Oleptal Tablet
Oxcarbazepine
600 mg
Torrent Pharmaceuticals Ltd.
| Pack size | 1 |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 27.77 NPR |
Available as:
Indications
Oleptal Tablet is used for:
Partial seizures, Generalised tonic-clonic seizures
Adult Dose
Oral
Partial seizures
Adult:
Adjunctive treatment
300 mg PO q12hr initially; may increase at weekly intervals by 600 mg/day up to 1200 mg/day
Monotherapy (if converting from other AED)
Initial: 300 mg PO q12hr; increase by 600 mg/day qWeek up to 2400 mg/day
Reduce and withdraw concomitant antiepileptic drugs (AEDs) over 3-6 weeks while reaching maximum oxcarbazepine dose in 2-4 weeks
Monotherapy (if AED naive)
Initial: 300 mg PO q12hr; increase by 300 mg/day q3Day to 1200 mg/day divided q12hr
Diabetic Neuropathy
150-300 mg/day PO initially; may increase to 900-1200 mg/day (general recommendation)
Neuralgia/Neuropathy
300 mg PO q8-12hr initially; may adjust dose to 400-2000 mg divided q8-12hr (maximum tolerated or effective dose)
Hepatic impairment
Mild to moderate: No dose adjustment required
Severe: Unknown if dosage adjustment necessary
Child Dose
Partial Seizures (Adjunctive Treatment)
(age 2-4 years)
Initial: 8-10 mg/kg/day PO divided q12hr; not to exceed 600 mg/day
<20 kg: May start with16-20 mg/kg/day; may titrate to higher dose over 2-4 weeks; not to exceed 60 mg/kg/day
(age 4-16 years)
Initial: 8-10 mg/kg/day PO divided q12hr; not to exceed 600 mg/day
Target maintenance dose: May titrate to higher dose over 2 weeks to reach the following dosage ranges
20-29 kg: 450 mg PO q12hr
29.1-39 kg: 600 mg PO q12hr
>39 kg: 900 mg PO q12hr
Partial Seizures (Monotherapy)
(age 4-16 years)
AED: Initial, 8-10 mg/kg/day PO divided q12hr; may increase qWeek by maximum increment of 10 mg/kg/day
AED-naive: Initial 8-10 mg/kg/day PO divided q12hr; may increase q3Days by 5 mg/kg/day
Target maintenance: Weight-based dosing may be as high as 2100 mg/day for >60 kg
20-24.99 kg: 600-900 mg/day
25-34.99 kg: 900-1200 mg/day
35-44.99 kg: 900-1500 mg/day
45-49.99 kg: 1200-1500 mg/day
50-59.99 kg: 1200-1800 mg/day
60-69.99 kg: 1200-2100 mg/day
70 kg: 1500-2100 mg/day
Renal Dose
Renal impairment
CrCl <30 mL/min: Decrease initial dose by 50%, titrate up slowly
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Lactation.
Precautions
Patient carrying the HLA-B*1502 allele. Avoid abrupt withdrawal. Severe renal and hepatic impairment. Pregnancy. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor seizure frequency, serum Na, symptoms of CNS depression, hypersensitivity reactions, serum levels of concomitant antiepileptic drugs during titration; periodic thyroid function test and CBC.
Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human milk; milk-to-plasma concentration ratio of 0.5 was found for both
Because of the potential for serious adverse reactions in nursing infants, a decision should be made as to whether a mother should discontinue nursing or whether she should discontinue use of the drug, taking into account the drug's importance to the mother
Pregnancy-Lactation
Interactions
Reduced serum levels with carbamazepine, phenobarbitone, phenytoin, valproic acid. May reduce levels/effects of CYP3A4 substrates (e.g. benzodiazepines, calcium channel blockers, clarithromycin, ciclosporin, erythromycin, oestrogens, mirtazapine, nateglinide, nefazodone, nevirapine, protease inhibitors, tacrolimus, venlafaxine). May reduce efficacy of oral contraceptives. May reduce levels/effects of maraviroc. May increase levels of phenobarbitone, phenytoin.
Adverse Effects
Side effects of Oxcarbazepine :
>10%
Dizziness (30-50%),Diplopia (30-50%),Headache (26-30%),Nausea/vomiting (26-30%),Nystagmus (26-30%),Somnolence (26-30%),Ataxia (10-30%),Abnormal gait (16-20%),Tremor (16-20%),Abdominal pain (11-15%),Fatigue (11-15%),Vertigo (11-15%),Vision abnormalities (11-15%)
1-10%
Dyspepsia (5-6%),Rash (4%),Insomnia (2-4%),Abnormal thinking (<4%),Hyponatremia (1-3%),Muscle weakness (1-2%),Hypotension (<2%),Speech disorder (1%),Asthenia
Mechanism of Action
Oxcarbazepine blocks voltage-sensitive sodium channels, which inhibits repetitive firing, stabilises hyperexcited neuronal membranes and decreases release of synaptic impulses. These effects may prevent the spread of epileptic seizures.
Note
Oleptal 600 mg Tablet manufactured by Torrent Pharmaceuticals Ltd.. Its generic name is Oxcarbazepine. Oleptal is availble in Nepal.
Farmaco Nepal drug index information on Oleptal Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.