Sulfamethoxazole and Trimethoprim

SULFAMETHOXAZOLE AND TRIMETHOPRIM — sulfamethoxazole and trimethoprim injection, solution, concentrate
Somerset Therapeutics, LLC

1 INDICATIONS AND USAGE

1.1 Pneumocystis jirovecii Pneumonia

Limitation of Use:

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (1.3)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria

1.2 Shigellosis

Sulfamethoxazole and trimethoprim injection is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in adults and pediatric patients two months of age and older.

1.3 Urinary Tract Infections

Sulfamethoxazole and trimethoprim injection is indicated in the treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii , Proteus mirabilis and Proteus vulgaris when oral administration of sulfamethoxazole and trimethoprim injection is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract.

1.4 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim injection and other antibacterial drugs, sulfamethoxazole and trimethoprim injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.

Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the results of these studies.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adults and Pediatric Patients (Two Months of Age and Older)

The maximum recommended daily dose is 60 mL (960 mg trimethoprim) per day.

Table 1: Dosage in Adults and Pediatric Patients (Two Months of Age and Older) by Indication

Dosage Guidelines
Infection Total Daily Dose (based on trimethoprim content) Frequency Duration
Pneumocystis jirovecii Pneumonia* 15-20 mg/kg (in 3 or 4 equally divided doses) Every 6 to 8 hours 14 days
Severe Urinary Tract Infections 8-10 mg/kg (in 2 to 4 equally divided doses) Every 6, 8 or 12 hours 14 days
Shigellosis 8-10 mg/kg (in 2 to 4 equally divided doses) Every 6, 8 or 12 hours 5 days

* A total daily dose of 10 to 15 mg/kg was sufficient in 10 adult patients with normal renal function in a published literature.1

2.2 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

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

2.3 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.

2.4 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.

3 DOSAGE FORMS AND STRENGTHS

Sulfamethoxazole and trimethoprim injection, USP is available as an injection containing 80 mg/mL of sulfamethoxazole and 16 mg/mL of trimethoprim in 5 mL single-dose, 10 mL single-dose and 30 mL multiple-dose vials.

4 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 (5.3)]
  • Documented megaloblastic anemia due to folate deficiency [see Warnings and Precautions (5.10)]
  • Pediatric patients less than two months of age [see Use in Specific Populations (8.4)]
  • Marked hepatic damage [see Warnings and Precautions (5.10, 5.13)]
  • Severe renal insufficiency when renal function status cannot be monitored [see Warnings and Precautions (5.10, 5.13)]
  • Concomitant administration with dofetilide2,3 [see Drug Interactions (7)]

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