Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
Timolol (UNII: 817W3C6175) (Timolol Anhydrous - UNII:5JKY92S7BR)
Akorn
Timolol
Timolol Anhydrous 2.5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Timolol is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree atrioventricular block, bronchial asthma or history of bronchial asthma, or severe chronic obstructive pulmonary disease, or hypersensitivity to any component of this product.
Timolol Ophthalmic Solution is a clear, colorless solution. Timolol Ophthalmic Solution 0.25% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows: STORAGE: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 TML00N Rev. 07/15
Abbreviated New Drug Application
TIMOLOL MALEATE- TIMOLOL SOLUTION/ DROPS AKORN ---------- TIMOLOL OPHTHLAMIC SOLUTION, 0.25% AND 0.5% DESCRIPTION Timolol ophthalmic solution, 0.25% and 0.5%, is a non-selective beta-adrenergic antagonist for ophthalmic use. The chemical name of the active ingredient is (S)-1-[(1,1- dimethylethyl)amino]-3-[(4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2- propanol. Timolol hemihydrate is the levo isomer. Specific rotation is [α] 405nm= -16° (C=10% as the hemihydrate form in 1N HCl). The molecular formula of timolol is Formula C H N O S and its structural formula is: Timolol (as the hemihydrate) is a white, odorless, crystalline powder which is slightly soluble in water and freely soluble in ethanol. Timolol hemihydrate is stable at room temperature. Timolol ophthalmic solution is a clear, colorless, isotonic, sterile, microbiologically preserved phosphate buffered aqueous solution. It is supplied in two dosage strengths, 0.25% and 0.5%. Each mL of Timolol 0.25% contains 2.56 mg of timolol hemihydrate equivalent to 2.5 mg Timolol. Each mL of Timolol 0.5% contains 5.12 mg of timolol hemihydrate equivalent to 5 mg timolol. Inactive ingredients: monosodium and disodium phosphate dihydrate to adjust pH (6.5 to 7.5) and water for injection, benzalkonium chloride 0.01% added as preservative. The osmolality of timolol ophthalmic solution is 260 to 320 mOsmol/kg. CLINICAL PHARMACOLOGY Timolol is a non-selective beta-adrenergic antagonist. It blocks both beta1- and beta2-adrenergic receptors. Timolol does not have significant intrinsic sympathomimetic activity, local anesthetic (membrane-stabilizing) or direct myocardial depressant activity. Timolol, when applied topically in the eye, reduces normal and elevated intraocular pressure (IOP) whether or not accompanied by glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher 25 13 24 4 3 the level of IOP, the greater the likelihood of glaucomatous visual field loss and optic nerve damage. The predomina read_full_document