FDA label 4995ef74-5377-6fdf-5a0a-0ea1925c35fb

WARNINGS Drug Dependence Physical dependence, psychological dependence, and abuse haveoccurred. When chronic intoxication from prolonged use occurs, itusually involves ingestion of greater than recommended doses and ismanifested by ataxia, slurred speech, and vertigo. Therefore, carefulsupervision of dose and amounts prescribed is advised, as well asavoidance of prolonged administration, especially for alcoholics andother patients with a known propensity for taking excessive quantitiesof drugs. Sudden withdrawal of the drug after prolonged and excessive use mayprecipitate recurrence of pre-existing symptoms such as anxiety,anorexia, insomnia, or withdrawal reactions such as vomiting, ataxia,tremors, muscle twitching, confusional states, hallucinosis, andrarely, convulsive seizures. Such seizures are more likely to occur inpersons with central nervous system damage or pre-existent or latentconvulsive disorders. Onset of withdrawal symptoms occurs usuallywithin 12 to 48 hours after discontinuation of meprobamate;symptoms usually cease within the next 12 to 48 hours. When excessive dosage has continued for weeks or months, dosageshould be reduced gradually over a period of one or two weeks ratherthan abruptly stopped. Alternatively, a long-acting barbiturate may besubstituted, then gradually withdrawn. Potentially Hazardous Tasks Patients should be warned that meprobamate may impair the mentaland/or physical abilities required for performance of potentiallyhazardous tasks such as driving or operating machinery. Additive Effects Since the effects of meprobamate and alcohol or meprobamate andother CNS depressants or psychotropic drugs may be additive,appropriate caution should be exercised with patients who take morethan one of these agents simultaneously. Usage in Pregnancy and Lactation An increased risk of congenital malformations associated with theuse of minor tranquilizers (meprobamate, chlordiazepoxide anddiazepam) during the first trimester of pregnancy has beensuggested in several studies. Because use of these drugs is rarelya matter of urgency, their use during this period should almostalways be avoided. The possibility that a woman of childbearingpotential may be pregnant at the time of institution of therapyshould be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant theyshould communicate with their physician about the desirability ofdiscontinuing the drug. Meprobamate passes the placental barrier. It is present both inumbilical cord blood at or near maternal plasma levels and inbreast milk of lactating mothers at concentrations two to four timesthat of maternal plasma. When use of meprobamate iscontemplated in breastfeeding patients, the drug's higherconcentration in breast milk as compared to maternal plasmashould be considered. Usage in Children Meprobamate tablets should not be administered to children underage six, since there is a lack of documented evidence for safety andeffectiveness in this age group.

ADVERSE REACTIONS Central Nervous System Drowsiness, ataxia, dizziness, slurred speech, headache, vertigo,weakness, paresthesias, impairment of visual accommodation,euphoria, overstimulation, paradoxical excitement, fast EEG activity. Gastrointestinal Nausea, vomiting, diarrhea. Cardiovascular Palpitation, tachycardia, various forms of arrhythmia, transient ECGchanges, syncope; also hypotensive crisis (including one fatal case). Allergic or Idiosyncratic Allergic or idiosyncratic reactions are usually seen within the period ofthe first to fourth dose in patients having had no previous contact withthe drug. Milder reactions are characterized by an itchy, urticarial, orerythematous maculopapular rash which may be generalized orconfined to the groin. Other reactions have included leukopenia, acutenonthrombocytopenic purpura, petechiae, ecchymoses, eosinophilia,peripheral edema, adenopathy, fever, fixed drug eruption with crossreaction to carisoprodol, and cross sensitivity betweenmeprobamate/mebutamate and meprobamate/carbromal. More severe hypersensitivity reactions, rarely reported, includehyperpyrexia, chills, angioneurotic edema, bronchospasm, oliguriaand anuria. Also, anaphylaxis, erythema multiforme, exfoliativedermatitis, stomatitis, proctitis, Stevens-Johnson syndrome andbullous dermatitis, including one fatal case of the latter followingadministration of meprobamate in combination with prednisolone. In case of allergic or idiosyncratic reactions to meprobamate,discontinue the drug and initiate appropriate symptomatic therapy,which may include epinephrine, antihistamines, and in severe cases,corticosteroids. In evaluating possible allergic reactions, also considerallergy to excipients. Hematologic (See also Allergic or Idiosyncratic ). Agranulocytosis and aplasticanemia have been reported. These cases rarely were fatal. Rare casesof thrombocytopenic purpura have been reported. Other Exacerbation of porphyric symptoms.