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What is Butabarbital Sodium (Butisol Sodium) ?
BUTISOL SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is a non-selective central nervous system depressant which is used as a sedative or hypnotic. It is available for oral administration as Tablets containing 30 mg or 50 mg butabarbital sodium; and as Oral Solution containing 30 mg/5 mL, with alcohol (by volume) 7%.
Indications and Dosage
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 (butabarbital sodium tablets) SODIUM® in treating insomnia should be limited to this time.
Dosage and Administration
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.
BUTISOL SODIUM® (butabarbital sodium tablets, USP):
30 mg – colored green, scored, imprinted “BUTISOL (butabarbital sodium tablets) SODIUM” and 37/113 in bottles of 100 (NDC 0037-0113-60).
50 mg – colored orange, scored, imprinted “BUTISOL (butabarbital sodium tablets) SODIUM” and 37/114 in bottles of 100 (NDC 0037-0114-60).
BUTISOL (butabarbital sodium tablets) 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).
The following adverse reactions have been observed with the use of barbiturates in hospitalized patients. Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.
More than 1 in 100 patients. The most common adverse reaction, somnolence, is estimated to occur at a rate of 1 to 3 patients per 100.
Less than 1 in 100 patients. The most common adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are:
Central nervous system/psychiatric: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality.
Gastrointestinal: Nausea, vomiting, constipation.