LAMITOR Tablet Ref.[50455] Active ingredients: Lamotrigine

It is important to adhere to the recommended dosages especially in combination therapy with valproate where one-tenth of the normal dose is used.

Do not exceed the maximum dosage (see WARNINGS). To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed if necessary. If the doses calculated for children according to bodyweight, do not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets.

Dosage in monotherapy

Adults and children over 12 years of age

Initial dose in monotherapy: 25 mg once daily for two weeks, followed by 50 mg once daily for two weeks. The dosage may be increased by a maximum of 50 – 100 mg every 1 to 2 weeks until the optimal response is achieved.

Maintenance dose in monotherapy: The usual dose to achieve optimal response is 100–200 mg per day given in one dose or two divided doses. Some patients have required 500 mg/day of LAMITOR to achieve the desired response.

Adults and Children over 12 years (total daily dose):

The recommended initial dose and subsequent dose escalation should not be exceeded to minimise the risk of skin rash (see WARNINGS).

Dosage in add-on therapy

Adults and children over 12 years of age

The initial LAMITOR dose in those patients not taking sodium valproate: The initial dose is 50 mg once a day for two weeks, then 100 mg a day, divided into two doses, for two weeks. The dosage may be increased by a maximum of 100 mg every 1 to 2 weeks until the optimal response is achieved. The usual maintenance dose is 200 – 400 mg/day given in two divided doses.

In those patients taking sodium valproate: The initial dose is 25 mg once every other day for two weeks, then 25 mg once a day for two weeks. The dosage may be increased by a maximum of 25–50 mg a day every 1 or 2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100–200 mg/day given once a day or in two divided doses. In patients taking antiepileptic drugs where the pharmacokinetic interaction with LAMITOR is currently not known, the dose escalation as recommended for LAMITOR with concurrent valproate should be used. Thereafter, the dose should be increased until the optimal response is achieved.

Adults and Children over 12 years (total daily dose):

The recommended initial dose and subsequent dose escalation should not be exceeded to minimise the risk of skin rash (see WARNINGS).

Children aged 2 to 12 years

The initial LAMITOR dose in those children not taking sodium valproate: The initial dose is 0,6 mg/kg body-weight daily given in two divided doses for two weeks, followed by 1,2 mg/kg daily in 2 divided doses for two weeks. Thereafter, the dose should be increased by a maximum of 1,2 mg/kg every 1 to 2 weeks until the optimal response is achieved. The usual maintenance dose is 5–15 mg/kg/day given in two divided doses. A maximum daily dose of 400 mg must not be exceeded.

In those children taking sodium valproate: The initial dose of 0,15 mg/kg once daily for two weeks, followed by 0,3 mg/kg once daily for two weeks. Thereafter the dose is increased by a maximum of 0,3 mg/kg every 1 to 2 weeks until the optimal response is achieved. The usual maintenance dose is 1 – 5 mg/kg, which may be given once a day or in two divided doses. A maximum daily dose of 200 mg must not be exceeded.

In patients taking antiepileptic drugs where the pharmacokinetic interaction with LAMITOR is currently not known, the dose escalation as recommended for LAMITOR with concurrent valproate should be used. Thereafter, the dose should be increased until the optimal response is achieved.

Children aged 2 to 12 years (total daily dose):

The recommended initial dose and subsequent dose escalation should not be exceeded to minimise the risk of skin rash (see WARNINGS).

Note: If the calculated daily dose is 2,5–5 mg, then 5 mg LAMITOR may be taken on alternate days for the first two weeks. If the calculated daily dose is less than 2,5 mg, then LAMITOR should not be administered. Patients aged 2–6 years may require a maintenance dose at the higher end of the recommended range.

Dosage in seizures associated with Lennox-Gastaut Syndrome

The dosing guidelines outlined above for both adults and children aged 2–12 years apply for the treatment of seizures associated with Lennox-Gastaut Syndrome.

Children aged less than 2 years

There is insufficient information on the use of LAMITOR in children aged less than two years.

Symptoms and signs

Acute ingestion of doses in excess of 10 – 20 times the maximum therapeutic doses has been reported. Overdose has resulted in symptoms including nystagmus, ataxia, impaired consciousness and coma.

Treatment

In the event of overdosage, the patient should be admitted to hospital and given appropriate supportive therapy. Gastric lavage should be performed if indicated.

Store at or below 25ºC in a dry place.

Keep tablets in the original blister packs until a dose is to be taken.

KEEP OUT OF REACH OF CHILDREN.

LAMITOR–25: 60 tablets, as six PVC/Aluminium foil blister strips of 10 tablets each, in a carton.

LAMITOR–50: 60 tablets, as six PVC/Aluminium foil blister strips of 10 tablets each, in a carton.

LAMITOR–100: 60 tablets, as six PVC/Aluminium foil blister strips of 10 tablets each, in a carton.

LAMITOR–200: 60 tablets, as six PVC/Aluminium foil blister strips of 10 tablets each, in a carton.