Nadolol 40 MG Oral Tablet

Details

Generic Name: NADOLOL

Brand Name: Nadolol

Substance Name(s):
NADOLOL

WARNINGS

Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure.

Although beta-blockers should be avoided in overt congestive heart failure, if necessary, they can be used with caution in patients with a history of failure who are well-compensated, usually with digitalis and diuretics.

Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.

IN PATIENTS WITHOUT A HISTORY OF HEART FAILURE, continued use of beta-blockers can, in some cases, lead to cardiac failure.

Therefore, at the first sign or symptom of heart failure, the patient should be digitalized and/or treated with diuretics, and the response observed closely, or nadolol should be discontinued (gradually, if possible).

Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.

When discontinuing chronically administered nadolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored.

If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken.

Patients should be warned against interruption or discontinuation of therapy without the physician’s advice.

Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension.

Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema) PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS.

Nadolol should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.

Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Diabetes and Hypoglycemia Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia and blood pressure changes) of acute hypoglycemia.

This is especially important with labile diabetics.

Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs.

Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.

Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blockade which might precipitate a thyroid storm.

DRUG INTERACTIONS

Drug Interactions When administered concurrently, the following drugs may interact with beta-adrenergic receptor blocking agents: Anesthetics, General Exaggeration of the hypotension induced by general anesthetics (see WARNINGS, Major Surgery).

Antidiabetic Drugs (oral agents and insulin) Hypoglycemia or hyperglycemia; adjust dosage of antidiabetic drug accordingly (see WARNINGS, Diabetes and Hypoglycemia).

Catecholamine-depleting Drugs (e.g., reserpine) Additive effect; monitor closely for evidence of hypotension and/or excessive bradycardia (e.g., vertigo, syncope, postural hypotension).

Digitalis Glycosides Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate.

Concomitant use can increase the risk of bradycardia.

Response to Treatment for Anaphylactic Reaction While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic.

Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

OVERDOSAGE

Nadolol can be removed from the general circulation by hemodialysis.

In addition to gastric lavage, the following measures should be employed, as appropriate.

In determining the duration of corrective therapy, note must be taken of the long duration of the effect of nadolol.

Excessive Bradycardia Administer atropine (0.25 to 1 mg).

If there is no response to vagal blockade, administer isoproterenol cautiously.

Cardiac Failure Administer a digitalis glycoside and diuretic.

It has been reported that glucagon may also be useful in this situation.

Hypotension Administer vasopressors, e.g., epinephrine or levarterenol.

(There is evidence that epinephrine may be the drug of choice.) Bronchospasm Administer a beta2-stimulating agent and/or a theophylline derivative.

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: C17H27NO4 MW 309.40 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.

structural formula

HOW SUPPLIED

Nadolol Tablets USP, 20 mg are available as white, round tablets 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 100 tablets.

Nadolol Tablets USP, 40 mg are available as white, round tablets debossed “40” on one side, and a bisect on the other side with “Z” on the upper half and “4236” on the lower half, containing 40 mg of nadolol, USP packaged in bottles of 100 tablets.

Nadolol Tablets USP, 80 mg are available as white, round tablets debossed “80” on one side, and a bisect on the other side with “Z” on the upper half and “4237” on the lower half, containing 80 mg of nadolol, USP packaged in bottles of 100 tablets.

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 In India By: EMCURE PHARMACEUTICALS LTD.

Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev.

B 8/2013

INDICATIONS AND USAGE

Angina Pectoris Nadolol Tablets USP are indicated for the long-term management of patients with angina pectoris.

Hypertension 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 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 USP may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

BOXED WARNING

Patients should be warned against interruption or discontinuation of therapy without the physician’s advice.

Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension.

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 tablets once daily.

Dosage may be gradually increased in 40 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 or 80 mg administered once daily.

Doses up to 160 or 240 mg administered once daily may be needed.

The usefulness and safety in angina pectoris of dosage exceeding 240 mg per day have not been established.

If treatment is to be discontinued, reduce the dosage gradually over a period of one to two weeks (see WARNINGS).

Hypertension The usual initial dose is 40 mg nadolol tablets once daily, whether it is used alone or in addition to diuretic therapy.

Dosage may be gradually increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved.

The usual maintenance dose is 40 or 80 mg administered once daily.

Doses up to 240 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