Classes
DEA Class; Rx
Common Brand Names; Primsol, Proloprim, TMP
- Antibiotics, Other
Description
Synthetic antifolate-type antiinfective agent. Has activity against gram-positive and gram-negative bacteria. Commonly used for UTI, prophylaxis of UTI, traveler’s diarrhea, and in combination with sulfamethoxazole or dapsone for prophylaxis and treatment of Pneumocystis infections.
Indications
Indicated for the treatment of acute otitis media due to susceptible strains of S. pneumoniae or H. influenzae.
Other Indications and Uses
UTI caused by E. coli, Enterobacter spp., K. pneumoniae, P. mirabilis, coagulase-neg Staphylococcus spp.
Contraindications
Hypersensitivity
Megaloblastic anemia due to folate deficiency
Adverse Effects
- Aseptic meningitis
- Fever
- Maculopapular rash (3-7% at 200 mg/day; incidence higher with larger daily doses)
- Erythema multiforme
- Exfoliative dermatitis
- Pruritus (common)
- Phototoxic skin eruptions
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Hyperkalemia
- Hyponatremia
- Epigastric distress
- Glossitis
- Nausea
- Vomiting
- Leukopenia
- Megaloblastic anemia
- Methemoglobinemia
- Neutropenia
- Thrombocytopenia
- Liver enzyme elevation
- Cholestatic jaundice
- BUN and creatinine increased
- Anaphylaxis
- Hypersensitivity reactions
Warnings
Decreases urinary potassium excretion; may cause hyperkalemia, particularly with high doses, renal insufficiency, or when combined with other drugs that cause hyperkalemia
Large doses or long term therapy may interfere with hematopoiesis; the presence of clinical signs, such as sore throat, fever, pallor, or purpura may be early indications of serious blood disorders; monitor for signs/symptoms of hematologic disorders
If clinical signs of blood disorder noted, obtain a complete blood count and discontinue drug if significant reduction in count of any blood element found
Prolonged use may cause fungal or bacterial superinfection, including clostridium difficile-associated diarrhea and pseudomembranous colitis; may occur >2 months postantibiotic treatment
Hypersensitivity reactions reported
Use caution in patients with renal or hepatic impairment
Use caution in patients with potential for folate deficiency, including malnourished, chronic anticonvulsant therapy, or elderly; folates may be administered concomitantly without interfering with antibacterial action of trimethoprim
Some dosage forms may contain benzyl alcohol and derivatives; avoid in neonates
Not indicated for prophylactic or prolonged administration in otitis media at any age
Pregnancy and Lactation
Pregnancy Category: C
Lactation: enters breast milk
Maximum Dosage
200 mg/day PO is FDA-approved maximum dosage; however, doses up to 15 mg/kg/day PO have been used off-label for PCP in HIV-infected patients.
200 mg/day PO is FDA-approved maximum dosage; however, doses up to 15 mg/kg/day PO have been used off-label for PCP in HIV-infected patients.
400 mg/day PO is FDA-approved maximum dosage; however, doses up to 15 mg/kg/day PO have been used off-label for PCP in HIV-infected patients.
10 mg/kg/day PO (Max: 400 mg/day) is FDA-approved maximum dosage; however, doses up to 15 mg/kg/day PO have been used off-label for PCP in HIV-infected patients.
6 to 11 months: 10 mg/kg/day PO is FDA-approved maximum dosage; however, doses up to 15 mg/kg/day PO have been used off-label for PCP in HIV-infected patients.
1 to 5 months: Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO have been used off-label for PCP in HIV-infected patients.
Safety and efficacy have not been established.
How supplied
Trimethoprim
oral solution
- 50mg/5mL
tablet
- 100mg