Meprobamate 400 mg/1
Meprobamate · TABLET · Cipla USA Inc.
Meprobamate is a tablet containing meprobamate at 400 mg/1, taken oral. Manufactured by Cipla USA Inc..
Key Facts
- Brand Name
- Meprobamate
- Generic Name
- Meprobamate
- NDC Code (Product)
69097-975- Manufacturer
- Cipla USA Inc.
- Strength
- 400 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA040797
- Marketing Start
- 06/07/2021
Recall History
Watson Laboratories Inc
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Watson Laboratories Inc
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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. The physician should periodically reassess the usefulness of the drug for the individual patient.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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
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 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 o…
Contraindications
CONTRAINDICATIONS Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.
Adverse Reactions
ADVERSE REACTIONS 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, a…
Frequently Asked Questions
What is Meprobamate used for?
Meprobamate contains Meprobamate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Meprobamate a controlled substance?
Yes, Meprobamate is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Meprobamate?
The generic name for Meprobamate is Meprobamate. There are 2 other brand versions of Meprobamate.
What is the NDC code for Meprobamate 400 mg/1?
The NDC (National Drug Code) for Meprobamate 400 mg/1 is 69097-975, listed by Cipla USA Inc..