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What is the most important information I should know about Fortrim?
Fortrim (Fortrim (Fortrim tablet) tablet) tablets are contraindicated in individuals hypersensitive to Fortrim (Fortrim (Fortrim tablet) tablet) and in those with documented megaloblastic anemia due to folate deficiency.
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What are the possible side effects of Fortrim?
To report SUSPECTED ADVERSE REACTIONS, contact FSC Laboratories, Inc. at 1-866-764- 7822, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse Events Reported During Pediatric Clinical Trials With FortrimThe following table lists those drug-related adverse events reported most frequently during the clinical trials in pediatric patients aged 6 months to 12 years. Most of these events were determined to be mild. The incidence of drug-related adverse events was significantly lower for Fortrim, which was most apparent for those events related to skin/appendages as a body system.
| Drug-related Adverse Event | Percent of Pediatric Patients | |
| Fortrim (N=310) | SMX + TMP* (N=197) | |
| Body as a whole | ||
| abdominal pain | < 1 | 2.5 |
| Digestive system | ||
| diarrhea | 4.2 | 4.6 |
| vomiting | 1.6 | 1.5 |
| Skin/Appendages | ||
| rash | 1.3 | 6.1 |
| * sulfamethoxazole + Fortrim oral suspension |
An increase in lymphocytes and eosinophils was noted in some pediatric patients following treatment with Fortrim or sulfamethoxazole + Fortrim oral suspension.
Adverse Reactions Reported For FortrimIn addition to the adverse events listed above which have been observed in pediatric patients receiving Fortrim, the following adverse reactions and altered laboratory tests have been previously reported for Fortrim and therefore, may occur with Fortrim therapy:
Dermatologic reactions: pruritus and exfoliative dermatitis. At the recommended adult dosage regimens of 100 mg b.i.d., or 200 mg q.d., each for 10 days, the incidence of rash is 2.9% to 6.7%. In clinical studies which employed high doses of Fortrim in adults, an elevated incidence of rash was noted. These rashes were maculopapular, morbilliform, pruritic and generally mild to moderate, appearing 7 to 14 days after the initiation of therapy.
Gastrointestinal reactions: Epigastric distress, nausea, and glossitis.
Hematologic reactions: Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia and methemoglobinemia.
Metabolic reactions: Hyperkalemia, hyponatremia.
Miscellaneous reactions: Fever, elevation of serum transaminase and bilirubin, and increases in BUN and serum creatinine levels.
Fortrim Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Pediatric PatientsAcute Otitis MediaFor the treatment of acute otitis media due to susceptible strains of Streptococcus pneumoniae and Haemophilus influenzae.
NOTE: Moraxella catarrhalis isolates were found consistently resistant to Fortrim in vitro.
Therefore, when infection with Moraxella catarrhalis is suspected, the use of alternative antimicrobial agents should be considered. Fortrim is not indicated for prophylactic or prolonged administration in otitis media at any age.
AdultsUrinary Tract InfectionsFor the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species and coagulase-negative Staphylococcus species, including S. saprophyticus.
Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to Fortrim. Therapy may be initiated prior to obtaining the results of these tests.
Fortrim is used to treat infections of the urinary tract. It may also be used for other problems as determined by your doctor. It will not work for colds, flu, or other virus infections.
Fortrim is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Fortrim is used in certain patients for the following medical conditions:
For patients taking Fortrim for prevention of urinary tract infections:
A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to pyrimethamine. The interference with folic acid metabolism may cause a depression of hematopoiesis. It is potentiated by sulfonamides and the Fortrim-sulfamethoxazole combination is the form most often used. It is sometimes used alone as an antimalarial. Fortrim resistance has been reported. [PubChem]
Use Fortrim solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Fortrim solution.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsCystitis, acute uncomplicated, treatment (tablets, oral solution): Treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species and coagulase-negative Staphylococcus species, including S. saprophyticus.
Otitis media, acute (oral solution): Treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae and Haemophilus influenzae.
Off Label UsesAcne vulgaris
Data from a limited number of controlled and noncontrolled trials suggest that Fortrim may be beneficial for the treatment of acne vulgaris. Additional data may be necessary to further define the role of Fortrim in this condition.
Based on the American Academy of Dermatology guidelines of care for the management of acne vulgaris, Fortrim, in combination with topical therapy, may be considered as an alternative therapeutic option for the management of moderate and severe acne. However, use should be limited to patients who are unable to tolerate tetracycline antibiotics or patients with treatment-resistant acne. Concomitant topical therapy with benzoyl peroxide or a retinoid should be administered with systemic antibiotic therapy (eg, Fortrim) and continued for maintenance after the antibiotic course is completed.
