Nadolol (Corgard)
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Nadolol (Corgard)

CORGARD
(nadolol) Tablet

DRUG DESCRIPTION

CORGARD (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. Structural formula:

CORGARD (nadolol) Structural Formula Illustration

C17H27NO4      MW 309.40

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 are the possible side effects of nadolol (Corgard)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • slow or uneven heartbeats;
  • numbness or cold feeling;
  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • hallucinations, behavior changes; or
  • nausea, upper stomach pain,...

Read All Potential Side Effects and See Pictures of Corgard »

What are the precautions when taking nadolol (Corgard)?

Before taking nadolol, tell your doctor or pharmacist if you are allergic to it; or to other beta blockers (e.g., atenolol, propranolol); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: very slow heartbeat (e.g., sinus bradycardia, second- or third-degree atrioventricular block), a certain serious heart condition (cardiogenic shock), uncontrolled severe heart failure, asthma.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe allergic reactions...

Read All Potential Precautions of Corgard »

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Angina Pectoris

CORGARD (nadolol) is indicated for the long-term management of patients with angina pectoris.

Hypertension

CORGARD (nadolol) is indicated in the management of hypertension; it may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

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/1.73m²) Dosage Interval (hours)
> 50 24
31–50 24–36
10–30 24–48
< 10 40–60

HOW SUPPLIED

CORGARD Tablets (Nadolol Tablets USP)

20 mg tablets in bottles of 100 (NDC 60793–800–01),
40 mg tablets in bottles of 100 (NDC 60793–801–01) and
80 mg tablets
in bottles of 100 (NDC 60793–802–01).

All tablets are scored (bisect bar) and easy to break. Tablet identification numbers: 20 mg, 232; 40 mg, 207; and 80 mg, 241.

Storage

Store at room temperature; avoid excessive heat. Protect from light. Keep bottle tightly closed.

February 2011. Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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.

Read the Corgard (nadolol) Side Effects Center for a complete guide to possible side effects »

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.

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

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.

PRECAUTIONS

Impaired Renal Function

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

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

Category C

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.

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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 1.0 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.

CONTRAINDICATIONS

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

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL 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 beta1 receptors located chiefly in cardiac muscle and the beta2 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. Beta2-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 PRECAUTIONS and DOSAGE AND ADMINISTRATION). 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.

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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.

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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.

Last reviewed on RxList: 7/8/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Corgard Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

NADOLOL - ORAL

(NAY-doe-lol)

WARNING: If you have chest pain (angina) or heart disease (e.g., coronary artery disease, ischemic heart disease, high blood pressure), do not stop using this drug without first consulting your doctor. Your condition may become worse when the drug is suddenly stopped. If your doctor decides you should no longer use this drug, you must gradually decrease your dose according to your doctor's instructions.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease work for the heart. Seek immediate medical attention if you develop worsening chest pain, tightness/pressure in the chest, chest pain spreading to the jaw/neck/arm, sweating, trouble breathing, or fast/irregular heartbeat.

USES: Nadolol is used alone or with other medications to treat high blood pressure (hypertension) and to prevent chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. In the management of chest pain, nadolol may also help to reduce the frequency of chest pain episodes and improve your ability to exercise.

Nadolol belongs to a class of medications called beta blockers. It works by blocking the action of certain natural substances such as adrenaline (epinephrine) on the heart and blood vessels. This results in a lowering of heart rate, blood pressure, and strain on the heart.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to protect the heart after a heart attack, treat irregular heartbeat (e.g., atrial fibrillation, atrial flutter), and prevent migraine headaches. Your doctor may also use this medication to treat other conditions.

HOW TO USE: See also the Warning section.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Your dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. This medication treats, but does not cure, high blood pressure. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Do not stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition persists or worsens (e.g., routine blood pressure readings increase).

Disclaimer

Corgard Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, weakness, and cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Tell your doctor immediately if any of the following unlikely but serious side effects occur: bluish color of the fingers/toes/nails, hair loss (reversible), mental/mood changes (e.g., depression, confusion, memory problems), numbness/tingling, decreased sexual ability, swelling of the ankles/feet, severe tiredness, vision changes, wheezing, unexplained/sudden weight gain.

Seek immediate medical attention if any of these unlikely but very serious side effects occur: chest pain, jaw/left arm pain, slow/irregular/fast heartbeat, severe dizziness/fainting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Corgard (nadolol) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking nadolol, tell your doctor or pharmacist if you are allergic to it; or to other beta blockers (e.g., atenolol, propranolol); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: very slow heartbeat (e.g., sinus bradycardia, second- or third-degree atrioventricular block), a certain serious heart condition (cardiogenic shock), uncontrolled severe heart failure, asthma.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe allergic reactions (e.g., anaphylaxis), breathing problems (e.g., COPD, emphysema), blood circulation problems (e.g., Raynaud's disease), low blood flow to the heart/brain (coronary artery disease, stroke, transient ischemic attack), diabetes, heart problems (e.g., heart failure, heart attack, valve problems), kidney disease, mental/mood disorders (e.g., depression), muscle problems (e.g., myasthenia gravis), certain skin conditions (atopy, psoriasis), overactive thyroid (hyperthyroidism), certain types of tumor (pheochromocytoma).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst or urination.

