SULFATRIM (Page 6 of 6)

Prophylaxis

Adults

The recommended dosage for prophylaxis in adults is four teaspoonfuls (20 mL) of the oral suspension daily. ¹¹

Children

For children, the recommended dose is 750 mg/m ² /day sulfamethoxazole with 150 mg/m ² /day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim. ¹² The following table is a guideline for the attainment of this dosage in children:

Body Surface Area	Dose every 12 hours
(m 2)	Teaspoonfuls
0.26	½ (2.5 mL)
0.53	1 (5 mL)
1.06	2 (10 mL)

Travelers’ Diarrhea in Adults

For the treatment of travelers’ diarrhea, the usual adult dosage is four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension every 12 hours for 5 days.

HOW SUPPLIED

Sulfamethoxazole and Trimethoprim Oral Suspension USP, containing 200 mg sulfamethoxazole and 40 mg trimethoprim per teaspoonful (5 mL), is a cherry flavored suspension available in:

NDC 0121-0854-16: 16 fl oz (473 mL) bottle

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light.

SHAKE WELL BEFORE USING.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rx only

REFERENCES

1. Kremers P, Duvivier J, Heusghem C. Pharmacokinetic Studies of Co-Trimoxazole in Man after Single and Repeated Doses. J Clin Pharmacol. Feb-Mar 1974; 14:112–117.

2. Kaplan SA, et al. Pharmacokinetic Profile of Trimethoprim-Sulfamethoxazole in Man. J Infect Dis. Nov 1973; 128 (Suppl): S547– S555.

3. Varoquaux O, et al. Pharmacokinetics of the trimethoprim-sulfamethoxazole combination in the elderly. Br J Clin Pharmacol. 1985;20:575–581.

4. Rudoy RC, Nelson JD, Haltalin KC. Antimicrobial Agents Chemother. May 1974;5:439–443.

5. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically ; Approved Standard – Fourth Edition. NCCLS Document M7–A4, Vol.17, No. 2, NCCLS, Wayne, PA, January, 1997.

6. Hardy DW, et al. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome. N Engl J Med. 1992; 327: 1842–1848.

7. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. Gerontol. 45:209–212.

8. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. J. Nephrol. 14:410–414.

9. Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. J Infect Dis. Nov 1973; 128 (Suppl):S657–S663.

10. Masur H. Prevention and treatment of Pneumocystis pneumonia. N Engl J Med. 1992; 327: 1853–1880.

11. Recommendations for prophylaxis against Pneumocystis carinii pneumonia for adults and adolescents infected with human immunodeficiency virus. MMWR. 1992; 41(RR-4):1–11.

12. CDC Guidelines for prophylaxis against Pneumocystis carinii pneumonia for children infected with human immunodeficiency virus. MMWR. 1991; 40(RR-2):1–13.

Manufactured for:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
R02/18

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

NDC 0121- 0854 -16

SULFATRIM™
PEDIATRIC
SUSPENSION
(sulfamethoxazole and
trimethoprim
oral suspension USP)

CHERRY FLAVOR

Each 5 mL (teaspoonful) contains:

Sulfamethoxazole, USP 200 mg
Trimethoprim, USP 40 mg
Alcohol NMT 0.5%

Rx Only

16 FL OZ (473 mL)

Pharmaceutical
Associates, Inc. Greenville, SC 29605

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SULFATRIM sulfamethoxazole and trimethoprim suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1657(NDC:0121-0854) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFAMETHOXAZOLE (SULFAMETHOXAZOLE) SULFAMETHOXAZOLE 200 mg in 5 mL TRIMETHOPRIM (TRIMETHOPRIM) TRIMETHOPRIM 40 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL METHYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM PROPYLPARABEN ANHYDROUS CITRIC ACID POLYSORBATE 80 PROPYLENE GLYCOL WATER SACCHARIN SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 SUCROSE DIMETHICONE SILICON DIOXIDE

Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67296-1657-2 200 mL in 1 BOTTLE None 2 NDC:67296-1657-1 100 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018615 07/01/1983

Labeler — RedPharm Drug, Inc. (828374897)

Establishment
Name	Address	ID/FEI	Operations
EPM Packaging, Inc.		079124340	repack (67296-1657)

Revised: 01/2022 RedPharm Drug, Inc.