Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
a174991a-53e7-c791-3cee-b706a48e0ec5
HUMAN PRESCRIPTION DRUG LABEL
Apr 5, 2023
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sulfamethoxazole and Trimethoprim
PRODUCT DETAILS
INGREDIENTS (6)
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children
Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
Children 2 months of age or older:
Weight |
Dose – every 12 hours | |
lb |
kg |
Tablets |
22 |
10 |
|
44 |
20 |
1 |
66 |
30 |
1½ |
88 |
40 |
2 or 1 DS tablet |
For Patients with Impaired Renal Function
When renal function is impaired, a reduced dosage should be employed using the following table:
Creatinine Clearance (mL/min) |
Recommended Dosage Regimen |
Above 30 |
Usual standard regimen |
15 to 30 |
½ the usual regimen |
Below 15 |
Use not recommended |
Acute Exacerbations of Chronic Bronchitis in Adults
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet, or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.
Pneumocystis jirovecii** Pneumonia**
Treatment
Adults and Children:
The recommended dosage for treatment of patients with documented Pneumocystis jirovecii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days12. The following table is a guideline for the upper limit of this dosage:
Weight |
Dose – every 6 hours | |
lb |
kg |
Tablets |
18 |
8 |
|
35 |
16 |
1 |
53 |
24 |
1 ½ |
70 |
32 |
2 or 1 DS tablet |
88 |
40 |
2 ½ |
106 |
48 |
3 or 1 ½ DS tablets |
141 |
64 |
4 or 2 DS tablets |
176 |
80 |
5 or 2 ½ DS tablets |
For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.
Prophylaxis
Adults:
The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim double strength tablet daily13.
Children:
For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1,600 mg sulfamethoxazole and 320 mg trimethoprim14. The following table is a guideline for the attainment of this dosage in children:
Body Surface Area |
Dose – every 12 hours |
(m2) |
Tablets |
0.26 |
|
0.53 |
½ |
1.06 |
1 |
Traveler’s Diarrhea in Adults
For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.