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Corgard
Overview
What is Corgard?
CORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(-butyl-amino)-3-[(5,6,7,8-tetrahydro--6,7-dihydroxy-1-naphthyl) oxy]-2-propanol. Structural formula:
Nadolol is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide.
CORGARD (nadolol) is available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: microcrystalline cellulose, colorant (FD& C Blue No. 2), corn starch, magnesium stearate, povidone (except 20 mg and 40 mg), and other ingredients.
What does Corgard look like?
What are the available doses of Corgard?
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What should I talk to my health care provider before I take Corgard?
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How should I use Corgard?
CORGARD (nadolol) is indicated for the long-term management of patients with angina pectoris.
DOSAGE MUST BE INDIVIDUALIZED. CORGARD (NADOLOL) MAY BE ADMINISTERED WITHOUT REGARD TO MEALS.
What interacts with Corgard?
Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see ).
What are the warnings of Corgard?
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).
Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after discontinuation of such therapy.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 beta 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.
What are the precautions of Corgard?
Impaired Renal Function
Nadolol should be used with caution in patients with impaired renal function (see ).
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
Antidiabetic drugs (oral agents and insulin)
Catecholamine-depleting drugs (e.g., reserpine)
Digitalis glycosides
Response to Treatment for Anaphylactic 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.
What are the side effects of Corgard?
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 , , and ).
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 and ).
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.
What should I look out for while using Corgard?
Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see ).
What might happen if I take too much Corgard?
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.
How should I store and handle Corgard?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Dispense and keep product in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet. Repackaged By:Cardinal HealthZanesville, OH 43701L49929540815CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths:20 mg tabletsNDC40 mg tabletsNDC80 mg tabletsNDCAll tablets are scored (bisect bar) and easy to break. USWM is imprinted above the bisect bar.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CORGARD (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.
CORGARD (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. CORGARD 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 CORGARD 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. CORGARD has low lipophilicity as determined by octanol/water partition coefficient, a characteristic of certain beta-blocking agents that has been correlated with the limited extent to which these agents cross the blood-brain barrier, their low concentration in the brain, and low incidence of CNS-related side effects.
In controlled clinical studies, CORGARD (nadolol) at doses of 40 to 320 mg/day has been shown to decrease both standing and supine blood pressure, the effect persisting for approximately 24 hours after dosing.
The mechanism of the antihypertensive effects of beta-adrenergic receptor blocking agents has not been established; however, factors that may be involved include (1) competitive antagonism of catecholamines at peripheral (non-CNS) adrenergic neuron sites (especially cardiac) leading to decreased cardiac output, (2) a central effect leading to reduced tonic-sympathetic nerve outflow to the periphery, and (3) suppression of renin secretion by blockade of the beta-adrenergic receptors responsible for renin release from the kidneys.
While cardiac output and arterial pressure are reduced by nadolol therapy, renal hemodynamics are stable, with preservation of renal blood flow and glomerular filtration rate.
By blocking catecholamine-induced increases in heart rate, velocity and extent of myocardial contraction, and blood pressure, CORGARD (nadolol) generally reduces the oxygen requirements of the heart at any given level of effort, making it useful for many patients in the long-term management of angina pectoris. On the other hand, nadolol can increase oxygen requirements by increasing left ventricular fiber length and end diastolic pressure, particularly in patients with heart failure.
Although beta-adrenergic receptor blockade is useful in treatment of angina and hypertension, there are also situations in which sympathetic stimulation is vital. For example, in patients with severely damaged hearts, adequate ventricular function may depend on sympathetic drive. Beta-adrenergic blockade may worsen AV block by preventing the necessary facilitating effects of sympathetic activity on conduction. Beta-adrenergic blockade results in passive bronchial constriction by interfering with endogenous adrenergic bronchodilator activity in patients subject to bronchospasm and may also interfere with exogenous bronchodilators in such patients.
Absorption of nadolol after oral dosing is variable, averaging about 30 percent. Peak serum concentrations of nadolol usually occur in three to four hours after oral administration and the presence of food in the gastrointestinal tract does not affect the rate or extent of nadolol absorption. Approximately 30 percent of the nadolol present in serum is reversibly bound to plasma protein.
Unlike many other beta-adrenergic blocking agents, nadolol is not metabolized by the liver and is excreted unchanged, principally by the kidneys.
The half-life of therapeutic doses of nadolol is about 20 to 24 hours, permitting once-daily dosage. Because nadolol is excreted predominantly in the urine, its half-life increases in renal failure (see and ). Steady-state serum concentrations of nadolol are attained in six to nine days with once-daily dosage in persons with normal renal function. Because of variable absorption and different individual responsiveness, the proper dosage must be determined by titration.
Exacerbation of angina and, in some cases, myocardial infarction and ventricular dysrhythmias have been reported after abrupt discontinuation of therapy with beta-adrenergic blocking agents in patients with coronary artery disease. Abrupt withdrawal of these agents in patients without coronary artery disease has resulted in transient symptoms, including tremulousness, sweating, palpitation, headache, and malaise. Several mechanisms have been proposed to explain these phenomena, among them increased sensitivity to catecholamines because of increased numbers of beta receptors.
Non-Clinical Toxicology
Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see ).When administered concurrently, the following drugs may interact with beta-adrenergic receptor blocking agents:
Anesthetics, general
Antidiabetic drugs (oral agents and insulin)
Catecholamine-depleting drugs (e.g., reserpine)
Digitalis glycosides
Response to Treatment for Anaphylactic Reaction
Nadolol should be used with caution in patients with impaired renal function (see ).
Most adverse effects have been mild and transient and have rarely required withdrawal of therapy.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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