Oxetol-150mg Tablet

Description

Oxetol-150mg Tablet: Comprehensive Overview

Product Overview: Oxetol-150mg Tablet is a branded medication containing Oxcarbazepine 150 mg as its active pharmaceutical ingredient. It belongs to the class of drugs known as antiepileptic drugs (AEDs) or anticonvulsants. Oxetol is manufactured by Sun Pharmaceutical Industries Ltd., a well-known pharmaceutical company with a strong presence in Nepal and globally.

Oxcarbazepine is structurally a derivative of carbamazepine, but it is often favored due to a potentially improved side effect profile, particularly regarding certain serious blood disorders and liver toxicity, though ongoing monitoring is still necessary. The 150mg strength is a lower dose often used for initiation of treatment, for children, or as part of a titration schedule to reach higher therapeutic doses.

Mechanism of Action: Oxcarbazepine primarily exerts its anticonvulsant effects through its active metabolite, 10-monohydroxy derivative (MHD). The main mechanism involves the blockade of voltage-sensitive sodium channels in the brain’s nerve cells. By stabilizing the hyperexcited neuronal membranes and inhibiting the rapid, repetitive firing of neurons, it effectively reduces the abnormal electrical activity that triggers seizures. This action prevents the initiation and spread of epileptic discharges. It may also have some minor influence on calcium channels and other neurotransmitter systems, contributing to its overall seizure-suppressing effects.

Therapeutic Uses (Indications): Oxetol-150mg is primarily prescribed for:

1. Partial (Focal) Seizures: This is its main indication. It is effective in controlling both simple partial seizures (where consciousness is maintained) and complex partial seizures (where consciousness is impaired). It can be used alone (monotherapy) or in combination with other AEDs (adjunctive therapy).
2. Generalized Tonic-Clonic Seizures (Grand Mal Seizures): While primarily indicated for partial seizures, Oxetol is also effective for managing primary generalized tonic-clonic seizures (grand mal seizures).
3. Neuropathic Pain (Off-label Use): Due to its nerve-calming properties, Oxcarbazepine is sometimes used off-label to help manage certain types of nerve pain, such as trigeminal neuralgia.
4. Bipolar Disorder (Off-label Use): In some clinical settings, it might be used off-label as a mood stabilizer in bipolar disorder, especially for patients who cannot tolerate or respond to other mood stabilizers.

Dosage and Administration:

• Oral Tablet: Oxetol-150mg tablets are taken orally, with or without food.
• Swallow Whole: The tablets should be swallowed whole with water. They should not be crushed, chewed, or broken unless specifically designed as a dispersible tablet (which should be mentioned on the packaging), as this can alter the drug’s release and effectiveness.
• Typical Dosing: The dosage is highly individualized and must be determined by a qualified healthcare professional. It is typically initiated at a lower dose (like 150mg or 300mg/day) and gradually increased over several days or weeks to achieve optimal seizure control with minimal side effects. It is usually taken twice daily.
• Consistency is Key: It is crucial to take the medication regularly at the same time each day to maintain consistent blood levels and maximize its effectiveness in preventing seizures.
• Do NOT stop suddenly: NEVER discontinue Oxetol-150mg abruptly without consulting your doctor. Abrupt withdrawal can significantly increase the risk of seizures, potentially leading to a life-threatening condition called status epilepticus. The dosage must be tapered gradually under medical supervision.
• Missed Dose: If a dose is missed, take it as soon as you remember, unless it is almost time for the next scheduled dose (e.g., within a few hours). In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to compensate for a missed one.
• Duration of Treatment: Treatment with Oxetol is often long-term. The duration will be decided by your doctor based on your response and seizure control.

Side Effects:

Like all medications, Oxetol-150mg can cause side effects. Many are mild and may subside as your body adjusts. However, some can be more serious and warrant immediate medical attention.

