Sulfamethoxazole and Trimethoprim DS 800 mg/1

Sulfamethoxazole and Trimethoprim · TABLET · Advanced Rx Pharmacy of Tennessee, LLC

No Recall History

Plain English

Sulfamethoxazole and Trimethoprim DS is a tablet containing sulfamethoxazole and trimethoprim at 800 mg/1, taken oral. Manufactured by Advanced Rx Pharmacy of Tennessee, LLC.

Key Facts

Brand Name: Sulfamethoxazole and Trimethoprim DS
Generic Name: Sulfamethoxazole and Trimethoprim
NDC Code (Product): 80425-0003
Manufacturer: Advanced Rx Pharmacy of Tennessee, LLC
Strength: 800 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA090624
Drug Class: Sulfonamide Antimicrobial [EPC]; Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
Marketing Start: 02/16/2010

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Indications and Usage Section INDICATIONS AND USAGE 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 Haemoph…

Dosage & Administration

Dosage and Administration Section Sulfamethoxazole and trimethoprim tablets are contraindicated 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: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage: 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 When renal function is impaired, a reduced dosage should be employed using the following table: Creatinine Cle…

Warnings

Warnings Embryofetal Toxicity Some epidemiologic studies suggest that exposure to sulfamethoxazole and 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 and 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 (see PRECAUTIONS). Hypersensitivity and Other Serious or Fatal Reactions Fatalities and serious adverse reactions including severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim (see ADVERSE REACTI…

Contraindications

Contraindications Sulfamethoxazole and trimethoprim tablets are contraindicated in the following situations: known hypersensitivity to trimethoprim or sulfonamides history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides documented megaloblastic anemia due to folate deficiency pediatric patients less than 2 months of age marked hepatic damage severe renal insufficiency when renal function status cannot be monitored concomitant administration with dofetilide (see PRECAUTIONS).

Adverse Reactions

Adverse Reactions The following adverse reactions associated with the use of sulfamethoxazole and trimethoprim were identified in clinical trials, postmarketing or published reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). Fatalities and serious adverse reactions, including severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim (see WARNINGS). Hematologic: Agranulocytosis, apl…

Frequently Asked Questions

What is Sulfamethoxazole and Trimethoprim DS used for?

Sulfamethoxazole and Trimethoprim DS contains Sulfamethoxazole and Trimethoprim. It is a tablet taken oral. Consult your doctor for specific uses.

Is Sulfamethoxazole and Trimethoprim DS a controlled substance?

Sulfamethoxazole and Trimethoprim DS is not classified as a controlled substance by the DEA.

What is the generic name for Sulfamethoxazole and Trimethoprim DS?

The generic name for Sulfamethoxazole and Trimethoprim DS is Sulfamethoxazole and Trimethoprim. There are 12 other brand versions of Sulfamethoxazole and Trimethoprim.

What is the NDC code for Sulfamethoxazole and Trimethoprim DS 800 mg/1?

The NDC (National Drug Code) for Sulfamethoxazole and Trimethoprim DS 800 mg/1 is 80425-0003, listed by Advanced Rx Pharmacy of Tennessee, LLC.

Product NDC

80425-0003

Package NDC

80425-0003-1

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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