"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
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Central Nervous System
Occasionally a patient becomes somnambulistic and he may be disoriented and incoherent and show paranoid behavior. Rarely, excitement, tolerance, addiction, delirium, drowsiness, staggering gait, ataxia, lightheadedness, vertigo, dizziness, nightmares, malaise, mental confusion and hallucinations have been reported.
Some patients experience gastric irritation and occasionally nausea and vomiting, flatulence, diarrhea, and unpleasant taste occur.
DRUG ABUSE AND DEPENDENCE
Drug Enforcement Administration Schedule IV.
Chloral hydrate may be habit- forming. Patients known to be addiction- prone and patients who actively solicit hypnotics in increasing doses are potential addicts. Many patients take higher doses of hypnotics than they admit, and slurring of speech, incoordination, tremulousness, and nystagmus should arouse suspicion. Drowsiness, lethargy, and hangover are frequently observed from excessive drug intake.
Prolonged use of larger than usual therapeutic doses may result in psychic and physical dependence. Tolerance and psychologic dependence may develop by the second week of continued administration.
Chloral hydrate addicts may take huge doses of the drug (i.e., up to 12 g nightly has been reported). This abuse is similar to alcohol addiction and sudden withdrawal may result in central nervous excitation, with tremor, anxiety, hallucination, or even delirium which may be fatal. In patients suffering from chronic chloral hydrate intoxication, gastritis is common and skin eruptions may develop. Parenchymatous renal injury may also occur. Withdrawal should be undertaken in a hospital and supportive treatment similar to that used during barbiturate withdrawal is recommended.
Read the Noctec (chloral hydrate) Side Effects Center for a complete guide to possible side effects
Chloral hydrate may cause hypoprothrombinemic effects in patients taking oral anticoagulants (See WARNINGS).
Administration of chloral hydrate followed by intravenous furosemide may result in sweating, hot flashes, and variable blood pressure including hypertension due to a hypermetabolic state caused by displacement of thyroid hormone from its bound state.
Caution is recommended in combining chloral hydrate with other CNS depressants such as alcohol barbiturates and tranquilizers. Administration of chloral hydrate should be delayed in patients who have ingested significant amounts of alcohol in the preceding 12 to 24 hours. CNS depressants are additive in effect and the dosage should be reduced when such combinations are given concurrently.
Read the Noctec Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/8/2004
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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