Information about CARDIZEM R.R

COMPOSITION:
Each prolonged release capsule contains: Diltiazem hydrochloride 180 as pellets equivalent to Diltiazem 165.45 mg
PHARMACOLOGICAL CLASSIFICATION:
Ischemic Heart Disease drugs.
PHARMACOKINETICS:
• Absorption: After administration of 180 mg of Diltiazem formulation, a peak plasma concentration is obtained after 5.5 hours.
• Distribution: Diltiazem is 80% bound to plasma proteins.
• Excretion: The elimination half-life varies from 6 to 8 hours.
• Metabolism: Diltiazem is metabolized in liver by CYP3A4.
INDICATIONS:
Cardizem Prolonged Release Capsules is indicated for the management of angina pectoris, and management of mild to moderate hypertension.
CONTRAINDICATIONS:
• Sick sinus syndrome except in the presence of a functioning ventricular pacemaker.
• Second or third degree AV block except in the presence of a functioning ventricular pacemaker.
• Severe bradycardia (below 40 bpm).
• Decompensated cardiac failure.
• Left ventricular failure with pulmonary congestion.
• Hypersensitivity to Diltiazem or to any of the excipients.
• Concomitant use of dantrolene infusion.
• Combination with ivabradine.
• Lactation.
ADVERSE REACTIONS:
Some adverse events might be seen when using Diltiazem such as: Headache, Dizziness, Bradycardia, Atrioventricular block, Palpitations, Flushing, Constipation, Dyspepsia, Gastric pain, Nausea, Erythema, Malaise, Peripheral oedema, Heart failure, Acute hepatic injury, Severe skin reactions.
DOSAGE and ADMINISTRATION:
Adults:
Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. Although individual patients may respond to lower doses, the usual optimum dosage range in clinical trials was 240 to 360 mg/day. Higher doses up to 480 mg/day have been used with benefit in some patients especially in unstable angina.
Elderly and patients with renal and hepatic dysfunction: 
Care should be taken by monitoring of this group of patients. Where the patient is currently prescribed 180 mg /day , this dose may, by careful titration, be increased to 240 mg. The dose should not be increased if the heart rate falls below 50 beats per minute.
Children:
Diltiazem preparations are not recommended for children.
STORAGE:
Do not Store above 30°C. Store in the original package.
PACKAGE:
Carton pack of 20 Prolonged Release Capsules.