Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Meprobamate Tablets USP 200 mg are white, round, biconvex tablets debossed with I and 7 on one side and bisect on the other. Supplied in bottles of 100. Bottles of 100: NDC 69097-974-07 Meprobamate Tablets USP 400 mg are white, round, biconvex tablets debossed with I and 4 on one side and bisect on the other. Supplied in bottles of 100. Bottles of 100: NDC 69097-975-07 Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Rev. 04/2020; PRINCIPAL DISPLAY PANEL NDC 69097-974-07 Rx Only Meprobamate Tablets, USP CIV 200 mg 100 Tablets Cipla NDC 69097-975-07 Rx Only Meprobamate Tablets, USP CIV 400 mg 100 Tablets Cipla 200-100 400-100
- HOW SUPPLIED Meprobamate Tablets USP 200 mg are white, round, biconvex tablets debossed with I and 7 on one side and bisect on the other. Supplied in bottles of 100. Bottles of 100: NDC 69097-974-07 Meprobamate Tablets USP 400 mg are white, round, biconvex tablets debossed with I and 4 on one side and bisect on the other. Supplied in bottles of 100. Bottles of 100: NDC 69097-975-07 Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Rev. 04/2020
- PRINCIPAL DISPLAY PANEL NDC 69097-974-07 Rx Only Meprobamate Tablets, USP CIV 200 mg 100 Tablets Cipla NDC 69097-975-07 Rx Only Meprobamate Tablets, USP CIV 400 mg 100 Tablets Cipla 200-100 400-100
Overview
Meprobamate is a white powder with a characteristic odor and a bitter taste. It is slightly soluble in water, freely soluble in acetone and alcohol, and sparingly soluble in ether. The structural formula of meprobamate is: C 9 H 18 N 2 O 4 M.W.218.25 Meprobamate Tablets USP 200 mg and 400 mg for oral administration contain the following inactive ingredients: microcrystalline cellulose,sodium starch glycolate, pre-gelatinized starch, colloidal silicondioxide, stearic acid and magnesium stearate. structure
Indications & 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
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
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 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. Additive Effects Since the effects of meprobamate and alcohol or meprobamate and other CNS depressants or psychotropic drugs may be additive,appropriate caution should be exercised with patients who take more than one of these agents simultaneously. Usage in Pregnancy and Lactation An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chlordiazepoxide and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug. Meprobamate passes the placental barrier. It is present both in umbilical cord blood at or near maternal plasma levels and in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breastfeeding patients, the drug's higher concentration in breast milk as compared to maternal plasma should be considered. Usage in Children Meprobamate tablets should not be administered to children under age six, since there is a lack of documented evidence for safety and effectiveness in this age group.
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
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 (See also Allergic or Idiosyncratic ). 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.
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