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Drug Catalog - Product Detail

NADOLOL TABS 80MG 100CT

NDC Mfr Size Str Form
50742-0180-01 INGENUS PHARMACEUTICALS 100 80MG NA
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Description
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. Its structural formula is: Nadolol, USP is a White to off-white, practically odourless, crystalline powder. It is freely soluble in Alcohol and in methanol; soluble in water at pH 2; slightly soluble in chloroform, in methylene chloride, isopropyl alcohol, and in water (between pH 7 and pH 10); insoluble in acetone, in benzene, in ether, in hexane, and in trichloroethane. Nadolol tablets, USP are available for oral administration contains 20 mg, 40 mg or 80 mg of nadolol, USP and the following inactive ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, hydroxypropyl cellulose and magnesium stearate. Structure
How Supplied
HOW SUPPLIED Nadolol Tablets, USP are available containing 20 mg, 40 mg and 80 mg The 20 mg tablets are White to off-white, round biconvex tablets, debossed with "ING" above "178" on one side and score line on other side. They are available as follows: NDC 50742-178-01 bottles of 100 tablets NDC 50742-178-10 bottles of 1000 tablets The 40 mg tablets are White to off-white, round biconvex tablets, debossed with "ING" above "179" on one side and score line on other side. They are available as follows: NDC 50742-179-01 bottles of 100 tablets NDC 50742-179-10 bottles of 1000 tablets The 80 mg tablets are White to off-white, round biconvex tablets, debossed with "ING" above "180" below the score line on one side and plain on other side. They are available as follows: NDC 50742-180-01 bottles of 100 tablets NDC 50742-180-10 bottles of 1000 tablets Store at 20 o to 25 o C (68 o F to 77 o F) [See USP Controlled Room temperature] Protect from light. Dispense in a tight, light-resistant container. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004 Issued: 06/2018
Indications & Usage
INDICATIONS AND USAGE 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 National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Dosage and Administration
DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. NADOLOL TABLETS MAY BE ADMINISTERED WITHOUT REGARD TO MEALS. Angina Pectoris The usual initial dose is 40 mg nadolol once daily. Dosage may be gradually increased in 40 mg to 80 mg increments at 3 to 7 day intervals until optimum clinical response is obtained or there is pronounced slowing of the heart rate. The usual maintenance dose is 40 mg or 80 mg administered once daily. Doses up to 160 mg or 240 mg administered once daily may be needed. The usefulness and safety in angina pectoris of dosages exceeding 240 mg per day have not been established. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 to 2 weeks (see WARNINGS ). Hypertension The usual initial dose is 40 mg nadolol once daily, whether it is used alone or in addition to diuretic therapy. Dosage may be gradually increased in 40 mg to 80 mg increments until optimum blood pressure reduction is achieved. The usual maintenance dose is 40 mg or 80 mg administered once daily. Doses up to 240 mg or 320 mg administered once daily may be needed. Dosage Adjustment in Renal Failure Absorbed nadolol is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment. The following dose intervals are recommended: Creatinine Clearance ( mL / min / 1 . 73m2 ) Dosage Interval ( hours ) > 50 24 31 to 50 24 to 36 10 to 30 24 to 48 < 10 40 to 60