Sulfamethoxazole and trimethoprim intravenous
Other products: Sulfamethoxazole and trimethoprim
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From MedlinePlus, U.S. National Library of Medicine
Dihydrofolate Reductase Inhibitor Antibacterial, Sulfonamide Antimicrobial
Dosing in kidney impairment
Dosage Modifications in Patients with Impaired Renal Function When renal function is impaired, a reduced dosage should be employed, as shown in Table 2 . Table 2: Impaired Renal Function Dosage Guidelines [See table below.]
| Creatinine Clearance (mL/min) | Recommended Dosage Regimen |
| Above 30 | Usual standard dosage regimen |
| 15 – 30 | ½ the usual dosage regimen |
| Below 15 | Use not recommended |
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Preparation and administration
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Important Administration Instructions Administer the solution by intravenous infusion over a period of 60 to 90 minutes. Avoid administration by rapid infusion or bolus injection. Do NOT administer Sulfamethoxazole and trimethoprim injection intramuscularly. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Method of Preparation Dilution of Single- and Multiple-Dose Vials Sulfamethoxazole and trimethoprim injection must be diluted. Each 5 mL should be added to 125 mL of 5% dextrose in water. After diluting with 5% dextrose in water, the solution should not be refrigerated and should be used within 6 hours. If a dilution of 5 mL per 100 mL of 5% dextrose in water is desired, it should be used within 4 hours.
In those instances where fluid restriction is desirable, each 5 mL may be added to 75 mL of 5% dextrose in water. Under these circumstances the solution should be mixed just prior to use and should be administered within 2 hours. If upon visual inspection there is cloudiness or evidence of crystallization after mixing, the solution should be discarded and a fresh solution prepared.
Do NOT mix sulfamethoxazole and trimethoprim injection in 5% dextrose in water with drugs or solutions in the same container. Multiple-dose Vials (Handling) After initial entry into the vial, the remaining contents must be used within 48 hours. Infusion Systems for Intravenous Administration The following infusion systems have been tested and found satisfactory: unit-dose glass containers; unit-dose polyvinyl chloride and polyolefin containers.
No other systems have been tested and therefore no others can be recommended.
Drug interactions
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- Sulfamethoxazole and trimethoprim intravenous
Label text (11 paragraphs)
Potential for Sulfamethoxazole and trimethoprim injection to Affect Other Drugs Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid coadministration of sulfamethoxazole and trimethoprim injection with drugs that are substrates of CYP2C8 and 2C9 or OCT2. Table 4: Drug Interactions with Sulfamethoxazole and trimethoprim injection Drug(s) Recommendation Comments Diuretics Avoid concurrent use In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported.
Warfarin Monitor prothrombin time and INR It has been reported that sulfamethoxazole and trimethoprim injection may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). This interaction should be kept in mind when sulfamethoxazole and trimethoprim injection is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed. Phenytoin Monitor serum phenytoin levels Sulfamethoxazole and trimethoprim injection may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate).
Sulfamethoxazole and trimethoprim injection, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect. Methotrexate Avoid concurrent use Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations.
Cyclosporine Avoid concurrent use There have been reports of marked but reversible nephrotoxicity with coadministration of sulfamethoxazole and trimethoprim injection and cyclosporine in renal transplant recipients. Digoxin Monitor serum digoxin levels Increased digoxin blood levels can occur with concomitant sulfamethoxazole and trimethoprim injection therapy, especially in elderly patients Indomethacin Avoid concurrent use Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin.
Pyrimethamine Avoid concurrent use Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if sulfamethoxazole and trimethoprim injection is prescribed. Tricyclic Antidepressants (TCAs) Monitor therapeutic response and adjust dose of TCA accordingly The efficacy of tricyclic antidepressants can decrease when coadministered with sulfamethoxazole and trimethoprim injection.
Oral hypoglycemics Monitor blood glucose more frequently Like other sulfonamide-containing drugs, sulfamethoxazole and trimethoprim injection potentiates the effect of oral hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted. Amantadine Avoid concurrent use In the literature, a single case of toxic delirium has been reported after concomitant intake of sulfamethoxazole and trimethoprim injection and amantadine (an OCT2 substrate).
Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported. Angiotensin Converting Enzyme Inhibitors Avoid concurrent use In the literature, three cases of hyperkalemia in elderly patients have been reported after concomitant intake of sulfamethoxazole and trimethoprim injection and an angiotensin converting enzyme inhibitor. 6,7 Zidovudine Monitor for hematologic toxicity Zidovudine and sulfamethoxazole and trimethoprim injection are known to induce hematological abnormalities. Hence, there is potential for an additive myelotoxicity when coadministered.
