BUTISOL® SODIUM
Carter Horner
Butabarbital Sodium
Sedative – Hypnotic
Indications And Clinical Uses: A daytime sedative when mild sedation is required for relief of symptoms of anxiety or tension resulting from emotional, physical, or situational stress. May be used in such conditions as: neuroses and anxiety-tension states, functional gastrointestinal disorders, peptic ulcer, menopausal syndrome, premenstrual tension, hyperthyroidism, essential hypertension, coronary artery disease, congestive heart failure, preoperative apprehension and insomnia.
Contra-Indications: Barbiturate idiosyncrasy, patients with porphyria.
Precautions: Use with caution in patients with moderate to severe hepatic disease. Discontinue if urticaria, itching, or redness occurs.
Occupational Hazards: Barbiturates may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. The concomitant use of alcohol or other CNS depressants may have an additive effect. Warn patients accordingly.
Barbiturates induce liver microsomal enzyme activity. This accelerates the biotransformation of various drugs and is probably part of the mechanism of the tolerance which is seen with barbiturates. Butabarbital may decrease the potency of coumarin anticoagulants so that patients receiving such concomitant therapy should have more frequent prothrombin determinations.
Prolonged use of barbiturates, even in therapeutic dosages, may result in psychic dependence. Withdrawal symptoms may occur after chronic use of large doses, resulting in delirium, convulsions, or death.
A reduced efficacy and increase in incidence of breakthrough bleeding have been reported in oral contraceptive users treated concomitantly with barbiturates.
Adverse Reactions: Drowsiness at daytime sedative dose levels, skin rashes, hangover, and systemic disturbances may rarely occur. Elderly or debilitated patients may react to barbiturates with marked excitement or depression.
Symptoms And Treatment Of Overdose: In humans, the lethal dose is quite variable but is in the range of 100 mg/kg. There have been cases of survival following ingestion of as much as 10 g. The lethal dose may be lowered considerably in the presence of hepatic, renal or severe debilitating disease.
In children, the lethal dose will vary with the age, weight and physical condition. A 10-month-old child recovered after ingesting 270 mg and a 3-year-old child recovered after ingesting 540 mg.
The picture may be confused by prior consumption of alcohol or by the patient’s possession of other CNS depressant drugs. Accurate differentiation depends upon identification of the compound in the blood or urine.Symptoms: Moderate overdosage may resemble alcoholic inebriation. In more severe intoxication, the patient is comatose but the deep reflexes may be present. The pupils may be constricted and react to light, but late in the course show paralytic dilation. Respirations are usually depressed or Cheyne-Stokes respirations may be present. The blood pressure may fall and the patient may be in shock due to depression of the medullary vasomotor centres and to the peripheral effects on the myocardium and vascular smooth muscle. Complications of intoxication are pulmonary atelectasis, pulmonary edema or bronchopneumonia, and renal failure. Symptoms of butabarbital intoxication may be exaggerated in patients with liver disease since the drug is probably detoxified in the liver.
Chronic overdosage may lead to habituation and chronic poisoning. The symptoms include weakness, vertigo and malaise. Fever may occur. The mental functions are impaired, memory is defective and there may be delirium with visual hallucinations.
Treatment: Gastric lavage should be carried out or emesis induced if the patient is seen within 2 to 3 hours after ingestion of the drug. Pulmonary aspiration of gastric contents is a potential hazard. This may be reduced by inserting a cuffed endotracheal tube prior to gastric lavage. Maintain a patent airway through the use of an oropharyngeal airway or endotracheal tube. Tracheotomy should be performed if intubation is required for more than 24 hours. Artificial respiration or a mechanical respirator may be useful for respiratory depression. Analeptic drugs should not be used. The patient should receive oxygen and should be turned from side to side every 4 hours. If atelectasis develops, it should be treated by tracheobronchial suction or bronchoscopy. Shock may be counteracted by use of plasma, dextran, concentrated albumin, or vasopressor drugs such as dopamine, if necessary. If renal function is satisfactory, excretion of the drug may be hastened by forced diuresis and alkalinization of the urine with i.v. administration of sodium bicarbonate or lactate together with osmotic diuretics such as mannitol and urea. If renal failure occurs or if the patient does not respond to the above measures, carry out extracorporeal hemodialysis or peritoneal dialysis.
Dosage: Adults: As a daytime sedative, 15 to 30 mg 3 or 4 times daily. As a hypnotic, 50 to 100 mg daily. Children: As a daytime sedative, dose range is 7.5 to 30 mg depending upon age, weight, and the degree of sedation required.
Availability And Storage: 15 mg: Each lavender, top bisected, round, uncoated tablet with convex top and bottom surfaces contains: butabarbital sodium 15 mg. Nonmedicinal ingredients: calcium phosphate, calcium stearate, cornstarch, FD&C Blue No. 1 and Red No. 3. Energy: 0.4 kJ (0.1 kcal).
30 mg: Each green, top bisected, round, uncoated tablet with convex top and bottom surfaces, contains: butabarbital sodium 30 mg. Nonmedicinal ingredients: calcium phosphate, calcium stearate, cornstarch, FD&C Blue No. 1 and Yellow No. 5 (tartrazine). Energy: 0.4 kJ (0.1 kcal).
100 mg: Each pink, top bisected, round, uncoated tablet with convex top and bottom surfaces, contains: butabarbital sodium 100 mg. Nonmedicinal ingredients: calcium phosphate, calcium stearate, cornstarch, FD&C Red No. 2 and Red No. 3. Energy: 1.7 kJ (0.4 kcal). Sodium:
BUTISOL® SODIUM Carter Horner Butabarbital Sodium Sedative – Hypnotic
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