Lamitor DT

Description

Lamitor DT Tablet (Lamotrigine)

Manufacturer: Torrent Pharmaceuticals Ltd. Generic Name: Lamotrigine Availability: Available in Nepal

Indications: Lamitor DT Tablet is used for:

• Epilepsy
• Bipolar disorder

Dosage:

Adult Oral Dose:

• Epilepsy (Monotherapy):
  • Initially: 25 mg once daily for 2 weeks, followed by 50 mg once daily for 2 weeks.
  • Thereafter: Increase the dose by a maximum of 50-100 mg every 1-2 weeks.
  • Usual maintenance doses: 100-200 mg daily, as a single dose or in 2 divided doses.
  • Some patients may require up to 500 mg daily.
• Adjunct in Epilepsy:
  • With Valproate:
    • Initially: 25 mg on alternate days for 2 weeks, followed by 25 mg once daily for 2 weeks.
    • Thereafter: Increase by a maximum of 25-50 mg every 1-2 weeks.
    • Usual maintenance doses: 100-200 mg daily in 1-2 divided doses.
  • With enzyme-inducing antiepileptics (but not with valproate):
    • Initially: 50 mg once daily for 2 weeks, followed by 50 mg twice daily for 2 weeks.
    • Thereafter: Increase by a maximum of 100 mg every 1-2 weeks.
    • Usual maintenance doses: 200-400 mg/day in 2 divided doses; up to 700 mg/day in some patients.
  • With oxcarbazepine (but no enzyme-inducing or -inhibiting antiepileptics):
    • Initially: 25 mg once daily for 2 weeks, followed by 50 mg once daily for 2 weeks.
    • Thereafter: Increase dose by a maximum of 50-100 mg every 1-2 weeks.
    • Usual maintenance doses: 100-200 mg daily in 1-2 divided doses; up to 500 mg daily in some patients.
• Bipolar Disorder:
  • Monotherapy:
    • Initially: 25 mg once daily for 2 weeks, followed by 50 mg once daily for 2 weeks.
    • Thereafter: Double the daily dose at weekly intervals to usual maintenance dose of 200 mg daily.
    • Max dose: 200 mg/day.
  • With Valproate:
    • Initially: 25 mg every other day for 2 weeks, followed by 25 mg once daily for 2 weeks.
    • Thereafter: Double the daily dose at weekly intervals to usual maintenance dose of 100 mg daily.
  • With enzyme-inducing antiepileptics (but not with valproate):
    • Initially: 50 mg once daily for 2 weeks, followed by 100 mg daily in 2 divided doses for 2 weeks.
    • Thereafter: Increase in 100-mg increments weekly to usual maintenance dose of 400 mg daily in 2 divided doses.
• Hepatic Impairment:
  • Moderate impairment (Child-Pugh category B): Reduce dose by about 50%.
  • Severe impairment (Child-Pugh category C): Reduce dose by about 75%.

Child Oral Dose:

• Epilepsy (Monotherapy):
  • >12 years: Initially, 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 weeks; thereafter, increase the dose by a maximum of 50-100 mg every 1-2 weeks to usual maintenance doses of 100-200 mg daily, as a single dose or in 2 divided doses. Some patients may require up to 500 mg daily.
  • <12 years: Not recommended.
• Adjunct in Epilepsy:
  • With Valproate:
    • Initially: 0.15 mg/kg once daily for 2 weeks, followed by 0.3 mg/kg once daily for 2 weeks.
    • Thereafter: Increase by a maximum of 0.3 mg/kg every 1-2 weeks to usual maintenance doses of 1-5 mg/kg once daily or in 2 divided doses.

Renal Dose:

• Renal impairment: Use with caution; dose reduction may be considered in significant renal impairment.

Administration: May be taken with or without food.

Contraindications:

• Known hypersensitivity to lamotrigine or any of its components.

Precautions:

• Hepatic or renal impairment: Use with caution.
• Closely monitor patients.
• Monitor children’s body weight.
• Advise patients to report any hypersensitivity reaction (e.g., rash).
• Avoid abrupt withdrawal unless severe skin reactions have developed.
• May impair ability to drive or operate machinery.
• Pregnancy and lactation: Use with caution.

Pregnancy-Lactation:

• Lactation: Distributed into human breast milk; caution advised.
• Pregnancy: Use with caution.

Interactions:

• Metabolism enhanced by: Enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination).
• Metabolism reduced by: Sodium valproate.

Adverse Effects:

>10%:

• Dizziness (38%)
• Diplopia (26-30%)
• Headache (29%)
• Ataxia (22%)
• Blurred vision (16-20%)
• Rhinitis (11-15%)
• Somnolence (14%)

1-10%:

• Insomnia (6-10%)
• Fatigue (8%)
• Chest pain (5%)
• Peripheral edema (2-5%)
• Suicidal ideation (2-5%)
• Dermatitis (2-5%)
• Dry skin (2-5%)
• Increased libido (2-5%)
• Rectal hemorrhage (2-5%)
• Weakness (2-5%)
• Agitation (1-5%)
• Dysarthria (1-5%)
• Edema (1-5%)
• Fever (1-5%)
• Migraine (1-5%)
• Abnormal thoughts (1-5%)
• Urinary frequency (1-5%)
• Tremor (4%)

Frequency Not Defined:

• Palpitations
• Anxiety
• Chills
• Depression
• Decreased memory
• Emotional lability
• Incoordination
• Malaise
• Seizure exacerbation
• Vertigo
• Pruritus
• Rash
• Amenorrhea
• Hot flashes
• Abdominal pain
• Constipation
• Diarrhea
• Dyspepsia
• Nausea
• Vomiting
• Arthralgia
• Neck pain
• Cough
• Flu syndrome
• Infection
• Vaginitis
• Nystagmus

Potentially Fatal:

• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Mechanism of Action: Lamotrigine inhibits voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and consequently inhibiting the pathological release of excitatory amino acids (e.g., glutamate and aspartate). These amino acids play a role in the generation and spread of epileptic seizures.

Note: Farmaco Nepal drug index information on Lamitor DT Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment