Lamostad 50

Rx

Indications:

Epilepsy

Adults and children over 12 years of age:

• Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures.
• Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.

Children aged 2 to 12 years:

• Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.
• Monotherapy of typical absence seizures.

Bipolar disorder

Adults aged 18 years and above: Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes.

Dosage:

Epilepsy

Monotherapy:

Adults and children > 12 years of age: Initial with 25 mg, once a day x 2 weeks; thereafter 50 mg, once a day x 2 weeks, then should increase, maximum of 50 – 100 mg every 1-2 weeks until the optimal response is achieved; maintain: 100 – 200 mg daily, once or two divided doses.

Add-on therapy:

Adults and children > 12 years of age:

• In patients taking valproate with/ without any other antiepileptic drug: Initial with 25 mg on alternate days, in 2 weeks; thereafter 25 mg once a day in 2 weeks, then should increase, maximum of 25-50 mg every 1-2 weeks until the optimal response is achieved; maintain: 100 – 200 mg daily, once or two divided doses.
• In those patients taking concomitant AEDs or other medications that induce lamotrigine glucuronidation with/ without other AEDs (except valproate): Initial with 50 mg, once a day x 2 weeks; thereafter 100 mg, two divided doses, in 2 weeks, then should increase, maximum of 100 mg every 1-2 weeks until the optimal response is achieved; maintain: 200 – 400 mg daily, two divided doses.
• In those patients taking oxcarbazepine without any other inducers or inhibitors of lamotrigine glucuronidation: Initial with 25 mg, once a day x 2 weeks; thereafter 50 mg , once a day x 2 weeks, then should increase, maximum of 50 – 100 mg every 1-2 weeks until the optimal response is achieved; maintain: 100 – 200 mg daily, once or two divided doses.

Children 2 – 12 years:

• In patients taking valproate with/ without any other antiepileptic drug: Initial with 0.15 mg/kg daily, once a day x 2 weeks; thereafter 0.3 mg/ kg daily x once a day x 2 weeks, then should increase, maximum of 0.3 mg/kg every 1-2 weeks until the optimal response is achieved; maintain: 1-5 mg/kg daily, once or two divided doses.
• In those patients taking concomitant AEDs or other medications that induce lamotrigine glucuronidation with/ without other AEDs: Initial with 0.6 mg/kg daily, two divided doses in 2 weeks; thereafter 1.2 mg/ kg daily, two divided doses in 2 weeks, then should increase, maximum of 1.2 mg/kg every 1-2 weeks until the optimal response is achieved; maintain: 5 – 15 mg/kg daily, two divided doses.
• In those patients taking oxcarbazepine without any other inducers or inhibitors of lamotrigine glucuronidation: Initial with 0.3 mg/kg daily once or two divided doses in 2 weeks; thereafter 0.6 mg/ kg daily, once or two divided doses in 2 weeks, then should increase, maximum of 0.6 mg/kg every 1-2 weeks until the optimal response is achieved. Maintain: 1 – 10 mg/kg daily, once or two divided doses, maximum of 200 mg daily.

Bipolar disorder

Monotherapy with lamotrigine or adjunctive therapy without valproate and without inducers of lamotrigine glucuronidation: initial 25 mg, once a day in 2 weeks; thereafter 50 mg once or two divided doses in 2 weeks; increase to 100 mg, once or two divided doses in 5^th week; target stabilisation dose* of 200 mg, once or two divided doses in 6^th

Adjunctive therapy with valproate (inhibitor of lamotrigine glucuronidation): initial 25 mg on alternate days in 2 weeks; thereafter 25 mg, once a day x 2 weeks; increase to 50 mg once or two divided doses in 5^th week; target stabilisation dose* of 100 mg, once or two divided doses in 6th week. Maximum dose of 200 mg daily depending on clinical response.

Adjustment of lamotrigine daily dosing following the addition of valproate:

• If current lamotrigine stabilisation dose is 200 mg daily: 1^st week: 100 mg daily; 2^nd and 3^rd week onwards: maintain 100 mg daily;
• If current lamotrigine stabilisation dose is 300 mg daily: 1^st week: 150 mg daily; 2^nd and 3^rd week onwards: maintain 150 mg daily;
• If current lamotrigine stabilisation dose is 400 mg daily: 1^st week: 200 mg daily; 2^nd and 3^rd week onwards: maintain 200 mg daily.

