Zeptol 200 mg

Description

Indications Zeptol is prescribed for the treatment of:

• Partial and secondary generalized tonic-clonic seizures
• Primary generalized tonic-clonic seizures
• Trigeminal neuralgia
• Prophylaxis of bipolar disorder

Use this medication only as directed by a registered physician.

Pharmacology Carbamazepine, the active ingredient in Zeptol, works by suppressing neural activity in the nucleus ventralis of the thalamus. It reduces the synaptic transmission of excitatory impulses and decreases the likelihood of neural discharge by limiting sodium ion influx across cell membranes. Additionally, it stimulates the release of antidiuretic hormone (ADH), enhancing its effect in promoting water reabsorption.

Dosage & Administration

Epilepsy:

• Adults and children over 12 years:
  • Initial dose: 200 mg twice daily (b.i.d.) for tablets or controlled-release tablets, or 1 teaspoon four times daily (q.i.d.) for suspension (400 mg/day).
  • Dose may be increased weekly by up to 200 mg/day using a b.i.d., t.i.d., or q.i.d. regimen until the optimal therapeutic response is achieved.
• Children aged 12-15 years:
  • Maximum recommended dose: 1000 mg per day.
  • In patients above 15 years, the daily dosage may go up to 1200 mg.
  • In rare cases, adults may require up to 1600 mg daily.
  • Maintenance dose: Typically 800-1200 mg daily.
• Children aged 6-12 years:
  • Initial dose: 100 mg twice daily (b.i.d.) for tablets or controlled-release tablets, or 1/2 teaspoon four times daily (q.i.d.) for suspension (200 mg/day).
  • The dose may be increased weekly by up to 100 mg/day.
  • Maximum dose: 1000 mg per day.
  • Maintenance dose: Typically 400-800 mg daily.
• Children under 6 years:
  • Initial dose: 10-20 mg/kg/day, given in divided doses as tablets (b.i.d. or t.i.d.) or as suspension (q.i.d.).
  • Dose adjustments should be made weekly to achieve an optimal clinical response.
  • Maximum recommended dose: 35 mg/kg per day.

Combination Therapy: Zeptol can be used alone or with other anticonvulsants. If adding to an existing regimen, the dose should be adjusted gradually while maintaining or reducing the dose of other anticonvulsants, except phenytoin, which may require an increase.

Trigeminal Neuralgia:

• Initial dose: 100 mg twice daily (b.i.d.) for tablets or controlled-release tablets, or 1/2 teaspoon four times daily (q.i.d.) for suspension (200 mg/day).
• The dose can be increased by up to 200 mg/day using increments of 100 mg every 12 hours (for tablets) or 50 mg q.i.d. (for suspension) as needed for pain relief.
• Maximum daily dose: 1200 mg.
• Maintenance dose: Generally, 400-800 mg daily is sufficient, though some patients may require as little as 200 mg or as much as 1200 mg per day.
• Dose reduction or discontinuation should be attempted at least once every three months.

Use this medication only as directed by a registered physician.

Drug Interactions

• Some women taking oral contraceptives have reported galactorrhoea within the first two months of Zeptol use.
• Hepatic enzyme inducers like Zeptol and phenytoin may interact, increasing Zeptol metabolism, which may require a dosage adjustment.

Contraindications Zeptol should not be used in patients with:

• Allergies to Carbamazepine or any of its ingredients
• Atrioventricular (AV) block
• History of bone marrow depression
• Hereditary blood disorders such as porphyrias
• Allergy to tricyclic antidepressants
• Recent use (within 14 days) of a monoamine-oxidase inhibitor (MAOI)

Side Effects Common side effects may include:

• Dizziness, drowsiness, ataxia
• Dry mouth, nausea, vomiting, abdominal pain
• Anorexia, leucopenia, proteinuria
• Bradycardia, heart failure, hypotension
• Erythematous skin rash, aplastic anemia

Severe adverse reactions have been observed in the hematologic, dermatologic, and cardiovascular systems, particularly during early treatment. Increased sensitivity to sunlight has been reported; sun exposure, tanning beds, and sunlamps should be avoided. Protective clothing or sunscreen is recommended for prolonged outdoor activities.

Pregnancy & Lactation

• Pregnancy Category D: Zeptol may pose risks to the fetus.
• Carbamazepine and its metabolites are excreted in breast milk. A decision should be made whether to discontinue breastfeeding or the medication.

Precautions & Warnings

• This medication may cause drowsiness or dizziness; caution is advised when operating machinery or driving.
• If skin reactions such as rashes, peeling, or itching occur, consult a physician immediately.
• Rare cases of liver complications have been reported; medical consultation is necessary for symptoms like jaundice, dark urine, nausea, vomiting, abdominal pain, or flu-like symptoms.
• Zeptol reduces blood levels of estrogen- and progesterone-containing contraceptives, potentially decreasing their effectiveness. Women requiring contraception should use a method containing at least 50 micrograms of estrogen or opt for non-hormonal alternatives (e.g., condoms).
• Zeptol should not be stopped abruptly unless directed by a physician, as sudden discontinuation can lead to symptom relapse.

Caution is advised in patients with:

• Mixed seizures, including absence seizures
• Elderly individuals
• Heart, kidney, or liver disease
• Psychotic illness history
• Increased intraocular pressure (e.g., glaucoma)
• Previous blood disorders caused by medications
• Prior discontinuation of Zeptol due to side effects or allergic reactions

Therapeutic Class Primary anti-epileptic drugs

Storage Conditions

• Store below 30°C in a dry place, away from light and moisture.
• Keep out of the reach of children.