International generic name Phenobarbital
Drug form and composition Solution for injection. One ampoule of 2 ml (10%) contains 200 mg Sodium Phenobarbital (100 mg/ml).
Indications The injection solution is used as an anticonvulsive agent in the treatment of following conditions: epilepsy, epileptic status, convulsions, due to hyperpyrexia or overdosing of medicines, stimulating the CNS. The preparation is used as a premedication and after surgery, in combination with analgesics. In prevention of neonatal bilirubin encephalopathy.
Dosage and administration As an anticonvulsive medicine in adults the preparation is used intravenously in dose 100-320 mg, till maximal dose of 600 mg /24 hours. In children it is applied intravenously in dose 10-20 mg per kg body weight. The maintaining daily dose is 1-6 mg per kg body weight. Preoperatively in adults is applied intramuscularly in dose 130-200 mg, 6-9 minutes before the surgery. In the treatment of hyperbilirubinemia in newborns is applied intramuscularly, in dose 5-10 mg per kg body weight in the first several days after the birth.
Contraindications Hypersensitivity to barbiturates; porphyria; severe liver disorders; renal failure; respiratory tract diseases, accompanied with dyspnea and obstruction; pregnancy and lactation.
Special warnings and precautions In elderly and debil patients, as well as in children a higher sensitivity to barbiturates is seen, which is expressed by different reaction, including excitation, confusion or depression. It requires in such patients the dose to be carefully specified and reduced. In long-term treatment dependence to the drug is possible to appear (mental and physical). In abrupt discontinuation of the treatment a severe abstinence could be seen. Aforementioned requires the preparation to be applied for a short time, and to be stopped gradually. Phenobarbital exerts powerful influence on the active attention, reflex activity to external stimuli. It retards reactions of the patient, for this reason the preparation should not be used in drivers and machinery operating persons.
Drug interactions Phenobarbital is an inductor of the liver microsomal drugs, including metabolizing enzymes. It diminishes the action of the oral anticoagulants; griseofulvin; gestagens and estrogen; glucocorticoids; increases the toxicity of the metotrexat; potentiates effects of the antihypertensive drugs.
Adverse reactions Risk of addiction; abstinence syndrome (after abrupt discontinuation of long-term treatment); prominent sedation in patients with epilepsy; spirits changes; memory and cognitive function disorders; exantema; photosensibility.
Pharmacological mechanisms Phenobarbital is a barbiturate derivative possessing a nonselective depressive effect on the CNS. It facilitates the inhibitor action of the GAFA in several regions of CNS. Together with potentiating of the GAFA mediation Phenobarbital depresses unselectively the action of the stimulating neuromediators and influences the neuron membrane function out of synapse zone. As an anticonvulsive preparation Phenobarbital depresses selectively abnormally excited neurons in epileptic status, prolonged the posttetanic potentiation and improving the presynaptic inhibition. Phenobarbital possesses following additional pharmacology effects: analgesic; spasmolytic (on the smooth muscles) and moderate hypotensive effect.
Supplied 10 or 100 ampoules of 2 ml (200 mg).
Expiry 2 years. |