Mebutamate

Mebutamate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• 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 usuallydo 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 clinicalstudies. The physician should periodically reassess the usefulness ofthe drug for the individual patient.

Dosage

• Meprobamate Tablets USP: The usual adult daily dosage is 1200 mgto 1600 mg, in three or four divided doses; adaily dosage above 2400mg is not recommended.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Mebutamate in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Mebutamate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

• 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 usuallydo 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 clinicalstudies. The physician should periodically reassess the usefulness ofthe drug for the individual patient.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Mebutamate in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Mebutamate in pediatric patients.

Contraindications

• Acute intermittent porphyria as well as allergic or idiosyncraticreactions to meprobamate or related compounds such ascarisoprodol, mebutamate, tybamate, or carbromal.

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

Clinical Trials Experience

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, or erythematous maculopapular rash which may be generalized orconfined to the groin. Other reactions have included leukopenia, acute non thrombocytopenic 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, 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 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

• Agranulocytosis and aplastic anemia have been reported. These cases rarely were fatal. Rare casesof thrombocytopenic purpura have been reported.

Other

• Exacerbation of porphyric symptoms.

Postmarketing Experience

• There is limited information regarding Postmarketing Experience of Mebutamate in the drug label.

Drug Interactions

There is limited information regarding Mebutamate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mebutamate in women who are pregnant.

Labor and Delivery

• There is no FDA guidance on use of Mebutamate during labor and delivery.

Nursing Mothers

• There is no FDA guidance on the use of Mebutamate with respect to nursing mothers.

Pediatric Use

• There is no FDA guidance on the use of Mebutamate with respect to pediatric patients.

Geriatic Use

• There is no FDA guidance on the use of Mebutamate with respect to geriatric patients.

Gender

• There is no FDA guidance on the use of Mebutamate with respect to specific gender populations.

Race

• There is no FDA guidance on the use of Mebutamate with respect to specific racial populations.

Renal Impairment

• There is no FDA guidance on the use of Mebutamate in patients with renal impairment.

Hepatic Impairment

• There is no FDA guidance on the use of Mebutamate in patients with hepatic impairment.

Females of Reproductive Potential and Males

• There is no FDA guidance on the use of Mebutamate in women of reproductive potentials and males.

Immunocompromised Patients

• There is no FDA guidance one the use of Mebutamate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

• There is limited information regarding Monitoring of Mebutamate in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Mebutamate and IV administrations.

Overdosage

• Suicidal attempts with meprobamate have resulted in drowsiness,lethargy, stupor, ataxia, coma, shock, vasomotor, and respiratorycollapse. Some suicidal attempts have been fatal.

• The following data on meprobamate tablets have been reported in theliterature and from other sources. These data are not expected tocorrelate with each case (considering factors such as individual susceptibility and length of time from ingestion to treatment), butrepresent the usual ranges reported.

Acute simple overdose

• Death has beenreported with ingestion of as little as 12 g meprobamate and survivalwith as much as 40 g.

Blood levels

• 0.5-2 mg% represents the usual blood level range of meprobamateafter therapeutic doses. The level may occasionally be as high as 3mg%.

• 3-10 mg% usually corresponds to findings of mild to moderatesymptoms of overdosage, such as stupor or light coma.

• 10-20 mg% usually corresponds to deeper coma, requiring moreintensive treatment. Some fatalities occur.

• At levels greater than 20 mg%, more fatalities than survivals can beexpected.

Acute combined overdose

• (Meprobamate with alcohol or other CNSdepressants or psychotropic drugs): Since effects can be additive, ahistory of ingestion of a low dose of meprobamate plus any of thesecompounds (or of a relative low blood or tissue level) cannot be usedas a prognostic indicator.

• In cases where excessive doses have been taken, sleep ensues rapidlyand blood pressure, pulse, and respiratory rates are reduced to basallevels. Any drug remaining in the stomach should be removed andsymptomatic therapy given. Should respiration or blood pressurebecome compromised, respiratory assistance, central nervous systemstimulants, and pressor agents should be administered cautiously asindicated. Meprobamate is metabolized in the liver and excreted by thekidney. Diuresis, osmotic (mannitol) diuresis, peritoneal dialysis, andhemodialysis have been used successfully. Careful monitoring ofurinary output is necessary and caution should be taken to avoidoverhydration. Relapse and death, after initial recovery, have beenattributed to incomplete gastric emptying and delayed absorption.Meprobamate can be measured in biological fluids by two methods:colorimetric (Hoffman, A.J. and Ludwig, B.J.: J Amer Pharm Assn 48:740, 1959) and gas chromatographic.

Pharmacology

There is limited information regarding Mebutamate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Mebutamate Mechanism of Action in the drug label.

Structure

• Meprobamate is awhite powder with a characteristic odor and a bittertaste. It is slightly soluble in water, freely soluble in acetone andalcohol, and sparingly soluble in ether. The structural formula of meprobamate is:

[[|thumb|none|600px|This image is provided by the National Library of Medicine.]]

• C9H18N2O4 M.W.218.25

• Meprobamate Tablets USP 200 mg and 400 mg for oral administrationcontain the following inactive ingredients: microcrystalline cellulose,sodium starch glycolate, pre-gelatinized starch, colloidal silicondioxide, stearic acid and magnesium stearate.

Pharmacodynamics

• There is limited information regarding Pharmacodynamics of Mebutamate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Mebutamate in the drug label.

Nonclinical Toxicology

• There is limited information regarding Nonclinical Toxicology of Mebutamate in the drug label.

Clinical Studies

• There is limited information regarding Clinical Studies of Mebutamate in the drug label.

How Supplied

• Meprobamate Tablets USP 200 mg are white, round, biconvex tabletsdebossed with I and 7 on one side and bisect on the other.

• Supplied in bottles of 100 and 1000.
• Bottles of 100: NDC 55111-640-01
• Bottles of 1000: NDC 55111-640-10

• Meprobamate Tablets USP 400 mg are white, round, biconvex tabletsdebossed with I and 4 on one side and bisect on the other.

• Supplied in bottles of 100 and 500.

• Bottles of 100: NDC 55111-641-01
• Bottles of 500: NDC 55111-641-05

• Dispense in well-closed container with child-resistant closure.

Storage

• Store at 20°-25°C (68°-77°F)

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Mebutamate in the drug label.

Precautions with Alcohol

• Alcohol-Mebutamate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• MEPROBAMATE ®

Look-Alike Drug Names

There is limited information regarding Mebutamate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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