Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
Nadolol (UNII: FEN504330V) (Nadolol - UNII:FEN504330V)
Rebel Distributors Corp
Nadolol
Nadolol 20 mg
ORAL
PRESCRIPTION DRUG
Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Nadolol tablets are indicated in the management of hypertension; they may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS ).
Nadolol Tablets USP, 20 mg are available as white, round tablet debossed “20” on one side, and a bisect on the other side with “Z” on the upper half and “4235” on the lower half, containing 20 mg of nadolol USP packaged in bottles of 30 tablets. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Iss. 6/2011 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320
Abbreviated New Drug Application
NADOLOL- NADOLOL TABLET REBEL DISTRIBUTORS CORP ---------- 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. The structural formula is: Nadolol USP is a white to off-white, practically odorless, crystalline powder. It is freely soluble in water at pH2, in alcohol, and in methanol and slightly soluble in chloroform. Nadolol USP is available for oral administration as 20 mg, 40 mg, and 80 mg tablets and contains the following inactive ingredients: citric acid, 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 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. In dogs, only minimal amounts of nadolol were detected in the brain relative to amounts in blood and other organs and tissues. Nadolol has Pročitajte cijeli dokument