Cardizem Cd

— THERAPEUTIC CATEGORIES —
  • Angina
  • Hypertension
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Cardizem Cd Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diltiazem HCl 120mg, 180mg, 240mg, 300mg, 360mg; ext-rel caps.

    Pharmacological Class

    Calcium channel blocker (CCB) (benzothiazepine).

    See Also

    How Supplied

    LA tabs—30, 90; CD 120mg, 180mg, 240mg, 300mg—30, 90; CD 360mg—90; Tabs 30mg—100, 500; 60mg, 90mg, 120mg—100

    How Supplied

    Cardizem CD Extended-Release Capsules 

    • 120 mg: Light turquoise blue/light turquoise blue capsule imprinted with “cardizem CD 120 mg” on body. Supplied in 30- and 90-count bottles.

    • 180 mg: Light blue/light turquoise blue capsule imprinted with “cardizem CD 180 mg” on body. Supplied in 30- and 90-count bottles.

    • 240 mg: Light blue/light blue capsule imprinted with “cardizem CD 240 mg” on body.  Supplied in 30- and 90-count bottles.

    • 300 mg: Light blue/light gray capsule imprinted with “cardizem CD 300 mg” on body. Supplied in 30- and 90-count bottles.

    • 360 mg: Light blue/white capsule imprinted with “cardizem CD 360 mg” on body. Supplied in a 90-count bottle.

    Storage

    • Storage conditions: 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 and temperatures above 30°C (86°F).

    Manufacturer

    Bausch Health Companies Inc.

    Mechanism of Action

    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. Diltiazem has been shown to increase exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. It has shown to be a potent dilator of coronary arteries, both epicardial and subendocardial.

    Cardizem Cd Indications

    Indications

    Vasospastic and chronic stable angina.

    Cardizem Cd Dosage and Administration

    Adult

    Initially 120–180mg once daily. Titrate over 7–14 days; usual max 480mg once daily. Concomitant simvastatin: max 240mg/day.

    Children

    Not established.

    Cardizem Cd Contraindications

    Contraindications

    Sick sinus syndrome, 2nd- or 3rd-degree AV block unless paced. Hypotension. Acute MI and pulmonary congestion documented by X-ray on admission.

    Cardizem Cd Boxed Warnings

    Not Applicable

    Cardizem Cd Warnings/Precautions

    Warnings/Precautions

    CHF. Renal or hepatic impairment (monitor). Discontinue if persistent rash occurs. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

    Warnings/Precautions

    Cardiac Conduction

    • Diltiazem prolongs AV node refractory periods without significantly prolonging sinus node recovery time except in patients with sick sinus syndrome. This may have additive effects on cardiac conduction when used with beta-blockers or digitalis.

    Congestive Heart Failure (CHF)

    • Patients with preexisting impairment of ventricular function may develop worsening of CHF.

    • Use caution when using in combination with beta-blockers among patients with impaired ventricular function.

    Hypotension

    • Decreased blood pressure with diltiazem therapy may lead to symptomatic hypotension.

    Acute Hepatic Injury

    • Significant elevations in liver enzymes such as alkaline phosphatase, LDH, AST (SGOT), ALT (SGPT) and signs of acute hepatic injury have been reported with diltiazem therapy. 

    • Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies.

    • These reactions have been transient and frequently resolved even with continued diltiazem treatment. Moreover, the reactions have typically occurred early after initiating treatment and were reversible with discontinuation of therapy.

    General

    • Monitor renal and hepatic function at regular intervals.

    • Dermatological events may be transient and may disappear despite continued use of diltiazem. Discontinue if a dermatologic reaction persists.

    Pregnancy Considerations

    • No well-controlled studies in pregnant women. Use diltiazem in pregnant women only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mother Considerations

    • Diltiazem is excreted in human milk.

    • Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or diltiazem.

    Pediatric Considerations

    • Safety and efficacy in pediatric patients have not been established.

