Sulfamethoxazole and Trimethoprim description, usages, side effects, indications, overdosage, supplying and lots more!

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Sulfamethoxazole and Trimethoprim

Gen-Source Rx
Aurobindo Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


SULFAMETHOXAZOLE AND TRIMETHOPRIM DESCRIPTION




N1101133
Sulfamethoxazole and Trimethoprim
141843
Sulfamethoxazole and Trimethoprim
Inactive Ingredients:

CLINICAL PHARMACOLOGY


4

DOSAGE AND ADMINISTRATION 142

Geriatric Pharmacokinetics


3

Microbiology




In vitro

in vitro INDICATIONS AND USAGE



Streptococcus pneumoniae



Escherichia coli
Klebsiella
Enterobacter
Haemophilus influenzae
Morganella morganii
Proteus mirabilis
Proteus vulgaris
Shigella flexneri
Shigella sonnei



Pneumocystis carinii



Dilution Techniques

4

a. These interpretative standards are applicable only to broth microdilution susceptibility tests with Haemophilus influenzae using Haemophilus Test Medium (HTM).4
b. These interpretative standards are applicable only to broth microdilution susceptibility tests using cation-adjusted Mueller-Hinton broth with 2% to 5% lysed horse blood.4
   For testing Enterobacteriaceae:
MIC (mcg/mL)
Interpretation
≤2/38
 Susceptible (S)
≥4/76
 Resistant (R)
   When testing either Haemophilus influenzae a or  Streptococcus pneumoniae b:
MIC (mcg/mL)
Interpretationb
≤0.5/9.5
 Susceptible (S)
1/19 - 2/38
 Intermediate (I)
≥4/76
 Resistant (R)



Quality Control


Microorganism MIC (mcg/mL)
c. This quality control range is applicable only to Haemophilus influenzae ATCC 49247 tested by broth microdilution procedure using Haemophilus Test Medium (HTM). 4
d. This quality control range is applicable to tests performed by the broth microdilution method only using cation-adjusted Mueller-Hinton broth with 2% to 5% lysed horse blood.4
   Escherichia coli                                                   ATCC 25922
 ≤0.5/9.5
   Haemophilus influenzae c                                               ATCC 49247
 0.03/0.59 – 0.25/4.75
   Streptococcus pneumoniae d                                    ATCC 49619
 0.12/2.4 – 1/19

Diffusion Techniques

5


For testing either Enterobacteriaceae or Haemophilus influenzae e:
e. These zone diameter standards are applicable only for disk diffusion testing with Haemophilus influenzae and Haemophilus Test Medium (HTM).5
Zone Diameter (mm)
Interpretation
≥16
 Susceptible (S)
11 – 15
 Intermediate (I)
≤10
 Resistant (R)

When testing Streptococcus pneumoniae f:
f. These zone diameter interpretative standards are applicable only to tests performed using Mueller-Hinton agar supplemented with 5% defibrinated sheep blood when incubated in 5% CO2.5
Zone Diameter (mm)
Interpretation
≥19
 Susceptible (S)
16 – 18
 Intermediate (I)
≤15
 Resistant (R)



Quality Control


Microorganism Zone Diameter Ranges
(mm)
* Mueller-Hinton agar should be checked for excessive levels of thymidine or thymine. To determine whether Mueller-Hinton medium has sufficiently low levels of thymidine and thymine, an Enterococcus faecalis (ATCC 29212 or ATCC 33186) may be tested with sulfamethoxazole and trimethoprim disks. A zone of inhibition ≥20 mm that is essentially free of fine colonies indicates a sufficiently low level of thymidine and thymine.
g. This quality control range is applicable only to Haemophilus influenzae ATCC 49247 tested by a disk diffusion procedure using Haemophilus Test Medium (HTM).5
h. This quality control range is applicable only to tests performed by disk diffusion using Mueller-Hinton agar supplemented with 5% defibrinated sheep blood when incubated in 5% CO2.5
   Escherichia coli                                                          ATCC 25922
 23–29
   Haemophilus influenzae g                                              ATCC 49247
 24–32
   Streptococcus pneumoniae h                                        ATCC 49619
 20–28

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








in vitro



Pregnancy




Pregnancy Category C







9





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








Children 2 months of age or older:
Weight
 Dose–every 12 hours
lb
 kg
 Tablets
22
 10
 –
44
 20
 1
66
 30
 1½
88
 40
 2 or 1 DS tablet

For Patients with Impaired Renal Function


Creatinine Clearance (mL/min)
 Recommended Dosage Regimen
Above 30
 Usual standard regimen
15–30
 ½ the usual regimen
Below 15
 Use not recommended

Acute Exacerbations of Chronic Bronchitis in Adults



Pneumocystis Carinii Pneumonia



Adults and Children

Pneumocystis carinii 10
Weight
 Dose–every 6 hours
lb
 kg
 Tablets
18
 8
 –
35
 16
 1
53
 24
 1½   
70
 32
 2 or 1 DS tablet
88
 40
 2½ 
106
 48
 3 or 1½  DS tablets
141
 64
 4 or 2 DS tablets
176
 80
 5 or 2½ DS tablets





Adults

11

Children

2212
Body Surface Area
 Dose–every 12 hours
(m2)
 Tablets
0.26
 –
0.53
 ½
1.06
 1

Traveler’s Diarrhea in Adults

HOW SUPPLIED


Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg




Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg




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.














PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg/80 mg (100 Tablet Bottle)


NDC 52343-009-01
Sulfamethoxazole
and Trimethoprim
Tablets, USP
400 mg/80 mg
Rx only             100 Tablets
GEN-SOURCE Rx
Sulfamethoxazole and Trimethoprim

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 800 mg/160 mg (100 Tablet Bottle)


NDC 52343-010-01
Sulfamethoxazole
and Trimethoprim
Tablets, USP
800 mg/160 mg
DOUBLE STRENGTH
Rx only             100 Tablets
GEN-SOURCE Rx
Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and Trimethoprim TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-009
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SULFAMETHOXAZOLE sulfamethoxazole 400 mg
TRIMETHOPRIM Trimethoprim 80 mg

Inactive Ingredients

Ingredient Name Strength
DOCUSATE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
SODIUM BENZOATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 11 mm H;48 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-009-01 100 in 1 BOTTLE
2 NDC:52343-009-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090624 2010-02-16


Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and Trimethoprim TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52343-010
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SULFAMETHOXAZOLE sulfamethoxazole 800 mg
TRIMETHOPRIM Trimethoprim 160 mg

Inactive Ingredients

Ingredient Name Strength
DOCUSATE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
SODIUM BENZOATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 19 mm H;49 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52343-010-01 100 in 1 BOTTLE
2 NDC:52343-010-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090624 2010-02-16


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Be sure to consult your doctor before taking any medication!
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