くすりのしおり

Injection
Revised: 10/2013

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 :
Fostoin 750mg for Injection
 Active ingredient:
Fosphenytoin sodium hydrate
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine suppresses epileptic seizures and uncontrolled convulsive seizures due to other causes.
It is usually used to treat status epilepticus and to prevent epileptic seizures.

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 heart disease, hypotension, liver disease, kidney disease, blood disease, hypothyroidism or diabetic mellitus; are debilitated.
  • 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))
  • For suppression of status epilepticus and epileptic seizures during brain surgery or consciousness disturbance (e.g. head injury) : In general, this medicine is injected intravenously.
    For temporary alternative therapy in epilepsy patients taking oral phenytoin : In general, this medicine is injected intravenously once a day or in divided doses.
  • The treatment period with this medicine depends on your response to this medicine.

Precautions while taking this medicine

  • Since this medicine may cause sleepiness or loss of concentration, avoid driving a car or operating dangerous machinery after an injection.
  • Avoid taking any food containing St. John's wort because it may diminish the medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nystagmus, dizziness, light headedness, somnolence, ataxic gait, decreased blood pressure, liver dysfunction, pruritus and fever. 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.
  • high fever, bloodshot eye, erosion of lips, sore throat, redness in a wide range of skin [toxic epidermal necrolysis]
  • high fever, bloodshot eye, eye mucus, swelling of eyelids, difficult to open eyes, erosion of lips and genitalia, pain at urination/defecation, sore throat, redness in a wide range of skin  [oculomucocutaneous syndrome]
  • redness in a wide range of skin, high fever, sore throat, general malaise, loss of appetite, swelling of lymph nodes [hypersensitivity syndrome]
  • general malaise, joint pain, fever, butterfly-shaped red spots on the face, swelling of lymph nodes [SLE (systemic lupus erythematosus)-like symptoms]
  • dizziness, nose bleeding, gum bleeding, palpitation or shortness of breath at ascending stairs or slope, shortness of breath, palpitation, bruising, bleeding tendency [aplastic anemia, pancytopenia, monocytic leukemia, decreased platelets]
  • sudden high fever, chills, sore throat  [agranulocytosis]
  • general malaise, light headedness, fatiguability, dizziness at standing up, dizziness, dull headache, yellowing of the white of eyes, palpitation or shortness of breath at exertion, yellowing of skin, brown urine [hemolytic anemia]
  • general malaise, dizziness, shortness of breath, palpitation [pure red-cell aplasia]
  • general malaise, loss of appetite, fever, yellowing of the white of eyes, yellowing of skin, rash, nausea, vomiting, itching [fulminant hepatitis, liver dysfunction, jaundice]
  • fever, dry cough, shortness of breath, breathing difficulty [interstitial pneumonia]
  • loss of consciousness, loss of breathing [cardiac arrest, respiratory arrest]
  • dizziness, darkening of vision, chest pain, chest discomfort, palpitation [ventricular fibrillation]
  • arching back, general stiffness, general muscle rigidity, convulsion with muscle stiffness [tonic seizure]
  • swelling of lymph nodes, night sweat, decreased body weight, fever, loss of appetite [malignant lymphoma, swelling of lymph nodes]
  • dizziness, awkward speech, unclear pronunciation, unable to move limbs smoothly [cerebellar atrophy]
  • lassitude, numbness of limbs, stiffness of limbs, muscle pain, reddish brown urine [rhabdomyolysis]
  • decreased urine output, anuria, general malaise, edema, fever, joint pain, nausea, vomiting, diarrhea, abdominal pain [acute renal failure, interstitial nephritis]
  • high fever, sweating, tremor of limbs, body stiffness, difficulty in speaking, drooling, difficulty in swallowing, increased pulse or respiratory rate [malignant syndrome]
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

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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