くすりのしおり

Internal
Revised: 2/2021

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 :
ZITHROMAC Capsules for Pediatric Use 100mg
 Active ingredient:
Azithromycin hydrate
 Dosage form:
orange/pale yellowish white capsule, diameter: 5.6 mm, length: 15.7 mm
 Print on wrapping:
(Face) ZITHROMAC 100mg, ジスロマック, 100mg, (Back) ジスロマック100mg, ZTM 100

Effects of this medicine

This medicine is a macrolide antibiotic and exerts antibacterial effect by inhibiting proteosynthesis of pathogen.
It is usually used to treat respiratory infections, otitis media, etc.

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 dysfunction or cardiac disease.
    If you have previously experienced any shocks to any medicines (hives, edema, chest distress, facial pallor, cold sweat, breathing difficulty, etc.).
    If you or your family member has allergic tendencies such as hives/asthma.
  • 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 children, take 10 mg (titer) of azithromycin per kilogram of the body weight once a day for 3 days. However, the maximum daily dose is 500 mg (titer), which is maximum daily dose for adults. This preparation contains 100 mg (titer) of azithromycin in a capsule. Strictly follow the instructions.
  • If you miss a dose and remember it within a day, take the missed dose when you remember. 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

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, vomiting, abdominal pain, rash, hives, itch, deterioration of atopic dermatitis, photosensitivity reaction (reddened in the body portion that was exposed to light), erythema, blister, skin peeling, erythema multiforme, night sweat, hyperhidrosis, dry skin, skin discoloration and hair loss. 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.
  • respiratory distress, wheezing (whistling breath), edema of face or lips/swelling in throat [shock, anaphylaxis]
  • rash, mucosal erosion/blister, high fever [toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [hepatitis, liver dysfunction, jaundice, liver failure]
  • decreased urine output, edema of hands, feet or face, thirst [acute renal disorder]
  • abdominal pain, frequent diarrhea, bloody stool [pseudomembranous colitis, hemorrhagic colitis]
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.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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