くすりのしおり

Internal
Revised: 10/2018

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 :
Lexiva Tablets 700
 Active ingredient:
Fosamprenavir calcium hydrate
 Dosage form:
pale reddish white tablet, major axis: 20.5 mm, minor axis: 9.5 mm, thickness: 7.4 mm
 Print on wrapping:

Effects of this medicine

This medicine is converted into its active form in the body, and suppresses the progression of diseases such as decreased immune function, weight loss, swollen lymph node and opportunistic infection by inhibiting the activity of HIV protease and subsequently reducing the growth of human immunodeficiency viruses (HIVs).
It is usually used to treat HIV infection always in combination with other anti-HIV drugs.

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.
  • 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 receiving treatment with an anti-HIV drug for the first time, one of the followings will be indicated:
    First regimen: In general, for adults, take 1 tablet (700 mg of fosamprenavir) at a time, combined with 100 mg of ritonavir twice a day.
    Second regimen: In general, for adults, take 2 tablets (1,400 mg) at a time, combined with 100 mg or 200 mg of ritonavir once a day.
    Third regimen: In general, for adults, take 2 tablets (1,400 mg) at a time, twice a day.
    For patients who have ever used a HIV protease inhibitor: In general, for adults, take 1 tablet (700 mg of fosamprenavir) at a time, combined with 100 mg of ritonavir twice a day.
    In any case, strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. 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. If you stop taking this medicine only because your subjective symptoms have disappeared, your condition may deteriorate.

Precautions while taking this medicine

  • It is important that you receive medical examination on a regular basis to check on the appropriateness of the dosage and any side effect that may have occurred without your noticing.
  • This medicine is not used for radical cure of HIV infection. The disease may progress even if you are taking this medicine. Inform your doctor of any change of your physical condition.
  • Pay attention not to take St. John's wort, since it may decrease the blood concentration of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, nausea, vomit 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.
  • severe rash, rash accompanied by systemic symptoms or mucosal symptoms [muco-cutaneo-ocular syndrome]
  • dry mouth, polyuria, fatigability [hyperglycemia, diabetes mellitus]
  • subcutaneous bleeding, nose bleeding, bloody urine [bleeding tendency]
  • numbness of limbs, reddish brown urine, muscle pain [rhabdomyolysis, myositis, muscle pain, increased CK (CPK)]
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. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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