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Phenobarbitone Idaman

Phenobarbitone Idaman

phenobarbital

Manufacturer:

Idaman Pharma

Distributor:

Pharmaniaga Logistics
Concise Prescribing Info
Contents
Phenobarb
Indications/Uses
Short-term treatment of insomnia. Relieve anxiety, tension & apprehension. Long-term anticonvulsant therapy for generalised tonic clonic & simple partial seizures. Prophylaxis & treatment of febrile seizures. Prevention & treatment of hyperbilirubinemia in neonates. Lower bilirubin conc in patients w/ congenital non-haemolytic unconjugated hyperbilirubinemia or chronic intrahepatic cholestasis.
Dosage/Direction for Use
Usual dose: 30-125 mg tds, up to 350 mg daily in divided doses.
Contraindications
Hypersensitivity to phenobarb or barbiturates. Acute intermittent or history or porphyria; severe resp depression. Severe renal or hepatic impairment.
Special Precautions
Discontinue use if signs or symptoms of SJS or TEN, early manifestation of hypersensitivity are present; evidence of significant bone marrow depression develops. Resp depression; acute chronic pain. Monitor for signs of suicidal ideation & behaviours. Avoid sudden w/drawal. Long-term use. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Avoid concomitant use of telithromycin during & for 2 wk after last dose; concomitant use of voriconazole, eplerenone. May affect ability to drive & use machines. Renal impairment, existing hepatic disease. During labour & delivery. Pregnancy & lactation. Childn. Young, debilitated, geriatric or senile patients.
Adverse Reactions
Megaloblastic anaemia, agranulocytosis, thrombocytopenia; Dupuytren's contracture, frozen shoulder, arthralgia, osteomalacia, rickets; Peyronie's disease; paradoxical reaction, hallucinations, restlessness & confusion in elderly, mental depression, memory & cognitive impairment, drowsiness, lethargy, feeling faint, headache, nightmare, trouble sleeping, unusual irritability; hyperactivity, behavioural disturbances in childn, ataxia, nystagmus; hypotension; resp depression; hepatitis, cholestasis; allergic skin reactions, other skin reactions eg, exfoliative dermatitis, erythema multiforme; antiepileptic hypersensitivity syndrome, nausea, vomiting.
Drug Interactions
Additive CNS depressant effect w/ alcohol, other CNS depressants. Antagonized antiepileptic activity by antidepressants eg, MAOIs, SSRI, TCAs. Increased plasma conc by oxcarbazepine, phenytoin, Na valproate; methylphenidate. Decreased plasma conc by vigabatrin. Reduced serum levels of chlorpromazine, thioridazine; anticoagulants; paroxetine, mianserin; carbamazepine, lamotrigine, tiagabine, zonisamide, primidone, ethosuximide; itraconazole, posaconazole; aripiprazole; abacavir, amprenavir, darunavir, lopinavir, indinavir, nelfinavir, saquinavir; clonazepam; aprepitant; metoprolol, timolol, propranolol; felodipine, isradipine, diltiazem, verapamil, nimodipine, nifedipine; digitoxin; ciclosporin, tacrolimus; corticosteroids; etoposide, irinotecan; haloperidol; gestrinone, toremifene; methadone; montelukast; tibolone; tropisetron. Decreased seizure control w/ folic acid supplements. Reduced effect w/ memantine. Loss of disopyramide, quinidine arrhythmia control. Reduced antifungal effects of griseofulvin. Reduced contraceptive effects of oestrogens, progestogens. Enhanced effects of Na oxybate. Increased requirements for theophylline, thyroid hormones in hypothyroidism, vit D. Concomitant use w/ chloramphenicol, doxycycline, metronidazole, rifampicin.
MIMS Class
Anticonvulsants
ATC Classification
N03AA02 - phenobarbital ; Belongs to the class of barbiturates and derivatives antiepileptics.
Presentation/Packing
Form
Phenobarbitone Idaman tab 30 mg
Packing/Price
5 × 10's
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