Common Side Effects (occurring frequently):

• Central Nervous System (CNS) Effects:
  • Dizziness, lightheadedness
  • Drowsiness, sleepiness, fatigue
  • Headache
  • Ataxia (unsteadiness, problems with balance and coordination)
  • Nystagmus (involuntary, rapid eye movements)
  • Tremor
  • Difficulty concentrating, memory impairment, confusion
• Gastrointestinal Effects:
  • Nausea, Vomiting
  • Abdominal pain
  • Diarrhea, Constipation
• Vision Problems:
  • Diplopia (double vision)
  • Blurred vision
• Other:
  • Weight gain (some individuals)

Precautions and Warnings:

Before taking Oxetol-150mg, and throughout treatment, it is essential to be aware of certain precautions and inform your doctor about your complete medical history.

• Abrupt Discontinuation: DO NOT STOP TAKING OXETOL-150MG SUDDENLY. Abrupt withdrawal can precipitate or worsen seizures, potentially leading to status epilepticus. Any dose reduction or discontinuation must be done gradually under strict medical supervision.
• Low Sodium Levels (Hyponatremia): Patients are at risk of developing low blood sodium levels. This risk is higher in individuals with kidney problems, heart conditions, or those taking other medications that can lower sodium (e.g., diuretics). Regular monitoring of blood sodium levels may be necessary, particularly during the initial phase of treatment and if symptoms of hyponatremia appear.
• Allergies: Do not take Oxetol-150mg if you have a known hypersensitivity to Oxcarbazepine, to any of its components, or if you have a known allergy to Carbamazepine (due to a cross-reactivity risk of about 25-30%).
• Liver and Kidney Impairment: Use with caution in patients with kidney disease or severe liver impairment. Dosage adjustments may be required, and regular monitoring of liver and kidney function may be necessary.
• Heart Conditions: Use with caution in patients with heart conditions, particularly those with heart rhythm issues or heart failure.
• Driving and Operating Machinery: Oxetol-150mg can cause dizziness, drowsiness, blurred vision, and problems with coordination. Therefore, avoid driving, operating heavy machinery, or performing tasks requiring mental alertness until you know how the medication affects you.
• Alcohol Consumption: Avoid alcohol while on Oxetol-150mg, as it can intensify central nervous system side effects like drowsiness and dizziness, and may also lower the seizure threshold.
• Pregnancy: Consult your doctor if you are pregnant, planning to become pregnant, or could become pregnant. Oxcarbazepine can cross the placenta and may be associated with an increased risk of birth defects and developmental problems. Your doctor will weigh the benefits against the potential risks and discuss alternative medications or supplemental folic acid. Effective contraception is essential for women of childbearing potential.
• Breastfeeding: Oxcarbazepine and its active metabolite pass into breast milk. It is generally not recommended during breastfeeding due to the potential for adverse effects on the infant (e.g., excessive sleepiness, poor feeding). Discuss this with your doctor.
• Children: Oxetol-150mg can be used in children. The dosage in children is usually based on age and body weight, determined by the doctor. Safety and efficacy in children younger than 2 years as adjunctive therapy and younger than 4 years as monotherapy have not been fully established.
• Drug Interactions: Oxcarbazepine can interact with various medications, potentially altering their effectiveness or increasing side effects. Key interactions include:
  • Hormonal Contraceptives: Oxcarbazepine can significantly reduce the effectiveness of hormonal birth control (pills, patches, injections), increasing the risk of unintended pregnancy. Patients should use alternative or additional non-hormonal birth control methods.
  • Other Antiepileptic Drugs: It can affect the blood levels of other AEDs (e.g., phenytoin, carbamazepine, valproic acid, lamotrigine), potentially requiring dose adjustments.
  • Certain Antidepressants (e.g., MAOIs, lithium).
  • Diuretics.
  • Always inform your doctor about all prescription and over-the-counter medications, herbal supplements, and vitamins you are taking.
• Regular Monitoring: Your doctor may recommend regular blood tests to monitor sodium levels, liver function, and other parameters, especially during the initial treatment phase or if side effects occur.

Prescription Information:

Oxetol-150mg Tablet is a prescription-only medication (POM). This means:

• It cannot be purchased over-the-counter without a valid prescription from a licensed medical doctor (typically a neurologist or psychiatrist).
• A doctor or neurologist must diagnose the condition (epilepsy or other indicated uses) and determine the appropriate dosage and duration of treatment.
• Regular follow-up appointments and necessary laboratory tests (e.g., blood sodium levels, liver function tests) are often required to ensure the medication’s effectiveness and manage potential side effects.