Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
BETAXOLOL HYDROCHLORIDE (UNII: 6X97D2XT0O) (BETAXOLOL - UNII:O0ZR1R6RZ2)
KVK-TECH, INC.
BETAXOLOL HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics. Betaxolol tablets, USP is contraindicated in patients with known hypersensitivity to the drug. Betaxolol tablets, USP is contraindicated in patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see Warnings ).
Betaxolol Tablets, USP are available as follows: Betaxolol Tablets, USP 10 mg: (Each tablet contains 10 mg betaxolol HCl equivalent to 8.94 mg betaxolol) are as white, round, film-coated biconvex tablets, debossed "k" above bisect "13" on one side and plain on the other. Bottles of 100, NDC 10702-013-01 Betaxolol Tablets, USP 20 mg: (Each tablet contains 20 mg betaxolol HCl equivalent to 17.88 mg betaxolol) are as white, round, film-coated biconvex tablets, debossed "K" above "14" on one side and plain on the other. Bottles of 100, NDC 10702-014-01 Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940 ID # 006037/10 02/2024 Manufacturer’s Code: 10702
Abbreviated New Drug Application
BETAXOLOL HYDROCHLORIDE- BETAXOLOL HYDROCHLORIDE TABLET, COATED KVK-TECH, INC. ---------- BETAXOLOL TABLETS, USP DESCRIPTION: Betaxolol hydrochloride is a ß -selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol hydrochloride is chemically described as 2-propanol, 1- [4-[2-(cyclopropylmethoxy) ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It has the following chemical structure: Betaxolol hydrochloride is a water-soluble white crystalline powder with a molecular formula of C 18H 29NO 3•HCl and a molecular weight of 343.9. It is freely soluble in water, ethanol, chloroform, and methanol, and has a pKa of 9.4. The inactive ingredients are carnauba wax, hypromellose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, stearic acid and titanium dioxide. CLINICAL PHARMACOLOGY: Betaxolol is a ß -selective (cardioselective) adrenergic receptor blocking agent that has weak membrane-stabilizing activity and no intrinsic sympathomimetic (partial agonist) activity. The preferential effect on ß receptors is not absolute, however, and some inhibitory effects on ß receptors (found chiefly in the bronchial and vascular musculature) can be expected at higher doses. PHARMACOKINETICS AND METABOLISM: In man, absorption of an oral dose is complete. There is a small and consistent first-pass effect resulting in an absolute bioavailability of 89% ± 5% that is unaffected by the concomitant ingestion of food or alcohol. Mean peak blood concentrations of 21.6 ng/ml (range 16.3 to 27.9 ng/ml) are reached between 1.5 and 6 (mean about 3) hours after a single oral dose, in healthy volunteers, of 10 mg of betaxolol. Peak concentrations for 20-mg and 40-mg doses are 2 and 4 times that of a 10-mg dose and have been shown to be linear over the dose range of 5 to 40 mg. The peak to trough ratio of plasma concentrations over 24 hours is 2.7. The mean elimination Прочитать полный документ