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Cartia XT

[Diltiazem]

Diltiazem Hydrochloride Extended-release Capsules USP (once-a-day dosage) decreases vascular resistance, increases cardiac output (by increasing stroke volume); and produces a slight decrease or no change in heart rate. During dynamic exercise, increases in diastolic pressure are inhibited, while maximum achievable systolic pressure is usually reduced. Chronic therapy with Diltiazem Hydrochloride Extended-release Capsules USP (once-a-day dosage) produces no change or an increase in plasma cate-cholamines. No increased activity of the reninangiotensin-aldosterone axis has been observed.

Diltiazem Hydrochloride Extended-release Capsules USP (once-a-day dosage) reduces the renal and peripheral effects of angiotensin II. Hypertensive animal models respond to diltiazem with reductions in blood pressure and increased urinary output and natriuresis without a change in urinary sodium/ potassium ratio. In a double-blind, parallel dose-response study of doses from 60 mg to 480 mg once daily, diltiazem hydrochloride extended-release capsule (once-a-day dosage) increased time to termination of exercise in a linear manner over the entire dose range studied.

The improvement in time to termination of exercise utilizing a Bruce exercise protocol, measured at trough, for placebo, 60 mg, 120 mg, 240 mg, 360 mg, and 480 mg was 29, 40, 56, 51, 69 and 68 seconds, respectively. As doses of diltiazem hydrochloride extended-release capsule (once-a-day dosage) were increased, overall angina frequency was decreased. Diltiazem hydrochloride extended-release capsule (once-a-day dosage), 180 mg once daily, or placebo was administered in a double-blind study to patients receiving concomitant treatment with long-acting nitrates and/ or beta-blockers.

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A significant increase in time to termination of exercise and a significant decrease in overall angina frequency was observed. In this trial the overall frequency of adverse events in the diltiazem hydrochloride extended-release capsule (once-a-day dosage) treatment group was the same as the placebo group.

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