Information about CARDIZEM 60

COMPOSITION:
Each Modified Release Tablet Contains: 60 mg Diltiazem Hydrochloride.
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 Modified Release Tablets 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:
Dosages must be adjusted to each patient’s needs, starting with 60 to 120 mg twice daily. 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 480mg/day have been used with benefit in some patients especially in unstable angina. 
Elderly and patients with renal and hepatic dysfunction: 
The starting dose should be 60 mg diltiazem twice daily. If necessary, the dose may be increased gradually, but careful monitoring of this group of patients is advised. Where the patient is currently prescribed 120 mg this dose may, by careful titration, be increased to 240 mg OD, 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 30 Modified Release Tablets.