Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)
NuCare Pharmaceuticals,Inc.
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, 0.5% timolol equivalent, is supplied in a white opaque, plastic ophthalmic bottle with a controlled drop tip as follows: 2.5 mL, 5 mL, 10 mL and 15 mL. NDC 68071-1563-5 Bottle 5mL Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Protect from light. AKORN Manufactured By: Akorn, Inc. Lake Forest, IL 60045 TL00NS Rev. 08/16
Abbreviated New Drug Application
TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS NUCARE PHARMACEUTICALS,INC. ---------- TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP Rx only DESCRIPTION Timolol maleate ophthalmic solution 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 nominal 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 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: TIMOLOL MALEATE OPHTHALMIC SOLUTION, 0.25% EACH ML CONTAINS: ACTIVE: timolol maleate 3.4 mg, equivalent to 2.5 mg timolol (0.25%). INACTIVES: dibasic sodium phosphate, monobasic sodium phosphate, sodium hydroxide to adjust pH and Water for Injection, USP. The pH of the solution is approximately 7.0, and the osmolarity is 274-328 mOsm. PRESERVATIVE: benzalkonium chloride 0.1 mg (0.01%). TIMOLOL MALEATE OPHTHALMIC SOLUTION, 0.5% EACH ML CONTAINS: ACTIVE: timolol maleate 6.8 mg, equivalent to 5 mg timolol (0.5%). INACTIVES: dibasic sodium phosphate, monobasic sodium phosphate, sodium hydroxide to adjust pH and Water for Injection, USP. PRESERVATIVE: benzalkonium chloride 0.1 mg (0.01%). CLINICAL PHARMACOLOGY MECHANISM OF ACTION Timolol maleate is a beta1 and beta2 (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 outpu Lue koko asiakirja