くすりのしおり

Internal
Revised: 3/2017

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 :
OZEX fine granules 15% for pediatric
 Active ingredient:
Tosufloxacin tosilate hydrate
 Dosage form:
pale red fine granules
 Print on wrapping:

Effects of this medicine

This medicine is new quinolone antimicrobials to inhibit DNA replication of bacteria and shows antibacterial action.
It is usually used in the treatment of pneumonia and otitis media.

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: convulsive disease such as epilepsy or a history of convulsive disease, renal dysfunction, myasthenia gravis.
  • 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 0.04 g (6 mg of the active ingredient) per kilogram of body weight at a time, twice a day. However, the dosage is limited to 1.2 g (180 mg) at a time, 2.4 g (360 mg) daily. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue 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.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, vomiting, somnolence, fever, loss of appetite, abdominal pain and constipation. 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.
  • breathing difficulty, swelling around eyes or lips, redness  [shock, anaphylaxis]
  • red rash in the skin, blister, bulbar conjunctival congestion  [toxic epidermal necrosis, Stevens-Johnson syndrome]
  • general malaise, loss of appetite, yellowing in the skin or conjunctiva  [hepatic dysfunction, jaundice]
  • abdominal pain, diarrhea, melena  [pseudomembranous colitis, hemorrhagic colitis]
  • muscular pain in limbs, weakness, reddish brown urine  [rhabdomyolysis]
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, 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.