Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: SPONSOR: PSM Healthcare Limited, t/a API Consumer Brands, 14-16 Norman Spencer Drive, PO Box 76 401, Manukau City, AUCKLAND 2241, Telephone 0508 776746
Accepted: Phenobarbital is indicated for use as preoperative medication to help reduce anxiety and facilitate induction of anaesthesia.
Phenobarbital a long acting barbiturate is indicated as long term anticonvulsant therapy for the treatment of generalised tonic-clonic and simple partial (cortical focus) seizures.
Seizures (prophylaxis and treatment) of febrile seizures.
Phenobarbital is a barbiturate which may be used as an antiepileptic agent to control tonic-clonic (grand mal) and partial (focal) seizures.
The dose should be adjusted to the needs of the individual patient to achieve adequate control of seizures; this usually requires plasma concentrations of 10 to 40mcg per ml (43 to 172 micromoles per litre).
Up to 350 mg daily in divided doses may be taken.
Overdosage of barbiturates produce CNS depression ranging from sleep to profound coma to death; respiratory depression which may progress to Cheyne-Stoke respiration, central hypoventilation and cyanosis; cold, clammy skin and/or hypothermia or later fever, areflexia, tachycardia, hypotension and decreased urine formation. Pupils are usually slightly constricted but may be dilated in severe poisoning.
Patients with severe overdosage often experience typical shock syndrome; apnoea, circulatory collapse, respiratory arrest and death may occur. Complications such as pneumonia, pulmonary oedema or renal failure may also prove fatal. Other complications which may occur are congestive heart failure, cardiac arrhythmias and urinary tract infections. Some patients have developed bullous cutaneous lesions which heal slowly.
In an overdose of a barbiturate, the stomach may be emptied by lavage. The prime objectives of management are then intensive symptomatic and supportive therapy with particular attention being paid to the maintenance of cardiovascular, respiratory, and renal functions and to the maintenance of the electrolyte balance. Standard treatment for shock should be administered if necessary.
Several methods aimed at the active removal of a barbiturate with a long elimination half-life such as Phenobarbital have been employed and include forced diuresis, haemodialysis, peritoneal dialysis, and charcoal haemoperfusion, but with the possible exception of charcoal haemoperfusion the hazards of such procedures are generally considered to outweigh any purported benefits.
60 months from the date of manufacture when stored below 25°C.
Store below 25°C. Store in original package.
Keep out of reach of children.
Blister packs of 500 tablets.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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