Corgard

Name: Corgard

Dosing & Uses

Dosage Forms & Strengths

tablet

  • 20mg
  • 40mg
  • 80mg

Hypertension

40-320 mg PO qDay

Angina Pectoris

Initial 40 mg/day PO, increase gradually q 3-7Days

Doses up to 160-240mg qDay may be needed

SVT, Maintenance (Off-label)

60-160 mg/day PO

Aggressive Behavior; Upper GI Rebleed (Off-label)

40-160 mg/day PO

Migraine, Prophylaxis (Off-label)

40-80 mg PO qDay (up to 240 mg/day)

Renal Impairment

CrCl >50 mL/min: Give qDay

CrCl 31-50 mL/min: Give q24-36hr

CrCl 10-30 mL/min: Give q24-48hr

CrCl <10 mL/min: Give q40-60hr

Hepatic Impairment

Dose adjustments not necessary

Additional Information

Less effective than thiazide diuretics in black and geriatric patients

Shown to decrease mortality in hypertension and post-myocardial infarction

Other Indications & Uses

Off-label: Arrhythmias, GI bleed, hyperthyroidism, reduce IOP, SVT

Not approved

Hypertension

20-320 mg PO qDay

Angina Pectoris

Initial 20 mg/day PO, increase gradually q 3-7Days

Doses up to 160-240mg qDay may be needed

What is nadolol, and how does it work (mechanism of action)?

Nadolol is a member of a class of drugs called beta-adrenergic receptor blockers that is used for treating high blood pressure and heart pain (angina). Examples of other beta-adrenergic blockers include propanolol (Inderal, Inderal LA), atenolol (Tenormin), and timolol (Blocadren). Norepinephrine and epinephrine (adrenaline) are chemicals released within the body that attach to receptors on several types of cells, including nerves and some muscles, and changes the way the cells function, either stimulating the cells or suppressing them. Nadolol prevents norepinephrine and epinephrine from binding to beta receptors on nerves. By blocking the effect of norepinephrine and epinephrine, beta blockers reduce heart rate, reduce the force of the heart's contractions, and reduce blood pressure by relaxing the muscles surrounding the blood vessels.

Heart pain (angina) occurs when the workload of the heart requires more oxygen than the blood can supply. By slowing the heart rate and decreasing the force of contractions of the heart, nadolol reduces the demand of the heart's muscle for oxygen and thereby prevents angina. Beta blockers may cause difficulty breathing since they cause the muscles surrounding the air passages of the lung to contract, thus narrowing the air passages and making it more difficult for air to pass through . The FDA approved nadolol in 1979.

Is nadolol available as a generic drug?

GENERIC AVAILABLE: Yes

Do I need a prescription for nadolol?

Yes

What Is Nadolol (Corgard) ?

Nadolol is the generic form of the brand-name medicine Corgard, which is used to treat high blood pressure and chest pain.

This prescription medicine is also sometimes given to prevent migraine headaches. In addition, it's used to treat Parkinson's disease (a movement disorder) and irregular heartbeat.

Nadolol belongs to a class of drugs called beta-blockers. It works by relaxing blood vessels and slowing the heart rate.

The U.S. Food and Drug Administration (FDA) approved nadolol in 1979.

Nadolol Warnings

Nadolol contains a black box warning because it could cause chest pain or a heart attack if you stop taking it suddenly.

Don't stop using this medicine without first talking to your doctor. Your healthcare provider will gradually take you off nadolol.

Before you use this medicine, tell your doctor if you have, or have ever had:

  • Breathing conditions, such as bronchitis, asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD)
  • Heart failure, a heart blockage, a slow heart rate, heart disease, chest pain, or any other heart problems
  • Blood vessel problems
  • Circulation problems
  • Stroke
  • A thyroid disorder
  • Liver or kidney disease
  • Diabetes
  • Psoriasis (a skin condition)
  • Myasthenia gravis (a chronic neuromuscular disease)
  • Pheochromocytoma (a tumor on a small gland near the kidneys)
  • Depression
  • Severe allergies

Tell your healthcare provider that you're using this medicine before having any type of surgery, including a dental procedure.

If you have diabetes, this medicine may mask the symptoms of a low blood sugar episode. Monitor your blood sugar levels carefully while using nadolol.

Your doctor may recommend following a diet and exercise plan while taking nadolol. Follow these instructions carefully.

Keep all appointments with your doctor and laboratory while taking this medicine. You'll need to have your blood pressure and heart rate checked regularly.

Your doctor may also order other tests to check your body's response to this medicine.

Pregnancy and Nadolol

It's not known whether nadolol could harm an unborn baby if it's taken during pregnancy.

Tell your doctor if you're pregnant, or plan to become pregnant before using this medicine.

This drug passes into breast milk. Don't breastfeed a baby without first talking to your doctor while using nadolol.

Corgard Overview

Corgard is a prescription medication used to used to treat high blood pressure. It is also used in the long-term management of angina (chest pain). Corgard belongs to a group of drugs called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.

This medication comes in tablet form and is taken typically once a day, with or without food.

Common side effects of Corgard include tiredness, slow heart rate, and dizziness. Do not drive or operate heavy machinery until you know how Corgard affects you.

Corgard FDA Warning

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 Corgard, 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, Corgard 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 Corgard therapy abruptly even in patients treated only for hypertension.

How should I take Corgard (nadolol)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Nadolol is usually taken once per day. Follow your doctor's dosing instructions very carefully.

Do not skip doses or stop using nadolol suddenly. Stopping suddenly may make your condition worse. Follow your doctor's instructions about tapering your dose.