    Geriatric Considerations

    • Use caution in elderly patients and select dose starting at the low end of the range due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Cardizem Cd Pharmacokinetics

    Absorption

    • More than 95% of drug is absorbed from the Cardizem CD formulation compared to a regimen of Cardizem tablets at steady-state.

    • Peak plasma levels of Cardizem CD 360 mg are reached between 10 and 14 hours.

    Distribution

    • 70–80% plasma protein bound.

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: 5–8hrs.

    Cardizem Cd Interactions

    Interactions

    Concomitant ivabradine, rifampin, alcohol: avoid. Caution with digoxin, β-blockers, others that may affect cardiac conduction (may lead to AV block). Monitor heart rate with concomitant clonidine. Potentiates propranolol, benzodiazepines, buspirone, cyclosporine, carbamazepine, quinidine, lovastatin, simvastatin (limit to max 10mg/day); monitor. Caution with CYP3A4 substrates, inhibitors (eg, cimetidine), or inducers. Anesthetics may potentiate cardiac depression.

    Cardizem Cd Adverse Reactions

    Adverse Reactions

    Edema, headache, fatigue, dizziness, asthenia, 1st-degree AV block, bradycardia, rash (may be serious); rare: hypotension, liver abnormalities.

    Adverse Reactions

    The most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving Cardizem CD up to 360 mg are the following: 

    • Headache (5.4%), dizziness (3.0%), bradycardia (3.3%), AV block first degree (3.3%), edema (2.6%), and asthenia 1.8%).

    The following events were reported infrequently (<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, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase, thirst, vomiting, weight increase.

    • Dermatological: Petechiae, photosensitivity, pruritus, urticaria.  

    • Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties. 

    Cardizem Cd Clinical Trials

    Clinical Trials

    Angina

    • The efficacy of Cardizem CD at doses from 60 to 480 mg once daily was evaluated in a double-blind, parallel, dose-response study.

      • Results showed that Cardizem CD increased time to termination of exercise in a linear manner over the entire dose range studied.

      • The improvement in time to termination of exercise utilizing a Bruce exercise protocol, measured at trough, for placebo, 60 mg, 120 mg, 240 mg, 360 mg, and 480 mg was 29, 40, 56, 51, 69, and 68 seconds, respectively. As doses of Cardizem CD were increased, overall angina frequency was decreased.  

    • In a double-blind study, Cardizem CD 180 mg once daily was compared to placebo in patients who were taking long-acting nitrates and/or beta-blockers.

      • Results showed a significant increase in time to termination of exercise and a significant decrease in overall angina frequency.

    Cardizem Cd Note

    Not Applicable

    Cardizem Cd Patient Counseling

    See Literature

    Cardizem Cd Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diltiazem HCl 120mg, 180mg, 240mg, 300mg, 360mg; ext-rel caps.

    Pharmacological Class

    Calcium channel blocker (CCB) (benzothiazepine).

    See Also

    How Supplied

    LA tabs—30, 90; CD 120mg, 180mg, 240mg, 300mg—30, 90; CD 360mg—90

    How Supplied

    Cardizem® LA Extended-Release Tablets

    • Cardizem® LA is supplied as capsule shaped, white film-coated tablets, debossed with “B” on one side and the diltiazem content (mg) on the other side in the following strengths: 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, 420 mg.

    • Cardizem LA is supplied in 30- and 90-count bottles for all dosage strengths.

    Storage

    • Storage conditions: 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 and temperatures above 30°C (86°F).

    Manufacturer

    Bausch Health Companies Inc.

    Mechanism of Action

    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. The antihypertensive effect of diltiazem is produced primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance.

    Cardizem Cd Indications

    Indications

    Hypertension.

    Cardizem Cd Dosage and Administration

    Adult

    Initially 180–240mg once daily; adjust at 2-week intervals. Usual range: 240–360mg once daily; usual max 480mg once daily. Concomitant simvastatin: max 240mg/day.

    Children

    Not established.

    Cardizem Cd Contraindications

    Contraindications

    Sick sinus syndrome, 2nd- or 3rd-degree AV block unless paced. Hypotension. Acute MI and pulmonary congestion documented by X-ray on admission.

