くすりのしおり

Internal
Revised: 5/2018

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
LAMOTRIGINE TABLETS FOR PEDIATRIC 2mg "TOWA"
 Active ingredient:
Lamotrigine
 Dosage form:
pale yellowish white tablet with split line, diameter: 5.0 mm, thickness 2.0 mm
 Print on wrapping:
ラモトリギン小児用2mg「トーワ」,ラモトリギン,2mg,小児用,Lamotrigine 2,必ず医師または薬剤師の指示通りに飲んでください

Effects of this medicine

This medicine modulates excitatory neurotransmitter release to suppress excessive excitation of neurons, and exerts anticonvulsant effect.
It is usually used for adjunctive therapy with other antiepileptic agents to treat partial-onset seizures, tonic-clonic seizures and generalized seizures associated with Lennox-Gastaut syndrome.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have or have had suicidal ideations.
    If you have: organic brain disorder, predisposition to schizophrenia, liver disorder or renal disorder.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In patients taking sodium valproate:
    In general, for children, in the first and second week take 0.15 mg/kg/day, once a day; in the third and 4th week take 0.3 mg/kg/day, once a day. The dosage will then be gradually increased by a maximum of 0.3 mg/kg/day, every one to two weeks. The usual daily maintenance dose is 1 to 3 mg/kg/day, in two divided doses. In patients taking sodium valproate concomitantly with phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir/ritonavir, atazanavir/ritonavir or ethinylestradiol/levonorgestrel (oral contraceptive), etc., the usual daily maintenance dose is 1 to 5 mg/kg/day, in two divided doses. In any case, the maximum daily dose is 200 mg.
    In patients taking phenytoin, carbamazepine, phenobarbital, primidone, rifampicin or lopinavir/ritonavir, etc. and NOT taking sodium valproate:
    In general, for children, in the first and second week take 0.6 mg/kg/day, in two divided doses; in the third and 4th week take 1.2 mg/kg/day, in two divided doses. The dosage will then be gradually increased by a maximum of 1.2 mg/kg/day, every one to two weeks. The usual daily maintenance dose is 5 to 15 mg/kg/day, in two divided doses. The maximum daily dose is 400 mg.
    In patients taking aripiprazole, olanzapine, zonisamide, gabapentin, cimetidine, topiramate, pregabalin, lithium, levetiracetam, perampanel or lacosamide, etc. and NOT taking sodium valproate:
    In general, for children, in the first and second week take 0.15 mg/kg/day, once a day; in the third and 4th week take 0.3 mg/kg/day, once a day. The dosage will then be gradually increased by a maximum of 0.3 mg/kg/day, every one to two weeks. The usual daily maintenance dose is 1 to 3 mg/kg/day, in two divided doses. The maximum daily dose is 200 mg.
    This preparation contains 2 mg of the active ingredient in a tablet, and may be used in combination with preparations containing 5 mg, 25 mg or 100 mg of the active ingredient in a tablet.Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • This medicine may cause rash or serious skin disorders. You and your family members need to be informed of it from your doctor until you fully understand it. If any of these symptoms occur, contact your doctor immediately.
  • This medicine may cause sleepiness and decreased attentiveness/concentration/reflex action. Do not operate dangerous machinery, such as driving a car.
  • In patients with depression, this medicine may make them feel suicidal. If symptoms such as strong anxiety or suicidal ideation occur during medication, especially at the beginning of the treatment or at the time of dose changes, consult with your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include somnolence (absent-mindedness), dizziness and rash. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • fever, eye bloodshot, erosion in lips/oral mucosa/genitalia [toxic epidermal necrolysis, muco-cutaneo-ocular syndrome]
  • rash, fever, facial edema [drug-induced hypersensitivity syndrome]
  • symptoms of anemia, fever, sore throat [aplastic anemia, pancytopenia, agranulocytosis]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [hepatitis, liver dysfunction, jaundice]
  • neck stiffness, fever/headache, nausea/vomit [meningitis aseptic]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacy or medical institution on how to discard them.
  • [To family members] You need to be informed about the possible change in the patient's mood or behavior such as having suicidal ideations, being excitable, being aggressive or deterioration in mental condition due to slight irritation, or possible risk of worsening of their chronic disease such as depression. Please receive enough explanation from the doctor until you fully understand it, and monitor the patient's condition. If you notice any changes in behavior or symptoms in the patient, contact the doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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