NADOLOL 40 mg/1
NADOLOL · TABLET · Alembic Pharmaceuticals Inc.
NADOLOL is a tablet containing nadolol at 40 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Inc..
Key Facts
- Brand Name
- NADOLOL
- Generic Name
- NADOLOL
- NDC Code (Product)
62332-403- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 40 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211763
- Drug Class
- beta-Adrenergic Blocker [EPC]
- Marketing Start
- 06/08/2023
Recall History
Health Innovations Pharmacy, Inc
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sandoz Incorporated
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Angina Pectoris Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol. 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). Num…
Dosage & Administration
DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. NADOLOL MAY BE ADMINISTERED WITHOUT REGARD TO MEALS. Angina Pectoris The usual initial dose is 40 mg 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 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 elimin…
Warnings
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 chr…
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 ).
Drug Interactions
Drug Interactions When administered concurrently, the following drugs may interact with beta-adrenergic receptor blocking agents: Anesthetics, general exaggeration of the hypotension induced by general anesthetics (see WARNINGS: Major Surgery ). Antidiabetic drugs (oral agents and insulin) hypoglycemia or hyperglycemia; adjust dosage of antidiabetic drug accordingly (see WARNINGS: Diabetes and Hypoglycemia ). Catecholamine-depleting drugs (e.g., reserpine) additive effect; monitor closely for evidence of hypotension and/or excessive bradycardia (e.g., vertigo, syncope, postural hypotension). Digitalis glycosides Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Response to Treatment for Anaphylactic Reaction While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
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…
Frequently Asked Questions
What is NADOLOL used for?
NADOLOL contains NADOLOL. It is a tablet taken oral. Consult your doctor for specific uses.
Is NADOLOL a controlled substance?
NADOLOL is not classified as a controlled substance by the DEA.
What is the generic name for NADOLOL?
The generic name for NADOLOL is NADOLOL. There are 9 other brand versions of NADOLOL.
What is the NDC code for NADOLOL 40 mg/1?
The NDC (National Drug Code) for NADOLOL 40 mg/1 is 62332-403, listed by Alembic Pharmaceuticals Inc..