Lamotrigine Tablets (Lametec) is used as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome in adults as well as children above 2 years of age. Lamotrigine is also used for the prevention of mood episodes in patients with bipolar disorder.

1. Lamotrigine Tablets
Lamotrigine Tablets (Lametec) is used as
adjunctive therapy in the treatment of epilepsy, for
partial seizures and generalised seizures,
including tonic-clonic seizures and the seizures
associated with Lennox-Gastaut syndrome in
adults as well as children above 2 years of age.
Lamotrigine is also used for the prevention of
mood episodes in patients with bipolar
disorder.
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2. Lamotrigine Tablets
Chemical Structure
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3. Lamotrigine Tablets
Active Ingredient
The active pharmaceutical ingredient
present in Lametec tablets is
Lamotrigine.
Each Lametec 25 mg tablet contains
25 mg of the active ingredient
Lamotrigine.
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4. Lamotrigine Tablets
Recommended Adult Dosage
➔Dosage in Epilepsy add-on therapy for Adults
(over 12 years of age):
➔In patients taking valproate with/without any other
anti-epileptic medicine (AEM), the initial lamotrigine
dose is 25 mg every alternate day for two weeks,
followed by 25 mg once a day for two weeks.
Thereafter, the dose should be increased by a
maximum of 25 to 50 mg every 1 to 2 weeks until
the optimal response is achieved. The usual
maintenance dose to achieve optimal response is
100 to 200 mg/day given once a day or in two
divided doses.The recommended adult (over 12
years) dosage for lametec (mg/day) is given below:
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5. Lamotrigine Tablets
Recommended Adult Dosage
➔Usual Maintenance Dose With enzyme-inducing
antiepileptic drugs(EIAEDs) & No Valproic acid
(VPA):
➔Weeks 1 & 2: 50mg/day (Once a day)
➔Weeks 3 & 4: 100mg/day (Two divided doses)
➔Usual Maintenance Dose: 300mg to 500mg/day
(Two divided doses). To achieve maintenence doses
may be incresed by 100mg/day every 1-2 weeks.
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6. Lamotrigine Tablets
Recommended Adult Dosage
EIAEDs & Valproic acid (VPA):
➔Weeks 1 & 2: 25 mg every other day
➔Weeks 3 & 4: 25mg (Once a day)
➔Usual Maintenance Dose: 100mg to 400mg/day
(Two divided doses). To achieve maintenence doses
may be incresed by 25 mg - 50mg/day every 1-2
weeks. As there exists a risk of rash the initial dose
and subsequent dose escalation should not be
exceeded.
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7. Lamotrigine Tablets
Recommended Dose Children (2 to 12 years of age):
In patients taking valproate with/without any other AEM,
the initial lamotrigine dose for treatment of in Epilepsy is
0.15 mg/kg bodyweight/day given once a day for two
weeks, followed by 0.3 mg/kg/day once a day for two
weeks.
➔Thereafter, the dose should be increased by a
maximum of 0.3 mg/kg every 1-2 weeks until the optimal
response is achieved.
➔The usual maintenance dose to achieve optimal
response is 1 to 5 mg/kg/day given once a day or in two
divided doses, with a maximum of 200 mg/day. The
recommended dose escalation for lamotrigine (lametec)
for children aged 2-12 years (total daily dose in mg/kg
body weight/day) on combined drug therapy is given
below.
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8. Lamotrigine Tablets
Recommended Dose Children (2 to 12 years of age):
With AED regimen containing VPA:
➔Weeks 1 & 2: 0.15mg/kg/day (1 or 2
divided doses)
➔Weeks 3 & 4: 0.3mg/kg/day (1 or 2
divided doses)
➔Usual Maintenance Dose: 1 mg to 5
mg/kg/day (Maximum 200mg/day in One
or Two divided doses).
➔To achieve maintenence doses may be
incresed by 0.5 - 1mg/kg/day every 1-2
weeks
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9. Lamotrigine Tablets
Recommended Dose Children (2 to 12 years of age):
Added to EIAEDs and without VPA:
➔Weeks 1 & 2: 0.6mg/kg/day (2 divided doses)
➔Weeks 3 & 4: 1.2mg/kg/day (2 divided doses)
➔Usual Maintenance Dose: 5mg - 15mg/kg/day
(Maximum 400mg/day in One or Two divided
doses)
➔To achieve maintenence doses may be
increased by 2 to 3 mg/kg/day every 1-2 weeks
➔After initial 4 weeks of therapy, the daily dosage
of Lametec DT may be doubled at weekly
intervals until an effective maintenance dosage
of 200 mg daily is reached. The daily dosages
should not exceed 200 mg daily.
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10. Lamotrigine Tablets
Recommended Adult Dosage
Bipolar Disorder Adults (18 years of age and over):
➔Because of the risk of rash, the initial dose and
subsequent dose escalation should not be exceeded.
