* 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.
* 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.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Developed by:
* Class of Recommendation:
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Strength of Evidence:
* Dosing Information
|fdaLIADPed=* There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Acute intermittent porphyria as well as allergic or idiosyncraticreactions to meprobamate or related compounds such ascarisoprodol, mebutamate, tybamate, or carbromal.
|contraindications=* Acute intermittent porphyria as well as allergic or idiosyncraticreactions to meprobamate or related compounds such ascarisoprodol, mebutamate, tybamate, or carbromal.
|warnings='''Drug Dependence'''
|warnings='''Drug Dependence'''
Line 143:
Line 89:
* Exacerbation of porphyric symptoms.
* Exacerbation of porphyric symptoms.
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=* There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=* There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=* There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=* There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=* There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=* There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=* There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=* There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=* There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=* There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|monitoring=* There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
|IVCompat=* There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
====Management====
* Description
|overdose=* There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
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Overview
Mebutamate is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Meprobamate tablets are indicated for the management of anxietydisorders 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 (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)
There is limited information regarding FDA-Labeled Use of Mebutamate in pediatric patients.
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.
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.
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.
