Diltiazem Tablets (diltiazem hydrochloride)
OTHER BRAND NAMES
Calcium channel blocker (CCB) (nondihydropyridine)
Management of chronic stable angina and angina due to coronary artery spasm.
Chronic Stable Angina and Angina Due to Coronary Artery Spasm:
Initial: 30mg qid
Titrate: Increase gradually (given in divided doses tid-qid) at 1- to 2-day intervals until optimum response obtained
Usual Range: 180-360mg/day
Sublingual Nitroglycerin: May take as required to abort acute angina attacks during therapy
Prophylactic Nitrate Therapy: May be coadministered w/ short- and long-acting nitrates
Start at lower end of dosing range
Take ac and hs
Swallow tab whole; do not split, crush, or chew
Tab: 90mg*, (Cardizem) 30mg, 60mg*, 120mg* *scored
Sick sinus syndrome and 2nd- or 3rd-degree atrioventricular (AV) block (except w/ functioning ventricular pacemaker), hypotension (<90mmHg systolic), acute myocardial infarction (MI) and pulmonary congestion documented by x-ray on admission.
Prolongs AV node refractory periods w/o significantly prolonging sinus node recovery time, except in patients w/ sick sinus syndrome. Periods of asystole reported in a patient w/ Prinzmetal's angina. Caution w/ renal/hepatic/ventricular impairment. Symptomatic hypotension may occur. Significant elevations in enzymes (eg, alkaline phosphatase, lactate dehydrogenase, AST, ALT) and other phenomena consistent w/ acute hepatic injury noted in rare instances. Transient dermatological events and skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis have been reported; d/c if a dermatologic reaction persists.
Edema, headache, nausea, dizziness, rash, asthenia.
Potential additive effects w/ agents known to affect cardiac contractility and/or conduction; caution and careful titration are warranted. Additive effects in prolonging cardiac conduction w/ β-blockers or digitalis. CYP3A4 substrates, inhibitors, or inducers may have a significant impact on the efficacy and side effect profile; substrates, especially in patients w/ renal and/or hepatic impairment, may require dosage adjustment when starting or stopping therapy. May potentiate depression of cardiac contractility, conductivity and automaticity, and vascular dilation associated w/ anesthetics; carefully titrate anesthetics and calcium channel blockers when used concomitantly. May increase levels of midazolam, triazolam, carbamazepine, and lovastatin. May increase exposure and T1/2 of quinidine; monitor for adverse effects of quinidine. May increase levels of propranolol; adjustment of the propranolol dose may be warranted during initiation or withdrawal of therapy. May increase levels of buspirone; subsequent dose adjustments may be necessary. Increased levels w/ cimetidine; adjustment of diltiazem dose may be warranted. Sinus bradycardia resulting in hospitalization and pacemaker insertion reported w/ clonidine; monitor HR. Monitor cyclosporine/digoxin concentrations, especially when diltiazem therapy is initiated, adjusted, or discontinued. Rifampin may decrease concentrations; avoid rifampin or any CYP3A4 inducer when possible, and consider alternative therapy. May increase simvastatin exposure; limit daily doses of simvastatin to 10mg and diltiazem to 240mg if coadministration is required. Risk of myopathy/rhabdomyolysis w/ statins metabolized by CYP3A4 may be increased. When possible, use a non-CYP3A4-metabolized statin; otherwise, consider dose adjustments for both agents and closely monitor for signs/symptoms of any statin-related adverse events.
PREGNANCY AND LACTATION
Category C, not for use in nursing.
MECHANISM OF ACTION
Calcium channel blocker; inhibits influx of Ca2+ ions during membrane depolarization of cardiac and vascular smooth muscle. Angina Due to Coronary Artery Spasm: A potent dilator of coronary arteries both epicardial and subendocardial; inhibits spontaneous and ergonovine-induced coronary artery spasm. Exertional Angina: Produces increases in exercise tolerance by reducing myocardial oxygen demand, accomplished via reduction in HR and systemic BP at submaximal and maximal exercise workloads.
Absorption: Well-absorbed from GI tract. Absolute bioavailability (40%); Tmax=2-4 hrs. Distribution: Plasma protein binding (70-80%); found in breast milk. Metabolism: Liver (extensive). Elimination: Urine (2-4%, unchanged), bile. T1/2= approx 3-4.5 hrs.
Assess for previous hypersensitivity to the drug, sick sinus syndrome, 2nd- or 3rd-degree AV block, presence of functioning ventricular pacemaker, hypotension, acute MI, pulmonary congestion, ventricular/hepatic/renal impairment, pregnancy/nursing status, and possible drug interactions.
Monitor for bradycardia, AV block, symptomatic hypotension, dermatological reactions, and other adverse reactions. Monitor LFTs and renal function at regular intervals.
Inform about benefits/risks of therapy. Counsel to report any adverse reactions to physician and to notify physician if pregnant or nursing.
20-25°C (68-77°F). Protect from light. (Cardizem) 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Avoid excessive humidity.
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