くすりのしおり

Internal
Revised: 4/2019

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 :
CRAVIT TABLETS 500mg [current tablets]
 Active ingredient:
Levofloxacin hydrate
 Dosage form:
oval, pale orange tablet, major axis: 16.2 mm, minor axis: 7.9 mm
 Print on wrapping:
クラビット500mg, Cravit500mg, 抗菌剤です

Effects of this medicine

This medicine is a new quinolone antibacterial oral agent which inhibits DNA replication of bacteria at the time of infection, and shows bactericidal action.
It is usually used to treat a wide range of infections such as skin infections, respiratory infections, urinary tracts infections, gynecologic infections, ophthalmologic infections, otorhinologic infections or dental infections.

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: kidney dysfunction, cardiac diseases (arrhythmia, ischemic heart disease, etc.), convulsive disease such as epilepsy or a history of it, myasthenia gravis.
    If you are a pediatric patient.
  • If you are pregnant, possibly 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 adults, take one tablet (500 mg of the active ingredient) at a time, once a day. The dose may be adjusted according to the type of infection and symptoms. For pulmonary tuberculosis and other tuberculosis diseases, this medicine is basically co-administered with other anti-tuberculosis medicines.
    Typhoid and paratyphoid: In general, for adults, take one tablet (500 mg of the active ingredient) at a time, once a day for 14 days.
    In any case, strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. 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

  • This medicine may cause consciousness disorder. Pay attention when you operate dangerous machinery such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, insomnia, dizziness, headache, nausea, vomiting, diarrhea, abdominal discomfort and abdominal pain. 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.
  • erythema, chill, breathing difficulty, pale face, cold sweat [shock, anaphylaxis]
  • fever, erythema, blister, erosion [toxic epidermal necrolysis, oculomucocutaneous syndrome]
  • fitful muscular contraction [convulsion]
  • palpitation, chest pain, discomfort in chest [QT prolongation, ventricular tachycardia (including Torsades de pointes)]
  • fever, general malaise, decreased urine output, edema of limbs or face [acute renal disorder, interstitial nephritis]
  • nausea, vomiting, loss of appetite, malaise, itch, yellowing of the skin or white eyes [fulminant hepatitis, liver dysfunction, jaundice]
  • fever, sore throat, general malaise, bleeding tendency (e.g. gum/nose/subcutaneous bleeding) [pancytopenia, agranulocytosis, hemolytic anemia, thrombocytopenia]
  • fever, dry cough, breathing difficulty [interstitial pneumonia, eosinophilic pneumonia]
  • abdominal pain, frequent diarrhea, nausea [serious colitis with bloody stool such as pseudomembranous colitis]
  • muscle pain, lassitude, red-brown urine [rhabdomyolysis]
  • sweating, palpitation, lassitude [hypoglycemia]
  • pain in the periphery of tendons, edema [achilles tendonitis, tendinopathy such as tendon rupture]
  • difficulty in thinking, unable to recognize time or place, incoherent speech and action [psychiatric symptom such as confusion, delirium, depression]
  • fever, joint pain, purpura [hypersensitivity vasculitis]
  • loss of muscular strength in the limbs [exacerbation of myasthenia gravis]
  • hoarseness, swallowing difficulty, pain in the chest and back, bloody phlegm, breathing difficulty [aortic aneurysm, aortic dissection]
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 the 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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