Epitan Tablet
Phenobarbitone (Phenobarbital)
60mg
Reliance Formulation Pvt Ltd.
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Available as:
Indications
Epitan Tablet is used for:
Status epilepticus, Partial seizures, Sedation, Generalised tonic-clonic seizures, Hypnotic, Preoperative sedation
Adult Dose
Oral
Sedation
Adult: 30-120 mg daily in 2-3 divided doses, do not exceed 400 mg/day
Status epilepticus ; Emergency management of acute seizures
Adult: 100-300 mg daily at bedtime.
Generalised tonic-clonic seizures, Partial seizures
Adult: 60-180 mg/day at night.
Insomnia
Adult: 100-200 mg daily at bedtime, do not exceed 400 mg/day
As a hypnotic
Adult: 100-320 mg. Do not admin for >2 wk for the treatment of insomnia.
Elderly: Reduce dose.
Hepatic impairment: Reduce dose. Severe: Contraindicated.
Child Dose
Oral
Sedation
Child: 2 mg/kg daily in 3 divided doses.
Status epilepticus ; Emergency management of acute seizures
Child: 3-5 mg/kg or 125 mg/m2 daily.
Seizures
Neonates (<28 days): 3-5 mg/kg/day in 1-2 divided doses
Infants: 5-6 mg/kg/day in 1-2 divided doses
1-5 years: 6-8 mg/kg/day in 1-2 divided doses
6-12 years: 4-6 mg/kg/day in 1-2 divided doses
>12 years: 1-3 mg/kg/day in 1-2 divided doses, OR 50-100 mg BID/TID
Preoperative sedation
Child: 1-3 mg/kg pre-op.
Renal Dose
Renal impairment: Reduce dose. Severe: Contraindicated.
Administration
May be taken with or without food.
Contra Indications
Severe renal and hepatic disorders. Severe respiratory depression, dyspnoea or airway obstruction; porphyria. Pregnancy.
Precautions
Patient w/ history or sedative/hypnotic addiction; resp disease, depression or suicidal tendencies, hypoadrenalism. Avoid abrupt withdrawal. Mild to moderate renal and hepatic impairment. Elderly or debilitated patient, childn. Pregnancy and lactation. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor CBC, LFTs, mental status and seizure activity.
Lactation: Do not nurse
Pregnancy-Lactation
Interactions
May enhance the hepatotoxic potential of paracetemaol overdoses. May decrease levels/effects of various CYP isoenzyme substrates e.g. teniposide, methotrexate, antipsychotics, beta-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.
Adverse Effects
Side effects of Phenobarbitone (Phenobarbital) :
Common
Ataxia,Dizziness,Drowsiness,Dysarthria,Fatigue,Headache,Irritability,Nystagmus,Paresthesia restlessness,Vertigo
Geriatric patients: Excitement, confusion, depression
Pediatric patients: Paradoxical excitement/hyperactivity
Less Common
Mental dullness,Constipation,Diarrhea,Nausea,Vomiting,Megaloblastic (folate-deficiency) anemia
Uncommon
Rash,Hypocalcemia,Hepatotoxicity
Rare
Stevens-Johnson syndrome,Rickets,Osteomalacia
Potentially Fatal: Stevens-Johnson syndrome.
Mechanism of Action
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.
Note
Epitan 60mg Tablet manufactured by Reliance Formulation Pvt Ltd.. Its generic name is Phenobarbitone (Phenobarbital). Epitan is availble in Nepal.
Farmaco Nepal drug index information on Epitan Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.