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Sulfamethoxazole and Trimethoprim
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cytochrome P450 2C8 Inhibitors [MoA] | MoA | All 56 members |
| Cytochrome P450 2C9 Inhibitors [MoA] | MoA | All 34 members |
| Dihydrofolate Reductase Inhibitor Antibacterial [EPC] | EPC | 8 members — no class page |
| Dihydrofolate Reductase Inhibitors [MoA] | MoA | All 25 members |
| Organic Cation Transporter 2 Inhibitors [MoA] | MoA | All 32 members |
| Sulfonamide Antimicrobial [EPC] | EPC | 4 members — no class page |
| Sulfonamides [CS] | CS | All 18 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 091348-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SUSPENSION | SULFAMETHOXAZOLE; TRIMETHOPRIM | Prescription | AB | RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 19 | Labeling | Approved | February 21, 2025 | Standard |
| Supplement | 18 | Labeling | Approved | June 24, 2024 | Standard |
| Supplement | 14 | Labeling | Approved | September 21, 2022 | Standard |
| Supplement | 13 | Labeling | Approved | September 21, 2022 | Standard |
| Supplement | 8 | Labeling | Approved | September 21, 2022 | Standard |
| Supplement | 3 | Labeling | Approved | September 21, 2022 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | June 24, 2019 | — |
| Supplement | 2 | Labeling | Approved | December 6, 2012 | Standard |
| Supplement | 1 | Labeling | Approved | March 26, 2012 | — |
| Original application | 1 | Approved | June 8, 2010 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260825). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension, USP 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 oral suspension, USP in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension, USP 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 oral suspension, USP 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.
Dosage and Administration
openFDA Drug LabelingDOSAGE & ADMINISTRATION Sulfamethoxazole and trimethoprim is 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 four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension 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 Teaspoonfuls 22 10 1 (5 mL) 44 20 2 (10 mL) 66 30 3 (15 mL) 88 40 4 (20 mL) For Patients with Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table: Creatinine Clearance (mL/min) Recommended Dosage Regimen Above 30 Usual standard regimen 15–30 1⁄2 the usual regimen Below 15 Use not recommended Acute Exacerbations of Chronic Bronchitis in Adults: The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension every 12 hours for 14 days. Pneumocystis jirovecii Pneumonia: Treatment: Adults and Children: The recommended dosage for treatment of patients with documented Pneumocystis jirovecii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days. 12 The following table is a guideline for the upper limit of this dosage: Weight Dose - every 6 hours lb kg Teaspoonfuls 18 8 1 (5 mL) 35 16 2 (10 mL) 53 24 3 (15 mL) 70 32 4 (20 mL) 88 40 5 (25 mL) 108 48 6 (30 mL) 141 64 8 (40 mL) 176 80 10 (50 mL) 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: The recommended dosage for prophylaxis in adults is four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension daily. 13 Children: For children, the recommended dose is 750 mg/m 2 /day sulfamethoxazole with 150 mg/m 2 /day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim. 14 The following table is a guideline for the attainment of this dosage in children: Body Surface Area Dose – every 12 hours (m 2 ) Teaspoonfuls 0.26 1⁄2 (2.5 mL) 0.53 1 (5 mL) 1.06 2 (10 mL) Traveler's Diarrhea in Adults: For the treatment of traveler's diarrhea, the usual adult dosage is four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension every 12 hours for 5 days.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Sulfamethoxazole and trimethoprim is contraindicated in patients with a known hypersensitivity to trimethoprim or sulfonamides, in patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides, and in patients with documented megaloblastic anemia due to folate deficiency. Sulfamethoxazole and trimethoprim is also contraindicated in pregnant patients and nursing mothers, because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus. Sulfamethoxazole and trimethoprim oral suspension is contraindicated in pediatric patients less than 2 months of age. Sulfamethoxazole and trimethoprim is also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored.
