Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V)
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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, 20 mg are available as white round tablets debossed "730" on one side with break line and plain on other side, containing 20 mg of nadolol, USP packaged in bottles of 90 tablets (NDC 23155-730-09), 100 tablets (NDC 23155-730-01) and 1000 tablets (NDC 23155-730-10). Nadolol Tablets USP, 40 mg are available as white round tablets debossed "731" on one side with break line and plain on other side, containing 40 mg of nadolol, USP packaged in bottles of 90 tablets (NDC 23155-731-09), 100 tablets (NDC 23155-731-01) and 1000 tablets (NDC 23155-731-10). Nadolol Tablets USP, 80 mg are available as white round tablets debossed "732" on one side with break line and plain on other side, containing 80 mg of nadolol, USP packaged in bottles of 90 tablets (NDC 23155-732-09), 100 tablets (NDC 23155-732-01) and 1000 tablets (NDC 23155-732-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: RA CHEM PHARMA LIMITED Hyderabad - 500 076, INDIA. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 12/2019
Abbreviated New Drug Application
NADOLOL- NADOLOL TABLET HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- NADOLOL TABLETS USP RX ONLY DESCRIPTION Nadolol Tablets USP are 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. The structural formula is: Nadolol, USP is a white to off-white, practically odorless, crystalline powder. It is freely soluble in alcohol and in methanol, soluble in water at pH 2, and slightly soluble in chloroform. Nadolol Tablets USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets and contain the following inactive ingredients: citric acid anhydrous, corn starch, magnesium stearate, microcrystalline cellulose and povidone. In addition, the 80 mg tablets contain sodium starch glycolate. 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 beta1 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 has 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 th Đọc toàn bộ tài liệu