Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 24 February 2017

Indication(s)

INDICATIONS AND USAGE Angina Pectoris CORGARD (nadolol) is indicated for the long-term management of patients with angina pectoris.

Hypertension CORGARD (nadolol) is 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 CORGARD. 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.

CORGARD (nadolol) may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

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Advisory information

contraindications
CONTRAINDICATIONS Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS).
Special warnings and precautions

PRECAUTIONS Impaired Renal Function Nadolol should be used with caution in patients with impaired renal function (see DOSAGE AND ADMINISTRATION).

Information for Patients Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of nadolol therapy without the physician 's advice.

Although cardiac failure rarely occurs in properly selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult the physician at the first sign or symptom of impending failure.

The patient should also be advised of a proper course in the event of an inadvertently missed dose.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility In chronic oral toxicologic studies (one to two years) in mice, rats, and dogs, nadolol did not produce any significant toxic effects.

In two-year oral carcinogenic studies in rats and mice, nadolol did not produce any neoplastic, preneoplastic, or non-neoplastic pathologic lesions.

In fertility and general reproductive performance studies in rats, nadolol caused no adverse effects.

Pregnancy In animal reproduction studies with nadolol, evidence of embryo - and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/ kg basis) than the maximum indicated human dose.

No teratogenic potential was observed in any of these species.

There are no adequate and well-controlled studies in pregnant women.

Nadolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Neonates whose mothers are receiving nadolol at parturition have exhibited bradycardia, hypoglycemia, and associated symptoms.

Nursing Mothers Nadolol is excreted in human milk.

Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of CORGARD (nadolol) to the mother.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Adverse reactions

ADVERSE REACTIONS Most adverse effects have been mild and transient and have rarely required withdrawal of therapy.

Cardiovascular Bradycardia with heart rates of less than 60 beats per minute occurs commonly, and heart rates below 40 beats per minute and/or symptomatic bradycardia were seen in about 2 of 100 patients.

Symptoms of peripheral vascular insufficiency, usually of the Raynaud type, have occurred in approximately 2 of 100 patients.

Cardiac failure, hypotension, and rhythm/conduction disturbances have each occurred in about 1 of 100 patients.

Single instances of first degree and third degree heart block have been reported; intensification of AV block is a known effect of beta-blockers (see also CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).

Central Nervous System Dizziness or fatigue has been reported in approximately 2 of 100 patients; paresthesias, sedation, and change in behavior have each been reported in approximately 6 of 1000 patients.

Respiratory Bronchospasm has been reported in approximately 1 of 1000 patients (see CONTRAINDICATIONS and WARNINGS).

Gastrointestinal Nausea, diarrhea, abdominal discomfort, constipation, vomiting, indigestion, anorexia, bloating, and flatulence have been reported in 1 to 5 of 1000 patients.

Miscellaneous Each of the following has been reported in 1 to 5 of 1000 patients: rash; pruritus; headache; dry mouth, eyes, or skin; impotence or decreased libido; facial swelling; weight gain; slurred speech; cough; nasal stuffiness; sweating; tinnitus; blurred vision.

Reversible alopecia has been reported infrequently.

The following adverse reactions have been reported in patients taking nadolol and/or other beta-adrenergic blocking agents, but no causal relationship to nadolol has been established.

Central Nervous System Reversible mental depression progressing to catatonia; visual disturbances; hallucinations; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability with slightly clouded sensorium, and decreased performance on neuropsychometrics.

Gastrointestinal Mesenteric arterial thrombosis; ischemic colitis; elevated liver enzymes.

Hematologic Agranulocytosis; thrombocytopenic or nonthrombocytopenic purpura.

Allergic Fever combined with aching and sore throat; laryngospasm; respiratory distress.

Miscellaneous Pemphigoid rash; hypertensive reaction in patients with pheochromocytoma; sleep disturbances; Peyronie 's disease.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with nadolol.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. CORGARD (NADOLOL) MAY BE ADMINISTERED WITHOUT REGARD TO MEALS. Angina Pectoris The usual initial dose is 40 mg CORGARD (nadolol) 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 CORGARD (nadolol) 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/1.73 m2) Dosage Interval (hours) >50 24 31-50 24-36 10-30 24-48 <10 40-60

Pregnancy and lactation
Nursing Mothers Nadolol is excreted in human milk. Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of CORGARD (nadolol) to the mother.

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.

More information

Category Value
Authorisation number NDA018063
Agency product number FEN504330V
Orphan designation No
Product NDC 27505-100,27505-101,27505-102
Date Last Revised 09-03-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 201337
Storage and handling STORAGE Store at room temperature; avoid excessive heat. Protect from light. Keep bottle tightly closed.
Marketing authorisation holder US WorldMeds, LLC
Warnings

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.