Lamotrin

Lamotrigine

Adjunctive therapy or monotherapy for partial seizures & generalised seizures (including tonic-clonic seizures) in adults & adolescents ≥13 yr. Adjunctive therapy (but may be the initial antiepileptic drug) for seizures associated w/ Lennox-Gastaut syndrome in adults & adolescents ≥13 yr. Adjunctive therapy for partial seizures & generalised seizures (including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome) in childn & adolescents 2-12 yr. Monotherapy for typical absence seizures in childn & adolescents 2-12 yr. Prevention of depressive episodes in adults ≥18 yr w/ bipolar I disorder who experience predominantly depressive episodes.

Epilepsy Adult & adolescent ≥13 yr Monotherapy Wk 1 & 2: 25 mg/day (once a day). Wk 3 & 4: 50 mg/day (once a day). Maintenance dose: Increase by max of 50-100 mg every 1-2 wk until optimal response is achieved. Maintain at 100-200 mg/day (once a day or 2 divided doses). 500 mg/day has been required by some patients to achieve desired response. Adjunctive therapy w/ valproate Wk 1 & 2: 12.5 mg/day (or 25 mg on alternate days). Wk 3 & 4: 25 mg/day (once a day). Maintenance dose: Increase by max of 25-50 mg every 1-2 wk until optimal response is achieved. Maintain at 100-200 mg/day (once a day or 2 divided doses). Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation Wk 1 & 2: 50 mg/day (once a day). Wk 3 & 4: 100 mg/day (2 divided doses). Maintenance dose: Increase by max of 100 mg every 1-2 wk until optimal response is achieved. Maintain at 200-400 mg/day (2 divided doses). 700 mg/day has been required by some patients to achieve desired response. Adjunctive therapy w/o valproate & inducers of lamotrigine glucuronidation Wk 1 & 2: 25 mg/day (once a day). Wk 3 & 4: 50 mg/day (once a day). Maintenance dose: Increase by max of 50-100 mg every 1-2 wk until optimal response is achieved. Maintain at 100-200 mg/day (once a day or 2 divided doses). Childn & adolescent 2-12 yr Monotherapy (typical absence seizure) Wk 1 & 2: 0.3 mg/kg/day (once a day or 2 divided doses). Wk 3 & 4: 0.6 mg/kg/day (once a day or 2 divided doses). Maintenance dose: Increase by max of 0.6 mg/kg/day every 1-2 wk until optimal response is achieved. Maintain at 1-15 mg/kg/day (once a day or 2 divided doses), max at 200 mg/day. Adjunctive therapy w/ valproate Wk 1 & 2: 0.15 mg/kg/day (once a day). Wk 3 & 4: 0.3 mg/kg/day (once a day). Maintenance dose: Increase by max of 0.3 mg/kg/day every 1-2 wk until optimal response is achieved. Maintain at 1-5 mg/kg/day (once a day or 2 divided doses), max at 200 mg/day. Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation Wk 1 & 2: 0.6 mg/kg/day (2 divided doses). Wk 3 & 4: 1.2 mg/kg/day (2 divided doses). Maintenance dose: Increase by max of 1.2 mg/kg/day every 1-2 wk until optimal response is achieved. Maintain at 5-15 mg/kg/day (once a day or 2 divided doses), max at 400 mg/day. Adjunctive therapy w/o valproate & inducers of lamotrigine glucuronidation Wk 1 & 2: 0.3 mg/kg/day (once a day or 2 divided doses). Wk 3 & 4: 0.6 mg/kg/day (once a day or 2 divided doses). Maintenance dose: Increase by max of 0.6 mg/kg/day every 1-2 wk until optimal response is achieved. Maintain at 1-10 mg/kg/day (once a day or 2 divided doses), max at 200 mg/day. Bipolar disorder Adult ≥18 yr Monotherapy, or adjunctive therapy w/o valproate & inducers of lamotrigine glucuronidation Wk 1 & 2: 25 mg/day (once a day). Wk 3 & 4: 50 mg/day (once a day or 2 divided doses). Wk 5: 100 mg/day (once a day or 2 divided doses). Target stabilisation dose: 200 mg/day (once a day or 2 divided doses) for optimal response. Adjunctive therapy w/ valproate Wk 1 & 2: 12.5 mg/day (or 25 mg on alternate days). Wk 3 & 4: 25 mg/day (once a day). Wk 5: 50 mg/day (once a day or 2 divided doses). Target stabilisation dose: 100 mg/day (once a day or 2 divided doses) for optimal response. Max at 200 mg/day depending on clinical response. Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation Wk 1 & 2: 50 mg/day (once a day). Wk 3 & 4: 100 mg/day (2 divided doses). Wk 5: 200 mg/day (2 divided doses). Target stabilisation dose: 300 mg/day (2 divided doses) in wk 6. If necessary, increase to 400 mg/day (2 divided doses) in wk 7 to achieve optimal response.

