Fosfomax Sachet 3mg

Indications

This medication is specifically intended for treating uncomplicated urinary tract infections (acute cystitis) in women caused by susceptible strains of Escherichia coli and Enterococcus faecalis.

Pharmacology

Fosfomycin Trometamol is a synthetic, broad-spectrum, bactericidal antibiotic designed for oral administration. It exhibits in vitro activity against a wide range of gram-positive and gram-negative aerobic microorganisms commonly associated with uncomplicated urinary tract infections. Fosfomycin acts by irreversibly inhibiting enolpyruvyl transferase, an enzyme critical in bacterial cell wall synthesis.

Dosage & Administration

For women aged 18 years and older with acute cystitis, the recommended dosage is one sachet of Fosfomycin, to be taken with or without food. This medication is not suitable for use in children.

Preparation

Begin by pouring 100 ml of purified water into a glass. Add the entire contents of one Fosfomycin sachet into the water and stir thoroughly until completely dissolved. Consume the entire mixture immediately after preparation as per your healthcare provider’s advice.

Interaction

Co-administration of Fosfomycin with metoclopramide, a drug that enhances gastrointestinal motility, can reduce serum concentration and urinary excretion of fosfomycin. Similar effects may occur with other medications that increase gastrointestinal motility.

Contraindications

Fosfomycin should not be used in patients with known hypersensitivity to the drug, severe renal insufficiency, or those undergoing hemodialysis.

Side Effects

In clinical trials, common adverse events reported in more than 1% of participants, irrespective of drug relationship, included diarrhea (10.4%), headache (10.3%), vaginitis (7.6%), nausea (5.2%), and others. Less frequent adverse events, occurring in less than 1% of participants, included constipation, dry mouth, and insomnia.

Pregnancy & Lactation

Fosfomycin is categorized as pregnancy category B. Its use during pregnancy should be determined based on the benefits versus risks. Similarly, breastfeeding should be discontinued or the drug should not be administered, taking into consideration its importance to the mother.

Precautions & Warnings

Use of Fosfomycin, like other antibacterial agents, has been associated with Clostridium difficile-associated diarrhea (CDAD), due to alteration of normal colon flora. Avoid using more than one single dose for treating acute cystitis episodes, as repeated daily doses did not significantly improve outcomes but increased the risk of adverse events.

Overdose Effects

When co-administered with metoclopramide or similar agents that increase gastrointestinal motility, Fosfomycin’s serum concentration and urinary excretion may be reduced.

Therapeutic Class

Fosfomycin belongs to the category of intracellular antibiotics.

Storage Conditions

Store Fosfomycin in a dry place, below 25°C, and protect it from light. Keep out of reach of children.