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.
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.
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.
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.
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. |
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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. |
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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 |
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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). |
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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 |
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Phenobarbitone
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Phenobarbitone Containing Brands
Phenobarbitone is used in following diseases
Drug - Drug Interactions of Phenobarbitone
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