Lamotrigine is recommended for use in bipolar patients
at risk for a future depressive episode. The
recommended initial adult dosage of Lametec DT is 25
mg once daily for 2 weeks, followed by 50 mg once daily
for 2 weeks.
➔For Patients NOT TAKING Carbamazepine, Phenytoin,
Phenobarbital, Primidone, or Valproate
➔Weeks 1 and 2 25 mg daily
➔Weeks 3 and 4 50 mg daily
➔Week 5 100 mg daily
➔Week 6 and 7 200 mg daily
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11. Lamotrigine Tablets
Contraindications
Generic Lamotrigine Tablets (Lametec) is
contraindicated in patients with the
following conditions:
➔Known hypersensitivity to Lamotrigine or any
inactive ingredient of this medication.
➔Lamotrigine Tablets (Lametec) should not be
used in pregnancy unless, in the opinion of the
doctor, the potential benefits of treatment to the
mother outweigh any possible risks to the
developing foetus.
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12. Lamotrigine Tablets
Side Effects of Lamotrigine Tablets
The most common possible side effects of
Generic Lamotrigine Tablets (Lametec) with an
incidence rate of 10% or more in adult
epilepsy clinical studies were dizziness,
headache, diplopia, ataxia, nausea, blurred
vision, somnolence, rhinitis, and rash.
Additional adverse reactions (incidence rate of
10% or more) reported in children in epilepsy
clinical studies included vomiting, infection,
fever, accidental injury, pharyngitis, abdominal
pain, and tremor.
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13. Lamotrigine Tablets
Side Effects of Lamotrigine Tablets
The most common possible side
effects of Generic Lamotrigine
Tablets (Lametec) with an incidence
rate of greater than 5% in adult
bipolar clinical studies were nausea,
insomnia, somnolence, back pain,
fatigue, rash, rhinitis, abdominal
pain, and xerostomia.
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14. Lamotrigine Tablets
Warnings And Precautions
➔Life-threatening serious rash and/or rash-related
death may result.
➔Fatal or life-threatening hypersensitivity reaction:
Multiorgan hypersensitivity reactions, also known as
Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS), may be fatal or life threatening.
Early signs may include rash, fever, and
lymphadenopathy. These reactions may be
associated with other organ involvement, such as
hepatitis, hepatic failure, blood dyscrasias, or acute
multiorgan failure. Lamotrigine tablets (Lametec)
should be discontinued if alternate etiology for this
reaction is not found.
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15. Lamotrigine Tablets
Warnings And Precautions
➔Blood dyscrasias (e.g., neutropenia,
thrombocytopenia, pancytopenia) may occur,
either with or without an associated
hypersensitivity syndrome.
➔Suicidal behavior and ideation.
➔Clinical worsening, emergence of new
symptoms, and suicidal ideation/behaviors may
be associated with treatment of bipolar disorder.
Patients should be closely monitored, particularly
early in treatment or during dosage changes.
➔Aseptic meningitis reported in pediatric and adult
patients.
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16. Lamotrigine Tablets
Warnings And Precautions
➔Lamotrigine has been reported to pass into breast milk in
highly variable concentrations, resulting in total lamotrigine
levels in infants of up to approximately 50% of the mother’s.
The potential benefits of breast feeding should be weighed
against the potential risk of adverse effects occurring in the
infant.
➔Lamotrigine is cleared primarily by metabolism in the liver.
Lamotrigine (Lametec tablets) should be administered with
caution in patients with hepatic impairment as clearance is
reduced.
➔Medication errors involving Lamotrigine tablets (Lametec)
have occurred. In particular the name Lamotrigine can be
confused with names of other commonly used medications.
Medication errors may also occur between the different
formulations of Lamotrigine (Lametec tablets) .
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17. Lamotrigine Tablets
Overdose Symptoms
Acute ingestion of doses in excess of 10 to 30 times
the maximum therapeutic dose of Lamotrigine, have
been reported. Overdoses involving quantities up to
15 g have been reported for lamotrigine, some of
which have been fatal.
Overdose has resulted in symptoms including
nystagmus, ataxia, blurred vision, coma, dizziness,
headache, impaired consciousness, increased
seizures, nystagmus, somnolence and vomiting.
QRS broadening (intraventricular conduction delay)
has also been observed in overdose patients.
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18. Lamotrigine Tablets
Overdose Treatment
No specific antidotes are available to treat
overdosage of Lamotrigine (Lametec
tablets).
In the event of overdosage, the patient
should be admitted to hospital and given
appropriate supportive therapy.
Measures should be taken to protect the
airways, as consciousness may be
impaired.
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19. Lamotrigine Tablets
Lametec Tablets 25 mg, 50 mg
and 100 mg manufactured by
Cipla Ltd., India
For more information click here
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