CORGARD Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

US WorldMeds, LLC

Λέξεις κλειδιά

27505-100 27505-101 27505-102

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1. Description

CORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butyl-amino)3[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl) ...

2. 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 ...

3. Indications and Usage

Angina Pectoris CORGARD (nadolol) is indicated for the long-term management of patients with angina pectoris. Hypertension CORGARD (nadolol) is indicated for the treatment of hypertension, to lower blood ...

4. Contraindications

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

5. 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 ...

6.1. General

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

6.2. Information for Patients

Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of nadolol therapy without the physicians advice. Although cardiac failure ...

6.4. 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 ...

6.6. 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 ...

6.7. 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 ...

6.9. 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 ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

7. 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 ...

8. Drug Abuse and Dependence

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 ...

10. 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 ...

11. How Supplied

CORGARD Tablets (Nadolol Tablets USP) are available in bottles of 100 in the following strengths: 20 mg tablets (NDC 27505-100-01), imprinted CORGARD 20 40 mg tablets (NDC 27505-101-01), imprinted CORGARD ...

12. Storage and Handling

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