Increased digoxin blood levels can occur with concomitant sulfamethoxazole and trimethoprim therapy, especially in elderly patients. 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 bacteria. TMP = Trimethoprim; SMX = Sulfamethoxazole †Rudoy RC, Nelson JD, Haltalin KC, Antimicrob Agents Chemother. 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: To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Some sulfonamides are also devoid of antibacterial activity, e.g., the anticonvulsant sultiame. Sulfamethoxazole and Trimethoprim Double Strength. Cough, shortness of breath and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment. In in vitro Comet, micronucleus and chromosomal damage assays using cultured human lymphocytes, trimethoprim was positive. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, Bactrim (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. Bibactin (manufactured by PPM and distributed in Cambodia and some African countries), Graprima Forte Kaplet (manufactured by PT Graha Farma and distributed in Indonesia), Sanprima (manufactured by PT Sanbe Farma and distributed in Indonesia), Vactrim (manufactured and distributed in Laos), This page was last edited on 15 November 2020, at 17:21. It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. , Its use during pregnancy is contraindicated, although it has been placed in Australian pregnancy category C and American pregnancy category D. Its use during the first trimester (during organogenesis) and 12 weeks prior to pregnancy has been associated with an increased risk of congenital malformations, especially malformations associated with maternal folic acid deficiency (which is most likely related to the mechanism of action of co-trimoxazole) such as neural tube defects such as spina bifida, cardiovascular malformations (e.g. Potential for Sulfamethoxazole and Trimethoprim to Affect Other Drugs. In in vitro and in vivo tests in animal species, sulfamethoxazole/trimethoprim did not damage chromosomes.  In the United States, it is about US$0.40 per dose.. Peak blood levels for the individual components occur 1 to 4 hours after oral administration. The trimethoprim component of sulfamethoxazole and trimethoprim may cause hyperkalemia when administered to patients with underlying disorders of potassium metabolism, with renal insufficiency or when given concomitantly with drugs known to induce hyperkalemia, such as angiotensin converting enzyme inhibitors. Lastly, outcome measures varied between studies, limiting cross-study comparisons. Talk with your doctor if you have concerns about this. C. difficile produces toxins A and B which contribute to the development of CDAD. Carcinogenesis: Sulfamethoxazole was not carcinogenic when assessed in a 26-week tumorigenic mouse (Tg-rasH2) study at doses up to 400 mg/kg/day sulfamethoxazole; equivalent to 2.4-fold the human systemic exposure (at a daily dose of 800 mg sulfamethoxazole b.i.d.). , Co-trimoxazole was claimed to be more effective than either of its components individually in treating bacterial infections, although this was later disputed. Trimethoprim/sulfamethoxazole may be abbreviated as SXT, TMP-SMX, TMP-SMZ, or TMP-sulfa. Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim DS (double strength) Tablets USP, 800 mg/160 mg, are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side. These may be symptoms of a serious intestinal infection. This medicine may cause electrolyte problems, such as high potassium in the blood (hyperkalemia) and low sodium in the blood (hyponatremia). It is used to treat or prevent certain kinds of bacterial infections.It will not work for colds, flu, or other viral infections. These effects are reversible by folinic acid therapy. Trimethoprim/sulfamethoxazole (TMP/SMX), also known as co-trimoxazole among other names, is an antibiotic used to treat a variety of bacterial infections. The recommended dosage for treatment of patients with documented Pneumocystis jiroveci 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 days9.  Severe allergic reactions and Clostridium difficile diarrhea may occasionally occur. However, if a patient develops skin rash or any sign of adverse reaction, therapy with sulfamethoxazole and trimethoprim should be reevaluated (see WARNINGS). Impairment of Fertility: No adverse effects on fertility or general reproductive performance were observed in rats given oral dosages as high as 350 mg/kg/day sulfamethoxazole plus 70 mg/kg/day trimethoprim doses roughly two times the recommended human daily dose on a body surface area basis.  It appears to be safe for use during breastfeeding as long as the baby is healthy. The efficacy of tricyclic antidepressants can decrease when co-administered with sulfamethoxazole and trimethoprim. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. The following table is a guideline for the attainment of this dosage: For Patients with Impaired Renal Function. Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache. The mean maximum serum trimethoprim concentration was higher and mean renal clearance of trimethoprim was lower in geriatric subjects compared with younger subjects (see CLINICAL PHARMACOLOGY: Geriatric Pharmacokinetics). Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Detectable amounts of sulfamethoxazole and trimethoprim are present in the blood 24 hours after drug administration. As with all drugs containing sulfonamides, caution is advisable in patients with porphyria or thyroid dysfunction. Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. Just five months previously, the Japanese firm Shionogi, had registered suphamethoxazole for exactly the same purposes and licensed its use to pharmaceutical super-giant Hoffmann-La-Roche. , Organisms against which co-trimoxazole can be effective include:, The only notable nonsusceptible organisms are Pseudomonas aeruginosa, the mycoplasmae and Francisella tularensis (the causative organism of tularaemia). TMP/kg/DOSE PO BID (max: 320 mg TMP/DOSE) Alternative to TMP-SMX2 if sulfa allergy Doxycycline3 2.2 mg/kg/DOSE PO BID (max: 100 mg/DOSE) Alternative for low/medium-risk allergy4 to cephalexin5, OR high-risk allergy6/contraindication7 to beta-lactams: Clindamycin 10 mg/kg/DOSE PO TID (max: 450 mg/DOSE) Duration: 5 days S. aureus isolates from impetigo are commonly methicillin susceptible … 2013;47(12):1618-1626. doi:10.1177/1060028013509973, methicillin-resistant Staphylococcus aureus, World Health Organization's List of Essential Medicines, List of side effects of trimethoprim/sulfamethoxazole, "Sulfamethoxazole / trimethoprim Use During Pregnancy", "Sulfamethoxazole / trimethoprim Pregnancy and Breastfeeding Warnings", "Sulfamethoxazole; Trimethoprim - Drug Usage Statistics", "Antibiotics versus no treatment for toxoplasma retinochoroiditis", "Bactrim, Bactrim DS (trimethoprim/sulfamethoxazole) dosing, indications, interactions, adverse effects, and more", "Tularemia: Epidemiology, Diagnosis, and Treatment", "Exposure to trimethoprim/sulfamethoxazole but not other FDA category C and D anti-infectives is associated with increased risks of preterm birth and low birth weight", "Co-Trimoxazole Tablets 80/400mg - Summary of Product Characteristics (SPC)", "BACTRIM DS (sulfamethoxazole and trimethoprim) tablet BACTRIM (sulfamethoxazole and trimethoprim) tablet [AR Scientific, Inc.]", "Trimethoprim, a sulphonamide potentiator", "Effect of co-trimoxazole prophylaxis on morbidity, mortality, CD4-cell count, and viral load in HIV infection in rural Uganda", "Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized, placebo-controlled trial", "Drug Prophylaxis for Travelers' Diarrhea", "Maintenance therapy of melioidosis with ciprofloxacin plus azithromycin compared with cotrimoxazole plus doxycycline", "Outcomes of patients with melioidosis treated with cotrimoxazole alone for eradication therapy", "Trimethoprim-sulfamethoxazole versus trimethoprim-sulfamethoxazole plus doxycycline as oral eradicative treatment for melioidosis (MERTH): a multicentre, double-blind, non-inferiority, randomised controlled trial", "Prospective Randomized Trial of Empiric Therapy with Trimethoprim-Sulfamethoxazole or Doxycycline for Outpatient Skin and Soft Tissue Infections in an Area of High Prevalence of Methicillin-Resistant, "Activities of Clindamycin, Daptomycin, Doxycycline, Linezolid, Trimethoprim-Sulfamethoxazole, and Vancomycin against Community-Associated Methicillin-Resistant, "Co-trimoxazole versus vancomycin for the treatment of methicillin-resistant, "Dose of Trimethoprim-Sulfamethoxazole To Treat Skin and Skin Structure Infections Caused by Methicillin-Resistant, "Daptomycin-Nonsusceptible Vancomycin-Intermediate, "Tuberculosis and trimethoprim-sulfamethoxazole", "The combination of sulfamethoxazole, trimethoprim, and isoniazid or rifampin is bactericidal and prevents the emergence of drug resistance in, "Evaluation of co-trimoxazole in the treatment of multidrug-resistant tuberculosis", "Whipple's disease in Spain: a clinical review of 91 patients diagnosed between 1947 and 2001", "Safety and Efficacy of Co-Trimoxazole for Treatment and Prevention of, "Randomized Trial of Trimethoprim-Sulfamethoxazole versus Pyrimethamine-Sulfadiazine for Therapy of Toxoplasmic Encephalitis in Patients with AIDS", "Trimethoprim-Sulfamethoxazole as Toxoplasmosis Prophylaxis for Heart Transplant Recipients", "Cotrimoxazole for treatment of cerebral toxoplasmosis: an observational cohort study during 1994-2006", "Treatment of toxoplasmic lymphadenitis with co-trimoxazole: double-blind, randomized clinical trial", "Successful treatment of cerebral toxoplasmosis with cotrimoxazole", "Novo-Trimel Advanced Patient Information - Drugs.com", "Septran/Sepman Double Strength - Co-Trimoxazole Oral Formulations", "SEPTRIN FORTE Comp. In those concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported. Prescribing sulfamethoxazole and trimethoprim tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Available from: MEDLINE Complete, Ipswich, MA. Thus, sulfamethoxazole and trimethoprim blocks two consecutive steps in the biosynthesis of nucleic acids and proteins essential to many bacteria.  Trimethoprim and sulfamethoxazole have a greater effect when given together than when given separately, because they inhibit successive steps in the folate synthesis pathway. The following list of brand names is incomplete: Trimethoprim/sulfamethoxazole is relatively inexpensive as of 2019. The effects of trimethoprim causes a backlog of dihydrofolate (DHF) and this backlog can work against the inhibitory effect the drug has on tetrahydrofolate biosynthesis; this is where the sulfamethoxazole comes in, its role is in depleting the excess DHF by preventing it from being synthesised in the first place. Check with your doctor if you have anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty with concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness. Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. In mice following oral administration of trimethoprim, no DNA damage in Comet assays of liver, kidney, lung, spleen, or bone marrow was recorded. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AIDS patients may not tolerate or respond to sulfamethoxazole and trimethoprim in the same manner as non-AIDS patients.
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