Composition:
Each tablet contains:
Trimethoprime …………................... 160mg
Sulphamethoxazole ….................…. 800mg
Properties:
Sutaprim D.S. has a unique mode of action:
► Trimethoprime
represents a group of compounds which affect
the nucleoprotein
metabolism of the cell of
the micro-organism by interference with the
folic-folinic acid
systems.
► Sulphamethoxazole
acts on the same biological pathway at a
different point.
► The effect of
both agents is markedly synergistic. The
preparation has a bactericidal effect
against a wide range of gram positive and
gram negative bacteria and the resistance is
less
likely than when either agent is used
alone.
Indications:
► Urinary tract infections:
• For the treatment of urinary tract infections due
to susceptible following organisms: E.Coli, Klebsiella Sp., Enterobacter
Sp.,
Morganella morgani, Proteus mirabilis and Proteus vulgaris.
► For
the treatment of acute otitis media:
due to susceptible strains.
► For the treatment of enteritis acute exacerbation of chronic bronchitis in adults:
due to susceptible strains.
► For the treatment of enteritis travelers diarrhea in adults:
due to susceptible strains.
► For the treatment of enteritis:
caused by susceptible strains.
► Pneumocysts carinii pneumonia:
• For the treatment of documented Pneumocysts carinii pneumonia
• For the prophylaxis against Pneumocysts carinii
pneumonia in individuals who immunosupressed and considered to be at
increased
risk of developing Pneumocysts carinii pneumonia.
Contraindications:
► Sutaprim D.S.
is contraindicated in severe renal
insufficiency, marked liver damage and
glucose 6-phosphate dehydrogenase
deficiency.
► It should not be administrated during
pregnancy or breast feeding mothers and
babies less than 2 months of age.
► Hematological disorders and porphyria.
► Hypersensitivity to sulphonamides is a
contraindication.
Precautions:
1-If exanthema develops during treatment
with Sulphamethoxazole and Trimethoprime
tablets, the drug should be discontinued.
2-Incases of renal impairment, the dosage
should be reduced to avoid accumulation of
the drug.
3-Patients should be monitored during
treatment to discover the serious side
effects such as skin inflammations, anemia,
liver toxicity.
4-Special care should be exercised in
treating elderly patients or suspected
folate deficient patients.
5-It should be given with caution to
patients with severe allergy or bronchial
asthma.
6-Reular hematological examination should be
done during prolonged courses of treatment.
7-It should be used only under medical
supervision for children less than 3 years.
Drug Interactions:
► Anesthetics:
effect of thiopentane enhanced.
► Antiarrhythmics: the drug increases the
risk of ventricular arrhythmias with
amiodarone (avoid concomitant use).
► Anticoagulants: effect of dicoumarol and
warfarin is enhanced.
► Antidiabetic:
effect of sulphonylureas
enhanced.
► Antiepileptic: antifolate effect and plasma
concentration of phenytoin increased by the
drug.
► Antimalarial: with pyrimethamine in a dose
exceeding 25 mg weekly may develop
megaloblastic anemia.
► Cytotoxics: antifolate effect of
methotrexate increased by the drug.
► Indomethacin may increase blood level of
Sulphamethoxazole.
► Increased Digoxin blood level may occurs.
Adverse reactions:
Sutaprim D.S. is generally well tolerated.
The majority of side effects observed were
of mild or moderate severity and were
normally tolerated with continued treatment.
Gastrointestinal, the most frequently
observed side effect was diarrhea/loose
stool. Nausea, vomiting, epigastric
distress, and abdominal pain/cramps have
been observed.
Hypersensitivity reactions:
urticaria
,erythema multiform and exfoliate
dermatitis.
It is expected that the adverse reactions
associated with use of ampicillin may be
occasionally observed.
Dosage and administration:
► Adults ................................................. Once tablets twice daily for at least 5 days.
► In severe infections ............................. 2.88g (3 tablets) daily in 2 divided doses may be given.
Side effects:
Nausea, Vomiting, Skin rash, Hematological
changes are rarely reported.
Packing:
Box of 10 tablets.
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