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TRIMPEX
Overview
What is TRIMPEX?
TRIMPEX (trimethoprim hydrochloride oral solution) is a solution of the synthetic antibacterial trimethoprim in water prepared with the aid of hydrochloric acid. Each 5 mL for oral administration contains trimethoprim hydrochloride equivalent to 50 mg trimethoprim and the inactive ingredients bubble gum flavor, fructose, glycerin, methylparaben, monoammonium glycyrrhizinate, povidone, propylparaben, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water and hydrochloric acid and/or sodium hydroxide to adjust pH to a range of 3.0 - 5.0. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. Trimethoprim is a white to cream-colored, odorless, bitter compound with a molecular formula of CHNOand a molecular weight of 290.32 and the following structural formula:
What does TRIMPEX look like?
What are the available doses of TRIMPEX?
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What should I talk to my health care provider before I take TRIMPEX?
Sorry No records found
How should I use TRIMPEX?
TRIMPEX Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
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:
What interacts with TRIMPEX?
TRIMPEX is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.
What are the warnings of TRIMPEX?
The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see
).
Experience with trimethoprim alone is limited, but it has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods.
The presence of clinical signs such as sore throat, fever, pallor or purpura may be early indications of serious blood disorders.
What are the precautions of TRIMPEX?
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 culturedwith 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
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.
What are the side effects of TRIMPEX?
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.
An increase in lymphocytes and eosinophils was noted in some pediatric patients following treatment with TRIMPEX or sulfamethoxazole + trimethoprim oral suspension.
| Drug-related Adverse Event | Percent of Pediatric Patients | |
|---|---|---|
| TRIMPEX(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 |
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:
Array
Gastrointestinal reactions:
Hematologic reactions:
Metabolic reactions:
Miscellaneous reactions:
What should I look out for while using TRIMPEX?
TRIMPEX is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.
Experience with trimethoprim alone is limited, but it has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods.
The presence of clinical signs such as sore throat, fever, pallor or purpura may be early indications of serious blood disorders.
What might happen if I take too much TRIMPEX?
How should I store and handle TRIMPEX?
Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYTRIMPEX (trimethoprim hydrochloride oral solution) is a dye-free, alcohol-free, bubble gum flavored, oral solution containing trimethoprim hydrochloride equivalent to 50 mg of trimethoprim in each 5 mL.NDC 70868-120-20: 20 mL (2/3 ounce)NDC 70868-120-16: 473 mL (1 Pint)TRIMPEX (trimethoprim hydrochloride oral solution) is a dye-free, alcohol-free, bubble gum flavored, oral solution containing trimethoprim hydrochloride equivalent to 50 mg of trimethoprim in each 5 mL.NDC 70868-120-20: 20 mL (2/3 ounce)NDC 70868-120-16: 473 mL (1 Pint)TRIMPEX (trimethoprim hydrochloride oral solution) is a dye-free, alcohol-free, bubble gum flavored, oral solution containing trimethoprim hydrochloride equivalent to 50 mg of trimethoprim in each 5 mL.NDC 70868-120-20: 20 mL (2/3 ounce)NDC 70868-120-16: 473 mL (1 Pint)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Trimethoprim is rapidly absorbed following oral administration.
It exists in the blood as unbound, protein-bound and metabolized forms. Ten to twenty percent of trimethoprim is metabolized, primarily in the liver; the remainder is excreted unchanged in the urine. The principal metabolites of trimethoprim are the 1- and 3-oxides and the 3′- and 4′- hydroxy derivatives. The free form is considered to be the therapeutically active form. Approximately 44% of trimethoprim is bound to plasma proteins.
Mean peak plasma concentrations of approximately 1 mcg/mL occur 1 to 4 hours after oral administration of a single 100 mg dose. A single 200 mg dose will result in plasma concentrations approximately twice as high. The mean half-life of trimethoprim is approximately 9 hours. However, patients with severely impaired renal function exhibit an increase in the half-life of trimethoprim, which requires either dosage regimen adjustment or not using the drug in such patients (seesection). During a 13-week study of trimethoprim tablets administered at a dosage of 50 mg , the mean minimum steady-state concentration of the drug was 1.1 mcg/mL. Steady-state concentrations were achieved within two to three days of chronic administration and were maintained throughout the experimental period.
Excretion of trimethoprim is primarily by the kidneys through glomerular filtration and tubular secretion. Urine concentrations of trimethoprim are considerably higher than are the concentrations in the blood. After a single oral dose of 100 mg, urine concentrations of trimethoprim ranged from 30 to 160 mcg/mL during the 0- to 4-hour period and declined to approximately 18 to 91 mcg/mL during the 8- to 24-hour period. A 200 mg single oral dose will result in trimethoprim urine concentrations approximately twice as high. After oral administration, 50% to 60% of trimethoprim is excreted in the urine within 24 hours, approximately 80% of this being unmetabolized trimethoprim.
Trimethoprim half-life, clearance, and volume of distribution vary with age. Excluding newborns, an apparent trend of increasing half-life, volume of distribution, and decreasing clearance is observed with increasing age until adulthood.
Since normal vaginal and fecal flora are the source of most pathogens causing urinary tract infections, it is relevant to consider the distribution of trimethoprim into these sites.
Concentrations of trimethoprim in vaginal secretions are consistently greater than those found simultaneously in the serum, being typically 1.6 times the concentrations of simultaneously obtained serum samples. Sufficient trimethoprim is excreted in the feces to markedly reduce or eliminate trimethoprim-susceptible organisms from the fecal flora. The dominant non-fecal organisms,spp. andspp., are not susceptible to trimethoprim concentrations obtained with the recommended dosage. Trimethoprim also concentrates into middle ear fluid (MEF) very efficiently. In a study in children aged 1 to 12 years, administration of a single 4 mg/kg dose resulted in a mean peak MEF concentration of 2.0 mcg/mL.
Trimethoprim also passes the placental barrier and is excreted in breast milk.
Non-Clinical Toxicology
TRIMPEX is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.Experience with trimethoprim alone is limited, but it has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods.
The presence of clinical signs such as sore throat, fever, pallor or purpura may be early indications of serious blood disorders.
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.
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.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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