くすりのしおり

Internal
Revised: 7/2020

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 :
Strattera Oral Solution 0.4%
 Active ingredient:
Atomoxetine hydrochloride
 Dosage form:
clear and colorless solution (oral solution)
 Print on wrapping:

Effects of this medicine

This medicine regulates neurotransmitters which transmit information between nerve cells in the brain, and improves symptoms such as inattention, hyperactivity or impulsiveness.
It is usually used to treat attention-deficit/hyperactivity disorder (ADHD).

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: cardiovascular disease, pheochromocytoma or a history of pheochromocytoma, or angle-closure glaucoma.
  • 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))
  • For patients younger than 18 years: In general, this medicine should be initiated at total daily dose of 0.125 mL/kg (0.5 mg/kg of atomoxetine) and should be increased to 0.2 mL/kg (0.8 mg/kg) daily. After that, the daily dose should be increased to 0.3 mL/kg (1.2 mg/kg). The maintenance dose should range from 0.3 to 0.45 mL/kg (1.2 to 1.8 mg/kg) daily. The dose should be increased at intervals of 1 week or longer. Take this medicine in 2 divided doses daily in any case. The dose may be adjusted according to clinical requirements. However, the total daily dose should not exceed 0.45 mL/kg (1.8 mg/kg) or 30 mL (120 mg), whichever is less.
    For patients aged 18 years and older: In general, this medicine should be initiated at total daily dose of 10 mL (40 mg) and should be increased to 20 mL (80 mg) daily. The maintenance dose should range from 20 to 30 mL (80 to 120 mg) daily. The daily dose, up to 20 mL (80 mg), should be increased at intervals of 1 week or longer. After the daily dose reaches 20 mL (80 mg), the daily dose should be increased at intervals of 2 weeks or longer. Take this medicine either as a single daily dose or as 2 divided doses daily. The dose may be adjusted according to clinical requirements. However, the total daily dose should not exceed 30 mL (120 mg).
    This solution contains 4 mg of atomoxetine per milliliter. Strictly follow the instructions.
  • Measure the dose of solution accurately by a provided pipette. Follow the instruction leaflet. Take the full-strength product, without diluting with water or mixing with beverages or food, etc.
  • This solution is an ocular irritant. If this solution is attached to the eye, wash the eye with water and consult with your doctor. Wash your hands or other part of your body with water, if this solution is attached to them.
  • If you miss a dose, take a dose as soon as you remember. 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 sleepiness and dizziness. Avoid driving a car or operating dangerous machinery after taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, loss of appetite, sleepiness, headache, abdominal pain, dry mouth, vomiting, constipation, dizziness, insomnia, weight loss and palpitation. 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.
  • general malaise, loss of appetite, yellowing of the skin or conjunctiva ocular [liver dysfunction, jaundice, liver failure]
  • swelling around the eyes or lips, hives, respiratory distress [anaphylaxis]
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 this medicine standing its bottle straight up at room temperature (1 to 30 degrees Celsius), away from light.
  • Do not take after 45 days of first opening the bottle. If the additional instruction on use-by date is provided by your doctor or pharmacist, follow it. Seek advice of your doctor or pharmacist about proper disposal of unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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