Phenobarbitone

Indications
Oral
Partial seizures
Adult: 60-180 mg daily taken at night. Titrate dose according to patient's needs to achieve adequate control of seizures. Plasma concentrations of 15-40 mcg/ml (65-170 micromol/l) are usually required.
Child: 1 mth-12 yr: Initially, 1-1.5 mg/kg bid. Increase by 2 mg/kg daily, as required, to a maintenance dose of 2.5-4 mg/kg once or bid. 12-18 yr: Initially, 60-180 mg bid. Maintenance: 60-180 mg once daily.
CrCl (ml/min)Dosage Recommendation
<10Administer every 12-16 hr.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose as necessary.
Oral
Generalised tonic-clonic seizures
Adult: 60-180 mg daily taken at night. Titrate dose according to patient's needs to achieve adequate control of seizures. Plasma concentrations of 15-40 mcg/ml (65-170 micromol/l) are usually required.
Child: 1 mth-12 yr: Initially, 1-1.5 mg/kg bid. Increase by 2 mg/kg daily, as required, to a maintenance dose of 2.5-4 mg/kg once or bid. 12-18 yr: Initially, 60-180 mg bid. Maintenance: 60-180 mg once daily.
CrCl (ml/min)Dosage Recommendation
<10Administer every 12-16 hr.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose as necessary.
Oral
Sedation
Adult: 30-120 mg/day in 2-3 divided doses.
Child: 6 mg/kg/day or 180 mg/m2/day divided in 3 equal doses.
CrCl (ml/min)Dosage Recommendation
<10Administer every 12-16 hr.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose as necessary.
Oral
Hypnotic
Adult: 100-320 mg at bedtime. Do not admin for >2 wk for the treatment of insomnia.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose as necessary.
Oral
Preoperative sedation
Child: 1-3 mg/kg 1-1.5 hr before procedure.
Intramuscular
Emergency management of acute seizures
Adult: As sodium: 200 mg IM repeated after 6 hr if necessary.
Child: As sodium: 15 mg/kg IM as a single dose.
Intravenous
Status epilepticus
Adult: Doses of 10 mg/kg to a max of 1 g.
Child: As sodium: Neonates and children up to 12 yr: Initially, 20 mg/kg by slow IV inj then 2.5-5 mg/kg once or bid. 12-18 yr: Initially 20 mg/kg (max 1 g) by slow IV inj then 300 mg bid.
Intravenous
Generalised tonic-clonic seizures
Child: As sodium: Neonates: Loading dose is 20 mg/kg by slow IV inj followed by 2.5-5 mg/kg once daily either by slow IV inj or orally.
Intravenous
Partial seizures
Child: As sodium: Neonates: Loading dose is 20 mg/kg by slow IV inj followed by 2.5-5 mg/kg once daily either by slow IV inj or orally.
Intramuscular
Sedation
Adult: As sodium: 30-120 mg/day in 2-3 divided doses.
CrCl (ml/min)Dosage Recommendation
<10Administer every 12-16 hr.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose as necessary.
Parenteral
Hypnotic
Adult: As sodium: 100-320 mg at bedtime via IM/IV/SC inj.
Child: As sodium: 3-5 mg/kg at bedtime via IM/IV/SC inj.
Hepatic impairment: Severe: Monitor plasma levels and adjust dose accordingly.
Intramuscular
Preoperative sedation
Adult: As sodium: 100-200 mg 1-1.5 hr before procedure.
Child: As sodium: 16-100 mg 1-1.5 hr before procedure.
Intravenous
Preoperative sedation
Child: As sodium: 1-3 mg/kg 1-1.5 hr before procedure.

Reconstitution: Inj should be diluted 1 in 10 although 15 mg/ml may be considered in fluid-restricted children. Give dose over 20 min at a rate no >1 mg/kg/min.
Incompatibility: Y-site admin incompatible with amphotericin B cholesteryl sulfate complex, hydromorphone. Do not mix in the same syringe with hydromorphone, pentazocine, ranitidine, sufentanil. Do not admix with chlorpromazine, cimetidine, clindamycin, dimenhydrinate, diphenhydramine, droperidol, ephedrine, hydralazine, hydrocortisone sodium succinate, hydroxyzine, insulin (regular), kanamycin, levorphanol, meperidine, morphine, norepinephrine, pancuronium, penicillin G, pentazocine, phenytoin, procaine, prochlorperazine, promazine, promethazine, streptomycin, succinylcholine, vancomycin.
