Drug Information Sheet("Kusuri-no-Shiori")
Internal
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 Combination Tablet
Active ingredient:Trimethoprim
Sulfamethoxazole
Dosage form:white tablet, diameter: approx. 11mm, thickness: approx. 5.3mm
Print on wrapping:バクトラミン配合錠
Effects of this medicine
This medicine contains 2 kinds of active ingredients working on folate which is necessary for bacteria; one is for
blocking folate biosynthesis and another is for blocking folate activation. Consequently, it has antibacterial effect
synergistically.
It is usually used to treat general infections such as pneumonia, secondary infection caused by chronic respiratory
lesion, complicated cystitis, pyelonephritis, infectious enteritis, typhoid, or paratyphoid. It is also usually used to
treat pneumocystis pneumonia and to suppress symptom onset.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, bronchial asthma, etc.) to any medicines.
If you have: glucose-6-phosphate dehydrogenase deficiency, hepatic/renal disorder, folate deprivation or folate
metabolism abnormality (a history of gastric resection, just after delivery, congenital folate metabolism
abnormality).
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 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>>
・General infections: In general, for adults, take 2 tablets at a time, twice a day. It should be adjusted according to
your disease, age and symptoms.
Treatment of pneumocystis pneumonia: In general, for adults, take 9 to 12 tablets in 3 to 4 divided doses a day. In
general, for children, take 15 to 20 mg/kg of trimethoprim in 3 to 4 divided doses a day. The dosage should be
adjusted according to your age and symptoms in any case.
Suppression of symptom onset of pneumocystis pneumonia: In general, for adults, take 1 to 2 tablets at a time, once
a day. In general, for children, take 2 to 4 mg/kg of trimethoprim at a time, twice a day.
Each tablet contains 80 mg of trimethoprim and 400 mg of sulfamethoxazole as the active ingredients. Strictly follow
the instructions in any case.
・If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, take a dose as
soon as possible and skip the next dose. 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
・Contact your doctor immediately when you notice that you are having such symptoms as anemia, bleeding tendency
(nose bleeding, etc.), continuous bleeding, persistent bruise, rash, hives, blister and itch.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, nausea, stomach discomfort, rash, hives,
erythema, bulla, pruritus and hematologic disorder (anemia, bleeding tendency). 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
1/4
immediately.
・palpitation/shortness of breath when moving, going upstairs or 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, haemolytic anaemia,
anaemia megaloblastic, methaemoglobinaemia, pancytopenia, agranulocytosis, thrombocytopenia]
・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
with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the
genitalia, joint pain [toxic epidermal necrolysis (TEN), oculomucocutaneous syndrome (Stevens-Johnson
syndrome)]
・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
・Keep out of the reach of children. Store at room temperature (1-30 ℃), away from light and moisture.
・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
2/4
Drug Information Sheet("Kusuri-no-Shiori")
Internal
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 Combination Granule
Active ingredient:Trimethoprim
Sulfamethoxazole
Dosage form:white to faintly yellowish white granule
Print on wrapping:
Effects of this medicine
This medicine contains 2 kinds of active ingredients working on folate which is necessary for bacteria; one is for
blocking folate biosynthesis and another is for blocking folate activation. Consequently, it has antibacterial effect
synergistically.
It is usually used to treat general infections such as pneumonia, secondary infection caused by chronic respiratory
lesion, complicated cystitis, pyelonephritis, infectious enteritis, typhoid, or paratyphoid. It is also usually used to
treat pneumocystis pneumonia and to suppress symptom onset.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, bronchial asthma, etc.) to any medicines.
If you have: glucose-6-phosphate dehydrogenase deficiency, hepatic/renal disorder, folate deprivation or folate
metabolism abnormality (a history of gastric resection, just after delivery, congenital folate metabolism
abnormality).
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 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>>
・General infections: In general, for adults, take 2 g at a time, twice a day. It should be adjusted according to your
disease, age and symptoms.
Treatment of pneumocystis pneumonia: In general, for adults, take 9 to 12 g in 3 to 4 divided doses a day. In
general, for children, take 15 to 20 mg/kg of trimethoprim in 3 to 4 divided doses a day. The dosage should be
adjusted according to your age and symptoms in any case.
Suppression of symptom onset of pneumocystis pneumonia: In general, for adults, take 1 to 2 g at a time, once a
day. In general, for children, take 2 to 4 mg/kg of trimethoprim at a time, twice a day.
One gram of this medicine contains 80 mg of trimethoprim and 400 mg of sulfamethoxazole as the active ingredients.
Strictly follow the instructions in any case.
・If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, take a dose as
soon as possible and skip the next dose. 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
・Contact your doctor immediately when you notice that you are having such symptoms as anemia, bleeding tendency
(nose bleeding, etc.), continuous bleeding, persistent bruise, rash, hives, blister and itch.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, nausea, stomach discomfort, rash, hives,
erythema, bulla, pruritus and hematologic disorder (anemia, bleeding tendency). 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
3/4
immediately.
・palpitation/shortness of breath when moving, going upstairs or 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, haemolytic anaemia,
anaemia megaloblastic, methaemoglobinaemia, pancytopenia, agranulocytosis, thrombocytopenia]
・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
with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the
genitalia, joint pain [toxic epidermal necrolysis (TEN), oculomucocutaneous syndrome (Stevens-Johnson
syndrome)]
・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
・Keep out of the reach of children. Store at room temperature (1-30 ℃), away from light and moisture.
・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
4/4