ALTIAZEM TAB; diltiazem, cardiovascular agents .
ACTIVE-INGREDIENT OF ALTIAZEM TAB
Each MR tablet contains: Diltiazem hydrochloride 60 mg.
INDICATION OF ALTIAZEM TAB
Prophylaxis and treatment of angina pectoris. Treatment of mild to moderate arterial hypertension.
DOSAGE OF ALTIAZEM TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
The tablets should be swallowed whole with some water, without crushing or chewing. Adults: The usual dose is one tablet (60 mg) three times daily. However, Patient responses may vary and dosage requirments can differ significantly between individual patients. If necessary the dosage may be increased up to 360 mg/day. Higher doses, up to 480 mg/day, have been used with benefit in some patients, especially in the treatment of unstable angina. Mild to moderate arterial hypertension: Half tablet (30 mg) three times daily. Elderly patients or patients with impaired hepatic or renal function: Plasma levels of diltiazem can be increased in patients. The recommended intial dose is half tablet (30 mg) three times daily. Heart rate should be monitored regularly in these patients and the dose should not be increased if the heart rate falls below 50 beats per minute. In patients suffering from liver problems, periodical checks of liver function are recommended during treatment with Altiazem 60 mg MR Tablet. Children: Not recommended.
OVER-DOSAGE OF ALTIAZEM TAB
Experience of overdosage in man is limited, but cases of spontaneous recovery have been reported. However, it is recommended that patients with suspected overdose should be placed under observation in a cornary care unit with facilities available for treatment of any possible hypotension and conduction disturbances that may occur. Most patients suffering from overdosage of diltiazem become hypotensive within 8 hours of ingestion. With bradycardia and first to third degree atrioventricular block also developing, cardiac arrest may ensue. Hyperglycaemia is also a recognised complication. The elimination half-life of diltiazem after overdosage is estimated to be about 5.5 – 10.2 hours. If a patient presents early after overdose, gastric lavage should be performed and activated charcoal administered to reduce diltiazem absorption. Hypotension should be corrected with plasma expanders, intravenous calcium gluconate and inotropic agents (dopamine, dobutamine or isoprenaline). Symptomatic bradycardia and high grade AV block may respond to atropine, isoprenalline or occasionally cardiac pacing which may be useful if cardiac standstill occurs. Altiazem tablets are sustained release tablets and effects may be slow in onset and prolonged, therefore, monitoring should be carried out of longer periods than following overdose with immediate release dosage forms.
CONTRA-INDICATION OF ALTIAZEM TAB
Congestive heart failure, stick sinus syndrome (sinoatrial (SA) and 2nd or 3rd degree atrioventricular (AV) block), in patients without a functioning pacemaker, marked bradycardia (less than 50 beats per minute). Altiazem should not be used in pregnancy. In women of child-bearing potential or in monthers who are breast-feeding. Left ventricular failure with pulmonary stasis. Hypersensitivity to diltiazem or to any of its excipients. Altiazem like any calcium-channel blocker should not be administered concurrently with dantrolene infustion, because of the risk of ventricular fibrillation. The product product contains lactose. Patients with rare hereditary proplems of galactose intolerance, the Lapp lactose deficiency or glucose galactose matabsorption should not take this medicine.
STORAGE OF ALTIAZEM TAB
Store in a dry place at temperature not exceeding 30° C . Store in the original package. Keep container in the outer carton.
PACK OF ALTIAZEM TAB
Blisters of 10 MR tablets each. Boxes of 20 MR tablets each.
ALTIAZEM TAB MANUFACTURED BY
EGYPTIAN INT . PHARMACEUTICAL INDUSTRIES CO. E.I.P.CO. TENTH OF RAMADAN CITY , AREA B1 P.O.BOX 149 TENTH,EGYPT