Fosfomed
(Fosfomycin)




Composition

1 sachet of medicine contains:

active ingredient: fosfomycin (as fosfomycin trometamol) 3.0 g

inactive ingredients : saccharose, anhydrous colloidal silicon dioxide, orange flavor, tangerine flavor, sodium saccharin.

Therapeutic indications

- acute bacterial cystitis, acute onsets of recurrent bacterial cystitis;

- bacterial non-specific uretritis;

- asymptomatic massive bacteriuria in pregnant;

- post-operative infections of urinary tract;

- prophylaxis of urinary tract infections in surgery and transurethral diagnostic studies.

Contraindications

- Hypersensitivity to fosfomycin trometamol;

- Severe renal insufficiency (creatinine clearance <10 ml/min)

- Age under 5 years old.

Adverse effects

GIT adverse reactions (nausea, epigastric burning, diarrhea), rash, allergic reactions may develop.

Dosage and administration.

Fosfomed is for oral administration. The granules are dissolved in 1/3 glass of water. It should be taken about 2-3 hours before or after eating, preferably before bedtime, after emptying the bladder. 1 sachet (3 g) is administered once daily.

The recommended regimen for the prophylaxis of urinary tract infections in surgery and diagnostic procedure involving lower urinary tract in adult males and females is one Fosfomed 3 g sachet 3 hours before surgery and one 3 g sachet 24 hours after surgery.

The dosage for children aged 5-18 years old is 2 g once daily.

The duration of treatment is one day.

In severe cases (elderly patients, recurrent infections): 1 more sachet 24 hours later.

In renal insufficiency the dose is decreased and the intervals between administrations are prolonged.

Drug interactions

Fosfomycin/Metoclopramide combination should be avoided as when co-administered with fosfomycin, metoclopramide lowers the serum and urine concentrations of fosfomycin.

Pregnancy and lactation

Use of Fosfomed during pregnancy and lactation is possible only in case when the estimated benefit for mother overweighs a potential risk of adverse reactions.

The lactation should be withdrawn during the treatment with Fosfomed.

Manufactured form

Granulated powder for oral solution in sachets.

1 or 2 sachets with a leaflet in a carton box.

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