くすりのしおり

Internal
Revised: 8/2017

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 Fine Granules for Pediatric Use 10%
 Active ingredient:
Azithromycin hydrate
 Dosage form:
pale orange fine granule
 Print on wrapping:
ジスロマック細粒小児用10%

Effects of this medicine

This medicine is a macrolide antibiotic medicine and has 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 disorder.
    If you ever had any shocks to any medicines (hives, edema, chest distress, pale face, cold sweat, breathing difficulty, etc.).
    If you or your family member has allergic tendencies such as hives and 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 0.1 g/kg (0.1 g per 1 kilogram of body weight) [10 mg (titer) of azithromycin] once a day for three days. However, the maximum daily dose is 5 g [500 mg (titer)], which is maximum daily dose for adults. Strictly follow the instructions.
  • You may take the medicine with neutral beverage such as water and milk. Avoid taking with acid beverage (orange juice, lactic acid bacteria beverage, isotonic beverage, etc.) or chewing since it may produce a bitter taste.
  • If you miss a dose and remember it within one 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, solar sensitiveness (reddened in the body portion that was exposed with light), erythema, blister, skin peel, erythema multiform, 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), swelling in face/lip/throat [shock, anaphylaxis]
  • rash, mucosal erosion/blister, high fever [toxic epidermal necrolysis, mucocutaneous-ocular 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, swelling in hands/feet/face, thirst [acute renal failure]
  • 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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