PHENOBARBITAL SODIUM Solution for injection Ref.[7809] Active ingredients: Phenobarbital

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Macarthys Laboratories Ltd, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford RM3 8UG

Therapeutic indications

An anti-convulsant for the treatment all forms of epilepsy except absence seizures.

Posology and method of administration

Posology

Adults: 50-200mg as a single dose by intramuscular, subcutaneous or, after dilution 1 in 10 with Water for Injection, by intravenous injection, repeated, if necessary, after 6 hours.

Paediatric population: 3-5mg per kg body weight as a single dose by intramuscular injection.

Method of administration

Intramuscular, subcutaneous or intravenous injection.

Overdose

Symptoms

These include drowsiness, dysarthria, ataxia, nystagmus and disinhibition. There may also be coma, hypotension, hypotonia, hyporeflexia, hypothermia, and respiratory and cardiovascular depression. The duration and depth of cerebral depression varies with the dose and the tolerance of the patient.

Treatment

Supportive measures alone may be sufficient if symptoms are mild. If an overdose of solution for injection is given,or erroneously taken by mouth, the prime objective of treatment is to maintain vital functions, respiration, cardiovascular and renal functions and the electrolyte balance while the majority of the drug is metabolised by hepatic enzymes. Given normal renal function, forced alkaline diuresis (maintaining the urinary pH at approximately 8 by intravenous infusion) may enhance the excretion of the drug from the kidneys. Charcoal haemoperfusion is the treatment of choice for the majority of patients with severe barbiturate poisoning who fail to improve or who deteriorate despite good supportive care.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Protect from light.

Nature and contents of container

Clear type 1 Ph Eur glass ampoules each containing sufficient product to allow removal of 1ml. Sold in cardboard outers of 10 ampoules.

Special precautions for disposal and other handling

None stated.

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