May chew, disperse in small vol of water (at least enough to cover whole tab) or swallow whole w/ little water. Do not attempt to administer partial quantities.

Hypersensitivity.

Not indicated for acute treatment of manic or depressive episodes. Risk of potentially life-threatening rashes eg, SJS, TEN, DRESS; aseptic meningitis; photosensitivity reactions; haemophagocytic lymphohistiocytosis. Risk of serious rash is associated w/ high initial doses & exceeding recommended dose escalation, & concomitant use of valproate. Caution in patients w/ history of allergy or rash to other antiepileptic drugs. Do not restart treatment in patients who have discontinued due to rash/aseptic meningitis associated w/ prior lamotrigine treatment. Consider treatment discontinuation if lamotrigine-associated photosensitivity is suspected, & avoid exposure to sunlight & artificial UV light if continued treatment is considered clinically justified. Possibility of interference w/ folate metabolism during long-term therapy. Could potentially slow ventricular conduction (widen QRS) & induce proarrhythmia at therapeutically relevant conc in patients w/ heart disease. Carefully consider use in patients w/ clinically important structural or functional heart disease eg, Brugada syndrome or other cardiac channelopathies, heart failure, ischemic heart disease, heart block or ventricular arrhythmias. Concomitant use w/ ethinyloestradiol/levonorgestrel combination; Na channel blockers. Do not administer to patients being treated w/ other lamotrigine-containing prep. Patients should assess how Lamotrin therapy affects them before driving or operating machinery. Exercise caution when administering to patients w/ renal failure. Reduce dose by approx 50% in patients w/ moderate (Child-Pugh B) & 75% in severe (Child-Pugh C) hepatic impairment. Lowest possible therapeutic dose is recommended if therapy is considered necessary during pregnancy. Monitor serum conc before, during & after pregnancy, as well as shortly after birth. Weigh potential benefits of breast-feeding against potential risk of adverse effects in the infant. No data on the effect on growth, sexual maturation, & cognitive, emotional & behavioural developments in childn. Epilepsy: Monitor for signs of suicidal ideation & behaviours. Abrupt w/drawal may provoke rebound seizures. Weigh observed benefit of control for 1 seizure type against any observed worsening in another seizure type in patients w/ >1 seizure type. May worsen myoclonic seizures. Efficacy may not be maintained in all childn on treatment for typical absence seizures. Limited data on efficacy & safety for adjunctive therapy of partial seizures in childn aged 1 mth to 2 yr. No data in childn aged <1 mth. Not recommended in childn <2 yr. Bipolar disorder: Closely monitor for clinical worsening (including development of new symptoms) & suicidality, especially at the beginning of a course of treatment or at the time of dose changes. Increased risk of suicidal thinking & behaviour in childn & adolescents w/ major depressive disorder & other psychiatric disorders. Not recommended in childn <18 yr.

Headache; skin rash. Aggression, irritability; somnolence, dizziness, tremor, insomnia, agitation; nausea, vomiting, diarrhoea, dry mouth; arthralgia; tiredness, pain, back pain.

Increased conc w/ valproate. Decreased conc w/ atazanavir/ritonavir, carbamazepine, ethinyloestradiol/levonorgestrel combination, lopinavir/ritonavir, phenobarb, phenytoin, primidone, & rifampicin. Reports of CNS events (including dizziness, ataxia, diplopia, blurred vision & nausea) in patients taking carbamazepine following introduction of lamotrigine. Increased conc of topiramate. Increased clearance w/ perampanel. Slight increase in AUC of lamotrigine glucuronide w/ bupropion. Reduced AUC & C_max w/ olanzapine. Reports of somnolence w/ co-administration of risperidone & lamotrigine. Ave reduction in C_max & AUC w/ aripiprazole. Formation of 2-N-glucuronide (primary metabolite) was minimally inhibited by co-incubation w/ amitriptyline, bupropion, clonazepam, haloperidol or lorazepam. Modest increase in clearance of levonorgestrel & changes in serum FSH & LH. Reduced plasma AUC & C_min w/ paracetamol. Increased plasma levels of OCT2 substrates (eg, metformin, gabapentin, varenicline).

Anticonvulsants

N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.

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