BUTISOL SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is indicated for use as a sedative or hypnotic.

Since barbiturates appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks, use of BUTISOL SODIUM® in treating insomnia should be limited to this time (see CLINICAL PHARMACOLOGY above).

Usual adult dosage

Daytime sedative - 15 to 30 mg, 3 or 4 times daily.

Bedtime hypnotic - 50 to 100 mg.

Preoperative sedative - 50 to 100 mg, 60 to 90 minutes before surgery.

Usual pediatric dosage

Preoperative sedative - 2 to 6 mg/kg maximum 100 mg.

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 (see PRECAUTIONS).

BUTISOL SODIUM® (butabarbital sodium tablets, USP):

30 mg - colored green, scored, imprinted “BUTISOL SODIUM” and 37/113 in bottles of 100 (NDC 0037-0113-60).

50 mg - colored orange, scored, imprinted “BUTISOL SODIUM” and 37/114 in bottles of 100 (NDC 0037-0114-60).

BUTISOL SODIUM® (butabarbital sodium oral solution, USP): 30 mg/ 5 mL, alcohol (by volume) 7% - colored green, in bottles of one pint (NDC 0037-0110-16).

Contains FD&C Yellow No. 5 (See PRECAUTIONS).

Storage

Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in a tight container.

MedPointe Healthcare Inc Somerset, NJ 08873 Printed in U.S.A. Rev. 5/07. FDA Rev date: 9/28/2007

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