Drug Interaction:
Hormonal contrceptives, drugs causing hyponatraemia NSAIDs , alcohol, phenobarbitone, henytoin, carbamazepine.amotrigine, valproate, Diazepam, cyclosporin, tacrolimus CNS depresants, thyroid tests T4 Verapramil, felodipine.
MAOIS, lithium, Imipramine, amytriptyline, citalopram, clomipramine, cyclophosphamide, progesterone, Omeprazole, propranolol, lansoprazole, pantroprazole, Other drugs metabolised by CYP2C19 , Calcium antagonist, St Johns wort
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 47
Name of the Drug- Oxcarbazepine SR 450mg/900mg
( addl.stgth) Pharmacological Classification- Anti-epileptic
Date of Approval- 19-05-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
Partial seizures with or without secondary generalized tonic- clonic seizures
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Oxcarbazepine Anti-eplileptic 30-10-2001
2.Oxcarbazepine 13-08-2009
150/300/600mg tablet
Addl.Indn.
Treatment of Generalized toniclonic seizures in adults and
children
3.Oxcabazepine SR 19-05-2006
450/900mg
Addl.Stgth
Anti-epileptic
4.Oxcarbazepine 26-11-2009
150/300/600mg tablet
Addl.Indn
Monotherapy in the treatment of Partial seizures in children
ages 4-16
Adverse Reaction:
Fatigue, asthenia, CNS & g. i. disturbances, hyponatremia, dizziness, headache, somnolence, agitation, amnesia, impaired concentration, confusion, depression, emotional liability apathy, ataxia, tremor, abnormal gait, Abdominal pain, rash, acne,
Serious skin reactions, Toxic necrosis, Steven-Johnson syndrome Thrombocytopenia, Hepatitis, Loss of hair Multi-organ hypersentivity reactions
Diplopia, nystagmus, blurred vision Suicidal ideation or behaviour Rarely anaphylaxis and angoedema, involoving the larynx, glotis, lips and eyelids
Contra-Indications:
Lactation
Special precautions-
Pregnancy Hypersentivity to carbamazepine
Severe hepatic impairment Monitor sodium levels in patients at risk prior to and during therapy Elderly
Cardiovascular disease Monitor weight in cardiac insufficiency or heart failure
Cardiac conduction disturbances.
Monitor for skin reactions Withdraw immediately if occur and do not restart therapy Withdraw gradually
Dosages/ Overdosage Etc:
Date of Approval 2001
Indication-
Partial seizures with or without secondary generalized tonic- clonic seizures
Dosage-
Initially 600mg daily in two divided doses. Increase if necessary at weekly intrebvals using increments of up to 600mg daily Usually dose - 600mg -2400mg daily
Renal impairement - initially half usual dose Not recommended for children below 6 years.
Above 6 years - initially 8-10mg /kg daily in divided doses. Increase if necessary at weekly intrevals using increments of upto 10mg/kg daily Usual dose- 340mg/kg daily Maximum 46mg/kg daily
Pregnancy and lactation:
Contraindicated for use during pregnancy and lactation Observe caution if use needed
Manufacturer Details