Dosage/Direction for Use
Oral Susceptible infections, Urinary tract infections, Respiratory tract infections, Skin infections, Gastrointestinal infections, Genital infections, Ear, nose and/or throat infections Adult: Each tablet contains sulfamoxole 400 mg and trimethoprim 60 mg: Initially, 2 tablets, followed by 1 tablet bid. Each 5 ml contains sulfamoxole 200 mg and trimethoprim 40 mg: Initially, 20 ml, followed by 10 ml bid. Child: Each 5 ml contains sulfamoxole 200 mg and trimethoprim 40 mg: 4-12 mth: Initially, 2.5-5 ml followed by 1.2-2.5 ml bid; 1-6 yr: Initially, 5-10 ml, followed by 2.5-5 ml bid, 6-12 yr: Initially, 10-15 ml, followed by 5-10 ml bid. Renal impairment: Dose reduction is advisable. |
Contraindications
Hypersensitivity to sulfonamides; severe renal or hepatic impairment; porphyria, SLE; serious haematological disorders; megaloblastic anemia secondary to folate depletion. Infants <2 mth; pregnancy (3rd trimester), lactation.
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Special Precautions
Renal insufficiency, elderly, blood dyscrasias, G6PD deficiency, AIDS, patient with potential folate deficiency, children with fragile X chromosome associated with mental retardation. Perform regular haematological examination.
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Adverse Reactions
Nausea, vomiting, anorexia, diarrhoea, glossitis, stomatitis, drowsiness, headache, depression, hallucinations, hypersensitivity skin reaction, photosensitivity, drug fever, crystalluria, elevation of liver enzymes, hypothyroidism, hyponatremia, hyperkalemia, kernicterus in premature neonates, aseptic meningitis, cholestatic jaundice.
Potentially Fatal: Anaphylaxis; Stevens-Johnson syndrome; blood dyscrasias e.g. agranulocytosis, aplastic anaemia; toxic epidermal necrolysis. |
Overdosage
Nausea, vomiting, allergic reactions. If within 3 hrs of ingestion, gastric lavage to be performed, followed by IM folinic acid, vitamin B12 and supportive treatment. Perform LFT once a wk and FBC twice a wk for 3 wks.
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Drug Interactions
Concurrent use increases risk of blood dyscrasias with azathioprine, methotrexate, pyrimethamine; increased risk of hyperkalaemia with ACE inhibitors; increased risk of hyponatraemia when used with both potassium-sparing diuretics and thiazides; increases risk of bleeding with warfarin; increases risk of lithium toxicity; increases digoxin, phenytoin, procainamide, lamivudine, stavudine, repaglinide, rosiglitazone, dofetilide serum levels; decreases ciclosporin levels. Concurrent use with dapsone increases serum levels of both and increases risk of dapsone toxicity. Concurrent may potentiate antidiabetic effect of sulphonylureas.
Potentially Fatal: Concurrent use increases risk of blood dyscrasias with clozapine and pyrimethamine. |
Lab Interference
Interference with tests for urea, creatinine, urinary glucose, urobilinogen, serum methotrexate ( when dihydrofolate reductase is used) and creatinine assay (when Jaffe reaction is used).
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Action
Sulfamoxole interferes with nucleic acid synthesis in microorganisms by blocking the conversion of p-aminobenzoic acid to the coenzyme dihydrofolic acid. Trimethoprim inhibits the conversion of bacterial dihydrofolic acid to tetrahydrofolic acid which is important for the synthesis of DNA.
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Storage
Oral: Store below 25°C
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CIMS Class
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ATC Classification
J01EC03 - sulfamoxole ; Belongs to the class of intermediate-acting sulfonamides. Used in the systemic treatment of infections.
J01EA01 - trimethoprim ; Belongs to the class of trimethoprim and derivatives. Used in the systemic treatment of infections. |