Cystitis, uncomplicated, prophylaxis for recurrent infectionData from a double-blind, placebo-controlled trial and 2 other studies suggest that Fortrim may be beneficial in the prophylaxis of recurrent urinary tract infection (UTI) in women with ≥2 episodes of infection in the previous year.
Pneumocystis pneumonia, treatment of mild to moderate infectionBased on the US Department of Health and Human Services (HHS) Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents and the HHS Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-exposed and HIV-infected Children, Fortrim (in combination with dapsone) is an effective and recommended alternative agent for the treatment of mild to moderate Pneumocystis pneumonia (PCP) in HIV-infected patients.
Acute uncomplicated infections: 100 mg orally every 12 hours or 200 mg orally every 24 hours for 10 days
Usual Adult Dose for Cystitis Prophylaxis
(Not approved by FDA)
100 mg orally at bedtime for 6 weeks to 6 months
Usual Adult Dose for Pneumocystis Pneumonia
(Not approved by FDA)
Centers for Disease Control and Prevention (CDC) recommendations:
HIV-infected patients: 15 mg/kg/day orally in 3 divided doses (in addition to dapsone 100 mg daily) for 21 days
Fortrim with dapsone is recommended as alternative treatment of mild-to-moderate Pneumocystis jirovecii pneumonia.
Usual Pediatric Dose for Otitis Media
Acute infections:
6 months or older: 5 mg/kg orally every 12 hours for 10 days
Usual Pediatric Dose for Urinary Tract Infection
Acute uncomplicated infections:
12 to 18 years: 100 mg orally every 12 hours or 200 mg orally every 24 hours for 10 days
(Not approved by FDA)
2 months to less than 12 years: 2 to 3 mg/kg orally every 12 hours for 10 days
Usual Pediatric Dose for Pneumocystis Pneumonia
(Not approved by FDA)
CDC recommendations:
HIV-infected adolescents: 15 mg/kg/day orally in 3 divided doses (in addition to dapsone 100 mg daily) for 21 days
Fortrim with dapsone is recommended as alternative treatment of mild-to-moderate Pneumocystis jirovecii pneumonia.
Renal Dose Adjustments
CrCl 15 to 30 mL/min: Usual dose should be reduced by 50%.
CrCl less than 15 mL/min: Not recommended.
Liver Dose Adjustments
Caution is recommended in patients with hepatic impairment.
Precautions
Fortrim is contraindicated in patients with documented megaloblastic anemia due to folate deficiency.
High doses and/or prolonged use of Fortrim may cause bone marrow depression manifested as thrombocytopenia, leukopenia, and/or megaloblastic anemia.
Fortrim should be discontinued in patients if early symptoms of blood dyscrasias develop (sore throat, fever, pallor, or purpura) and if significant abnormalities in blood counts are found.
Monitoring of potassium concentrations is recommended, especially in elderly patients.
Safety and effectiveness have not been established in pediatric patients less than 2 months of age. Effectiveness in the treatment of acute otitis media has not been established in pediatric patients less than 6 months of age. The efficacy of Fortrim as a single agent in the treatment of urinary tract infection has not been established in pediatric patients less than 12 years of age.
Dialysis
CrCl less than 15 mL/min: Not recommended.
Peritoneal dialysis is not effective and hemodialysis only moderately effective in eliminating Fortrim.
Other Comments
Fortrim can interfere with serum methotrexate assays by the Competitive Binding Protein Technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. There is no interference with methotrexate radioimmunoassays (RIA). Fortrim may also interfere with creatinine assays using the Jaffe alkaline picrate reaction, resulting in 10% overestimations of the range of normal values.
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What other drugs will affect Fortrim?
Fortrim may inhibit the hepatic metabolism of phenytoin. Fortrim (Fortrim (Fortrim tablet) tablet), given at a common clinical dosage, increased the phenytoin half-life by 51% and decreased the phenytoin metabolic clearance rate by 30%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect.
Drug/Laboratory Test InteractionsFortrim (Fortrim (Fortrim tablet) tablet) can interfere with a serum methotrexate assay as determined by the Competitive Binding Protein Technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. No interference occurs, however, if methotrexate is measured by a radioimmunoassay (RIA). The presence of Fortrim (Fortrim (Fortrim tablet) tablet) may also interfere with the Jaffé alkaline picrate reaction assay for creatinine resulting in over estimations of about 10% in the range of normal values.
