SULFATRIM (Page 6 of 6)

Acute Exacerbations of Chronic Bronchitis in Adults

The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is four teaspoonfuls (20 mL) sulfamethoxazole and trimethoprim oral suspension every 12 hours for 14 days.

Pneumocystis Carinii Pneumonia

Treatment

Adults and Children: The recommended dosage for treatment of patients with documented Pneumocystis carinii 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 days.10 The following table is a guideline for the upper limit of this dosage:

Weight		Dose — every 6 hours
lb	kg	Teaspoonfuls
18	8	1 (5 mL)
35	16	2 (10 mL)
53	24	3 (15 mL)
70	32	4 (20 mL)
88	40	5 (25 mL)
106	48	6 (30 mL)
141	64	8 (40 mL)
176	80	10 (50 mL)

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 four teaspoonfuls (20 mL) of the oral suspension daily.11

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 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
(m2)	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

Product: 17856-0007

NDC: 17856-0007-2 20 mL in a CUP

NDC: 17856-0007-1 10 mL in a CUP

NDC: 17856-0007-5 5 mL in a CUP

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:

STI PHARMA LLC

Langhorne, PA 19047

Rev. 02/13

SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION

Label Image

SULFATRIM sulfamethoxazole and trimethoprim suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0007(NDC:54879-007) 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 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:17856-0007-2 20 mL in 1 CUP None 2 NDC:17856-0007-1 72 CUP in 1 BOX contains a CUP 2 10 mL in 1 CUP This package is contained within the BOX (17856-0007-1) 3 NDC:17856-0007-5 5 mL in 1 CUP None

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

Labeler — Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Operations
Atlantic Biologicals Corps		047437707	RELABEL (17856-0007), REPACK (17856-0007)

Revised: 11/2016 Atlantic Biologicals Corps