Clinical Pharmacology Details


LAMOTRIGINE


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Indications & Dose:

Monotherapy of focal seizures Monotherapy of primary nd secondary generalised tonic-clonic seizures


Monotherapy of seizures associated with Lennox-Gastaut syndrome



Child 12–17 years: Initially 25 mg once daily for 14 days, then increased to 50 mg once daily for further 14 days, then increased in steps of up to 100 mg every 7–14 days; maintenance 100–200 mg daily in 1–2 divided doses; increased if necessary up to 500 mg daily, dose titration should be repeated if restarting after interval of more than 5 days


Adult: Initially 25 mg once daily for 14 days, then increased to 50 mg once daily for further 14 days, then increased in steps of up to 100 mg every 7– 14 days; maintenance 100–200 mg daily in 1–2 divided doses; increased if necessary up to 500 mg daily, dose titration should be repeated if restarting after interval of more than 5 days


Adjunctive therapy of focal seizures with valproate


Adjunctive therapy of primary and secondary generalised tonic-clonic seizures with valproate


Adjunctive therapy of seizures associated with Lennox- Gastaut syndrome with valproate



Child 2–11 years (body-weight up to 13 kg): Initially 2 mg once daily on alternate days for first 14 days, then 300 micrograms/kg once daily for further 14 days, then increased in steps of up to 300 micrograms/kg every 7–14 days; maintenance 1– 5 mg/kg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days; maximum 200 mg per day


Child 2–11 years (body-weight 13 kg and above): Initially 150 micrograms/kg once daily for 14 days, then 300 micrograms/kg once daily for further 14 days, then increased in steps of up to 300 micrograms/kg every 7–14 days; maintenance 1– 5 mg/kg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days; maximum 200 mg per day


Child 12–17 years: Initially 25 mg once daily on alternate days for 14 days, then 25 mg once daily for further 14 days, then increased in steps of up to 50 mg every 7–14 days; maintenance 100–200 mg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days


Adult: Initially 25 mg once daily on alternate days for 14 days, then 25 mg once daily for further 14 days, then increased in steps of up to 50 mg every 7–14 days; maintenance 100–200 mg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days continued


Adjunctive therapy of focal seizures (with enzyme inducing drugs) without valproate Adjunctive therapy of primary and secondary generalised tonic-clonic seizures (with enzyme inducing drugs) without valproate


Adjunctive therapy of seizures associated with Lennox- Gastaut syndromes (with enzyme inducing drugs) without valproate



Child 2–11 years: Initially 300 micrograms/kg twice daily for 14 days, then 600 micrograms/kg twice daily for further 14 days, then increased in steps of up to 1.2 mg/kg every 7–14 days; maintenance 5–15 mg/kg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days; maximum 400 mg per day Child 12–17 years: Initially 50 mg once daily for 14 days, then 50 mg twice daily for further 14 days, then increased in steps of up to 100 mg every 7–14 days; maintenance 200–400 mg daily in 2 divided doses, increased if necessary up to 700 mg daily, dose titration should be repeated if restarting after interval of more than 5 days


Adult: Initially 50 mg once daily for 14 days, then 50 mg twice daily for further 14 days, then increased in steps of up to 100 mg every 7–14 days; maintenance 200–400 mg daily in 2 divided doses, increased if necessary up to 700 mg daily, dose titration should be repeated if restarting after interval of more than 5 days


Adjunctive therapy of focal seizures (without enzyme inducing drugs) without valproate Adjunctive therapy of primary and secondary generalised tonic-clonic seizures (without enzyme inducing drugs) without valproate Adjunctive therapy of seizures associated with Lennox- Gastaut syndromes (without enzyme inducing drugs) without valproate



Child 2–11 years: Initially 300 micrograms/kg daily in 1–2 divided doses for 14 days, then 600 micrograms/kg daily in 1–2 divided doses for further 14 days, then increased in steps of up to 600 micrograms/kg every 7–14 days; maintenance 1–10 mg/kg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days; maximum 200 mg per day Child 12–17 years: Initially 25 mg once daily for 14 days, then increased to 50 mg once daily for further 14 days, then increased in steps of up to 100 mg every 7–14 days; maintenance 100–200 mg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days Adult: Initially 25 mg once daily for 14 days, then increased to 50 mg once daily for further 14 days, then increased in steps of up to 100 mg every 7–14 days; maintenance 100–200 mg daily in 1–2 divided doses, dose titration should be repeated if restarting after interval of more than 5 days


Monotherapy or adjunctive therapy of bipolar disorder (without enzyme inducing drugs) without valproate



Adult: Initially 25 mg once daily for 14 days, then 50 mg daily in 1–2 divided doses for further 14 days, then 100 mg daily in 1–2 divided doses for further 7 days; maintenance 200 mg daily in 1–2 divided doses, patients stabilised on lamotrigine for bipolar disorder may require dose adjustments if other drugs are added to or withdrawn from their treatment regimens—consult product literature, dose titration should be repeated if restarting after interval of more than 5 days; maximum 400 mg per day


Adjunctive therapy of bipolar disorder with valproate 



Adult: Initially 25 mg once daily on alternate days for 14 days, then 25 mg once daily for further 14 days, then 50 mg daily in 1–2 divided doses for further 7 days; maintenance 100 mg daily in 1–2 divided doses, patients stabilised on lamotrigine for bipolar disorder may require dose adjustments if other drugs are added to or withdrawn from their treatment regimens—consult product literature, dose titration should be repeated if restarting after interval of more than 5 days;maximum 200 mg per day


Adjunctive therapy of bipolar disorder (with enzyme inducing drugs) without valproate 



Adult: Initially 50 mg once daily for 14 days, then 50 mg twice daily for further 14 days, then increased to 100 mg twice daily for further 7 days, then increased to 150 mg twice daily for further 7 days; maintenance 200 mg twice daily, patients stabilised on lamotrigine for bipolar disorder may require dose adjustments if other drugs are added to or withdrawn from their treatment regimens— consult product literature, dose titration should be repeated if restarting after interval of more than 5 days

Contraindications:

Children <16 yr (high incidence of severe, potentially life-threatening rashes) . 

Side Effects:

Cautions:

Precautions:

Abrupt discontinuation (reduce by 50% qwk over at least 2 wk), renal/hepatic function impairment, children, cardiac function impairment 

Interaction:

 Drugs


Carbamazepine: Increased carbamazepine epoxide levels; decreased lamotrigine levels


Phenobarbital, primidone, phenytoin: Decreased lamotrigine concentrations


Valproic acid: Increased lamotrigine concentration; decreased valproic acid concentration


 

Warnings:

Adverse Effects:

Lactations:

Pasties into breast milk, effects on infants exposed by this route are unknown 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Anxiety, ataxia, chills, confusion, decreased memory, depression, dizziness, emotional lability, fever, headache, insomnia, irritability, seizure exacerbation, sleep disorder, somnolence, speech disorder, tremor, vertigo


CV: Hot flushes, palpitations


 EENT: Blurred vision, diplopia, ear pain, tinnitus


GI:Abdominal pain, nausea, vomiting


GU: Amenorrhea, dysmenorrhea, vaginitis


MS: Arthralgia, joint disorder, myasthenia, neck pain


RESP: Dyspnea, increased cough, pharyngitis, rhinitis


SKIN: Acne, alopecia, angioedema, photosensitivity, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis 

Patient And Carer Advice: