"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
In rare instances, the use of aspirin in persons allergic to salicylates may result in life-threatening allergic episodes.
Physical dependence, psychological dependence, and abuse have occurred. Chronic intoxication from prolonged ingestion of, usually, greater-than-recommended doses is manifested by ataxia, slurred speech, and vertigo. Therefore, careful supervision of dose and amounts prescribed is advised, as well as avoidance of prolonged administration, especially for alcoholics and other patients with a known propensity for taking excessive quantities of drugs.
Sudden withdrawal of the drug after prolonged and excessive use may precipitate recurrence of preexisting symptoms, such as anxiety, anorexia, or insomnia, or withdrawal reactions, such as vomiting, ataxia, tremors, muscle twitching, confusional states, hallucinosis, and rarely, convulsive seizures. Such seizures are more likely to occur in persons with central-nervous-system damage or preexistent or latent convulsive disorders. Onset of withdrawal symptoms occurs usually within 12 to 48 hours after discontinuation of meprobamate; symptoms usually cease within the next 12- to 48- hour period. When excessive dosage has continued for weeks or months, dosage should be reduced gradually over a period of 1 to 2 weeks rather than abruptly stopped. Alternatively, a short- acting barbiturate may be substituted, then gradually withdrawn.
Potentially Hazardous Tasks
Patients should be warned that meprobamate may impair the mental or physical abilities required for performance of potentially hazardous tasks, such as driving or operating machinery.
Since CNS- suppressant effects of meprobamate and alcohol or meprobamate and other psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously.
An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chiordiazepoxide, and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
Meprobamate passes the placental barrier. it is present both in umbilical-cord blood at or near maternal plasma levels and in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breast-feeding patients, the drug's higher concentrations in breast milk as compared to maternal plasma levels should be considered.
USAGE IN CHILDREN
Preparations containing aspirin should be kept out of the reach of children. Equagesic (meprobamate and aspirin) is not recommended for patients 12 years of age and under.
The lowest effective dose should be administered, particularly to elderly and/or debilitated patients, in order to preclude oversedation.
Meprobamate is metabolized in the liver and excreted by the kidney: to avoid its excess accumulation, caution should be exercised in the administration to patients with compromised liver or kidney function. Meprobamate occasionally may precipitate seizures in epileptic patients.
The drug should be prescribed cautiously and in small quantities to patients with suicidal tendencies.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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