Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V)
Alembic Pharmaceuticals Limited
ORAL
PRESCRIPTION DRUG
Angina Pectoris Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol 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 class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol 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 Nationa
Nadolol Tablets, USP are available containing 20 mg, 40 mg or 80 mg of nadolol, USP. The 20 mg tablets are light blue to blue color, round biconvex uncoated tablets with “L” and “19” debossed on either side of score line on one side and plain on other side. They are available as follows: NDC 46708-402-30 bottle of 30 tablets NDC 46708-402-31 bottle of 100 tablets NDC 46708-402-91 bottle of 1000 tablets The 40 mg tablets are light blue to blue color, round biconvex uncoated tablets with “L” and “713” debossed on either side of score line on one side and plain on other side. They are available as follows: NDC 46708-403-30 bottle of 30 tablets NDC 46708-403-31 bottle of 100 tablets NDC 46708-403-91 bottle of 1000 tablets The 80 mg tablets are light blue to blue color, round biconvex uncoated tablets with “L” and “714” debossed on either side of score line on one side and plain on other side. They are available as follows: NDC 46708-404-30 bottle of 30 tablets NDC 46708-404-31 bottle of 100 tablets NDC 46708-404-91 bottle of 1000 tablets STORAGE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep bottle tightly closed. Avoid excessive heat. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Revised: 09/2021
Abbreviated New Drug Application
NADOLOL - NADOLOL TABLET ALEMBIC PHARMACEUTICALS LIMITED ---------- NADOLOL TABLETS, USP RX ONLY DESCRIPTION Nadolol, USP 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 MW 309.40 Nadolol, USP is a white to off-white powder. It is freely soluble in alcohol and in methanol, soluble in water at pH 2, slightly soluble in chloroform, in methylene chloride, in isopropyl alcohol, and in water (between pH 7 and pH 10); insoluble in acetone, in benzene, in ether, in hexane, and in trichloroethane. Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of nadolol, USP and the following inactive ingredients: povidone K-30, corn starch, microcrystalline cellulose, citric acid monohydrate, FD&C Blue No. 2 Aluminum Lake, and magnesium stearate. 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. 17 27 4 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 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 Lugege kogu dokumenti