Data from FDA - Curated by EPG Health - Last updated 24 October 2017

Indication(s)

INDICATIONS AND USAGE TRIMPEX Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Pediatric Patients Acute Otitis Media For 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 trimethoprim in vitro. Therefore, when infection with Moraxella catarrhalis is suspected, the use of alternative antimicrobial agents should be considered. TRIMPEX is not indicated for prophylactic or prolonged administration in otitis media at any age. Adults Urinary Tract Infections For 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 trimethoprim. Therapy may be initiated prior to obtaining the results of these tests.

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Advisory information

contraindications
CONTRAINDICATIONS TRIMPEX is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.
Special warnings and precautions
PRECAUTIONS General Trimethoprim should be given with caution to patients with possible folate deficiency. Folates may be administered concomitantly without interfering with the antibacterial action of trimethoprim. Trimethoprim should also be given with caution to patients with impaired renal or hepatic function. If any clinical signs of a blood disorder are noted in a patient receiving trimethoprim, a complete blood count should be obtained and the drug discontinued if a significant reduction in the count of any formed blood element is found. Drug Interactions TRIMPEX may inhibit the hepatic metabolism of phenytoin. Trimethoprim, 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 Interactions Trimethoprim 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 trimethoprim may also interfere with the Jaffé alkaline picrate reaction assay for creatinine resulting in overestimations of about 10% in the range of normal values. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential have not been conducted with trimethoprim. Trimethoprim was demonstrated to be non-mutagenic in the Ames assay. No chromosomal damage was observed in human leukocytes cultured in vitro with trimethoprim; the concentration used exceeded blood levels following therapy with TRIMPEX. No adverse effects on fertility or general reproductive performance were observed in rats given trimethoprim in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females. Pregnancy Teratogenic Effects Pregnancy Category C Trimethoprim has been shown to be teratogenic in the rat when given in doses 40 times the human dose. In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with doses 6 times the human therapeutic dose. While there are no large well-controlled studies on the use of trimethoprim in pregnant women, Brumfitt and Pursell,4 in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or trimethoprim in combination with sulfamethoxazole. The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim plus sulfamethoxazole. There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received trimethoprim plus sulfamethoxazole at the time of conception or shortly thereafter. Because trimethoprim may interfere with folic acid metabolism, TRIMPEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival. Nursing Mothers Trimethoprim is excreted in human milk. Because trimethoprim may interfere with folic acid metabolism, caution should be exercised when TRIMPEX is administered to a nursing woman. Pediatric Use The safety of trimethoprim has not been established in pediatric patients below the age of 2 months. The effectiveness of trimethoprim in the treatment of acute otitis media has not been established in patients below the age of 6 months.
Adverse reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Key Therapeutics, LLC at 1-888-981-8337, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Adverse Events Reported During Pediatric Clinical Trials With TRIMPEX The 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 TRIMPEX, which was most apparent for those events related to skin/appendages as a body system. Drug-related Adverse Event Percent of Pediatric Patients TRIMPEX (N=310) SMX + TMPsulfamethoxazole + trimethoprim oral suspension (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 An increase in lymphocytes and eosinophils was noted in some pediatric patients following treatment with TRIMPEX or sulfamethoxazole + trimethoprim oral suspension. Adverse Reactions Reported For Trimethoprim In addition to the adverse events listed above which have been observed in pediatric patients receiving TRIMPEX, the following adverse reactions and altered laboratory tests have been previously reported for trimethoprim and therefore, may occur with TRIMPEX 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 trimethoprim 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Acute Otitis Media in Pediatric Patients The recommended dose for pediatric patients with acute otitis media is 10 mg/kg trimethoprim per 24 hours, given in divided doses every 12 hours for 10 days. The following table is a guideline for the attainment of this dosage: Pediatric patients 6 months of age or older: Weight Dose (every 12 hours) lb kg tsp mL 11 5 ½ 2.5 22 10 1 5 33 15 1½ 7.5 44 20 2 10 55 25 2½ 12.5 66 30 3 15 77 35 3½ 17.5 ≥88 ≥40 4 20 Uncomplicated Urinary Tract Infections The usual oral adult dosage is 100 mg (10 mL) every 12 hours or 200 mg (20 mL) every 24 hours, each for 10 days. Patients with Impaired Renal Function The use of trimethoprim in patients with a creatinine clearance of less than 15 mL/min is not recommended. Patients with a creatinine clearance of 15 to 30 mL/min should receive half the dose recommended for patients of the same age with normal renal function.
Pregnancy and lactation
Nursing Mothers Trimethoprim is excreted in human milk. Because trimethoprim may interfere with folic acid metabolism, caution should be exercised when TRIMPEX is administered to a nursing woman.

Interactions

Drug Interactions TRIMPEX may inhibit the hepatic metabolism of phenytoin. Trimethoprim, 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.

More information

Category Value
Authorisation number NDA074973
Agency product number 9XE000OU9B
Orphan designation No
Product NDC 70868-120
Date Last Revised 07-10-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 562707
Storage and handling Store between 15-25°C (59-77°F). Dispense in tight, light resistant glass or PET plastic containers as defined in USP. Protect from light.
Marketing authorisation holder Key Therapeutics, LLC