Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V)
Sandoz Inc
NADOLOL
NADOLOL 20 mg
ORAL
PRESCRIPTION DRUG
Nadolol tablets USP are indicated for the long-term management of patients with angina pectoris. Nadolol tablets USP 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 class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets USP. 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 Pres
Nadolol tablets USP for oral administration are available as: 20 mg: White, round, uncoated tablets stamped SZ above and 465 below the bisect line on one side and plain on the other side and supplied as: NDC 0781-1181-92 bottles of 90 NDC 0781-1181-01 bottles of 100 NDC 0781-1181-10 bottles of 1000 40 mg: White, round, uncoated tablets stamped SZ above and 466 below the bisect line on one side and plain on the other side and supplied as: NDC 0781-1182-92 bottles of 90 NDC 0781-1182-01 bottles of 100 NDC 0781-1182-10 bottles of 1000 80 mg: White, round, uncoated tablets stamped SZ above and 467 below the bisect line on one side and plain on the other side and supplied as: NDC 0781-1183-92 bottles of 90 NDC 0781-1183-01 bottles of 100 NDC 0781-1183-10 bottles of 1000 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container as defined in the USP. 07-2013M 7394 Sandoz Inc. Princeton, NJ 08540
Abbreviated New Drug Application
NADOLOL- NADOLOL TABLET SANDOZ INC ---------- NADOLOL TABLETS USP DESCRIPTION Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(_tert_-butylamino)-3-[(5, 6, 7, 8-tetrahydro-_cis_-6, 7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula: C H NO M.W. 309.4 0 C H NO M.W. 309.40 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 tablets USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, and purified water. CLINICAL PHARMACOLOGY 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 vascular musculature, inhibiting the chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation proportionately. Nadolol tablets have no intrinsic sympathomimetic activity and, unlike some other beta-adrenergic blocking agents, nadolol has little direct myocardial depressant activity and does not have an anesthetic-like membrane-stabilizing action. Animal and human studies show that nadolol slows the sinus rate and depresses AV conduction. In dogs, only minimal amounts of nadolol were detected in the brain relative to amounts in blood Прочетете целия документ