Sulfamethoxazole And Trimethoprim

Sulfamethoxazole And Trimethoprim

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Questions & Answers

Side Effects & Adverse Reactions

Embryofetal Toxicity

Some epidemiologic studies suggest that exposure to sulfamethoxazole/trimethoprim during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, and club foot. If sulfamethoxazole/trimethoprim is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazards to the fetus.

Hypersensitivity and Other Fatal 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.

Sulfonamides, including sulfonamide-containing products such as sulfamethoxazole/trimethoprim, should be discontinued at the first appearance of skin rash or any sign of adverse reaction. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders (see PRECAUTIONS). Clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura or jaundice may be early indications of serious reactions.

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.

Thrombocytopenia

Sulfamethoxazole/trimethoprim-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Thrombocytopenia usually resolves within a week upon discontinuation of sulfamethoxazole/trimethoprim.

Streptococcal Infections and Rheumatic Fever

The sulfonamides should not be used for treatment of group A β-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.

Clostridium difficile associated diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including sulfamethoxazole and trimethoprim, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Adjunctive treatment with Leucovorin for Pneumocystis jiroveci pneumonia

Treatment failure and excess mortality were observed when trimethoprim-sulfamethoxazole was used concomitantly with leucovorin for the treatment of HIV positive patients with Pneumocystis jiroveci pneumonia in a randomized placebo controlled trial.6 Co-administration of trimethoprim-sulfamethoxazole and leucovorin during treatment of Pneumocystis jiroveci pneumonia should be avoided.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.

Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent.

Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia: For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

History

There is currently no drug history available for this drug.

Other Information

Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration.

Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:

Chemical Structure

Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:

Chemical Structure

Inactive ingredients: Docusate sodium 85%, sodium benzoate 15%, sodium starch glycolate, magnesium stearate and pregelatinized starch.