Warnings
openFDA Drug LabelingWARNINGS 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 exanthematous 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 oral suspension (see ADVERSE REACTIONS ). Hypersensitivity Reactions of the Respiratory Tract Cough, shortness of breath, and pulmonary infiltrates potentially representing hypersensitivity reactions of the respiratory tract have been reported in association with sulfamethoxazole and trimethoprim treatment. Respiratory Failure Other severe pulmonary adverse reactions occurring within days to week of sulfamethoxazole and trimethoprim initiation and resulting in prolonged respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO), lung transplantation or death have also been reported in patients and otherwise healthy individuals treated with sulfamethoxazole and trimethoprim products. Circulatory Shock Circulatory shock with fever, severe hypotension, and confusion requiring intravenous fluid resuscitation and vasopressors has occurred within minutes to hours of re-challenge with sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim, in patients with history of recent (days to weeks) exposure to sulfamethoxazole and trimethoprim. Management of Hypersensitivity and Other Serious Reactions Sulfamethoxazole and trimethoprim oral suspension should be discontinued at the first appearance of skin rash or any sign of a serious adverse reaction. A skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AFND, AGEP, hepatic necrosis, or serious blood disorders (see PRECAUTIONS and ADVERSE REACTIONS ). Clinical signs, such as rash, pharyngitis, fever, arthralgia, cough, chest pain, dyspnea, pallor, purpura or jaundice may be early indications of serious reactions. Hemophagocytic Lymphohistiocytosis Cases of hemophagocytic lymphohistiocytosis (HLH) have been reported in patients treated with sulfamethoxazole-trimethoprim. HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation. Signs and symptoms of HLH may include fever, hepatosplenomegaly, rash, lymphadenopathy, neurologic symptoms, cytopenias, high serum ferritin, hypertriglyceridemia, and liver enzyme and coagulation abnormalities. If HLH is suspected, discontinue sulfamethoxazole and trimethoprim oral suspension immediately and institute appropriate management. Thrombocytopenia Sulfamethoxazole and trimethoprim oral suspension-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 and trimethoprim. Streptococcal Infections and Rheumatic Fever The sulfonamides should not be used for treatment of group A β-hemolytic strepto …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS 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, (see WARNINGS ). Hematologic Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia. Allergic Reactions Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schönlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash, periarteritis nodosa, systemic lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized erythematous pustulosis (AGEP), and acute febrile neutrophilic dermatosis (AFND) (see WARNINGS ). Gastrointestinal Hepatitis (including cholestatic jaundice and hepatic necrosis) elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia. Genitourinary Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine. Metabolic and Nutritional Hyperkalemia (see PRECAUTIONS: Use in the Treatment of and Prophylaxis for Pneumocystis Carinii Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS) ). Neurologic Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache. Psychiatric Hallucinations, depression, apathy, nervousness. Endocrine The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Musculoskeletal Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with sulfamethoxazole and trimethoprim, mainly in AIDS patients. Respiratory Cough, shortness of breath, pulmonary infiltrates, acute eosinophilic pneumonia, acute and delayed lung injury, interstitial lung disease, acute respiratory failure (see WARNINGS ). Cardiovascular Circulatory shock (see WARNINGS ), QT prolongation resulting in ventricular tachycardia and torsades de pointes . Miscellaneous Weakness, fatigue, insomnia. Postmarketing Experience The following adverse reactions have been identified during post-approval use of trimethoprim-sulfamethoxazole. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: • Thrombotic thrombocytopenia purpura • Idiopathic thrombocytopenic purpura
Drug Interactions