8 Dofetilide Concurrent administration is contraindicated Elevated plasma concentrations of dofetilide have been reported following concurrent administration of trimethoprim and dofetilide. Increased plasma concentrations of dofetilide may cause serious ventricular arrhythmias associated with QT interval prolongation, including torsade de pointes . 2,3 Procainamide Closely monitor for clinical and ECG signs of procainamide toxicity and/or procainamide plasma concentration if available Trimethoprim increases the plasma concentrations of procainamide and its active N-acetyl metabolite (NAPA) when trimethoprim and procainamide are coadministered.
The increased procainamide and NAPA plasma concentrations that resulted from the pharmacokinetic interaction with trimethoprim are associated with further prolongation of the QTc interval. 9 CYP2C8, CYP2C9 or OCT2 substrates: Use with caution when co-administering with Sulfamethoxazole and trimethoprim injection. (7) Warfarin: Monitor prothrombin time and INR. (7) Phenytoin: Monitor serum phenytoin levels. (7) Digoxin: Concomitant use may increase digoxin blood levels, especially in elderly patients. Monitor serum digoxin levels. (7) Oral hypoglycemics: Concomitant use may potentiate hypoglycemic effects. Monitor blood glucose more frequently.
(7) Zidovudine: Monitor for hematologic toxicity. (7) Procainamide: Monitor for signs of procainamide toxicity. (7)
7.1 Interactions with Laboratory or Diagnostic Testing Sulfamethoxazole and trimethoprim injection, specifically the trimethoprim component, can interfere with a serum methotrexate assay as determined by the competitive binding protein technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. No interference occurs, however, if methotrexate is measured by a radioimmunoassay (RIA). The presence of sulfamethoxazole and trimethoprim injection may also interfere with the Jaff¡SR alkaline picrate reaction assay for creatinine, resulting in overestimations of about 10% in the range of normal values.
Contraindications
Sulfamethoxazole and trimethoprim injection is contraindicated in the following situations: Known hypersensitivity to trimethoprim or sulfonamides [see Warnings and Precautions (5.2)] History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides [see Warnings and Precautions (5.4)] Documented megaloblastic anemia due to folate deficiency [see Warnings and Precautions (5.11)] Pediatric patients less than two months of age [see Use in Specific Populations (8.4)] Marked hepatic damage [see Warnings and Precautions (5.11, 5.14)] Severe renal insufficiency when renal function status cannot be monitored [see Warnings and Precautions (5.11, 5.14)] Concomitant administration with dofetilide 2,3 [see Drug Interactions (7)] Known hypersensitivity to trimethoprim or sulfonamides (4) History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides (4) Documented megaloblastic anemia due to folate deficiency (4) Pediatric patients less than two months of age (4) Marked hepatic damage (4) Severe renal insufficiency when renal function status cannot be monitored (4) Concomitant administration with dofetilide (4)
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for sulfamethoxazole and trimethoprim intravenous. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Sulfamethoxazole and trimethoprim injection may cause fetal harm if administered to a pregnant woman. Some epidemiologic studies suggest that exposure to sulfamethoxazole and trimethoprim injection during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular abnormalities, urinary tract defects, oral clefts, and club foot (see Human Data). One of 3 rat studies showed cleft palate at doses approximately 5 times the recommended human dose on a body surface area basis; the other 2 studies did not show teratogenicity at similar doses.
Studies in pregnant rabbits showed increased fetal loss at approximately 6 times the human dose on a body surface area basis ( see Animal Data). The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Advise pregnant women of the potential harm of sulfamethoxazole and trimethoprim injection to the fetus ( see Clinical Considerations).
Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Urinary tract infection in pregnancy is associated with adverse perinatal outcomes such as preterm birth, low birth weight, and pre-eclampsia, and increased mortality to the pregnant woman. P. jirovecii pneumonia in pregnancy is associated with preterm birth and increased morbidity and mortality for the pregnant woman. Sulfamethoxazole and trimethoprim injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Data Human Data While there are no large, prospective, well-controlled studies in pregnant women and their babies, some retrospective epidemiologic studies suggest an association between first trimester exposure to sulfamethoxazole and trimethoprim injection with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular abnormalities, urinary tract defects, oral clefts, and club foot. These studies, however, were limited by the small number of exposed cases and the lack of adjustment for multiple statistical comparisons and confounders.
These studies are further limited by recall, selection, and information biases, and by limited generalizability of their findings. Lastly, outcome measures varied between studies, limiting cross-study comparisons. Alternatively, other epidemiologic studies did…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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