Sulfamethoxazole And Trimethoprim Suspension

Sulfamethoxazole And Trimethoprim Suspension

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Questions & Answers

Side Effects & 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.

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 disorder (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.

The sulfonamides should not be used for the treatment of group A beta-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 (CDAD) has been reported with use of nearly all antibacterial agents, including sulfamethoxazole and trimethoprim oral suspension, USP, 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 antiobiotic 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.

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 oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 the 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 oral suspension 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. This product 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, in the judgment of the physician, sulfamethoxazole and trimethoprim oral suspension offers some advantage over the use of a single antimicrobial agent.

Travelers' Diarrhea in Adults

For the treatment of travelers' diarrhea due to susceptible strains of enterotoxigenic E. coli.

Shigellosis

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

Pneumocystis Carinii Pneumonia

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

History

There is currently no drug history available for this drug.

Other Information

Sulfamethoxazole and trimethoprim oral suspension USP is a synthetic antibacterial combination product. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white odorless, tasteless compound. It has the following structural formula:

Chemical Structure

C10H11N3O3S                   M.W. 253.28

Trimethoprim is a 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound. It has the following structural formula:

Chemical Structure

C14H18N4O3                     M.W. 290.32

Each teaspoonful (5 mL) of the oral suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim as well as the following inactive ingredients: alcohol 0.04% (v/v), carboxymethylcellulose sodium, cherry flavoring, citric acid, color red FD&C No. 40, glycerin, methylparaben, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, sodium benzoate, and sorbitol solution.

Sulfamethoxazole And Trimethoprim Suspension Manufacturers


  • Pharmaceutical Associates, Inc.
    Sulfamethoxazole And Trimethoprim Suspension [Pharmaceutical Associates, Inc.]
  • Apotheca, Inc.
    Sulfamethoxazole And Trimethoprim Suspension [Apotheca, Inc.]
  • Rebel Distributors Corp
    Sulfamethoxazole And Trimethoprim Suspension [Rebel Distributors Corp]
  • H.j. Harkins Company, Inc.
    Sulfamethoxazole And Trimethoprim Suspension [H.j. Harkins Company, Inc.]
  • Physicians Total Care, Inc.
    Sulfamethoxazole And Trimethoprim Suspension [Physicians Total Care, Inc.]
  • Hi-tech Pharmacal Co., Inc.
    Sulfamethoxazole And Trimethoprim Suspension [Hi-tech Pharmacal Co., Inc.]
  • Aurobindo Pharma Limited
    Sulfamethoxazole And Trimethoprim Suspension [Aurobindo Pharma Limited]
  • Preferred Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim Suspension [Preferred Pharmaceuticals, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Sulfamethoxazole And Trimethoprim Suspension [Preferred Pharmaceuticals, Inc.]
  • Qualitest Pharmaceuticals
    Sulfamethoxazole And Trimethoprim Suspension [Qualitest Pharmaceuticals]
  • Atlantic Biologicals Corps
    Sulfamethoxazole And Trimethoprim Suspension [Atlantic Biologicals Corps]

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