Fosfomycyna

Fosfomycin tromethamine

Zarejestrowane wskazania

• Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.
• If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected (see PRECAUTIONS and CLINICAL STUDIES sections).
• Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess.

Postacie i dawki

• Fosfomycin Tromethamine Granules for Oral Solution is supplied as a white to off-white powder in a single-dose sachet containing the equivalent of 3 grams of fosfomycin.

Jak się przyjmuje

• The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet of fosfomycin tromethamine granules for oral solution.
• Fosfomycin tromethamine granules for oral solution may be taken with or without food.
• Fosfomycin tromethamine granules for oral solution should not be taken in its dry form.
• Always mix fosfomycin tromethamine granules for oral solution with water before ingesting (see PREPARATION section).

Nie wolno stosować, gdy

• Fosfomycin tromethamine granules for oral solution is contraindicated in patients with known hypersensitivity to the drug.

Interakcje

• Metoclopramide When co-administered with fosfomycin tromethamine, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin.
• Other drugs that increase gastrointestinal motility may produce similar effects.
• Cimetidine Cimetidine does not affect the pharmacokinetics of fosfomycin when co-administered with fosfomycin tromethamine.

Ostrzeżenia i środki ostrożności

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including fosfomycin tromethamine, and may range in severity from mild diarrhea to fatal colitis.
• Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• C. difficile produces toxins A and B which contribute to the development of CDAD.
• Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

Częste działania niepożądane

• Clinical Trials In clinical studies, drug related adverse events which were reported in greater than 1% of the fosfomycin-treated study population are listed below: Drug-Related Adverse Events (%) in Fosfomycin and Comparator Populations Adverse Events Fosfomycin N=1,233 Nitrofurantoin N=374 Trimethoprim/sulfamethoxazole N=428 Ciprofoxacin N=455 Diarrhea 9.0 6.4 2.3 Vaginitis 5.5 5.3 4.7 Nausea...

Ciąża

Teratogenic Effects When administered intramuscularly as the sodium salt at a dose of 1 gram to pregnant women, fosfomycin crosses the placental barrier. Fosfomycin tromethamine crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1,000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m 2, respectively).

Podmiot odpowiedzialny:

Amneal Pharmaceuticals NY LLC

Wersja charakterystyki:

2 kwietnia 2024

Powyższe sekcje przytoczono z anglojęzycznej charakterystyki, ponieważ to ten dokument nosi rejestrację. Tam, gdzie europejski urząd publikuje tę samą informację po polsku, link znajduje się w źródłach. Sami nie tłumaczymy tekstów urzędowych: błąd tłumaczenia w przeciwwskazaniu byłby groźniejszy niż linijka w obcym języku.

Ta sekcja przytacza zatwierdzoną charakterystykę produktu leczniczego. Tekst jest skrócony na podstawie streszczenia sporządzonego przez sam urząd, a pełny dokument znajduje się w źródłach.