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Minimum therapeutic plasma diltiazem concentrations appear to be in the range of 50 to 200 ng/ mL. There is a departure from linearity when dose strengths are increased; the half-life is slightly increased with dose. A study that compared patients with normal hepatic function to patients with cirrhosis found an increase in half-life and a 69% increase in bioavailability in the hepatically impaired patients. A single study in patients with severely impaired renal function showed no difference in the pharmacokinetic profile of diltiazem compared to patients with normal renal function. When compared to a regimen of diltiazem tablets at steady-state, more than 95% of drug is absorbed from the diltiazem hydrochloride extended-release capsules (once-a-day dosage) formulation. A single 360-mg dose of the capsule results in detectable plasma levels within 2 hours and peak plasma levels between 10 and 14 hours; absorption occurs throughout the dosing interval. When diltiazem hydrochloride extended-release capsule (once-a-day dosage) was coadministered with a high fat content breakfast, the extent of diltiazem absorption was not affected. Dose-dumping does not occur. The apparent elimination half-life after single or multiple dosing is 5 to 8 hours. A departure from linearity similar to that seen with diltiazem tablets and diltiazem hydrochloride capsules (twice daily) is observed. Text Continues Below
As the dose of diltiazem hydro-chloride extended-release capsules (once-a-day dosage) is increased from a daily dose of 120 mg to 240 mg, there is an increase in the area-under-the curve of 2.7 times. When the dose is increased from 240 mg, to 360 mg there is an increase in the area-under-the-curve of 1.6 times. Page: << Prev | 1 | 2 | 3 | 4 | 5
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