If you already have diabetes, be sure to check your blood sugar regularly. This medication may mask the fast/pounding heartbeat, nervousness and shakiness you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar such as hunger, dizziness and sweating are unaffected by this drug.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects such as dizziness while using this drug.

This medication should be used only when clearly needed during pregnancy. If used near the time of delivery, the newborn may have problems such as slow heart rate or low blood sugar. Tell your doctor immediately if you notice a slow heart rate or signs of low blood sugar (e.g., shakiness, sweating) in your newborn. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Corgard Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: arbutamine.

If you are currently using this medication, tell your doctor or pharmacist before starting nadolol.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: alpha blockers (e.g., prazosin), other beta blockers (e.g., atenolol), bronchodilators (e.g., albuterol, theophylline), calcium channel blockers (e.g., diltiazem, verapamil), clonidine, epinephrine, fenoldopam, methyldopa, nasal decongestants (e.g., phenylephrine, pseudoephedrine), neuromuscular blocking agents (e.g., tubocurarine), reserpine, "water pills" (e.g., diuretics such as furosemide).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could cause drowsiness or increase your heart rate or blood pressure. Ask your pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: very slow heartbeat, severe dizziness/fainting, loss of consciousness, severe weakness, shortness of breath.

NOTES: Do not share this medication with others.

Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Laboratory and/or medical tests (e.g., blood pressure, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Have your blood pressure and pulse checked regularly while taking this medication. It may be best to learn how to monitor your own blood pressure and pulse.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.

Corgard Patient Information Including Side Effects

Brand Names: Corgard

Generic Name: nadolol (Pronunciation: na DOE lol)

What is nadolol (Corgard)?

Nadolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Nadolol is used to treat angina (chest pain) or hypertension (high blood pressure).

Nadolol may also be used for other purposes not listed in this medication guide.

Corgard 20 mg

round, gray, imprinted with BL232, CORGARD20

Corgard 80 mg

round, blue, imprinted with CORGARD80, BL241

Nadolol 20 mg-MYL

round, yellow, imprinted with M 28

Nadolol 20 mg-TEV

round, white, imprinted with Z 4235, 20

Nadolol 40 mg-APH

round, white, imprinted with AP 2462

Nadolol 40 mg-MYL

round, yellow, imprinted with M 171

Nadolol 40 mg-TEV

round, white, imprinted with Z 4236, 40

Nadolol 80 mg-MYL

round, yellow, imprinted with M 132

Nadolol 80 mg-TEV

round, white, imprinted with Z4237, 80

What are the possible side effects of nadolol (Corgard)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • slow or uneven heartbeats;
  • numbness or cold feeling;
  • feeling like you might pass out;
  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • hallucinations, behavior changes; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness, spinning sensation;
  • tired feeling;
  • mild nausea, diarrhea, constipation, upset stomach, bloating, gas; or
  • tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Corgard (nadolol) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about nadolol (Corgard)?

Do not stop taking nadolol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need surgery, tell the surgeon ahead of time that you are using nadolol. You may need to stop using the medicine for a short time.

Nadolol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Nadolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Side Effects Centers

Corgard Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking nadolol (Corgard)?

You should not take nadolol if you are allergic to it, or if you have:

  • asthma or chronic obstructive pulmonary disease (COPD;
  • certain serious heart conditions such as"AV block" or slow heart rhythm; or
  • conditions that cause very low blood pressure.

If you have any of these other conditions, you may need a nadolol dose adjustment or special tests:

  • bronchitis, emphysema, sleep apnea, or other breathing problem;
  • congestive heart failure;
  • liver or kidney disease;
  • diabetes;
  • a thyroid disorder; or
  • pheochromocytoma (tumor of the adrenal gland).

FDA pregnancy category C. It is not known whether nadolol will harm an unborn baby. Nadolol may cause heart or lung problems in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Nadolol can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking nadolol.

How should I take nadolol (Corgard)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Your blood pressure will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Do not skip doses or stop taking nadolol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need surgery, tell the surgeon ahead of time that you are using nadolol. You may need to stop using the medicine for a short time.

Taking nadolol can make it harder for you to tell when your blood sugar is low. If you have diabetes, check your blood sugar regularly.

This medication can cause false results with certain lab tests of the urine. Tell any doctor who treats you that you are using nadolol.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Nadolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Store at room temperature away from moisture, heat, and light.

Side Effects Centers

Corgard Patient Information including If I Miss a Dose

What happens if I miss a dose (Corgard)?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Corgard)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow heart rate, extreme dizziness, or fainting.

What should I avoid while taking nadolol (Corgard)?

Nadolol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of nadolol.

What other drugs will affect nadolol (Corgard)?

Tell your doctor about all other medicines you use, especially:

  • digoxin (digitalis, Lanoxin);
  • a diuretic (water pill);
  • insulin or oral diabetes medication; or
  • reserpine.

This list is not complete and other drugs may interact with nadolol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about nadolol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.02. Revision date: 12/15/2010.

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