Dilzem

Dilzem

diltiazem

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Diltiazem HCl
Indications/Uses
Treatment of angina pectoris due to coronary artery spasm; spontaneous coronary artery spasm presenting as Prinzmetal's variant angina. Management of chronic stable angina in patients who cannot tolerate therapy w/ β-blockers &/or nitrates or who remain symptomatic despite adequate doses of these agents. Treatment of HTN, either alone or in combination w/ other antihypertensives eg, diuretics. Prevention of graft failure following kidney transplantation. Reduction of ciclosporin A nephrotoxicity during immunosuppressive therapy after kidney transplantation.
Dosage/Direction for Use
Ischemic heart disease (exertional angina pectoris due to atherosclerotic CAD or angina pectoris at rest due to coronary artery spasm) Initially 120 mg/day in equally divided doses. Gradually increase in equally divided doses (bid-qid) at 1-2-day intervals until optimum response is obtained. Optimum dose range: 180-360 mg/day. Up to 480 mg/day in some cases. HTN Initially 120-240 mg/day in equally divided doses. Usual dose range: 240-360 mg/day. Kidney transplantation Initially 120 mg/day in 2 equally divided doses. May be increased up to a max of 360 mg/day in 3 equally divided doses. Optimum dose range: 180-360 mg/day.
Administration
Should be taken on an empty stomach: Preferably taken before meals & at bedtime.
Contraindications
Hypersensitivity. Sick sinus syndrome or 2nd- or 3rd-degree AV block, except in the presence of a functioning ventricular pacemaker. Hypotension (<90 mmHg systolic), acute MI, X-ray documented pulmonary congestion. Concurrent use of lomitapide.
Special Precautions
Prolongs AV node refractory periods w/o significantly prolonging sinus node recovery time, except in patients w/ sick sinus syndrome. Caution in patients w/ impaired ventricular, renal, or hepatic function. Risk of symptomatic hypotension. Rare instances of acute hepatic injury have been noted. Discontinue if dermatological reactions persist. Monitor lab parameters at regular intervals when given over prolonged periods. Concomitant use w/ β-blockers or digitalis. Administer to pregnant women only if potential benefit justifies any risk. Alternative methods of infant feeding should be instituted. Safety & effectiveness in childn have not been established.
Adverse Reactions
Headache, dizziness; 1st degree AV block, sinus bradycardia; flushing; nausea; rash; joint swelling; asthenia, fatigue, edema.
Drug Interactions
Potential for additive effects w/ any agent known to affect cardiac contractility &/or conduction. May competitively inhibit metabolism of concomitant drugs that undergo the same route of biotransformation (CYP3A4). Increased plasma conc of lomitapide. Increased exposure (Cmax, AUC) of ivabradine. Increased propranolol levels. Increased peak plasma levels & AUC w/ cimetidine. Monitor digoxin levels when initiating, adjusting, & discontinuing diltiazem therapy to avoid possible over- or under-digitalization. May potentiate depression of cardiac contractility, conductivity, & automaticity as well as vascular dilation associated w/ anesth. Increased plasma level of ciclosporin. May enhance plasma levels of carbamazepine & consequently the risk of toxicity. Avoid concurrent use w/ erythromycin in patients at risk for heart irregularities or w/ long QT manifestations. Reports of interactions w/ warfarin, rifampin or lithium. Increased AUC of some statins. Increased risk of myopathy & rhabdomyolysis w/ statins metabolized by CYP3A4. Increased Cmax & AUC of sirolimus. May increase blood conc of everolimus.
MIMS Class
Calcium Antagonists
ATC Classification
C08DB01 - diltiazem ; Belongs to the class of benzothiazepine derivative selective calcium-channel blockers with direct cardiac effects. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Dilzem SR tab 180 mg
Packing/Price
60's
Form
Dilzem SA tab 90 mg
Packing/Price
60's
Form
Dilzem tab 30 mg
Packing/Price
200's
Form
Dilzem tab 60 mg
Packing/Price
200's