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MEBARAL®
(mephobarbital) Tablets, USP

DESCRIPTION

Mephobarbital, 5-Ethyl-1-methyl-5-phenylbarbituric acid, is a babiturate with sedative, hypnotic, and anticonvulsant properties. It occurs as a white, nearly odorless, tasteless powder and is slightly soluble in water and in alcohol.

MEBARAL (mephobarbital) is available as tablets for oral administration. The structural formula is:

 

 

Inactive Ingredients: Lactose, Starch, Stearic Acid, Talc.

 

INDICATIONS

MEBARAL (mephobarbital) 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.

DOSAGE AND ADMINISTRATION

Epilepsy: Average dose for adults: 400 mg to 600 mg (6 grains to 9 grains) daily; children under 5 years: 16 mg to 32 mg (1/4 grain to ½ grain) three or four times daily; children over 5 years: 32 mg to 64 mg (½ grain to 1 grain) three or four times daily. MEBARAL (mephobarbital) is best taken at bedtime if seizures generally occur at night, and during the day if attacks are diurnal.

Treatment should be started with a small dose which is gradually increased over four or five days until the optimum dosage is determined. If the patient has been taking some other antiepileptic drug, it should be tapered off as the doses of MEBARAL (mephobarbital) are increased, to guard against the temporary marked attacks that may occur when any treatment for epilepsy is changed abruptly. Similarly, when the dose is lowered to a maintenance level or to be discontinued, the amount should be reduced gradually over four or five days.

Special Patient Population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease.

Combination with Other Drugs: MEBARAL (mephobarbital) may be used in combination with phenobarbital, either in the form of alternating courses or concurrently. When the two drugs are used at the same time, the dose should be about one-half the amount of each used alone. The average daily dose for an adult is from 50 mg to 100 mg (3/4 grain to 1 ½ grains) of phenobarbital and from 200 mg to 300 mg (3 grains to 4 ½ grains) of MEBARAL (mephobarbital) .

MEBARAL (mephobarbital) may also be used with phenytoin sodium; in some cases, combined therapy appears to give better results than either agent used alone, since phenytoin sodium is particularly effective for the psychomotor types of seizure but relatively ineffective for petit mal. When the drugs are employed concurrently, a reduced dose of phenytoin sodium is advisable, but the full dose of MEBARAL (mephobarbital) may be given. Satisfactory results have been obtained with an average daily dose of 230 mg (3 ½ grains) of phenytoin sodium plus about 600 mg (9 grains) of MEBARAL (mephobarbital) .

Sedation: Adults: 32 mg to 100 mg (½ grain to 1 ½ grains)–optimum dose, 50 mg (3/4 grain)–three to four times daily. Children: 16 mg to 32 mg (1/4 grain to ½ grain) three to four times daily.

HOW SUPPLIED

Tablets—white, round, convex and the 32 mg and 50 mg tablets are scored.

32 mg (½ grain), bottles of 250 (NDC 67386-801-02).

50 mg (3/4 grain), bottles of 250 (NDC 67386-802-02).

100 mg (1 ½ grains), bottles of 250 (NDC 67386-803-02).

Store at room temperature up to 25° C (77° F).

Distributed by : OVATION, Pharmaceuticals, Inc., Deerfield, I 60015, USA. Revised July 2003. FDA revision date: n/aLIDESHOW