Lamictal利必通

Lamictal

lamotrigine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Lamotrigine
Indications/Uses
Adjunctive or monotherapy treatment of partial & generalised seizures, including tonic-clonic seizures in adults & adolescents ≥13 yr. Adjunctive therapy for seizures associated w/ Lennox-Gastaut syndrome in adults & adolescents ≥13 yr; may be the initial anti-epileptic drug to start w/ in Lennox-Gastaut syndrome. Adjunctive therapy for partial & generalised seizures, including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome in childn & adolescents 2-12 yr. Monotherapy of 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.
Dosage/Direction for Use
Epilepsy Adult & adolescent ≥13 yr Monotherapy 25 mg once daily in wk 1 & 2, followed by 50 mg once daily in wk 3 & 4. Maintenance: 100-200 mg once daily or in 2 divided doses, may be increased by max 50-100 mg every 1-2 wk. Adjunctive therapy w/ valproate 25 mg given on alternate days in wk 1 & 2, followed by 25 mg once daily in wk 3 & 4. Maintenance: 100-200 mg once daily or in 2 divided doses, may be increased by max 25-50 mg every 1-2 wk. Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation 50 mg once daily in wk 1 & 2, followed by 100 mg/day in 2 divided doses in wk 3 & 4. Maintenance: 200-400 mg/day in 2 divided doses, may be increased by max 100 mg every 1-2 wk. Adjunctive therapy w/o valproate & w/o inducers of lamotrigine glucuronidation 25 mg once daily in wk 1 & 2, followed by 50 mg once daily in wk 3 & 4. Maintenance: 100-200 mg once daily or in 2 divided doses, may be increased by max 50-100 mg every 1-2 wk. Childn & adolescent 2-12 yr Monotherapy of typical absence seizures 0.3 mg/kg/day once daily or in 2 divided doses in wk 1 & 2, followed by 0.6 mg/kg/day once daily or in 2 divided doses in wk 3 & 4. Maintenance: 1-15 mg/kg/day once daily or in 2 divided doses, may be increased by max 0.6 mg/kg/day every 1-2 wk. Max: 200 mg/day. Adjunctive therapy w/ valproate 0.15 mg/kg once daily in wk 1 & 2, followed by 0.3 mg/kg once daily in wk 3 & 4. Maintenance: 1-5 mg/kg/day once daily or in 2 divided doses, may be increased by max 0.3 mg/kg every 1-2 wk. Max: 200 mg/day. Adjunctive therapy w/o valproate & w/ inducers of lamotrigine glucuronidation 0.6 mg/kg/day in 2 divided doses in wk 1 & 2, followed by 1.2 mg/kg/day in 2 divided doses in wk 3 & 4. Maintenance: 5-15 mg/kg/day once daily or 2 divided doses, may be increased by max 1.2 mg/kg every 1-2 wk. Max: 400 mg/day. Adjunctive therapy w/o valproate & w/o inducers of lamotrigine glucuronidation 0.3 mg/kg/day once daily or in 2 divided doses in wk 1 & 2, followed by 0.6 mg/kg/day once daily or in 2 divided doses in wk 3 & 4. Maintenance: 1-10 mg/kg/day once daily or in 2 divided doses, may be increased by max 0.6 mg/kg every 1-2 wk. Max: 200 mg/day. Bipolar disorder Adult ≥18 yr Recommended dose escalation to the maintenance total daily stabilisation dose: Monotherapy or adjunctive therapy w/o valproate & w/o inducers of lamotrigine glucuronidation 25 mg once daily in wk 1 & 2, followed by 50 mg once daily or in 2 divided doses in wk 3 & 4, then 100 mg once daily or in 2 divided doses in wk 5. Usual target stabilisation dose: 200 mg once daily or in 2 divided doses. Adjunctive therapy w/ valproate 25 mg given on alternate days in wk 1 & 2, followed by 25 mg once daily in wk 3 & 4, then 50 mg once daily or in 2 divided doses in wk 5. Usual target stabilisation dose: 100 mg once daily or in 2 divided doses. Max: 200 mg daily. Adjunct therapy w/o valproate & w/ inducers of lamotrigine glucuronidation 50 mg once daily in wk 1 & 2, followed by 100 mg/day in 2 divided doses in wk 3 & 4, then 200 mg/day in 2 divided doses in wk 5. Usual target stabilisation dose: 300 mg/day in 2 divided doses in wk 6, increasing to 400 mg/day in 2 divided doses in wk 7 if necessary.
Administration
May be taken with or without food: Tab: Swallow whole, do not chew/crush. Dispersible tab:  May be chewed/swallowed whole w/ a little water/dispersed in water.
Contraindications
Special Precautions
Adverse skin reactions generally occurring w/in the 1st 8 wk after treatment initiation; caution in patients w/ history of allergy or rash to other anti-epileptic drugs. Haemophagocytic lymphohistiocytosis (HLH). Suicidal ideation & behaviour. Arrhythmogenic ST-T abnormality & typical Brugada ECG pattern; carefully consider treatment w/ Lamictal in patients w/ Brugada syndrome. Slight inhibitory effect on dihydrofolic acid reductase. Concomitant use w/ hormonal contraceptives, or other prep containing lamotrigine. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Patients w/ renal or hepatic impairment. May affect ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Precautions relating to epilepsy: Abrupt w/drawal may provoke rebound seizures. Severe convulsive seizures including status epilepticus may lead to rhabdomyolysis, multiorgan dysfunction & disseminated intravascular coagulation. Clinically significant worsening of seizure frequency. Myoclonic seizures may be worsened. Efficacy may not be maintained in all patients for the treatment of typical absence seizures in childn. Not recommended in childn <2 yr. Precautions relating to bipolar disorder: Increased risk of suicidal thinking & behaviour in childn & adolescents <18 yr w/ major depressive disorder & other psychiatric disorders. Not recommended in childn <18 yr.
Adverse Reactions
Headache; skin rash. Aggression, irritability; somnolence, dizziness, tremor, insomnia, agitation; nausea, vomiting, diarrhoea, dry mouth; arthralgia; tiredness, pain, back pain.
Drug Interactions
Significant inhibition of lamotrigine glucuronidation w/ valproate. Significant induction of lamotrigine glucuronidation w/ carbamazepine, phenytoin, primidone, phenobarb, rifampicin, lopinavir/ritonavir, atazanavir/ritonavir, ethinylestradiol/levonorgestrel combination. Increased plasma levels of renally excreted medicinal products which are OCT2 substrates (eg, metformin, gabapentin, varenicline).
MIMS Class
Anticonvulsants
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Lamictal dispersible tab 25 mg
Packing/Price
30's
Form
Lamictal dispersible tab 5 mg
Packing/Price
30's
Form
Lamictal tab 100 mg
Packing/Price
30's
Form
Lamictal tab 50 mg
Packing/Price
30's
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