PHENOBARBITAL ACCORD Tablet Ref.[7807] Active ingredients: Phenobarbital

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Therapeutic indications

The treatment and control of all forms of epilepsy, except absence seizures. Phenobarbital should only be used in the treatment of febrile convulsions in exceptional circumstances.

Posology and method of administration

Adults: 60-180mg at night.

Child: 5-8mg/kg daily.

Elderly: Phenobarbital clearance diminishes in the elderly. Therefore the dose of phenobarbital is usually lower in elderly patients.

The dose of phenobarbital should be adjusted to meet the needs of individual patients. This usually requires plasma concentration of 15 to 40 micrograms/ml (65 to 170 micromoles/litre).

Method of Administration

For oral administration.

Overdose

Toxicity varies between patients; tolerance will develop with chronic use. Features of poisoning are to be expected after ingestion of 1g in adults.

Features

Drowsiness, dysarthria, ataxia, nystagmus and disinhibition. There may also be coma, cardiovascular collapse, cardiac arrest, hypotension, hypotonia, hyporeflexia, hypothermia, hypotension and respiratory depression.

Barbiturates decrease gut motility, which may lead to slow onset and worsening of symptoms or cyclical improvement and worsening of symptoms.

Management

Consider activated charcoal (50g for an adult, 10-15g for a child under 5 years) if more than 10mg/kg body weight of phenobarbital has been ingested within 1 hour, provided the airway can be protected. Repeat dose activated charcoal is the best method of enhancing elimination of phenobarbital in symptomatic patients. In severe hypotension dopamine or dobutamine can be used. Treat rhabdomyolysis with urinary alkalinistion. Haemodialysis or haemofiltration may be required for cases of acute renal or severe hyperkalaemia.

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

18 months.

Special precautions for storage

Store below 25ยฐC. Keep the blister in the outer carton in order to protect from light.

Nature and contents of container

The product may be supplied in blister packs.

  • 250ยตm white rigid PVC.
  • 20ยตm aluminium foil.

Pack size: 28 tablets.

Special precautions for disposal and other handling

No specific instructions. All medicines should be stored out of the reach of children.

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