くすりのしおり

Internal
Published: 2/2014

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 :
PREZISTANAIVE Tablets 800mg
 Active ingredient:
Darunavir ethanolate
 Dosage form:
dark red tablet, major axis 20.0 mm, minor axis 10.0 mm, thickness 7.5 mm
 Print on wrapping:
TMC

Effects of this medicine

This medicine is a human immunodeficiency virus (HIV)-1 protease inhibitor that suppresses growth of HIV to slow disease progression. It is indicated for the treatment together with other HIV protease inhibitors (such as ritonavir) to have a synergetic effect. Ritonavir increases the blood level of this medicine.
It is usually used in conjunction with ritonavir and other anti-HIV agents for treatment of HIV infection non-resistant to this medicine in anti-HIV agent treatment-experienced patients or of HIV infection in treatment-naive patients.

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 liver disorder, hemophilia, or bleeding tendency.
  • 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 general, for adults, take 1 tablet (800 mg of darunavir) at a time, simultaneously with 100 mg of ritonavir, once daily during or immediately after a meal. Strictly follow the instructions.
  • Do not miss any single dose because you may lose its effect if you miss a dose. If you miss a dose, take the missed dose during or immediately after a next meal. In that instance, do not take two doses (2 tablets) at one time, but take the usual single dose (1 tablet).
  • 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

  • Avoid taking food or beverage containing Saint John's wort. Because Saint John's wort (Hypericum perforatum) may decrease the blood concentration of this medicine and reduce its effect.
  • Dizziness has been reported to occur after taking this medicine. Be aware of operating dangerous machinery such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, nausea, headache, 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.
  • high fever (38 degrees or higher), red eyes, erosive mouth/lips, red rash [toxic epidermal necrolysis, mucocutaneous-ocular syndrome, polymorphic erythema, acute generalized exanthematous pustulosis]
  • dullness, loss of appetite, yellowing of the skin or whites of the eyes [liver dysfunction, jaundice]
  • severe upper abdominal pain, lumbodorsal pain, nausea [acute pancreatitis]
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 the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist or medical institutions about proper disposal of drugs.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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