Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 10/2014
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:Bactramin Injection
Active ingredient:Trimethoprim
Sulfamethoxazole
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine contains 2 kinds of active ingredients; one is for blocking folate biosynthesis and another is for
blocking folate activation. Consequently, it shows synergistic inhibitory effect on the growth of Pneumocystis carinii.
It is usually used to treat carinii pneumonia.
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/had blood disease.
If you or any of your parents or siblings have previously experienced any allergic reactions such as bronchial
asthma, rash, and hives.
If you have: hepatic/renal disorder, folate deprivation or folate metabolism abnormality (a history of gastric
resection, just after delivery, congenital folate metabolism abnormality), glucose-6-phosphate dehydrogenase
deficiency.
・If you are pregnant, breastfeeding or possibly pregnant.
・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, this medicine is given 3 times daily by intravenous drip infusion over 1 to 2 hours.
・The treatment period with this medicine depends on your response to the treatment.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include bulla, hives, photosensitivity, rash, erythema, pruritus,
bloody stool, convulsion, depression, feeling irritated, headache, drowsiness, light-headed feeling, numbness,
tremor, losing strength, malaise, dizziness and hallucination. 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.
・palpitation/shortness of breath when moving or going upstairs/uphill, palpitation, shortness of breath,
breathlessness, nose/gum bleeding, blue spot, bleeding tendency, continuous bleeding, subcutaneous bleeding,
glossitis accompanied by numbness and pain, facial pallor, toenails/fingernails/lips turning blue, easy fatigability,
lassitude, headache, fever, sore throat, dizziness, lightheadedness, dizziness on standing up, ear ringing, dull
headache, yellowness in the skin and/or the white of the eye, brown urine [aplastic anaemia, anaemia
megaloblastic, methaemoglobinaemia, thrombocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia]
・gum/nose bleeding, fever, subcutaneous bleeding, purplish bruise, blue spot, anemia, shortness of breath,
breathlessness, yellowness in the skin and/or the white of the eye, dark urine, decreased consciousness, impaired
mind/judgment, numbness, convulsion, decreased urinary volume, swelling [thrombotic thrombocytopenic purpura
(TTP), hemolytic uremic syndrome (HUS)]
・hoarseness, swelling around the eye and lips, hives, impaired judgment, palpitation, shortness of breath,
breathlessness, lassitude, impaired mind, glow, decreased consciousness, faint consciousness, lightheadedness,
dizziness, cold sweat, pale face [anaphylaxis, shock]
・lassitude, high fever, inflamed eyelid/eye, conjunctival sore, lip/intraoral sore, loss of appetite, red rash, red spot
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with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the
genitalia, joint pain [oculomucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis
(TEN)]
・chills, lightheadedness, heavy sweating, fever, faint consciousness, impaired mind, breathlessness, itch, rash,
numbness, impaired judgment [drug-induced hypersensitivity syndrome]
・sudden and severe abdominal/lower-back/back pain, fever, nausea, vomiting [acute pancreatitis]
・vomiting, feeling sick, abdominal pain, fever, diarrhea, bloody stool, frequent diarrhea, bloody diarrhea [serious
colitis with bloody stool caused by pseudomembranous colitis, etc.]
・fever, impaired judgment, decreased consciousness, flapping tremor in hands, impaired mind, yellowness in the skin
and/or the white of the eye, lassitude, loss of appetite, nausea, vomiting, rash, itch [severe liver disorder]
・decreased consciousness, swollen eye, decreased urinary volume, swollen body, headache, lassitude,
breathlessness, easy fatigability, joint pain, fever, rash, urine with blood [renal failure acute, nephritis interstitial]
・fever, headache, vomiting, inactive sensory, numbness in the limbs, weakness/muscle atrophy/pain of the limbs
[meningitis aseptic, peripheral neuritis]
・fever, cough, shortness of breath, breathlessness [interstitial pneumonia, PIE syndrome]
・dizziness, hungry feeling, lightheadedness, cold sweat, shaky limbs, feeling of weariness, headache, palpitation
[hypoglycaemic attack]
・loss of strength in the limbs, paralyzed limbs, numbness in the lips/limbs, muscle weakness, feeble muscles,
difficulty moving limbs, decreased consciousness, headache, nausea, vomiting, loss of appetite, convulsion
[hyperkalaemia, hyponatraemia]
・stiff limbs, numbness in the limbs, feeling of weariness, muscle pain, red-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
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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