Litizem Tablet
Diltiazem hydrochloride tablet

Presentation
Litizem   30  tablet: Each tablet contains 30 mg Diltiazem hydrochloride.
Litizem   60 tablet: Each tablet contains 60 mg Diltiazem hydrochloride.
 
Description
Diltiazem hydrochloride is a Benzothiazepine (non-dihydropyridine) type calcium channel antagonist. It inhibits the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. And thus, it has peripheral and coronary vasodilatory effect with some negative Inotropic action. Diltiazem inhibit cardiac conduction particularly sinoatrial and atrioventricular. Diltiazem has the following actions:
 
Antihypertensive: Relaxes vascular smooth muscle and the resultant decrease in peripheral resistance.
 
Antianginal: Diltiazem produces relaxation of coronary vascular smooth muscle and dilation of both large and small coronary artery, improves oxygen supply to myocardial tissue. It also relaxes vascular smooth muscle and the resultant, decrease in peripheral resistance, decrease cardiac work, and reduced oxygen requirements of myocardial tissues. 
 
Antiarrhythmic: It inhibites influx of calcium ions in cardiac tissues result in slowed electrophysiological activity through the SA and AV nodes without affecting accessory bypass conduction or altering normal atrial action potential or intraventricular conduction. 
 
Indications
    Prophylaxis and treatment of moderate to severe angina pectoris due to atherosclerotic coronary            artery disease or coronary artery spasm (vasospastic angina)
    Essential hypertension
    Prophylaxis of some selected supraventricular tachyarrhythmias
 
Dosage and administration
Angina: Initially 30 mg - 60 mg three times daily (in elderly >65 years, in hepatic and renal impairment, initially twice daily) or 120 mg twice daily before meal and at bedtime. Dosage must be adjusted to each patients needs. The maximum recommended dose is 360 mg/day.
 
Essential hypertension:  When used as monotherapy, reasonable starting doses are 30 mg- 60 mg three times daily (in elderly >65 years, in hepatic and renal impairment, initially twice daily) or 120 mg twice daily before meal and at bedtime, although some patients may respond to lower doses.
 
Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The maximum dosage range is 240- 360 mg.  
 
Side-effects
Bradycardia, headache, dizziness, AV block first degree, edema, ECG abnormality, asthenia, hypotension.
 
Precaution
Diltiazem recommended caution and careful dosage titration when Diltiazem is administered concomitantly with other drugs that can affect cardiac contractility and/ or conduction, and in patients with  impaired renal or hepatic function.
 
Use in pregnancy and lactation
There are no adequate and controlled studies to date with Diltiazem in pregnant women, and the drug should be used during pregnancy only when the potential benefit justified possible risks to the fetus. Because Diltiazem is distributed into milk, women receiving the drug should not breastfeed their infants; and alternative method of infant feeding should be used if Diltiazem therapy is considered necessary in nursing women.
 
Use in children
Not recommended for the children.
 
Contra-indication
Severe Bradycardia, left ventricular failure with pulmonary congestion, second or third degree AV block (unless pace maker fitted), systolic blood pressure <90 mmHg, hypersensitivity to Diltiazem.
 
Drug interactions
Diltiazem has been shown to increase serum digoxin concentration and to modify its pharmacokinetics. Concomitant prophylactic therapy with short and long acting nitrates may be admistered safely during Diltiazem therapy.        
 
Over dosage 
Events observed following Diltiazem overdose included Bradycardia, hypotension, heart block and cardiac failure. Bradycardia frequently responded favorably to atropine as did heart block. Fluids and vasopressors are used to maintain blood pressure, and in cases of cardiac  failure Inotropic agent are administered. In addition, some patients need to  receive treatment with ventilatory support, gastric lavage, activated charcoal and/or intravenous calcium.
 
Commercial pack
Litizem   30  tablet: Each box containing 5 blister strips of 10 tablets.

Litizem   60 tablet: Each box containing 3 blister strips of 10 tablets.