CARDIZEM CD Extended-release capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US LLC

Λέξεις κλειδιά

0187-0799 0187-0795 0187-0796 0187-0797 0187-0798

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1. Description

CARDIZEM CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, ...

2. Clinical Pharmacology

The therapeutic effects of diltiazem are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. Mechanisms ...

3. Indications and Usage

CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable ...

4. Contraindications

CARDIZEM CD is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence ...

5. Warnings

Cardiac Conduction Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely ...

6.1. General

Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Laboratory parameters of renal and hepatic function should be monitored at regular intervals. In ...

6.4. Drug Interactions

Because of the potential for additive effects, slow titration is warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. There was also no mutagenic ...

6.7. Pregnancy

Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended therapeutic dose has resulted ...

6.9. Nursing Mothers

Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of CARDIZEM CD is deemed essential, an alternative method of infant feeding ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been ...

9. Overdosage

The oral LD50s in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50s in these species were 60 and 38 mg/kg, respectively. The ...

10. Dosage and Administration

Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM CD capsules at the nearest equivalent total daily dose. Higher doses of CARDIZEM CD may be needed ...

11. How Supplied

CARDIZEM CD (diltiazem hydrochloride) Extended-Release Capsules: Strength Quantity NDC Number Description 120 mg 30 count 90 count 0187-0795-30 0187-0795-42 Light turquoise blue/light ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.