Description

Esafosfina 10 g Vial – Fosfomycin IV Solution

Esafosfina is a high-dose injectable form of fosfomycin sodium, a broad-spectrum bactericidal antibiotic used in the treatment of severe bacterial infections, particularly when resistance to standard therapies is suspected or confirmed.

Composition

Active ingredient: Fosfomycin sodium – 10 g per vial
Excipients: Sodium hydroxide or hydrochloric acid (for pH adjustment), water for injection (for reconstitution)

Pharmaceutical Form

Powder for solution for intravenous injection or infusion. Upon reconstitution, forms a clear to pale yellow sterile solution.

Therapeutic Indications

Complicated urinary tract infections (e.g. pyelonephritis, recurrent cystitis)
Lower respiratory tract infections (e.g. pneumonia)
Intra-abdominal infections (as part of combination therapy)
Skin and soft tissue infections (e.g. diabetic foot infections)
Bone and joint infections (off-label, in multidrug-resistant organisms)
Prophylaxis in major surgery with high infection risk

Mechanism of Action

Fosfomycin inhibits bacterial cell wall synthesis by irreversibly blocking the enzyme UDP-N-acetylglucosamine enolpyruvyl transferase (MurA). This results in rapid bacterial lysis. It is bactericidal against Gram-negative and Gram-positive pathogens, including ESBL-producing Enterobacteriaceae and MDR Pseudomonas aeruginosa.

Pharmacokinetics

Distribution: Wide distribution including lungs, kidneys, liver, bone, and CSF
Half-life: ~2–3 hours (prolonged in renal impairment)
Elimination: Renal (unchanged in urine); dose adjustment required in renal insufficiency

Contraindications

Hypersensitivity to fosfomycin or any component of the formulation
Severe renal insufficiency (CrCl < 20 mL/min), unless benefits outweigh risks
Dialysis patients without close monitoring

Warnings and Precautions

Risk of hypokalemia with prolonged or high-dose therapy — monitor electrolytes
Potential for neurotoxicity (confusion, seizures) at high concentrations, especially in renal impairment
Use caution in pregnancy and lactation; safety data is limited but no evidence of teratogenicity in animal studies
Monitor liver enzymes and renal function during prolonged treatment

Drug Interactions

Metoclopramide may reduce absorption of oral fosfomycin (not relevant for IV form)
Risk of additive nephrotoxicity with other renally excreted antibiotics (e.g., aminoglycosides)
Can increase exposure to certain antivirals (tenofovir, adefovir) — monitor renal function

Adverse Effects

Common: Diarrhea, nausea, rash, headache, injection site inflammation
Less common: Confusion, dizziness, elevated liver enzymes, hypokalemia
Rare but serious: Seizures, anaphylaxis, C. difficile-associated diarrhea

Pregnancy and Lactation

Fosfomycin crosses the placenta. Animal studies have not shown teratogenic effects, but data in pregnant women is limited. Use only if clearly needed. Caution is also advised during lactation as excretion into breast milk is unknown.

Dosage and Administration

Standard adult dose: 4–8 g IV every 8–12 hours (depending on infection type and severity)
Severe infections: Up to 12–16 g/day in divided doses (under strict supervision)
Infusion time: Over 30–60 minutes; reconstitute in 100–250 ml of suitable diluent
Renal impairment: Dose adjustment required per creatinine clearance

Instructions for Use

Dissolve the powder in sterile water for injection or 0.9% NaCl solution
Shake gently until fully dissolved
Use the reconstituted solution immediately; discard any unused portion

Storage

Store unopened vials below 25°C (77°F), protected from light and moisture
Do not freeze
Keep out of reach of children

Scientific References

Disclaimer

This information is intended for educational purposes only and does not replace professional medical advice. Always consult a licensed healthcare provider before starting any new treatment.

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