Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
timolol (UNII: 817W3C6175) (timolol - UNII:817W3C6175)
Vistakon Pharmaceuticals LLC
timolol
timolol 2.5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Betimol® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Betimol® 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.
Betimol® (timolol ophthalmic solution) is a clear, colorless solution. Betimol® 0.25% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows: Betimol® 0.5% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows: Rx Only Store between 15-25°C (59-77°F). Do not freeze. Protect from light.
New Drug Application
BETIMOL- TIMOLOL SOLUTION VISTAKON PHARMACEUTICALS LLC ---------- BETIMOL (TIMOLOL OPHTHALMIC SOLUTION) 0.25%, 0.5% DESCRIPTION Betimol (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] =-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. Betimol 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 Betimol 0.25% contains 2.56 mg of timolol hemihydrate equivalent to 2.5 mg Timolol. Each mL of Betimol 0.5% contains 5.12 mg of timolol hemihydrate equivalent to 5.0 mg timolol. Inactive ingredients: monosodium and disodium phosphate dihydrate to adjust pH (6.5 - 7.5) and water for injection, benzalkonium chloride 0.01% added as preservative. The osmolality of Betimol is 260 to 320 mOsmol/kg. CLINICAL PHARMACOLOGY Timolol is a non-selective beta-adrenergic antagonist. It blocks both beta -and beta -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) ® ® 25 405nm 13 24 4 3 ® ® ® ® 1 2 whether or not accompanied by glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher the level of IOP, the greater the likelihood of glaucomatous visual field loss and optic nerve damage. The pred Đọc toàn bộ tài liệu