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BACTRIM® |
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Product Information (Abridged) |
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Properties |
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| BACTRIM® consists of two components which
exhibit |
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mutual potentiation, the pyrimidine
derivative |
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trimethroprim (TM) and the sulphonamide, |
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sulfamethoxazole (SMZ). Both these active ingredients |
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have a simultaneous but different
effect on bacterial |
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metabolism and thus achieve a
bactericidal effect. |
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BACTRIM® is associated with good
tissue diffusion properties, broad antimicrobial
spectrum, high clinical efficacy and tolerability in
common infections of the respiratory tract, urinary
tract, skin and soft tissue etc. |
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Active
Ingredients / Compositions |
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Sulfamethoxazole (SMZ) and Trimethoprim
(TM) |
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SMZ |
TM |
| 1 Forte tablet |
800mg |
160mg |
| 1 measure (5ml) syrup |
200mg |
40mg |
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Indications |
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Treatment of infections of the
respiratory tract, urinary tract, gastro-intestinal
tract, skin and soft-tissue. Prophylaxis and treatment
of HIV/AIDS opportunistic infections. |
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Dosage /
Administration |
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Forte Tablets |
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Adults and children over 12
years of age |
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Morning |
Evening |
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Standard dosage |
1 |
1 |
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Minimium dosage and dosage
for long-term therapy (longer than 14 days) |
½ |
½ |
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High dosage (for particularly
severe cases) |
1½ |
1½ |
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Dose for uncomplicated
gonorrhoea (limited to 1 day) |
2½ |
2½ |
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| b. |
Children, according to age |
1 teaspoonful
(5ml) paediatric syrup |
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Morning |
Evening |
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6 weeks to 5 months |
½ |
½ |
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6 months to 5 years |
1 |
1 |
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6 years to 12 years |
2 |
2 |
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| c. |
Opportunistic infections –
Recommended BACTRIM® dosages |
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Pneumocystis carinii pneumonia |
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Prophylaxis: One (1)
BACTRIM® forte daily. |
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Treatment: 100 mg
sulfamethoxazole + 20mg Trimethoprim per kg body
weight daily for 2 – 4 weeks. |
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Nocardiosis / Toxoplasmosis /
Isosporiasis / Tuberculosis. |
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Contraindications |
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Marked liver parenchymal damage or
blood dyscrasias, severe renal insufficiency,
sulphonamide or trimethorprim hypersensitivity,
pregnancy, premature and newborn babies. |
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Precautions |
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Maintain an adequate urinary output.
Reduced dosage in renal impairment. Regular blood counts
are advisable with long-term therapy. Special caution is
required in patients predisposed to folate deficiency.
The usual caution in prescribing any drug for women of
childbearing age should be exercised. Both trimethoprim
and sulfamethoxazole are excreted in breast milk. |
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Side effects |
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Nausea, vomiting, glossitis,
skin rashes and blood dyscrasias can occur. Discontinue
treatment if a skin rash appears. Elderly patients are
more prone to blood dyscrasias. Megalobiastic changes in
the bone marrow are reversible with folinic acid. |
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Packs |
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Forte Tablets (Double Strength) |
10 |
100 |
| Paediatric syrup |
50ml |
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