations: timolol maleate ophthalmic solution, which contains the preservative benzalkonium chloride; and timolol maleate ophthalmic solution, the preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is 13 24 4 3 4 4 4 approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection. CLINICAL PHARMACOLOGY _Mechanism of Action_ Timolol maleate USP is a beta and beta (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, Lire le document complet