Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim Tablets, USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- Rx only
- SULFAMETHOXAZOLE AND TRIMETHOPRIM DESCRIPTION
- CLINICAL PHARMACOLOGY
- SULFAMETHOXAZOLE AND TRIMETHOPRIM INDICATIONS AND USAGE
- SULFAMETHOXAZOLE AND TRIMETHOPRIM 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
- Pregnancy
- Nursing Mothers
- Pediatric Use
- Geriatric Use
- SULFAMETHOXAZOLE AND TRIMETHOPRIM ADVERSE REACTIONS
- OVERDOSAGE
- SULFAMETHOXAZOLE AND TRIMETHOPRIM DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- REFERENCES
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg/80 mg
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 800 mg/160 mg
FULL PRESCRIBING INFORMATION
Rx only
SULFAMETHOXAZOLE AND TRIMETHOPRIM DESCRIPTION
N1101133
141843
Inactive Ingredients:
CLINICAL PHARMACOLOGY
4
DOSAGE AND ADMINISTRATION 142
Geriatric Pharmacokinetics
3
Microbiology
In vitro
in vitro INDICATIONS AND USAGE
Aerobic gram-positive microorganisms
Streptococcus pneumoniae
Aerobic gram-negative microorganisms
Escherichia coli
Klebsiella
Enterobacter
Haemophilus influenzae
Morganella morganii
Proteus mirabilis
Proteus vulgaris
Shigella flexneri
Shigella sonnei
Other Organisms
Pneumocystis carinii
Susceptibility Testing Methods
Dilution Techniques
4
Enterobacteriaceae:
Haemophilus influenzaea Streptococcus pneumoniaeb
b
a.Haemophilus influenzae Haemophilus 4
b. 4
Quality Control
Escherichia coli
Haemophilus influenzaec
Streptococcus pneumoniaed
c.Haemophilus influenzaeHaemophilus4
d.4
Diffusion Techniques
5
Enterobacteriaceae Haemophilus influenzaee
e.Haemophilus influenzae Haemophilus 5
Streptococcus pneumoniaef
f.2.5
Escherichia coli
Haemophilus influenzaeg
Streptococcus pneumoniaeh
Enterococcus faecalis
g.Haemophilus influenzae Haemophilus 5
h.2.5
SULFAMETHOXAZOLE AND TRIMETHOPRIM INDICATIONS AND USAGE
Urinary Tract Infections
Escherichia coli, Klebsiella Enterobacter Morganella morganii, Proteus mirabilis Proteus vulgaris.
Acute Otitis Media
Streptococcus pneumoniae Haemophilus influenzae
Acute Exacerbations of Chronic Bronchitis in Adults
Streptococcus pneumoniae Haemophilus influenzae
Shigellosis
Shigella flexneri Shigella sonnei
Pneumocystis Carinii Pneumonia
Pneumocystis carinii Pneumocystis carinii Pneumocystis carinii
Traveler's Diarrhea in Adults
E. coli.
SULFAMETHOXAZOLE AND TRIMETHOPRIM CONTRAINDICATIONS
WARNINGS
FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS.
SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS SULFAMETHOXAZOLE AND TRIMETHOPRIM, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. PRECAUTIONS
Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.
Thrombocytopenia
Clostridium difficile C. difficile
C. difficile C. difficile
C. difficile C. difficile,
PRECAUTIONS
General
CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION
Use in the Treatment of and Prophylaxis for Pneumocystis Carinii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS)
Pneumocystis carinii 6 WARNINGS
Pneumocystis carinii
Information for Patients
Laboratory Tests
Drug Interactions
7,8
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Mutagenesis
in vitro
Impairment of Fertility
Pregnancy
Teratogenic Effects
Pregnancy Category C
9
Nonteratogenic Effects
CONTRAINDICATIONS
Nursing Mothers
CONTRAINDICATIONS
Pediatric Use
INDICATIONS CONTRAINDICATIONS
Geriatric Use
WARNINGS ADVERSE REACTIONS DOSAGE AND ADMINISTRATION
CLINICAL PHARMACOLOGY: Geriatric Pharmacokinetics
SULFAMETHOXAZOLE AND TRIMETHOPRIM ADVERSE REACTIONS
FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS (SEE WARNINGS SECTION).
Hematologic
Allergic Reactions
Gastrointestinal
Genitourinary
Metabolic and Nutritional
PRECAUTIONS: Use in the Treatment of and Prophylaxis for Pneumocystis Carinii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS)
Neurologic
Psychiatric
Endocrine
Musculoskeletal
Respiratory
WARNINGS
Miscellaneous
Postmarketing Experience
Σ
Σ
OVERDOSAGE
Acute
Chronic
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOSAGE AND ADMINISTRATION
Not recommended for use 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
Children
Children 2 months of age or older:
| Weight |
Dose–every 12 hours |
|
| lb |
kg |
Tablets |
| 22 44 66 88 |
10 20 30 40 |
– 1 1½ 2 or 1 DS tablet |
For Patients with Impaired Renal Function
| Creatinine Clearance (mL/min) |
Recommended Dosage Regimen |
| Above 30 15–30 Below 15 |
Usual standard regimen ½ the usual regimen Use not recommended |
Acute Exacerbations of Chronic Bronchitis in Adults
Pneumocystis Carinii Pneumonia
Treatment
Adults and Children
Pneumocystis carinii 10
| Weight |
Dose–every 6 hours |
|
| lb |
kg |
Tablets |
| 18 35 53 70 88 106 141 176 |
8 16 24 32 40 48 64 80 |
– 1 1½ 2 or 1 DS tablet 2½ 3 or 1½ DS tablets 4 or 2 DS tablets 5 or 2½ 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
11
Children
22
12
| Body Surface Area |
Dose–every 12 hours |
| (m2) |
Tablets |
| 0.26 0.53 1.06 |
– ½ 1 |
Traveler’s Diarrhea in Adults
HOW SUPPLIED
Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg
| Bottles of 30 |
NDC 54868-4711-0 |
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg
| 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 |
Store at
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.
Aurobindo Pharma USA, Inc.
Aurobindo Pharma Limited
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg/80 mg
Sulfamethoxazole and
Trimethoprim Tablets, USP
400 mg/80 mg
Rx only
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 800 mg/160 mg
Sulfamethoxazole and
Trimethoprim Tablets, USP
800 mg/160 mg
DOUBLE STRENGTH
Rx only
Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
