Source: FDA, National Drug Code (US) Revision Year: 2023
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.
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.
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.
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.
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.
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 |
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.
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.
After initial entry into the vial, the remaining contents must be used within 48 hours.
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.
Since there has been no extensive experience in humans with single doses of sulfamethoxazole and trimethoprim injection in excess of 25 mL (400 mg trimethoprim and 2000 mg sulfamethoxazole), the maximum tolerated dose in humans is unknown.
Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage.
Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression.
General principles of treatment include the administration of intravenous fluids if urine output is low and renal function is normal. Acidification of the urine will increase renal elimination of trimethoprim. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating trimethoprim and sulfamethoxazole.
Use of Sulfamethoxazole and trimethoprim injection at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, the patient should be given leucovorin 5 to 15 mg daily until normal hematopoiesis is restored.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
DO NOT REFRIGERATE.
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