openFDA Drug LabelingDrug Interactions Potential for sulfamethoxazole and trimethoprim to Affect Other Drugs Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid coadministration of sulfamethoxazole and trimethoprim with drugs that are substrates of CYP2C8 and 2C9 or OCT2. Table 1: Drug Interactions with Sulfamethoxazole and Trimethoprim Oral Suspension Drug(s) Recommendation Comments Diuretics Avoid concurrent use In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported. Warfarin Monitor prothrombin time and INR It has been reported that sulfamethoxazole and trimethoprim may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). This interaction should be kept in mind when sulfamethoxazole and trimethoprim is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed. Phenytoin Monitor serum phenytoin levels Sulfamethoxazole and trimethoprim may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate). Sulfamethoxazole and trimethoprim, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect. Methotrexate Avoid concurrent use Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations. Cyclosporine Avoid concurrent use There have been reports of marked but reversible nephrotoxicity with coadministration of sulfamethoxazole and trimethoprim and cyclosporine in renal transplant recipients. Digoxin Monitor serum digoxin levels Increased digoxin blood levels can occur with concomitant sulfamethoxazole and trimethoprim therapy, especially in elderly patients. Indomethacin Avoid concurrent use Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin. Pyrimethamine Avoid concurrent use Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if sulfamethoxazole and trimethoprim is prescribed. Tricyclic Antidepressants (TCAs) Monitor therapeutic response and adjust dose of TCA accordingly The efficacy of tricyclic antidepressants can decrease when coadministered with Sulfamethoxazole and trimethoprim oral suspension. Oral Hypoglycemics Monitor blood glucose more frequently Like other sulfonamide-containing drugs, sulfamethoxazole and trimethoprim potentiates the effect of oral hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted. Amantadine Avoid concurrent use In the literature, a single case of toxic delirium has been reported after concomitant intake of sulfamethoxazole and trimethoprim and amantadine (an OCT2 substrate). Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported. Angiotensin Converting Enzyme Inhibitors Avoid concurrent use In the literature, three cases of hyperkalemia in elderly patients have been reported after concomitant intake of sulfamethoxazole and trimethoprim and an angiotensin converting enzyme inhibitor. 5,6 Zidovudine Monitor for hematologic toxicity Zidovudine and sulfamethoxazole and trimethoprim are known to induce hematological abnormalities. Hence, there is potential for an additive myelotoxicity when coadministered. 7 Dofetilide Concurrent administration is contraindicated Elevated plasma concentrations of dofetilide have been reported following concurrent administration of trimethoprim a …
Description
openFDA Drug LabelingDESCRIPTION Sulfamethoxazole and Trimethoprim Oral Suspension, USP is a synthetic antibacterial combination product with each teaspoonful (5 mL) containing 200 mg sulfamethoxazole and 40 mg trimethoprim. Sulfamethoxazole is N 1 -(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10 H 11 N 3 O 3 S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula: Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14 H 18 N 4 O 3 . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula: Each teaspoonful (5 mL) of sulfamethoxazole and trimethoprim oral suspension (cherry flavor) is an opaque pinkish orange suspension with a cherry aroma and contains 40 mg trimethoprim and 200 mg sulfamethoxazole and the inactive ingredients alcohol not more than 0.5%; methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives), artificial wild cherry flavor, citric acid anhydrous, FD&C Red #40, FD&C Yellow #6, glycerin, microcrystalline cellulose, polysorbate 80, purified water, saccharin sodium, sodium carboxymethylcellulose, sodium citrate dihydrate, and sorbitol solution. image description image description
Overdosage
openFDA Drug LabelingOVERDOSAGE Acute: The amount of a single dose of sulfamethoxazole and trimethoprim that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage. Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression. General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids, and the administration of intravenous fluids if urine output is low and renal function is normal. Acidification of the urine will increase renal elimination of trimethoprim. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating sulfamethoxazole and trimethoprim. Chronic: Use of sulfamethoxazole and trimethoprim at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, the patient should be given leucovorin 5 to 15 mg daily until normal hematopoiesis is restored.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Sulfamethoxazole and Trimethoprim Oral Suspension, USP (Cherry Flavor), opaque, pinkish orange suspension with a cherry aroma, containing 40 mg trimethoprim and 200 mg sulfamethoxazole in each teaspoonful (5 mL), and is available in a one pint (473 mL) bottle NDC 62135-749-47, 20 mL Unit-Dose Cup NDC 62135-873-52 and 20 Unit-Dose Cups of 20 mL each NDC 62135-873-24. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . REFERENCES 1. 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. 2. Kaplan SA, et al. Pharmacokinetic Profile of Trimethoprim-Sulfamethoxazole in Man. J Infect Dis . Nov 1973; 128 (Suppl): S547–S555. 3. Varoquaux O, et al. Pharmacokinetics of the trimethoprim-sulfamethoxazole combination in the elderly. Br J Clin Pharmacol . 1985;20:575–581. 4. Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis . 1994 Oct;170(4):912–7. 5. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. Gerontol .45:209–212. 6. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. J. Nephrol. 14:410–414. 7. Moh R, et al. Haematological changes in adults receiving a zidovudine-containing HAART regimen in combination with cotrimoxazole in Côte d'Ivoire. Antivir Ther . 2005;10(5):615-24. 8. Al-Khatib SM, LaPointe N, Kramer JM, Califf RM. What Clinicians Should Know About the QT Interval. JAMA . 2003;289(16):2120-2127. 9. Boyer EW, Stork C, Wang RY. Review: The Pharmacology and Toxicology of Dofetilide. Int J Med Toxicol . 2001;4(2):16. 10. Kosoglou T, Rocci ML Jr, Vlasses PH. Trimethoprim alters the disposition of procainamide and N-acetylprocainamide. Clin Pharmacol Ther . Oct 1988;44(4):467-77. 11. Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. J Infect Dis . Nov 1973; 128 (Suppl): S657–S663. 12. Masur H. Prevention and treatment of Pneumocystis pneumonia. N Engl J Med. 1992; 327: 1853–1880. 13. Recommendations for prophylaxis against Pneumocystis carinii pneumonia for adults and adolescents infected with human immunodeficiency virus. MMWR . 1992; 41(RR-4):1–11. 14. CDC Guidelines for prophylaxis against Pneumocystis carinii pneumonia for children infected with human immunodeficiency virus. MMWR . 1991; 40(RR-2):1–13. All trademarks are the property of their respective owners. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71664 Rev. 03/2025
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TRIMETHOPRIM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0525-0 | 50090-0525 | A-S Medication Solutions | 473 mL in 1 BOTTLE (50090-0525-0) | June 29, 2016 |
| 70954-258-10 | 70954-258 | ANI Pharmaceuticals, Inc. | 473 mL in 1 BOTTLE (70954-258-10) | February 8, 2022 |
| 17856-0496-4 | 17856-0496 | ATLANTIC BIOLOGICALS CORP. | 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1) | April 12, 2024 |
| 17856-0496-5 | 17856-0496 | ATLANTIC BIOLOGICALS CORP. | 50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3) | April 12, 2024 |
| 17856-0496-6 | 17856-0496 | ATLANTIC BIOLOGICALS CORP. | 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-6) / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2) | April 12, 2024 |
| 17856-0496-7 | 17856-0496 | ATLANTIC BIOLOGICALS CORP. | 48 SYRINGE in 1 CASE (17856-0496-7) / 5 mL in 1 SYRINGE | August 5, 2026 |
| 17856-0496-8 | 17856-0496 | ATLANTIC BIOLOGICALS CORP. | 48 SYRINGE in 1 CASE (17856-0496-8) / 10 mL in 1 SYRINGE | August 5, 2026 |
| 17856-0496-9 | 17856-0496 | ATLANTIC BIOLOGICALS CORP. | 48 CUP, UNIT-DOSE in 1 CASE (17856-0496-9) / 20 mL in 1 CUP, UNIT-DOSE | August 25, 2026 |
| 60687-442-75 | 60687-442 | American Health Packaging | 4 TRAY in 1 CASE (60687-442-75) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-442-53) / 20 mL in 1 CUP, UNIT-DOSE (60687-442-24) | November 7, 2024 |
| 65862-496-01 | 65862-496 | Aurobindo Pharma Limited | 100 mL in 1 BOTTLE (65862-496-01) | June 8, 2010 |
| 65862-496-47 | 65862-496 | Aurobindo Pharma Limited | 473 mL in 1 BOTTLE (65862-496-47) | June 8, 2010 |
| 65862-496-50 | 65862-496 | Aurobindo Pharma Limited | 50 mL in 1 BOTTLE (65862-496-50) | June 8, 2010 |
| 68999-873-24 | 68999-873 | Chartwell Governmental & Specialty RX, LLC. | 2 TRAY in 1 BOX (68999-873-24) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-873-52) | February 18, 2026 |
| 62135-749-47 | 62135-749 | Chartwell RX, LLC | 473 mL in 1 BOTTLE (62135-749-47) | October 11, 2023 |
| 62135-873-24 | 62135-873 | Chartwell RX, LLC | 2 TRAY in 1 BOX (62135-873-24) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-873-52) | May 30, 2024 |
| 81033-012-40 | 81033-012 | Kesin Pharma | 40 CUP, UNIT-DOSE in 1 CARTON (81033-012-40) / 20 mL in 1 CUP, UNIT-DOSE (81033-012-20) | April 4, 2025 |
| 0121-0853-20 | 0121-0853 | PAI Holdings, LLC dba PAI Pharma | 10 CUP, UNIT-DOSE in 1 TRAY (0121-0853-20) / 20 mL in 1 CUP, UNIT-DOSE | August 5, 2024 |
| 66993-727-57 | 66993-727 | Prasco Laboratories | 473 mL in 1 BOTTLE, PLASTIC (66993-727-57) | July 5, 2022 |
| 68788-8607-4 | 68788-8607 | Preferred Pharmaceuticals Inc. | 473 mL in 1 BOTTLE (68788-8607-4) | March 14, 2024 |
| 50090-0525 | 50090-0525 | A-S Medication Solutions | — | June 8, 2010 |
| 70954-258 | 70954-258 | ANI Pharmaceuticals, Inc. | — | February 8, 2022 |
| 17856-0496 | 17856-0496 | ATLANTIC BIOLOGICALS CORP. | — | October 4, 2017 |
| 60687-442 | 60687-442 | American Health Packaging | — | November 7, 2024 |
| 65862-496 | 65862-496 | Aurobindo Pharma Limited | — | June 8, 2010 |
| 68999-873 | 68999-873 | Chartwell Governmental & Specialty RX, LLC. | — | January 24, 2007 |
| 62135-749 | 62135-749 | Chartwell RX, LLC | — | January 24, 2007 |
| 62135-873 | 62135-873 | Chartwell RX, LLC | — | January 24, 2007 |
| 81033-012 | 81033-012 | Kesin Pharma | — | July 5, 2022 |
| 0121-0853 | 0121-0853 | PAI Holdings, LLC dba PAI Pharma | — | August 5, 2024 |
| 66993-727 | 66993-727 | Prasco Laboratories | — | July 5, 2022 |
| 68788-8607 | 68788-8607 | Preferred Pharmaceuticals Inc. | — | March 14, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.