くすりのしおり

Internal
Published: 2/2012

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 :
HYDRA TABLET "OTSUKA" 50 mg
 Active ingredient:
Isoniazid
 Dosage form:
white or pale yellow disc-like tablet with a scored line, diameter 7.0 mm, thickness 3.0 mm (in bottles or in heat-sealed package)
 Print on wrapping:
OG26

Effects of this medicine

This medicine has antibacterial effects by inhibiting proliferation of Mycobacterium tuberculosis.
It is usually used for the treatment of pulmonary tuberculosis and other types of tuberculosis.

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 hepatic dysfunction.
  • 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 adults, take 200 to 500 mg of the active ingredient (4 to 10 mg/kg) daily or twice a week in one to three divided doses. If necessary, the daily doses may be increased up to 1 g for adults or up to 20 mg/kg for children less than 13 years of age. The dosage should be adjusted according to your age or symptoms. This preparation contains 50 mg of the active ingredient in a tablet. This medicine is recommended to be administered in combination with other antituberculosis agents. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as 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

  • If you take fish containing higher levels of histidine such as tuna and mackerel, signs of histamine intoxication such as headache, erythema, vomiting, and pruritus may occur. Avoid such fish as much as possible.
  • If you take food containing higher levels of tyramine such as cheese, hypertension or palpitations may occur. Avoid such food as much as possible.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include bleeding tendency such as hemoptysis, bloody sputum, epistaxis and fundal hemorrhage, and headache, dizziness, malaise, anorexia, nausea, vomiting, abdominal fullness, abdominal pain, constipation, fever, and rash. 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.
  • loss of appetite, general malaise, nausea [severe hepatic dysfunction such as fulminant hepatitis]
  • reddening of skin in an extensive area, fever, arthralgia [toxic epidermal necrolysis (TEN), ocular-mucous membrane syndrome (Stevens-Johnson syndrome), erythroderma (dermatitis exfoliativa)]
  • rash, fever, lymphadenopathy [drug-induced hypersensitivity syndrome]
  • sore throat, headache, bleeding tendency (epistaxis, bleeding of gums, subcutaneous bleeding, etc.) [agranulocytosis, thrombocytopenia]
  • muscle contractions [convulsions]
  • loss of vision, central scotoma [optic neuritis, optic atrophy]
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 and moisture.
  • If there is any remainder of the medicine after use, discard the remainder. Do not store it.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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