Sulfamethoxazole and Trimethoprim Tablets, USP
Rx only
DESCRIPTION
CLINICAL PHARMACOLOGY
Geriatric Pharmacokinetics
Microbiology
Aerobic gram-positive microorganisms
Aerobic gram-negative microorganisms
Other Organisms
Susceptibility Testing Methods
Dilution Techniques
Diffusion Techniques
INDICATIONS AND USAGE
Urinary Tract Infections
Acute Otitis Media
Acute Exacerbations of Chronic Bronchitis in Adults
Shigellosis
Pneumocystis Carinii Pneumonia
Traveler's Diarrhea in Adults
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
General
Use in the Treatment of and Prophylaxis for Pneumocystis Carinii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS)
Information for Patients
Laboratory Tests
Drug Interactions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Mutagenesis
Impairment of Fertility
Pregnancy
Teratogenic Effects
Nonteratogenic Effects
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
OVERDOSAGE
Acute
Chronic
DOSAGE AND ADMINISTRATION
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children
Adults
Children
| Weight | Dose–every 12 hours |
| lb | kg | Tablets |
| 22446688 | 10203040 | –11½2 or 1 DS tablet |
For Patients with Impaired Renal Function
| Creatinine Clearance (mL/min) | Recommended Dosage Regimen |
| Above 3015–30Below 15 | Usual standard regimen½ the usual regimenUse not recommended |
Acute Exacerbations of Chronic Bronchitis in Adults
Pneumocystis Carinii Pneumonia
Treatment
Adults and Children
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.
| Weight | Dose–every 6 hours |
| lb | kg | Tablets |
| 1835537088106141176 | 816243240486480 | –11½2 or 1 DS tablet2½3 or 1½ DS tablets4 or 2 DS tablets5 or 2½ DS tablets |
Prophylaxis
Adults
Children
| Body Surface Area | Dose–every 12 hours |
| (m2) | Tablets |
| 0.260.531.06 | –½1 |
Traveler’s Diarrhea in Adults
HOW SUPPLIED
| Bottles of 30 | NDC 54868-4711-0 |
| Bottles of 10 | NDC 54868-0021-6 |
| Bottles of 14 | NDC 54868-0021-2 |
| Bottles of 15 | NDC 54868-0021-5 |
| Bottles of 20 | NDC 54868-0021-1 |
| Bottles of 30 | NDC 54868-0021-7 |
| Bottles of 60 | NDC 54868-0021-4 |
| Bottles of 100 | NDC 54868-0021-0 |
| Bottles of 120 | NDC 54868-0021-3 |
REFERENCES
- 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.
- Kaplan SA, et al. Pharmacokinetic Profile of Trimethoprim-Sulfamethoxazole in Man. J Infect Dis. Nov 1973; 128 (Suppl): S547-S555.
- Varoquaux O, et al Pharmacokinetics of the trimethoprim-sulfamethoxazole combination in the elderly. Br J Clin Pharmacol. 1985;20:575-581.
- Rudoy RC, Nelson JD, Haltalin KC. Antimicrobial Agents Chemother. May 1974;5:439-443.
- 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.
- 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.
- Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. Gerontol. 45:209-212.
- Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. J. Nephrol. 14:410-414.
- Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. J Infect Dis. Nov 1973; 128 (Suppl):S657-S663.
- Masur H. Prevention and treatment of Pneumocystis pneumonia. N Engl J Med. 1992; 327:1853-1880.
- Recommendations for prophylaxis against Pneumocystis carinii pneumonia for adults and adolescents infected with human immunodeficiency virus. MMWR. 1992; 41(RR-4):1-11.
- CDC Guidelines for prophylaxis against Pneumocystis carinii pneumonia for children infected with human immunodeficiency virus. MMWR. 1991; 40(RR-2):1-13.
SPL UNCLASSIFIED SECTION
Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146