Oxetol 150

Presentation: Each film-coated tablet contains oxcarbazepine 150 mg.

Indications: Oxetol is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults and in children aged 4 years and older.

Dosage and Administration: The dosage should be individualized according to the patient's clinical response.

• Adults:
  • Monotherapy: The recommended initial dose is 300 mg twice daily. The dose may be increased in increments of 300 mg per day every 3 days to a target maintenance dose of 1200 mg per day. In some patients, doses up to 2400 mg per day may be needed.
  • Adjunctive Therapy: The recommended initial dose is 300 mg twice daily. The dose may be increased in increments of 300 mg per day every 3 days to a target maintenance dose of 600 mg to 1200 mg per day.
• Children (4 to 16 years of age):
  • Adjunctive Therapy: The recommended initial dose is 8-10 mg/kg/day given in two divided doses. The maintenance target dose is achieved over 2 weeks and is dependent on weight.

Oxetol tablets should be swallowed with liquid. They can be taken with or without food.

Side Effects: Common side effects may include dizziness, drowsiness, headache, nausea, vomiting, diplopia (double vision), fatigue, and ataxia (uncoordinated movement). Other possible side effects include tremor, rash, hyponatremia (low sodium levels), and abnormal vision.

Precautions:

• Hyponatremia: Clinically significant hyponatremia can develop during oxcarbazepine use. Serum sodium levels should be monitored during maintenance therapy, particularly in patients at risk of hyponatremia.
• Hypersensitivity Reactions:Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported withoxcarbazepine. Discontinue immediately if signs or symptoms of serious skin reactions occur.
• Anaphylactic Reactions and Angioedema: Cases of anaphylaxis and angioedema involving the larynx, glottis, lips, and eyelids have been reported. Discontinue oxcarbazepine and institute appropriate medical therapy if these reactions occur.
• Suicidal Behavior and Ideation: Antiepileptic drugs, including oxcarbazepine, increase the risk of suicidal thoughts or behavior. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior,and/or any unusual changes in mood orbehavior.
• Hepatic Injury: Rare cases of hepatitis have been reported. Discontinue oxcarbazepine if signs or symptoms of hepatic dysfunction occur.
• Withdrawal of AEDs: Antiepileptic drugs should be withdrawn gradually to minimize the potential for increased seizure frequency.
• Drug Interactions: Oxcarbazepine can interact with other medications, including other antiepileptic drugs, oral contraceptives, and certain other drugs. Inform your doctor of all medications you are taking.
• Pregnancy and Lactation: Oxcarbazepine may cause fetal harm when administered during pregnancy. It is recommended that women of childbearing potential use effective contraception during treatment. It is not known whether oxcarbazepine or its active metabolite are excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug.

Storage: Store below 30°C, protected from moisture. Keep out of reach of children.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.