Cardizem Cd Recall
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Questions & Answers
Side Effects & Adverse Reactions
1. Cardiac Conduction. CARDIZEM prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (13 of 3290 patients or 0.40%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal’s angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem. (see
2. Congestive Heart Failure. Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction 24% ± 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt). Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. Experience with the use of CARDIZEM (diltiazem hydrochloride) in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.
3. Hypotension. Decreases in blood pressure associated with CARDIZEM therapy may occasionally result in symptomatic hypotension.
4. Acute Hepatic Injury. Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to CARDIZEM is uncertain in some cases, but probable in some. (see PRECAUTIONS).
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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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 angina and angina due to coronary artery spasm.
There is currently no drug history available for this drug.
CARDIZEM® (diltiazem hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. CARDIZEM CD is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, 300 mg, or 360 mg diltiazem hydrochloride. The 120 mg, 180 mg, 240 mg, and 300 mg capsules also contain: acetyl tributyl citrate, ammonio methylcrylate copolymer dispersion, black iron oxide, castor oil, ethylcellulose, FD&C Blue #1, fumaric acid, gelatin, silicone dioxide, simethicone, starch, steraic acid, sucrose, talc, titanium dioxide and white wax. The 360 mg capsule also contains: acetyl tributyl citrate, ammonio methylcrylate copolymer dispersion, black iron oxide, diethyl phthalate, FD&C Blue #1, gelatin, povidone, simethicone, sodium lauryl sulfate, starch, sucrose, talc and titanium dioxide.
For oral administration.