Generic Name: Oxcarbazepine 300mg
Manufacturer/Distributor: Sun Pharmaceutical Industries Ltd.
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Indications
A prescription drug called oxetol 300 is used to treat and prevent epilepsy (seizures).
Oxcarbazepine is used to treat the following conditions:
Adults: In the treatment of partial seizures, monotherapy or additional therapy is used.
Pediatrics: The use of monotherapy to treat partial seizures in children aged 4 to 16 years.
In the treatment of partial seizures in children aged 2 to 16, adjunctive therapy is used.
Pharmacology
The metabolite derivative of Oxcarbazepine (the monohydroxy derivative, MHD) is responsible for the majority of Oxcarbazepine's pharmacological activity. Oxcarbazepine and MHD are hypothesized to work primarily by blocking voltage-sensitive sodium channels, resulting in the stabilization of hyperexcited neural membranes, inhibition of repeated neuronal firing, and a reduction in synaptic impulse propagation.
Dosage & Administration
Adults: initiate with a dose of 600 mg/day, given twice-a-day
Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day
Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks; reach maximum dose of Oxcarbazepine in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day
Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day.
Creatinine Clearance <30 mL/min: Initiate at one-half the usual starting dose and increase slowly
Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.
Adjunctive Patients (Aged 2–16 Years): For patients aged 4 to 16 years, the target maintenance dose should be achieved over 2 weeks. For patients aged 2 to <4 years, the maximum maintenance dose should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day
Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
Initiation of Monotherapy for Patients (Aged 4–16 Years): Increments of 5 mg/kg/day every third day
Interaction
Because Oxcarbazepine and its metabolite block the enzyme CYP2C19, interactions may occur when high doses of Oxazep are used with medical medicines metabolized by CYP2C19 (e.g. phenobarbital, phenytoin). Oxazep used with hormonal contraceptives may make some contraceptives ineffective (e.g. Ethinylestradiol and Levonorgestrel preparations). Oxazep lowers felodipine's AUC and Verapamil lowers MHD's bioavailability when taken together.
Contraindications
It is not recommended for people who are hypersensitive to the active ingredient or any of the excipients.
Side Effects
Somnolence, headache, dizziness, diplopia, nausea, vomiting, and exhaustion are the most commonly reported side effects. During Oxazep use, clinically severe hyponatremia can occur in a small percentage of cases. Rashes, pruritus, urticaria, angioedema, and reports of anaphylaxis have all been reported as Class I (immediate) hypersensitivity reactions.
Pregnancy & Lactation
Pregnancy: Based on data from a small number of pregnancies, Oxcarbazepine may cause significant birth abnormalities (such as cleft palate) if used during pregnancy. In a newborn baby. Antiepileptic drugs have been linked to bleeding issues in newborns. Vitamin K1 should be given as a precaution in the last few weeks of pregnancy and to the infant as a preventive strategy. The active metabolite (MHD) of oxcarbazepine crosses the placenta. In one example, the plasma MHD concentrations of the fetus and the mother were comparable.
Oxcarbazepine and its active metabolite (MHD) are excreted in human milk during lactation. As a result, Oxazep should not be taken while breastfeeding.
Storage Conditions
Temperatures should be kept between 20 and 25 degrees Celsius.
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