Trimethoprim

Trimethoprim

Goedgekeurde toepassingen

• INDICATIONS & USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
• When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
• In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
• 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.

Vormen en sterktes

• Trimethoprim tablets, USP, 100 mg: White, round, convex tablet, debossed "N", bisect, "L" on one side and debossed "330" on the other, in bottles of 100.

Hoe het wordt ingenomen

• DOSAGE & ADMINISTRATION The usual oral adult dosage is 100 mg of trimethoprim every 12 hours or 200 mg of trimethoprim every 24 hours, each for 10 days.
• The use of trimethoprim in patients with a creatinine clearance of less than 15 mL/min is not recommended.
• For patients with a creatinine clearance of 15 to 30 mL/min, the dose should be 50 mg every 12 hours.

Mag niet worden gebruikt bij

• Trimethoprim is contraindicated in individuals hypersensitive to trimethoprim and in those with documented megaloblastic anemia due to folate deficiency.

Interacties

• Trimethoprim 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.

Waarschuwingen en voorzorgen

• Serious hypersensitivity reactions have been reported rarely in patients on trimethoprim therapy.
• Trimethoprim 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 (see OVERDOSAGE, Chronic).
• Complete blood counts should be obtained if any of these signs are noted in a patient receiving trimethoprim and the drug discontinued if a significant reduction in the count of any formed blood element is found.

Vaak voorkomende bijwerkingen

• The adverse effects encountered most often with trimethoprim were rash and pruritus. Dermatologic Rash, pruritus, and phototoxic skin eruptions.

Zwangerschap

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 six times the human therapeutic dose.

Werkingsmechanisme

Microbiology Mechanism of Action Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the required enzyme, dihydrofolate reductase. This binding is very much stronger for the bacterial enzyme than for the corresponding mammalian enzyme.

Handelsvergunninghouder:

Lupin Pharmaceuticals,Inc.

Versie van de productinformatie:

4 juni 2024

De secties hierboven zijn geciteerd uit de Engelstalige productinformatie, want dat is het document dat de goedkeuring draagt. Waar een Europese instantie dezelfde informatie in het Nederlands publiceert, staat de link bij de bronnen. Wij vertalen regelgevende teksten niet zelf: een vertaalfout in een contra-indicatie is gevaarlijker dan een regel in een vreemde taal.

Deze sectie geeft de goedgekeurde productinformatie weer. De formulering is ingedikt uit de samenvatting van de toezichthouder zelf, en het volledige document staat bij de bronnen.