Cardizem CD 180 mg/1
diltiazem hydrochloride · CAPSULE, COATED, EXTENDED RELEASE · Bausch Health US LLC
Cardizem CD is a prescription medication containing diltiazem that is used to treat high blood pressure and certain heart conditions. It is taken by mouth as an extended-release capsule, which allows the medication to work throughout the day.
Key Facts
- Brand Name
- Cardizem CD
- Generic Name
- diltiazem hydrochloride
- NDC Code (Product)
0187-0796- Manufacturer
- Bausch Health US LLC
- Strength
- 180 mg/1
- Dosage Form
- CAPSULE, COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA020062
- Marketing Start
- 04/11/2001
Recall History
Valeant Pharmaceuticals North America LLC
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLC
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLC
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America LLC
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 angina and angina due to coronary artery spasm.
Dosage & Administration
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 in some patients. Monitor patients closely. Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose. Hypertension: Adjust dosage to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, schedule dosage adjustments accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. Angina: Dosages for the treatment of angina should be adjusted to each patient’s nee…
Warnings
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 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 ADVERSE REACTIONS ). 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 reporte…
Contraindications
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 of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
Drug Interactions
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 (see WARNINGS ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with CARDIZEM CD (see WARNINGS ). Diltiazem is both a substrate and an inhibitor of the Pg-p and cytochrome P450 3A4 enzyme system which may affect exposure to diltiazem and concomitant drugs metabolized by those pathways. Patients with renal and/or hepatic impairment may be particularly at risk of exposure changes. Anesthetics: The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, titrate anesthetics and calcium blockers slowly. Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the C max by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1…
Adverse Reactions
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 excluded from these studies. The following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving CARDIZEM CD up to 360 mg with rates in placebo patients shown for comparison. CARDIZEM CD Capsule Placebo-Controlled Angina and Hypertension Trials Combined Adverse Reactions CARDIZEM CD (n=607) Placebo (n=301) Headache 5.4% 5.0% Dizziness 3.0% 3.0% Bradycardia 3.3% 1.3% AV Block First Degree 3.3% 0.0% Edema 2.6% 1.3% Asthenia 1.8% 1.7% In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials: Cardiovascular: Congestive heart failure, palpitations, syncope, ventricular extrasystoles. Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor. Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, m…
Frequently Asked Questions
What is Cardizem CD used for?
Cardizem CD is a prescription medication containing diltiazem that is used to treat high blood pressure and certain heart conditions. It is taken by mouth as an extended-release capsule, which allows the medication to work throughout the day.
Is Cardizem CD a controlled substance?
Cardizem CD is not classified as a controlled substance by the DEA.
What is the generic name for Cardizem CD?
The generic name for Cardizem CD is diltiazem hydrochloride. There are 11 other brand versions of diltiazem hydrochloride.
What is the NDC code for Cardizem CD 180 mg/1?
The NDC (National Drug Code) for Cardizem CD 180 mg/1 is 0187-0796, listed by Bausch Health US LLC.
Other Cardizem CD Dosages
Other Diltiazem Brands
See all →- Diltiazem hydrochloride120 mg/172578-202
- Diltiazem Hydrochloride60 mg/10615-8033
- Diltiazem Hydrochloride240 mg/10904-7219
- DILTIAZEM HYDROCHLORIDE120 mg/116714-523
- Diltiazem Hydrochloride240 mg/116729-305
- Diltiazem Hydrochloride120 mg/124979-026
- Cardizem LA360 mg/10187-2049
- TIAZAC EXTENDED RELEASE180 mg/10187-2613
- Diltiazem Hydrochloride120 mg/146708-725
- Diltiazem Hydrochloride240 mg/146708-817
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)