Mebaral® CIV
(brand of mephobarbital tablets, USP)

• Mebaral is a barbiturate.
• Mebaral is available for oral administration in 32 mg, 50 mg, and 100 mg tablets.

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Indication
MEBARAL® (brand of mephobarbital tablets, USP) is indicated for use as a sedative for the relief of anxiety, tension, and apprehension, and as an anticonvulsant for the treatment of grand mal and petit mal epilepsy.

Important Safety Information
MEBARAL is contraindicated in patients with a known hypersensitivity to any barbiturate, manifest or latent porphyria. Barbiturates including MEBARAL may be habit forming. Abrupt discontinuation may result in withdrawal symptoms, including delirium, convulsions, status epilepticus and possibly death.

Concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects. Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies or chronic or acute pain. Barbiturates should not be administered to patients showing premonitory signs of hepatic coma. Barbiturates can cause fetal damage and infants may have withdrawal symptoms if mothers receive barbiturates. Withdrawal symptoms occur in infants born to mothers who receive barbiturates during the last trimester of pregnancy. Prolonged treatment with barbiturates should be monitored.

Careful adjustment of dosage is required in elderly patients and patients with impaired renal, cardiac or respiratory function, myasthenia gravis and myxedema. The most commonly reported adverse event (>1 in 100 patients) is somnolence.

For more information, please see Full Prescribing Information.