This page is no longer updated.
It was archived on 8 July 2008 and is kept for historical purposes only. The latest content is available at http://www.who.int/selection_medicines/en/

 
WHO Essential Medicines Library

           Search
   

   
 
 
phenobarbital
Go back to Medicine List    

MODEL LIST INFORMATION
SECTION FORMULATION DISEASE/INDICATION RATIONALE FOR INCLUSION
05.00.00.00 ANTICONVULSANTS/ANTIEPILEPTICS Dosage form and strength

Injection: 200 mg/ml (phenobarbital sodium). 
Oral liquid: 15 mg/5 ml (phenobarbital) or 5 ml (phenobarbital sodium). 
Tablet: 15-100 mg (phenobarbital).



ATC Code
N03AA02

Type of List
Core List

All forms of epilepsy except absence seizures. Monitoring of therapeutic concentrations in palsma can improve safety and efficacy.

Effective and inexpensive.

Date added: 1977.

MODEL FORMULARY INFORMATION
GENERAL INFORMATION

Drug subject to international control under the Convention on Psychotropic Substances (1971)

 

Uses: generalized tonic-clonic seizures; partial seizures; neonatal seizures; febrile convulsions; status epilepticus (see notes above)

 

Contraindications: porphyria; absence seizures

 

Precautions: elderly, debilitated, children (may cause behavioural changes); impaired renal function (Appendix 4) or hepatic function (Appendix 5), respiratory depression (avoid if severe); pregnancy (see notes above; Appendix 2); breastfeeding (see notes above; Appendix 3); avoid sudden withdrawal; interactions: Appendix 1

 

SKILLED TASKS. May impair ability to perform skilled tasks, for example operating machinery, driving; see also notes above

 

Dose:

Generalized tonic-clonic seizures, partial seizures, by mouth, ADULT 60–180 mg at night; CHILD up to 8 mg/kg daily

Febrile convulsions, by mouth, CHILD up to 8 mg/kg daily

Neonatal seizures, by intravenous injection (dilute injection 1 in 10 with water for injections), NEONATE 5–10 mg/kg every 20–30 minutes up to plasma concentration of 40 mg/litre

Status epilepticus, by intravenous injection (dilute injection 1 in 10 with water for injections), ADULT 10 mg/kg at a rate of not more than 100 mg/minute (up to maximum total dose of 1 g); CHILD 5–10 mg/kg at a rate of not more than 30 mg/minute

 

NOTE. For therapeutic purposes phenobarbital and phenobarbital sodium may be considered equivalent in effect. Plasma concentration for optimum response 15–40 mg/litre (65–170 micromol/litre)

 

Adverse effects: sedation, mental depression, ataxia, nystagmus; allergic skin reactions including rarely, exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome (erythema multiforme); paradoxical excitement, restlessness and confusion in the elderly; irritability and hyperactivity in children; megaloblastic anaemia (may be treated with folic acid); osteomalacia; status epilepticus (on treatment withdrawal); hypotension, shock, laryngospasm and apnoea (with intravenous injection)

 



MEDICINE REFERENCES
WHO Guidelines: The treatment of epilepsy in developing countries: where do we go from here?
http://www.who.int/mental_health/media/en/98.pdf
Cochrane review: Phenobarbitone versus phenytoin monotherapy for partial onset seizures and generalized onset tonic-clonic seizures,
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD002217/frame.html
Cochrane review: Carbamazepine versus phenobarbitone monotherapy for epilepsy.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001904/frame.html