AQOPAM
Tablets

Psychiatric drugs

  • Chemical Composition

    Meprobamate 200 mg

  • Packing

    20Coated Tablets

  • Medical Id

    T92

  • License Number

    470/2012

  • License date

    16/12/2012

Excipients Acacia ‚ Carnauba wax ‚Corn starch ‚ Gelatin ‚ Magnesium carbonate ‚ Magnesium stearate ‚ Methylcellulose ‚ Sugar ‚Talc ‚ Titanium dioxide ‚ White wax.
Mechanism Of Action Meprobamate is a carbamate derivative which has been shown in animal studies to have effects at multiple sites in the central nervous system including the thalamus and limbic system.
INDICATIONS It is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
CONTRAINDICATIONS Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.
Side EFFECTS Central Nervous System: Drowsiness, ataxia, dizziness, slurred speech, headache, vertigo, weakness, paresthesias, impairment of visual accommodation, euphoria, overstimulation, paradoxical excitement, and fast EEG activity. Gastrointestinal: Nausea, vomiting, diarrhea. Cardiovascular: Palpitation, tachycardia, various forms of arrhythmia, transient ECG changes, syncope; and hypotensive crisis (including one fatal case). Allergic or Idiosyncratic:Allergic or idiosyncratic reactions are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Milderreactions are characterized by an itchy, urticarial, or erythematous maculopapular rash which may be generalized or confined to the groin. Other reactions haveincluded leukopenia, acute non-thrombocytopenic purpura, petechiae, ecchymoses, eosinophilia, peripheral edema, adenopathy, fever, fixed drug eruption with crossreaction to carisoprodol, and cross sensitivity between Meprobamate/mebutamate and Meprobamate/carbromal. In case of allergic or idiosyncratic reactions to Meprobamate, the drug should be discontinued and appropriate symptomatic therapy should be initiated. Hematologic: Agranulocytosis and aplastic anemia have been reported. These cases rarely were fatal. Rare cases of thrombocytopenicpurpura have been reported. Other: Exacerbation of porphyric symptoms.
WARNINGS • Drug Dependence: Physical dependence, psychological dependence, and abuse have occurred. When chronic intoxication from prolonged use occurs, it usually involves ingestion of greater than recommended doses and 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, insomnia, or withdrawal reactions (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 pre-existent 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 hours. When excessive dosage has continued for weeks or months, dosage should be reduced gradually over a period of one or two weeks rather than abruptly stopped. A long-acting barbiturate may be substituted, and then gradually withdrawn. • Potentially Hazardous Tasks: Patients should be warned that meprobamate may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving or operating machinery. • Additive Effects: Since the effects of meprobamate and alcohol or meprobamate and other CNS depressants or psychotropic drugs may be additive, caution should be exercised with patients who take more than one of these agents simultaneously. • The lowest effective dose should be administered, particularly to elderly and/or debilitated patients, in order to preclude oversedation. • The possibility of suicide attempts should be considered and the least amount of drug feasible should be dispensed at any time. • Meprobamate is metabolized in the liver and excreted by the kidney; to avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function. • Meprobamate occasionally may precipitate seizures in epileptic patients. • Usage in Pregnancy: An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chlordiazepoxide 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 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 physician about the desirability of discontinuing the drug. • Usage in Lactation: Meprobamate passes the placental barrier. When use of meprobamate is contemplated in breastfeeding patients, the drug's higher concentration in breast milk as compared to maternal plasma should be considered. • Geriatric Use:reported clinical experience has not identified difference in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. • Usage in Children: Meprobamate tablets should not be administered to children under age six, since there is a lack of documented evidence for safety and effectiveness in this age group.
Pregnancy And lactations You should consult a doctor if this drug is prescribed to pregnant or breastfeeding women
Dosage And Administration Adult: The usual daily dosage is 1200mg to 1600 mg, in three or four divided doses; a daily dosage above 2400 mg is not recommended. Children 6 - 12 years of age: The usual daily dosage for is 200 mg to 600 mg in two or three divided doses. This drug is not recommended for children under age 6.
OVERDOSE Suicidal attempts with Meprobamate have resulted in drowsiness, lethargy, stupor, ataxia, coma, shock, vasomotor, and respiratory collapse. Some suicidal attempts have been fatal. Acute simple overdose (Meprobamate alone): Death has been reported with ingestion of as little as 12 g Meprobamate and survival with as much as 40 g. Acute combined overdose (Meprobamate with alcohol or other CNS depressants or psychotropic drugs): Since effects can be additive, a history of ingestion of a low dose of Meprobamate plus any of these compounds cannot be used as a prognostic indicator. In cases where excessive doses have been taken, sleep ensues rapidly and blood pressure, pulse, and respiratory rates are reduced to basal levels. Any drug remaining in the stomach should be removed and symptomatic therapy given. Meprobamate is metabolized in the liver and excreted by the kidney. Diuresis, osmotic diuresis, peritoneal dialysis, and hemodialysis have been used successfully
Storage Conditions Store below 30° c. Keep out of reach of children