Sulfamethoxazole/trimethoprim Oral Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Sulfamethoxazole 200mg, trimethoprim 40mg; per 5mL; cherry or grape flavor; alcohol 0.26%.
Pharmacological Class
Sulfonamide + folic acid inhibitor.
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How Supplied
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Manufacturer
Sulfamethoxazole/trimethoprim Oral Suspension Indications
Indications
Susceptible infections including UTIs (not for initial uncomplicated episodes), shigellosis, prophylaxis and treatment of Pneumocystis jiroveci pneumonia (PJP), travelers' diarrhea or acute exacerbations of chronic bronchitis in adults, acute otitis media in children.
Sulfamethoxazole/trimethoprim Oral Suspension Dosage and Administration
Adult
1 DS tab, 2 regular tabs, or 20mL of susp every 12hrs for 5 days (shigellosis, travelers' diarrhea), or 10–14 days (UTIs), or 14 days (bronchitis). PJP treatment: 15–20mg/kg per day of trimethoprim (75–100mg/kg per day of sulfamethoxazole) in 4 divided doses at 6-hour intervals for 14–21 days; PJP prophylaxis: one DS tab daily. Renal impairment (CrCl 15–30mL/min): reduce dose by ½; (CrCl <15mL/min): not recommended.
Children
<2 months: see Contraindications. ≥2 months: 8mg/kg per day trimethoprim (40mg/kg per day of sulfamethoxazole) in 2 divided doses at 12-hour intervals for 5 days (shigellosis) or 10 days (otitis media, UTIs). PJP treatment: as adult; PJP prophylaxis or renal impairment: see full labeling.
Sulfamethoxazole/trimethoprim Oral Suspension Contraindications
Contraindications
History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides. Megaloblastic anemia due to folate deficiency. Children <2 months. Marked hepatic damage. Severe renal insufficiency when renal status cannot be monitored. Concomitant dofetilide.
Sulfamethoxazole/trimethoprim Oral Suspension Boxed Warnings
Not Applicable
Sulfamethoxazole/trimethoprim Oral Suspension Warnings/Precautions
Warnings/Precautions
Not for group A β-hemolytic strep. Avoid prolonged administration. Monitor CBCs, urine, and renal function. Hepatic or renal impairment: avoid. AIDS (increased risk of toxicity). Folate or G6PD deficiency. Severe allergy. Bronchial asthma. Circulatory shock. Malnutrition. Porphyria. Thyroid dysfunction. Disorders of potassium metabolism. Monitor for electrolyte abnormalities. Maintain adequate hydration. Discontinue at the 1st sign of skin rash or any other serious reaction. Elderly. Embryo-fetal toxicity. Pregnancy. Nursing mothers (IV: not recommended).
Sulfamethoxazole/trimethoprim Oral Suspension Pharmacokinetics
See Literature
Sulfamethoxazole/trimethoprim Oral Suspension Interactions
Interactions
See Contraindication. Caution with concomitant CYP2C8, 2C9, or OCT2 substrates. May potentiate oral anticoagulants (eg, warfarin), hypoglycemics, phenytoin, methotrexate, digoxin. May be potentiated by indomethacin. May increase risk of thrombocytopenia with diuretics (esp. thiazides). Nephrotoxicity with cyclosporine in renal transplant. Megaloblastic anemia with >25mg/week doses of pyrimethamine. May antagonize tricyclic antidepressants. May interfere with assays for serum methotrexate, creatinine. PJP treatment: avoid leucovorin.
Sulfamethoxazole/trimethoprim Oral Suspension Adverse Reactions
Adverse Reactions
Nausea, vomiting, anorexia, allergic skin reactions, blood dyscrasias (eg, thrombocytopenia, aplastic anemia, agranulocytosis), hemolysis, hepatic or renal toxicity, crystalluria, pancreatitis, photosensitivity, drug fever, rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, others), fulminant hepatic necrosis, lung injury, lupus-like syndrome, peripheral neuritis, depression, convulsions, ataxia, hypoglycemia, hyperkalemia, hyponatremia; C. difficile-associated diarrhea, thrombocytopenia.
Sulfamethoxazole/trimethoprim Oral Suspension Clinical Trials
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Sulfamethoxazole/trimethoprim Oral Suspension Note
Notes
Formerly known under the brand name Septra.
Sulfamethoxazole/trimethoprim Oral Suspension Patient Counseling
See Literature