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JANSSEN PHARMACEUTICAL K.K.
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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.
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Brand name :
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ITRIZOLE Capsules 50
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Dosage form:
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capsule with pale yellow opaque cap and body, diameter 6.35 mm, thickness 18.1 mm
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Print on wrapping:
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(Face) イトリゾール50 JK901 50mg
(Back) Itrizole 50 イトリゾール50mg
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Effects of this medicine
This medicine shows anti-mycotic action by inhibiting biosynthesis of cell membrane of fungus (a kind of mold) to suppress the growth of fungus that is responsible to infectious diseases.
Usually, used for treatment of fungal infection in internal organs such as respiratory organ, gastrointestinal tract or urinary tract (deep mycosis), deep fungal infection of the skin, superficial fungal infection of the skin such as tinea corporis (except for tinea unguium), and tinea unguium.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you have or have history of liver disorder, renal disorder or congestive heart failure.
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If you are pregnant or breastfeeding.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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General dosage regimen: For treatment of visceral fungal infection (deep mycosis), for adults, take 2-4 capsules (100-200 mg of the active ingredient) immediately after meal once a day. The dosage may be adjusted according to your age and symptoms. If you switched itraconazole injection to this medicine, take 4 capsules (200 mg) at a time immediately after meals twice a day. Strictly follow the instructions of your doctor/pharmacist.
For treatment of deep fungal infection of the skin, for adults, take 2-4 capsules (100-200 mg of the active ingredient) immediately after meals once a day. The dosage may be adjusted according to your age and symptoms, but not to exceed 4 capsules (200 mg) daily. Strictly follow the instructions of your doctor/pharmacist.
For treatment of superficial fungal infection of the skin (except for tinea unguium), for adults, take 1-2 capsules (50-100 mg of the active ingredient) immediately after meals once a day. The dosage may be adjusted according to your age and symptoms, but not to exceed 4 capsules (200 mg) daily. Strictly follow the instructions of your doctor/pharmacist.
For treatment of tinea unguium (pulse therapy), for adults, take 4 capsules (200 mg of the active ingredient) immediately after meals twice a day for a week, and then stop taking this medicine for 3 weeks. This treatment cycle will be repeated three times. The dosage may be adjusted, if needed. Strictly follow the instructions of your doctor/pharmacist.
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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 continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.
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If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
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Do not stop taking this medicine without the instructions of your doctor.
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Precautions while taking this medicine
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If you take this medicine for a long term, your liver function may be checked by a doctor on a regular basis.
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Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: liver dysfunction, discomfort in the stomach, nausea, rash, abdominal pain, flatus (gas accumulated in the bowel), diarrhea, hypokalemia (such as general dullness), etc.
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.
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leg/systemic edema, nausea, shortness of breath/dyspnea [congestive heart failure, pulmonary edema]
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general fatigue, loss of appetite, yellowing of the skin or whites of the eyes [liver disorder]
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high fever (38℃ or more), red eyes, erosive lips and mouth, redness of the face and general body [mucocutaneous-ocular syndrome, toxic epidermal necrolysis, exfoliative dermatitis]
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dyspnea, urticaria, impaired counciousness [anaphylactic symptoms]
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.
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Storage conditions and other information
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Keep out of the reach of children. Store away from direct sunlight, heat and humidity.
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Discard the remainder. Do not store them.
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