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Kusapin

Kusapin

oxcarbazepine

Manufacturer:

Kusum Healthcare

Distributor:

Kusum Healthcare
Concise Prescribing Info
Contents
Oxcarbazepine
Indications/Uses
Partial seizures w/ or w/o secondary generalized tonic-clonic seizures. Mono- or adjunctive therapy in adults & childn ≥6 yr.
Dosage/Direction for Use
Mono- & adjunctive therapy Adult Initially 600 mg daily (8-10 mg/kg daily) in 2 divided doses. Maintenance dose: May be increased by max of 600 mg daily increments at approx wkly intervals from starting dose. Max recommended dose: 2,400 mg/daily. Childn ≥6 yr Initially 8-10 mg/kg daily in 2 divided doses. Maintenance dose (in adjunctive therapy): 30-46 mg/kg daily. Max recommended dose: May be increased by max of 10 mg/kg daily increments at approx wkly intervals from starting dose, to max of 46 mg/kg daily. Renal impairment CrCl <30 mL/min Initially ½ the usual starting dose (300 mg daily) & increased in at least wkly intervals.
Administration
May be taken with or without food: Tab can be broken into 2 halves to make it easier for patient to swallow.
Contraindications
Special Precautions
Discontinue use if class I (immediate) hypersensitivity reactions develop; in case of seizure aggravation. Very rare reports of serious dermatological reactions including SJS, TEN (Lyell's syndrome) & erythema multiforme; agranulocytosis, aplastic anemia & pancytopenia. Screen individuals for HLA-B*1502 or HLA-A*3101 allele prior to treatment. Measure serum Na levels in patients w/ preexisting renal conditions associated w/ low Na or those treated concomitantly w/ Na-lowering medicinal products (eg, diuretics, desmopressin) as well as NSAIDs (eg, indometacin) prior to therapy & after approx 2 wk & then at mthly intervals for the 1st 3 mth during therapy. Regularly weigh patients w/ cardiac insufficiency & secondary heart failure to determine occurrence of fluid retention. Evaluate liver function & consider discontinuation when hepatic event is suspected. Monitor patients for signs of suicidal ideation & behaviours. Gradually w/draw when discontinuing use. May render hormonal contraceptives ineffective. Possible additive sedative effect w/ alcohol. Exercise caution when driving vehicle or operating machinery. Severe hepatic impairment. Renal impairment (CrCl <30 mL/min). Women of childbearing potential should use highly effective contraception during treatment. Do not interrupt therapy during pregnancy. Not to be used during lactation. Not recommended in childn <6 yr. Monitor thyroid function in the ped age group. Elderly.
Adverse Reactions
Somnolence, headache, dizziness; diplopia; vomiting, nausea; fatigue. Hyponatraemia; agitation (eg, nervousness), affect lability, confusional state, depression, apathy; ataxia, tremor, nystagmus, disturbance in attention, amnesia; blurred vision, visual disturbance; vertigo; diarrhoea, abdominal pain, constipation; rash, alopecia, acne; asthenia.
Drug Interactions
Lowered plasma conc of immunosuppressants (eg, ciclosporin, tacrolimus), OCs & some other antiepileptics (eg, carbamazepine). Decreased mean AUC values of ethinylestradiol & levonorgestrel. Decreased mean AUC & Cmin of carbamazepine. Increased mean AUC & Cmin of phenobarbitone & phenytoin. Decreased mean AUC & Cmin w/ carbamazepine, phenobarbitone, phenytoin & valproic acid. Increased risk of nausea, somnolence, dizziness & headache w/ lamotrigine. Possible interaction w/ MAOIs. May cause enhanced neurotoxicity w/ lithium.
MIMS Class
Anticonvulsants
ATC Classification
N03AF02 - oxcarbazepine ; Belongs to the class of carboxamide derivatives antiepileptic.
Presentation/Packing
Form
Kusapin FC tab 300 mg
Packing/Price
30's (P709.5/box)
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