pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • Meprobamate tablets are 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 do 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.

Contraindications

Sourced from openFDA
  • Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.contraindicated

Dosage & administration

Sourced from openFDA

Meprobamate Tablets USP: The usual adult daily dosage is 1200 mg to 1600 mg, in three or four divided doses; a daily dosage above 2400mg is not recommended. The usual daily dosage for children ages six to twelve years is 200 mg to 600 mg, in two or three divided doses. Not recommended for children under age 6 (see Usage in Children).

Warnings & precautions

Sourced from openFDA

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 pre-existing symptoms such as anxiety,anorexia, 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 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. Alternatively, a long-acting barbiturate may be substituted, 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.

Adverse reactions

Sourced from openFDA

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 ECG changes, syncope; also 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. Milder reactions are characterized by an itchy, urticarial, or erythematous maculopapular rash which may be generalized or confined to the groin. Other reactions have included leukopenia, acute nonthrombocytopenic purpura, petechiae, ecchymoses, eosinophilia,peripheral edema, adenopathy, fever, fixed drug eruption with cross reaction to carisoprodol, and cross sensitivity between meprobamate/mebutamate and meprobamate/carbromal. More severe hypersensitivity reactions, rarely reported, include hyperpyrexia, chills, angioneurotic edema, bronchospasm, oliguria and anuria. Also, anaphylaxis, erythema multiforme, exfoliative dermatitis, stomatitis, proctitis, Stevens-Johnson syndrome and bullous dermatitis, including one fatal case of the latter following administration of meprobamate in combination with prednisolone.

Overdosage

Sourced from openFDA

Suicidal attempts with meprobamate have resulted in drowsiness,lethargy, stupor, ataxia, coma, shock, vasomotor, and respiratory collapse. Some suicidal attempts have been fatal. The following data on meprobamate tablets have been reported in the literature and from other sources. These data are not expected to correlate with each case (considering factors such as individual susceptibility and length of time from ingestion to treatment), but represent the usual ranges reported. 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. Blood levels 0.5-2 mg% represents the usual blood level range of meprobamate after therapeutic doses. The level may occasionally be as high as 3mg%. 3-10 mg% usually corresponds to findings of mild to moderate symptoms of overdosage, such as stupor or light coma. 10-20 mg% usually corresponds to deeper coma, requiring more intensive treatment. Some fatalities occur. At levels greater than 20 mg%, more fatalities than survivals can be expected.

Approval history

Sourced from openFDA
  • Feb 27, 2008ANDAANDA040797Invagen Pharms
  • Feb 18, 2009ANDAANDA090122Alembic Pharms Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,269 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Toxicity To Various Agents32325%
  2. 2Drug Abuse16013%
  3. 3Completed Suicide12710%
  4. 4Overdose1219.5%
  5. 5Accidental Overdose1058.3%
  6. 6Drug Toxicity987.7%
  7. 7Cardiac Arrest957.5%
  8. 8Drug Ineffective796.2%
  9. 9Respiratory Arrest796.2%
  10. 10Death776.1%
  11. 11Multiple Drug Overdose544.3%
  12. 12Pulmonary Oedema544.3%
  13. 13Dyspnoea514.0%
  14. 14Accidental Death503.9%
  15. 15Cardio-respiratory Arrest463.6%

Literature

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Recent PubMed references pinned to Meprobamate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Frequently asked questions

How does Meprobamate work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Meprobamate used for?
According to FDA labeling, Meprobamate carries indications including: Meprobamate tablets are 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 do 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Meprobamate?
Meprobamate is classified as Carbamates, Unknown Cellular or Molecular Interaction, Decreased Central Nervous System Disorganized Electrical Activity, Decreased Spinal Cord Organized Electrical Activity.
What are the brand names for Meprobamate?
Meprobamate is marketed under brand names including Equagesic.
What are the contraindications for Meprobamate?
Meprobamate labeling lists contraindications including: Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.. Always consult the full prescribing information and a clinician.
Note. Data for meprobamate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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