"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"...
Chloral hydrate may be habit-forming. Long-term use of larger than the usual therapeutic doses may result in psychic and physical dependence; therefore, caution must be exercised when administering the drug to patients susceptible to drug abuse. Sudden withdrawal may result in delirium. Chloral hydrate may increase the rate of metabolism of concomitantly administered coumarin or coumarinrelated anticoagulants, thus reducing their effectiveness. Upon withdrawal of chloral hydrate, the rate of metabolism of the anticoagulant drug may decrease with a concomitant rise in plasma levels and with the possibility of a gradual increase of anticoagulant effects (i.e., development of bleeding tendency and hemorrhage). Patients on oral anticoagulant therapy who are also taking chloral hydrate should have close observation of prothrombin times.
Chloral hydrate has been reported to precipitate attacks of acute intermittent porphyria and should be used with caution in susceptible patients. Continued use of therapeutic doses of chloral hydrate has been shown to be without deleterious effect on the heart. Large doses of chloral hydrate, however, should not be used in patients with severe cardiac disease (See CONTRAINDICATIONS).
Drug/ Laboratory Test Interactions
Chloral hydrate may interfere with copper sulfate tests for glycosuria (suspected glycosuria should be confirmed by a glucose oxidase test when the patient is receiving chloral hydrate), fluorometric tests for urine catecholamines (it is recommended that the medication not be administered for 48 hours preceding the test), or urinary 17-hydroxycorticosteroid determinations (when using the Reddy, Jenkins, and Thorn procedure).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed.
Pregnancy Category C
Animal reproduction studies have not been conducted with chloral hydrate. Chloral hydrate crosses the placental barrier and chronic use during pregnancy may cause withdrawal symptoms in the neonate. It is not known whether chloral hydrate can affect reproduction capacity. Chloral hydrate should be given to a pregnant woman only if clearly needed.
Chloral hydrate is excreted in human milk, use by nursing mothers may cause sedation in the infant.
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
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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