Angina:
Indications for: CARDIZEM LA
Chronic stable angina.
Clinical Trials:
Angina
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In a randomized, double-blind, parallel-group, dose-response trial, the efficacy of Cardizem LA was evaluated in 311 patients with chronic stable angina. Patients were randomly assigned to receive evening doses of either placebo or Cardizem LA 180 mg, 360 mg, and 420 mg, or a morning dose of Cardizem LA 360 mg.
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All doses of Cardizem LA administered at night increased exercise tolerance when compared with placebo after 21 hours. The mean effect, placebo-subtracted, was 20 to 28 seconds for all three doses, and no dose-response was demonstrated.
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Cardizem LA 360 mg given in the morning, also improved exercise tolerance when measured 25 hours later.
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Cardizem LA had a larger effect to increase exercise tolerance at peak serum concentrations than at trough.
Adult Dosage:
Swallow whole; take at the same time each day (AM or PM). Initially 180mg once daily; adjust at 1–2 week intervals up to 360mg/day. Concomitant simvastatin: max 240mg/day.
Children Dosage:
Not established.
CARDIZEM LA 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 LA Warnings/Precautions:
CHF. Renal or hepatic impairment (monitor). Discontinue if persistent rash occurs. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
See Also:
CARDIZEM LA Classification:
Calcium channel blocker (CCB) (benzothiazepine).
CARDIZEM LA 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.
Adverse Reactions:
Edema, headache, fatigue, dizziness, asthenia, 1st-degree AV block, bradycardia, rash (may be serious); rare: hypotension, liver abnormalities.
Drug Elimination:
Renal. Half-life: 6–9hrs.
How Supplied:
LA tabs—30, 90; CD 120mg, 180mg, 240mg, 300mg—30, 90; CD 360mg—90; Tabs 30mg—100, 500; 60mg, 90mg, 120mg—100
Hypertension:
Indications for: CARDIZEM LA
Hypertension.
Clinical Trials:
Hypertension
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The efficacy of Cardizem LA at doses ranging from 120 to 540 mg once daily in the morning was evaluated in a randomized, double-blind, parallel, dose-response study which included 478 patients with essential hypertension.
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The mean reductions in diastolic blood pressure by ABPM (ambulatory blood pressure monitoring) at roughly 24 hours after the morning (4 AM to 8 AM) or evening (6 PM to 10 PM) administration (ie, the time corresponding to expected trough serum concentrations) for 120 mg, 240 mg, 360 mg, and 540 mg were –2.0, –4.4, and –8.1 mmHg, respectively, for evening doses, and for the morning dose of 360mg was –6.4 mmHg..
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In a second randomized, double-blind, parallel-group, dose-response study, 258 patients received morning doses of either placebo or Cardizem LA 120 mg, 180 mg, 300 mg, or 540 mg.
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Diastolic blood pressure measured by supine office cuff sphygmomanometer at trough (7 AM to 9 AM) decreased in an apparently linear manner over the dosage range studied.
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Group mean changes for placebo, 120 mg, 180 mg, 300 mg and 540 mg were –2.6, –1.9, –5.4, –6.1, and –8.6 mm Hg, respectively.
Adult Dosage:
Swallow whole; take at the same time each day (AM or PM). Initially 180–240mg once daily; adjust at 2-week intervals up to max 540mg/day. Concomitant simvastatin: max 240mg/day.
Children Dosage:
Not established.
CARDIZEM LA 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 LA Warnings/Precautions:
CHF. Renal or hepatic impairment (monitor). Discontinue if persistent rash occurs. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
See Also:
CARDIZEM LA Classification:
Calcium channel blocker (CCB) (benzothiazepine).
CARDIZEM LA 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.
Adverse Reactions:
Edema, headache, fatigue, dizziness, asthenia, 1st-degree AV block, bradycardia, rash (may be serious); rare: hypotension, liver abnormalities.
Drug Elimination:
Renal. Half-life: 6–9hrs.
How Supplied:
LA tabs—30, 90; CD 120mg, 180mg, 240mg, 300mg—30, 90; CD 360mg—90
