Neumogine

Neumogine

lamotrigine

Manufacturer:

Kenyaku

Distributor:

Biopharm

Marketer:

Biopharm
Concise Prescribing Info
Contents
Lamotrigine
Indications/Uses
Adjunctive or monotherapy in treatment of epilepsy for partial & generalised seizures, including tonic-clonic seizures & seizures associated w/ Lennox-Gastaut syndrome in adults, adolescents ≥13 yr & childn 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 on wk 1 & 2, followed by 50 mg once daily on wk 3 & 4. May be increased by max of 50-100 mg every 1-2 wk. Max in some patients: 500 mg daily. Usual maintenance dose: 100-200 mg once daily or in 2 divided doses. Adjunctive therapy w/ valproate 25 mg on alternate days for wk 1 & 2, followed by 25 mg once daily on wk 3 & 4. May be increased by max of 25-50 mg every 1-2 wk. Usual maintenance dose: 100-200 mg once daily or in 2 divided doses. Adjunctive therapy w/o valproate & w/ lamotrigine glucuronidation inducer 50 mg once daily on wk 1 & 2, followed by 100 mg daily in 2 divided doses on wk 3 & 4. May be increased by max of 100 mg every 1-2 wk. Max in some patients: 700 mg daily. Usual maintenance dose: 200-400 mg daily in 2 divided doses. Adjunctive therapy w/o valproate & lamotrigine glucuronidation inducers 25 mg once daily on wk 1 & 2, followed by 50 mg once daily on wk 3 & 4. May be increased by max of 50-100 mg every 1-2 wk. Usual maintenance dose: 100-200 mg once daily or in 2 divided doses. Adolescent & childn 2-12 yr Monotherapy 0.3 mg/kg once daily or in 2 divided doses on wk 1 & 2, followed by 0.6 mg/kg once daily or in 2 divided doses on wk 3 & 4, may be increased by max of 0.6 mg/kg daily every 1-2 wk. Max dose: 200 mg daily. Usual maintenance dose: 1-15 mg/kg once daily or in 2 divided doses. Adjunctive therapy w/ valproate 0.15 mg/kg once daily on wk 1 & 2, followed by 0.3 mg/kg once daily on wk 3 & 4, may be increased by max of 0.3 mg/kg every 1-2 wk. Max dose: 200 mg daily. Usual maintenance dose: 1-5 mg/kg once daily or in 2 divided doses. Adjunctive therapy w/o valproate & w/ lamotrigine glucuronidation inducers 0.6 mg/kg daily in 2 divided doses on wk 1 & 2, followed by 1.2 mg/kg daily in 2 divided doses on wk 3 & 4, may be increased by max of 1.2 mg/kg every 1-2 wk. Max dose: 400 mg daily. Usual maintenance dose: 5-15 mg/kg once daily or in 2 divided doses. Adjunctive therapy w/o valproate & lamotrigine glucuronidation inducers 0.3 mg/kg once daily or in 2 divided doses on wk 1 & 2, followed by 0.6 mg/kg once daily or in 2 divided doses on wk 3 & 4, may be increased by max of 0.6 mg/kg every 1-2 wk. Max dose: 200 mg daily. Usual maintenance dose: 1-10 mg/kg once daily or in 2 divided doses. Bipolar disorder Adult ≥18 yr Monotherapy 25 mg once daily on wk 1 & 2, followed by 50 mg once daily or in 2 divided doses on wk 3 & 4, then 100 mg once daily or in 2 divided doses on wk 5. Target stabilisation dose (wk 6): 200 mg once daily or in 2 divided doses. Adjunctive therapy w/ valproate 25 mg on alternate days for wk 1 & 2, followed by 25 mg once daily on wk 3 & 4, then 50 mg once daily or in 2 divided doses on wk 5. Target stabilisation dose (wk 6): 100 mg once daily or in 2 divided doses. Max dose: 200 mg daily. Adjunctive therapy w/o valproate & w/ lamotrigine glucuronidation inducers 50 mg once daily on wk 1 & 2, followed by 100 mg daily in 2 divided doses on wk 3 & 4, then 200 mg daily in 2 divided doses on wk 5. Target stabilisation dose (wk 6): 300 mg daily in 2 divided doses, may be increased to 400 mg daily in 2 divided doses in wk 7.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Special Precautions
Discontinue if signs & symptoms of hypersensitivity; photosensitivity reactions; haemophagocytic lymphohistiocytosis occur. History of allergy or rash to other antiepileptic drugs. Not to be restarted in patients who have discontinued due to rash or aseptic meningitis associated w/ prior treatment. Not for acute treatment of manic or depressive episodes. Patients w/ Brugada syndrome. Monitor for clinical worsening, suicidal ideation & behaviour, thoughts. Avoid exposure to sunlight & artificial UV light & use protective clothing & sunscreens. May provoke rebound seizure w/ abrupt w/drawal; worsen myoclonic seizures. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Avoid abrupt w/drawal. Gradually decrease over a period of 2 wk. Long-term use. Not to be administered in patients currently being treated w/ other prep containing lamotrigine. Concomitant use w/ hormonal contraceptives. May affect ability to drive & use machines. Renal failure. Hepatic impairment. Women of childbearing potential. Pregnancy & lactation. Major depressive & other psychiatric disorders in childn & adolescents <18 yr. Childn <2 yr w/ epilepsy.
Adverse Reactions
Headache; skin rash. Aggression, irritability; somnolence, dizziness, tremor, insomnia, agitation; nausea, vomiting, diarrhoea, dry mouth; arthralgia; tiredness, pain, back pain. SJS, TEN, DRESS.
Drug Interactions
Inhibited glucuronidation by valproate. Induced glucuronidation by carbamazepine, phenytoin, primidone, phenobarb, rifampicin, lopinavir/ritonavir/atazanavir, ethinylestradiol/levonorgestrel combination. Increased topiramate conc. Reduced AUC & Cmax w/ OCs. Increased plasma levels of renally excreted medicinal products OCT2 substrates eg, metformin, gabapentin & varenicline.
MIMS Class
Anticonvulsants / Antidepressants
ATC Classification
N03AX09 - lamotrigine ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Neumogine tab 100 mg
Packing/Price
3 × 10's
Form
Neumogine tab 25 mg
Packing/Price
3 × 10's
Form
Neumogine tab 50 mg
Packing/Price
3 × 10's
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