Adjustment of lamotrigine daily dosing following the withdrawal of concomitant valproate:

• If current lamotrigine stabilisation dose is 100 mg daily: 1^st week: 200 mg daily; 2^nd and 3^rd week onwards: maintain 200 mg daily in two divided doses.
• If current lamotrigine stabilisation dose is 200 mg daily: 1^st week: 300 mg daily; 2^nd week: 400 mg daily; 3^rd week onwards: maintain 400 mg daily.

Adjunctive therapy without valproate and with inducers of lamotrigine glucuronidation: initial 50 mg, once a day in 2 weeks; thereafter 100 mg, two divided doses in 2 weeks; increase to 200 mg, two divided doses in 5^th week; target stabilisation dose* of 300 mg, two divided doses in 6^th week, may alter depending on clinical response; to achieve optimal response: 400 mg daily, two divided doses in 7^th

Adjustment of lamotrigine daily dosing following the addition of inducers of lamotrigine glucuronidation:

• If current lamotrigine stabilisation dose is 200 mg daily: 1^st week: 200 mg daily; 2^nd week: 300 mg daily; 3^rd week onwards: 400 mg daily.
• If current lamotrigine stabilisation dose is 150 mg daily: 1^st week: 150 mg daily; 2^nd week: 225 mg daily; 3^rd week onwards: 300 mg daily.
• If current lamotrigine stabilisation dose is 100 mg daily: 1^st week: 100 mg daily; 2^nd week: 150 mg daily; 3^rd week onwards: 200 mg daily.

Adjustment of lamotrigine daily dosing following the withdrawal of inducers of lamotrigine glucuronidation:

• If current lamotrigine stabilisation dose is 400 mg daily: 1^st week: 400 mg daily; 2^nd week: 300 mg daily; 3^rd week onwards: 200 mg daily.
• If current lamotrigine stabilisation dose is 300 mg daily: 1^st week: 300 mg daily; 2^nd week: 225 mg daily; 3^rd week onwards: 150 mg daily.
• If current lamotrigine stabilisation dose is 200 mg daily: 1^st week: 200 mg daily; 2^nd week: 150 mg daily; 3^rd week onwards: 100 mg daily.

(The target stabilisation dose will alter depending on clinical response; maintain this dose following the addition/ withdrawal of medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation.)

Patients with moderate to severe hepatic impairment: dosage reduced by approximately 50% to 75%, end-stage renal failure: reduced maintenance doses.

Usage:

Lamostad tablets should be swallowed whole and not be crushed or chewed.

Known hypersensitivity to any of the active substance or excipients.

Very common: Headache, skin rash.

Common: Aggression, irritability, somnolence, dizziness, tremor, insomnia, agitation, nausea, vomiting, diarrhea, tiredness, pain, back pain, arthralgia.

Sudden unexplained death in epilepsy can occur.

Some reports of variably defined episodes of seizure exacerbation were made.

Suicidal ideation and behaviour have been reported in patients treated with AEDs in several indications.

Caution is also required when treating patients with a history of allergy or rash to other AEDs.

All patients (adults and children) who develop a rash should be promptly evaluated and lamotrigine withdrawn immediately unless the rash is clearly not drug related. Lamotrigine should not be restarted in patients with previous hypersensitivity.

Specialist contraceptive advice should be given to women who are of childbearing age. Women of child-bearing age should be encouraged to use effective alternative non-hormonal methods of contraception. Use of hormonal contraceptives increases the clearance of lamotrigine leading to loss of seizure control and may decrease contraceptive efficacy.

Abrupt withdrawal of lamotrigine may provoke rebound seizures, the dose of lamotrigine should be gradually decreased unless safety concerns require an abrupt withdrawal.

If therapy with lamotrigine is considered necessary during pregnancy, the lowest possible therapeutic dose is recommended. Appropriate clinical management of pregnant women during lamotrigine therapy should be ensured. The potential benefits of breast feeding should be weighed against the potential risk of adverse effects occurring in the infant.

Patients should be aware of how they react to Lamostad before driving or operating machinery.