Your blood pressure will need to be checked often.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using nadolol.

If you need surgery, tell the surgeon ahead of time that you are using nadolol.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine 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. Keep the bottle tightly closed when not in use.

What should I avoid while taking Corgard (nadolol)?

This medicine 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.

Introduction

Nonselective β-adrenergic blocking agent (β-blocker).a b

Advice to Patients

  • Importance of taking exactly as prescribed.a

  • Importance of not interrupting or discontinuing therapy without consulting clinician.a

  • Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure or if any difficulty in breathing occurs.a

  • Importance of patient informing anesthesiologist or dentist about nadolol therapy before undergoing major surgery.a

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Uses For Corgard

Nadolol is used alone or together with other medicines (such as hydrochlorothiazide) to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Nadolol is also used to treat severe chest pain (angina) .

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

This medicine is available only with your doctor's prescription .

Before Using Corgard

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nadolol in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of nadolol in geriatric patients .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clonidine
  • Crizotinib
  • Diltiazem
  • Dronedarone
  • Epinephrine
  • Fenoldopam
  • Fingolimod
  • Indacaterol
  • Lacosamide
  • Lidocaine
  • Oxymetazoline
  • Rivastigmine
  • Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acarbose
  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Albiglutide
  • Alfuzosin
  • Alogliptin
  • Amiodarone
  • Amtolmetin Guacil
  • Arbutamine
  • Aspirin
  • Bromfenac
  • Bufexamac
  • Bunazosin
  • Canagliflozin
  • Celecoxib
  • Chlorpropamide
  • Choline Salicylate
  • Clonixin
  • Dapagliflozin
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Digitoxin
  • Digoxin
  • Dipyrone
  • Doxazosin
  • Droxicam
  • Dulaglutide
  • Empagliflozin
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Exenatide
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Glimepiride
  • Glipizide
  • Glyburide
  • Ibuprofen
  • Indomethacin
  • Insulin Aspart, Recombinant
  • Insulin Degludec
  • Insulin Detemir
  • Insulin Glargine, Recombinant
  • Insulin Glulisine
  • Insulin Human Inhaled
  • Insulin Human Isophane (NPH)
  • Insulin Human Regular
  • Insulin Lispro, Recombinant
  • Ketoprofen
  • Ketorolac
  • Linagliptin
  • Liraglutide
  • Lixisenatide
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Metformin
  • Metildigoxin
  • Mibefradil
  • Miglitol
  • Morniflumate
  • Moxisylyte
  • Nabumetone
  • Naproxen
  • Nateglinide
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenelzine
  • Phenoxybenzamine
  • Phentolamine
  • Phenylbutazone
  • Piketoprofen
  • Pioglitazone
  • Piroxicam
  • Pramlintide
  • Pranoprofen
  • Prazosin
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Repaglinide
  • Rofecoxib
  • Rosiglitazone
  • Salicylic Acid
  • Salsalate
  • Saxagliptin
  • Sitagliptin
  • Sodium Salicylate
  • St John's Wort
  • Sulindac
  • Tamsulosin
  • Tenoxicam
  • Terazosin
  • Tiaprofenic Acid
  • Tolazamide
  • Tolbutamide
  • Tolfenamic Acid
  • Tolmetin
  • Trimazosin
  • Urapidil
  • Valdecoxib
  • Vildagliptin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Green Tea

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Bradycardia (slow heartbeat) or
  • Heart block or
  • Heart failure—Should not use in patients with these conditions .
  • Blood vessel disease—Use with caution. This medicine may worsen this condition .
  • Diabetes or
  • Hyperthyroidism (overactive thyroid) or
  • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .
  • Kidney disease or—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
  • Lung disease (e.g., bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Chest pain or pressure.
  • Feeling cold.
  • Change in the way you act.
  • Change in eyesight.
  • A burning, numbness, or tingling feeling that is not normal.
  • Fever or chills.
  • Sore throat.
  • Hallucinations (seeing or hearing things that are not there).
  • Memory problems or loss.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Slow heartbeat.
  • A heartbeat that does not feel normal.
  • Any unexplained bruising or bleeding.

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.

PRINCIPAL DISPLAY PANEL - 80 mg Tablet Bottle Label

NDC 27505-102-01

US WorldMeds

Corgard®
(nadolol tablets, USP)

80 mg

100 Tablets
Rx only

Corgard 
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:27505-100
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nadolol (nadolol) nadolol 20 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 2  
starch, corn  
magnesium stearate  
cellulose, microcrystalline  
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code Corgard;20;USWM
Contains     
Packaging
# Item Code Package Description
1 NDC:27505-100-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018063 04/01/2016
Corgard 
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:27505-101
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nadolol (nadolol) nadolol 40 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 2  
starch, corn  
magnesium stearate  
cellulose, microcrystalline  
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code Corgard;40;USWM
Contains     
Packaging
# Item Code Package Description
1 NDC:27505-101-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018063 04/01/2016
Corgard 
nadolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:27505-102
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nadolol (nadolol) nadolol 80 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 2  
starch, corn  
magnesium stearate  
cellulose, microcrystalline  
povidones  
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code Corgard;80;USWM
Contains     
Packaging
# Item Code Package Description
1 NDC:27505-102-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018063 04/01/2016
Labeler - US WorldMeds, LLC (087875626)
Establishment
Name Address ID/FEI Operations
UPM Pharmaceuticals 032125469 MANUFACTURE(27505-100, 27505-101, 27505-102)
Revised: 03/2016   US WorldMeds, LLC
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