Meprobamate

Meprobamate
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)

There is limited information regarding Meprobamate FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Meprobamate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

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 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.

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 consider allergy to excipients.

Hematologic

Agranulocytosis and  aplastic anemia have been reported. These cases rarely were fatal. Rare cases of thrombocytopenic Purpura have been reported.

Other

Exacerbation of porphyric symptoms.

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Meprobamate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Meprobamate in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Meprobamate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Meprobamate Storage in the drug label.

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 Meprobamate in the drug label.

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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