Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V), BENDROFLUMETHIAZIDE (UNII: 5Q52X6ICJI) (BENDROFLUMETHIAZIDE - UNII:5Q52X6ICJI)
Impax Generics
NADOLOL
NADOLOL 40 mg
ORAL
PRESCRIPTION DRUG
Nadolol and bendroflumethiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol and bendroflumethiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Pr
Nadolol and bendroflumethiazide tablets, 40 mg/5 mg, contain 40 mg nadolol combined with 5 mg bendroflumethiazide, and are white to off-white, round, bi-convex tablets debossed with "G" bisect "531" on one side and plain on the other. Nadolol and bendroflumethiazide tablets, 80 mg/5 mg, contain 80 mg nadolol combined with 5 mg bendroflumethiazide, and are white to off-white, round, bi-convex tablets debossed with "G" bisect "532" on one side and plain on the other. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.
Abbreviated New Drug Application
NADOLOL AND BENDROFLUMETHIAZIDE- NADOLOL AND BENDROFLUMETHIAZIDE TABLET IMPAX GENERICS ---------- NADOLOL AND BENDROFLUMETHIAZIDE TABLETS, USP, 40 MG/5 MG AND 80 MG/5 MG RX ONLY DESCRIPTION Nadolol and bendroflumethiazide tablets for oral administration combine two antihypertensive agents: nadolol, a nonselective beta-adrenergic blocking agent, and bendroflumethiazide, a thiazide diuretic- antihypertensive. Each tablet contains 40 mg or 80 mg nadolol combined with 5 mg bendroflumethiazide. Inactive ingredients: croscarmellose sodium, hypromellose (type 2910), lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch and talc. NADOLOL Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol is designated chemically as 1-(_tert_-butylamino)-3-{(5,6,7,8-tetrahydro-_cis_-6,7-dihydroxy-1- naphthyl)oxy}-2-propanol. Structural formula: BENDROFLUMETHIAZIDE Bendroflumethiazide is a white crystalline powder. It is soluble in alcohol and in sodium hydroxide, and insoluble in hydrochloric acid, water, and chloroform. Bendroflumethiazide is designated chemically as 3-benzyl-3,4-dihydro-6-(trifluoromethyl)-2_H_-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide. Structural formula: CLINICAL PHARMACOLOGY NADOLOL Nadolol is a nonselective beta-adrenergic receptor blocking agent. Clinical pharmacology studies have demonstrated beta-blocking activity by showing (1) reduction in heart rate and cardiac output at rest and on exercise, (2) reduction of systolic and diastolic blood pressure at rest and on exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. Nadolol specifically competes with beta-adrenergic receptor agonists for available beta receptor sites; it inhibits both the beta receptors located chiefly in cardiac muscle and the beta receptors located chiefly in the bronchial and vas Olvassa el a teljes dokumentumot