"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The signs and symptoms of chloral hydrate overdosage resemble those of barbiturate overdosage and especially affect the CNS and cardiovascular system. They may include: hypothermia; pinpoint pupils; blood pressure falls; comatose state; slow, or rapid and shallow breathing. Gastric irritation may result in vomiting and even gastric necrosis. If the patient survives, icterus due to hepatic damage and albuminuria from renal irritation may appear.
The toxic oral dose of chloral hydrate for adults is approximately 10 g; however, death has been reported from a dose of 4 g and some patients have survived after taking as much as 30 g.
Accidental overdosage should be treated with gastric lavage or by inducing vomiting to empty the stomach. Supportive measures may be used. Hemodialysis is reported to be effective in promoting the clearance of trichloroethanol.
Chloral hydrate is contraindicated in patients with marked hepatic or renal impairment and in patients with severe cardiac disease. Oral dosage forms of chloral hydrate are contraindicated in the presence of gastritis. Chloral hydrate is also contraindicated in patients who have previously exhibited an idiosyncrasy or hypersensitivity to the drug.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Noctec Information
- Noctec Drug Interactions Center: chloral hydrate oral
- Noctec Side Effects Center
- Noctec Overview including Precautions
- Noctec FDA Approved Prescribing Information including Dosage
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