    Cardizem Cd Boxed Warnings

    Not Applicable

    Cardizem Cd Warnings/Precautions

    Warnings/Precautions

    CHF. Renal or hepatic impairment (monitor). Discontinue if persistent rash occurs. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

    Warnings/Precautions

    Bradycardia or AV Block

    • May cause abnormally slow heart rates or second- or third-degree AV block.

    • Patients with sick sinus syndrome are at increased risk of bradycardia. Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction.

    Heart Failure (HF)

    • Patients with preexisting impairment of ventricular function may develop worsening of CHF.

    • Use caution when using in combination with beta-blockers among patients with impaired ventricular function.

    Acute Hepatic Injury

    • Significant elevations in liver enzymes such as alkaline phosphatase, LDH, AST (SGOT), ALT (SGPT) and signs of acute hepatic injury have been reported with diltiazem therapy. 

    • Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies.

    • These reactions have been transient and frequently resolved even with continued diltiazem treatment. Moreover, the reactions have typically occurred early after initiating treatment and were reversible with discontinuation of therapy.

    Severe Skin Reactions

    • Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and/or exfoliative dermatitis have been reported.

    Pregnancy Considerations

    • No well-controlled studies in pregnant women. Use diltiazem in pregnant women only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mother Considerations

    • Diltiazem is excreted in human milk.

    • Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or diltiazem.

    Pediatric Considerations

    • Safety and efficacy in pediatric patients have not been established.

    Geriatric Considerations

    • Use caution in elderly patients and select dose starting at the low end of the range due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Cardizem Cd Pharmacokinetics

    Absorption

    • Peak plasma levels of Cardizem LA 360 mg are reached between 11 and 18 hours.

    Distribution

    • 70–80% plasma protein bound.

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: 6–9hrs.

    Cardizem Cd Interactions

    Interactions

    Concomitant ivabradine, rifampin, alcohol: avoid. Caution with digoxin, β-blockers, others that may affect cardiac conduction (may lead to AV block). Monitor heart rate with concomitant clonidine. Potentiates propranolol, benzodiazepines, buspirone, cyclosporine, carbamazepine, quinidine, lovastatin, simvastatin (limit to max 10mg/day); monitor. Caution with CYP3A4 substrates, inhibitors (eg, cimetidine), or inducers. Anesthetics may potentiate cardiac depression.

    Cardizem Cd Adverse Reactions

    Adverse Reactions

    Edema, headache, fatigue, dizziness, asthenia, 1st-degree AV block, bradycardia, rash (may be serious); rare: hypotension, liver abnormalities.

    Adverse Reactions

    The most common adverse reactions (>2%) are:

    • lower limb edema, sinus congestion and rash in patients treated for hypertension, and lower limb edema, headache, dizziness, fatigue, bradycardia, first-degree AV block and cough in patients treated for angina. 

    The following events were reported infrequently (<1%) in angina or hypertension trials:

    • Cardiovascular: Angina, bundle branch block, palpitations, syncope, tachycardia, 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, thirst, vomiting, weight increase.

    • Dermatological: Petechiae, photosensitivity, pruritus, urticaria.  

    • Other: Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties.

    Cardizem Cd Clinical Trials

    Clinical Trials

    Hypertension

    • The efficacy of Cardizem CD at doses ranging from 90 to 540 mg once daily was evaluated in a double-blind, parallel, dose-response study. 

      • Results showed that Cardizem CD lowered supine diastolic blood pressure in an apparent linear manner over the entire dose range studied.

      • The changes in diastolic blood pressure, measured at trough, for placebo, 90 mg, 180 mg, 360 mg, and 540 mg were –2.9, –4.5, –6.1, –9.5, and –10.5 mmHg, respectively.

      • Patients who received Cardizem CD had decreased vascular resistance, increased cardiac output (due to increased stroke volume), and a slight decrease or no change in heart rate. Cardizem CD also reduced the renal and peripheral effects of angiotensin II.

    Cardizem Cd Note

    Not Applicable

    Cardizem Cd Patient Counseling

    See Literature

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