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Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only

Approved
Approval ID

a174991a-53e7-c791-3cee-b706a48e0ec5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 5, 2023

Manufacturers
FDA

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

NDC Product Code63629-1765
Application NumberANDA076899
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 21, 2022
Generic NameSulfamethoxazole and Trimethoprim

INGREDIENTS (6)

SULFAMETHOXAZOLEActive
Quantity: 800 mg in 1 1
Code: JE42381TNV
Classification: ACTIB
TRIMETHOPRIMActive
Quantity: 160 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/21/2022

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

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.

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