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3. Hypotension Decreases in blood pressure associated with diltiazem therapy may occasionally result in symptomatic hypotension. 4. Acute Hepatic Injury Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. Text Continues Below
In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy ini-tiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem is uncer-tain in some cases, but probable in some. (See PRECAUTIONS.) OVERDOSAGE The oral LD 50 's in mice and rats range from 415 to 740 mg/ kg and from 560 to 810 mg/ kg, respectively. The intravenous LD 50 's in these species were 60 and 38 mg/ kg, respectively. The oral LD 50 in dogs is considered to be in excess of 50 mg/ kg, while lethality was seen in monkeys at 360 mg/ kg. The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of diltiazem can vary over tenfold, limiting the usefulness of blood levels in overdose cases. There have been 29 reports of diltiazem overdose in doses ranging from less than 1 g to 10.8 g. Sixteen of these reports involved multiple drug ingestions. Twenty-two reports indicated patients had recovered from diltiazem overdose ranging from less than 1 g to 10.8 g. There were seven reports with a fatal outcome; although the amount of diltiazem ingested was unknown, multiple drug ingestions were confirmed in six of the seven reports. Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/ or drug treatment. Bradycardia frequently responded favorably to atropine as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure, and in cases of cardiac failure, inotropic agents were administered. Page: << Prev | 1 | 2 | 3 | Next >>
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