くすりのしおり

Internal
Published: 9/2014

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 :
DELTYBA Tablets 50mg
 Active ingredient:
Delamanid
 Dosage form:
brownish-yellow tablet, diameter: 11.7 mm, thickness: 5.3 mm
 Print on wrapping:
Front: デルティバ錠50mg, Otsuka; Back: デルティバ錠50mg, DELTYBA tab 50mg, 吸湿注意, Otsuka

Effects of this medicine

This medicine exerts its antibacterial activity against Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids in M. tuberculosis.
It is usually used to treat pulmonary multidrug-resistant tuberculosis.

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 are pregnant, possibly 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 general, for adults, take 2 tablets (100 mg of active ingredient) at a time, twice daily after breakfast and dinner. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as you remember it. However, if it is close to the 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

  • As periodic electrocardiographic monitoring and serum albumin concentration measurements are necessary while on this medicine, follow the instructions of your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include insomnia, headache, and somnolence. 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.
  • palpitations, chest discomfort, chest pain [QT prolongation]
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

  • As this medicine is hygroscopic, tablets should be kept in the package sheet and not be removed until immediately before use.
  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • If there is a remainder, this is to be discarded. Do not store it. Ask your pharmacist or medical institution about how to discard it.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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