Contraindications
Severe renal and hepatic disorders. Severe respiratory depression, dyspnoea or airway obstruction; porphyria. Pregnancy.
Warnings / Precautions
Elderly or debilitated patients, children. Withdraw gradually. Impaired renal, hepatic and respiratory function. Patients with acute pain and depressive disorders. May impair ability to drive or operate machinery. Lactation.
Adverse Reactions
Bradycardia, hypotension, syncope; drowsiness, lethargy, CNS excitation or depression, impaired judgment, hangover effect, confusion, somnolence, agitation, hyperkinesia, ataxia, nervousness, headache, insomnia, nightmares, hallucinations, anxiety, dizziness; rash, exfoliative dermatitis; nausea, vomiting, constipation; agranulocytosis, thrombocytopenia, megaloblastic anaemia; pain at inj site, thrombophlebitis (IV); oliguria: laryngospasm, respiratory depression, apnoea (especially with rapid IV admin), hypoventilation.
Potentially Fatal: Stevens-Johnson syndrome.
Overdose Reactions
Symptoms: Unsteady gait, slurred speech, confusion, jaundice, hypothermia, hypotension, respiratory depression, coma. Management: Charcoal haemoperfusion (in severe cases). Treatment is symptomatic and supportive.
Drug Interactions
May enhance the hepatotoxic potential of paracetemaol overdoses. May decrease levels/effects of various CYP isoenzyme substrates e.g. teniposide, methotrexate, antipsychotics, β-blockers, calcium-channel blockers, other anticonvulsants, chloramphenicol, cimetidine, corticosteroids, ciclosporin, doxycycline, oestrogens, felbamate, griseofulvin, tacrolimus, furosemide, methadone, oral contraceptives, theophylline, TCAs, warfarin. May reduce effects of guanfacine. Reduced metabolism and or increased toxicity with chloramphenicol, felbamate, MAOIs, valproic acid. May enhance the nephrotoxic effects of methoxyflurane.
Potentially Fatal: Additive sedation and/or respiratory depression with ethanol, sedatives, antidepressants, opioid analgesics, benzodiazepines and other CNS depressants. May decrease levels/effects of antiarrhythmic drugs e.g. disopyramide, propafenone, quinidine.
See Below for More phenobarbital Drug Interactions
Lab Interactions
May increase sulfobromophthalein retention and give elevated readings; do not administer within 24 hr preceding the test.
Food Interactions
Evening primrose may reduce seizure threshold. Increased CNS depression may occur with valerian, St John's wort, kava kava, gotu kola.
Mechanism of Actions
Phenobarbitone is a short-acting barbiturate. It depresses the sensory cortex, reduces motor activity, changes cerebellar function, and produces drowsiness, sedation and hypnosis. Its anticonvulsant property is exhibited at high doses.
Onset: Hypnosis: Oral: 20-60 min; IV: Approx 5 min.
Duration: Oral: 6-10 hr; IV: 4-10 hr.
Absorption: Readily absorbed from the GI tract (oral); peak plasma concentrations in about 2 hr (oral), and within 4 hr (IM).
Distribution: Crosses the placenta; enters breast milk. Protein-binding: 45-60%.
Metabolism: Partly hepatic.
Excretion: Via urine (as unchanged drug). Plasma half-life: 75-120 hr (adult), greatly prolonged (neonates), 21-75 hr (children).
Storage Conditions
Intramuscular: Protect from light. Intravenous: Protect from light. Oral: Protect from light. Parenteral: Protect from light.
ATC Classification
N03AA02 - phenobarbital ; Belongs to the class of barbiturates and derivatives antiepileptics.
Storage
Intramuscular: Protect from light. Intravenous: Protect from light. Oral: Protect from light. Parenteral: Protect from light.
Available As
  • Phenobarbitone 10 mg
  • Phenobarbitone 100 mg
  • Phenobarbitone 15 mg
  • Phenobarbitone 16 mg
  • Phenobarbitone 20 mg
  • Phenobarbitone 200 mg
  • Phenobarbitone 30 mg
  • Phenobarbitone 32 mg
  • Phenobarbitone 4 mg
  • Phenobarbitone 50 mg
  • Phenobarbitone 50 mg.
  • Phenobarbitone 6 mg
  • Phenobarbitone 60 mg
  • Phenobarbitone 8 mg
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