COMPOSITION: Each tablet contains 60 mg diltiazem hydrochloride.
PHARMACOLOGICAL CLASSIFICATION: A 7.1 Vasodilators, hypotensives.
PHARMACOLOGICAL ACTION: Dilatam is a calcium channel blocker which inhibits the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. The resultant pharmacological effects on the cardiovascular system include depression of mechanical contraction of myocardial and smooth muscle and depression of both impulse formation (automatically) and conduction velocity.
Dilatam dilates the coronary arteries and arterioles and therefore increases myocardial oxygen supply.
Dilatam dilates peripheral arterioles and reduces the total peripheral resistance (afterload) against which the heart works. This unloading of the heart reduces myocardial energy consumption and oxygen requirements.
Dilatam decreases sino-atrial and atrioventricular conduction and prolongs the AV node effective and functional refractory periods (ERP, FRP).
For the management of angina pectoris including Prinzmetal's variant angina.
For the treatment of mild to moderate hypertension.
CONTRA-INDICATIONS: Pregnancy and women of child bearing age.
Patients known to be hypersensitive to Dilatam.
Dilatam should not be administered to patients with decompensated cardiac insufficiency, sick sinus syndrome, conduction disturbances (sino-atrial or atrioventricular block) and bradycardia (pulse rate less than 55/min.), and hypotension (less than 90 mm Hg systolic).
Dilatam should not be administered to patients with liver and kidney impairment.
The administration of diltiazem is contra-indicated in patients with porphyria.
WARNINGS: Safe use in children has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Angina: Individualize dosage. Start with 30 mg four times daily, before meals and at bed-time, increase dosage gradually to 240 mg (given in equal divided doses three or four times daily) at 1 to 2 day intervals until optimum response is obtained. Hypertension: 60 - 120 mg three or four times a day to a maximum of 360 mg daily.
The tablets are not to be chewed.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Heartburn, gastric discomfort, nausea, dizziness, confusion, ankle oedema, headache, flushing, hypotension and gynaecomastia have been reported. Adverse effects associated with a depression of cardiac conduction include atrioventricular block, bradycardia and, less frequently, sinus arrest. Patients with sick sinus syndrome, pre-existing atrioventricular block, or bradycardia, or those taking beta-blocking agents or digitalis may be at particular risk of developing these reactions. Dilatam should be administered with caution to patients with pre-existing hypotension and probably also to those with impaired left ventricular function due to the potential negative inotropic properties of diltiazem. Transient increases in SGOT and SGPT have been observed. Dilatam should be administered with caution to patients with impairment of liver and kidney function. Hyperactivity with associated psychiatric symptoms may occur.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.
Dilatam 60 mg: A white, scored, biconvex, film-coated tablet, engraved "ABIC" on the one side.
PRESENTATION: Blister packs of 50.
STORAGE INSTRUCTIONS: Store below 25° C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
Dilatam 60 mg: X/7.1/328
NAME AND BUSINESS ADDRESS OF APPLICANT. Lennon Limited,
7 Fairclough Road,
PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 13 November 1991