Sulfamethoxazole And Trimethoprim Manufacturers


  • Cardinal Health
    Sulfamethoxazole And Trimethoprim Tablet [Cardinal Health]
  • Blenheim Pharmacal, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Blenheim Pharmacal, Inc.]
  • A-s Medication Solutions Llc
    Sulfamethoxazole And Trimethoprim Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Sulfamethoxazole And Trimethoprim Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Sulfamethoxazole And Trimethoprim Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Sulfamethoxazole And Trimethoprim Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Sulfamethoxazole And Trimethoprim Tablet [A-s Medication Solutions Llc]
  • Direct Rx
    Sulfamethoxazole And Trimethoprim Tablet [Direct Rx]
  • Proficient Rx Lp
    Sulfamethoxazole And Trimethoprim Tablet [Proficient Rx Lp]
  • Contract Pharmacy Services-pa
    Sulfamethoxazole And Trimethoprim Tablet [Contract Pharmacy Services-pa]
  • State Of Florida Doh Central Pharmacy
    Sulfamethoxazole And Trimethoprim Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Sulfamethoxazole And Trimethoprim Tablet [State Of Florida Doh Central Pharmacy]
  • Blenheim Pharmacal, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Blenheim Pharmacal, Inc.]
  • Keltman Pharmaceuticals Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Keltman Pharmaceuticals Inc.]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazle And Trimethoprim) Tablet [Remedyrepack Inc. ]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Sulfamethoxazole And Trimethoprim Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Rebel Distributors Corp.
    Sulfamethoxazole And Trimethoprim Tablet [Rebel Distributors Corp.]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) Tablet [Remedyrepack Inc. ]
  • Udl Laboratories, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Udl Laboratories, Inc.]
  • Physicians Total Care, Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) Tablet [Physicians Total Care, Inc.]
  • Medvantx, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Medvantx, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Mckesson Contract Packaging
    Sulfamethoxazole And Trimethoprim Tablet [Mckesson Contract Packaging]
  • Contract Pharmacy Services-pa
    Sulfamethoxazole And Trimethoprim Tablet [Contract Pharmacy Services-pa]
  • Golden State Medical Supply, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Golden State Medical Supply, Inc.]
  • Gen-source Rx
    Sulfamethoxazole And Trimethoprim Tablet [Gen-source Rx]
  • H.j. Harkins Company, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [H.j. Harkins Company, Inc.]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Life Line Home Care Services, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Life Line Home Care Services, Inc.]
  • Unit Dose Services
    Sulfamethoxazole And Trimethoprim Tablet [Unit Dose Services]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Sulfamethoxazole And Trimethoprim Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Stat Rx Usa Llc
    Sulfamethoxazole And Trimethoprim Tablet [Stat Rx Usa Llc]
  • Aidarex Pharmaceuticals Llc
    Sulfamethoxazole And Trimethoprim Tablet [Aidarex Pharmaceuticals Llc]
  • Aidarex Pharmaceuticals Llc
    Sulfamethoxazole And Trimethoprim Tablet [Aidarex Pharmaceuticals Llc]
  • Major Pharmaceuticals
    Sulfamethoxazole And Trimethoprim Tablet [Major Pharmaceuticals]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole) Tablet [Remedyrepack Inc. ]
  • Vista Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) Tablet [Vista Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Aurobindo Pharma Limited
    Sulfamethoxazole And Trimethoprim Tablet [Aurobindo Pharma Limited]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Sulfamethoxazole And Trimethoprim Tablet [Cardinal Health]
  • Blenheim Pharmacal, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Blenheim Pharmacal, Inc.]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Clinical Solutions Wholesale
    Sulfamethoxazole And Trimethoprim Tablet [Clinical Solutions Wholesale]
  • Teva Parenteral Medicines, Inc.
    Sulfamethoxazole And Trimethoprim Injection, Solution [Teva Parenteral Medicines, Inc.]
  • A-s Medication Solutions Llc
    Sulfamethoxazole And Trimethoprim Tablet [A-s Medication Solutions Llc]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Mutual Pharmaceutical Company, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Mutual Pharmaceutical Company, Inc.]
  • Kaiser Foundation Hospitals
    Sulfamethoxazole And Trimethoprim Tablet [Kaiser Foundation Hospitals]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole) Tablet [Remedyrepack Inc. ]
  • Unit Dose Services
    Sulfamethoxazole And Trimethoprim Tablet [Unit Dose Services]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • A-s Medication Solutions Llc
    Sulfamethoxazole And Trimethoprim Tablet [A-s Medication Solutions Llc]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole) Tablet [Remedyrepack Inc. ]
  • Qualitest Pharmaceuticals
    Sulfamethoxazole And Trimethoprim Tablet [Qualitest Pharmaceuticals]
  • Liberty Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Liberty Pharmaceuticals, Inc.]
  • Aurobindo Pharma Limited
    Sulfamethoxazole And Trimethoprim Tablet [Aurobindo Pharma Limited]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Sulfamethoxazole And Trimethoprim Tablet [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Cardinal Health
    Sulfamethoxazole And Trimethoprim Tablet [Cardinal Health]
  • Preferred Pharmaceuticals, Inc
    Sulfamethoxazole And Trimethoprim Tablet [Preferred Pharmaceuticals, Inc]
  • Preferred Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Preferred Pharmaceuticals, Inc.]
  • Teva Pharmaceuticals Usa Inc
    Sulfamethoxazole And Trimethoprim Tablet Sulfamethoxazole And Trimethoprim (Double Strength) (Sulfamethoxazole And Trimethoprim) Tablet [Teva Pharmaceuticals Usa Inc]
  • Glenmark Generics Inc. Usa
    Sulfamethoxazole And Trimethoprim Tablet [Glenmark Generics Inc. Usa]
  • Amneal Pharmaceuticals, Llc
    Sulfamethoxazole And Trimethoprim Tablet [Amneal Pharmaceuticals, Llc]
  • Remedyrepack Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Remedyrepack Inc. ]
  • State Of Florida Doh Central Pharmacy
    Sulfamethoxazole And Trimethoprim Tablet [State Of Florida Doh Central Pharmacy]
  • Readymeds
    Sulfamethoxazole And Trimethoprim Tablet [Readymeds]
  • Northwind Pharmaceuticals
    Sulfamethoxazole And Trimethoprim Tablet [Northwind Pharmaceuticals]
  • Aphena Pharma Solutions – Tennessee, Llc
    Sulfamethoxazole And Trimethoprim Tablet [Aphena Pharma Solutions – Tennessee, Llc]
  • Northwind Pharmaceuticals
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) Tablet [Northwind Pharmaceuticals]
  • American Health Packaging
    Sulfamethoxazole And Trimethoprim Tablet [American Health Packaging]
  • Bryant Ranch Prepack
    Sulfamethoxazole And Trimethoprim Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Sulfamethoxazole And Trimethoprim Tablet [Bryant Ranch Prepack]
  • Northwind Pharmaceuticals
    Sulfamethoxazole And Trimethoprim Tablet [Northwind Pharmaceuticals]
  • Cardinal Health
    Sulfamethoxazole And Trimethoprim Tablet [Cardinal Health]
  • Cardinal Health
    Sulfamethoxazole And Trimethoprim Tablet [Cardinal Health]
  • Tya Pharmaceuticals
    Sulfamethoxazole And Trimethoprim Tablet [Tya Pharmaceuticals]
  • Avpak
    Sulfamethoxazole And Trimethoprim Tablet [Avpak]
  • Pd-rx Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Proficient Rx Lp
    Sulfamethoxazole And Trimethoprim Tablet [Proficient Rx Lp]
  • Blenheim Pharmacal, Inc.
    Sulfamethoxazole And Trimethoprim Tablet [Blenheim Pharmacal, Inc.]
  • Direct Rx
    Sulfamethoxazole And Trimethoprim Tablet [Direct Rx]

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