Composition

Each 50 ml vial contains 5 g of Sodium Phosphate Monobasic as the active ingredient. Inactive components include water for injection and sodium hydroxide (used for pH adjustment).

Description

Esafosfina is a sterile, clear, and colorless intravenous solution designed to restore phosphate levels in patients with clinical hypophosphatemia. It is produced under stringent aseptic conditions and used in hospitals and clinical settings under medical supervision.

Indications

Esafosfina is indicated for:

• Treatment of moderate to severe hypophosphatemia
• Management of phosphate depletion due to diabetic ketoacidosis, alcohol withdrawal, refeeding syndrome
• Supplementation during total parenteral nutrition (TPN)
• Support in conditions of increased phosphate demand: pregnancy, lactation, rapid growth in pediatrics

Administration and Dosage

• Route: Intravenous (slow infusion)
• Dosage: Individualized based on age, weight, renal function, and serum phosphate levels
• Recommended infusion rate: Administer slowly to prevent complications
• Monitoring: Serum phosphate, calcium, potassium, and renal function must be assessed before and during treatment

Contraindications

• Hyperphosphatemia
• Severe renal impairment
• Addison’s disease
• Severe liver dysfunction
• Hypersensitivity to phosphate salts or any excipients

Precautions

• Risk of calcium-phosphate precipitation with rapid correction
• Caution in patients with cardiac disease, renal impairment, or electrolyte imbalances
• Not recommended for use in pediatric patients without strict monitoring
• Do not use with other phosphate-containing products simultaneously

Interactions

• May interact with digoxin, leading to altered cardiac effects
• Concurrent use with antacids containing calcium, aluminum, or magnesium may reduce phosphate absorption or increase toxicity risk
• Caution with potassium-sparing diuretics and vitamin D analogs

Side Effects

• Electrolyte imbalances: hypocalcemia, hyperphosphatemia, hyperkalemia
• Cardiovascular: hypotension, tachycardia
• Gastrointestinal: nausea, vomiting, abdominal cramps, diarrhea
• Injection site reactions: redness, pain, swelling
• Rare: Soft tissue calcification due to calcium-phosphate precipitation

Overdose

Symptoms of overdose include signs of hyperphosphatemia such as muscle cramps, tetany, arrhythmias, and possible renal damage. Treatment involves discontinuation, fluid management, and correction of electrolyte imbalance under medical supervision.

Storage

• Store at 15–25°C (59–77°F)
• Protect from light and moisture
• Do not freeze
• Keep out of reach of children and pets

Scientific References

• Hypophosphatemia – StatPearls – NCBI
• Intravenous phosphate therapy: a review – PubMed

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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

• Efficacy of Fosfomycin in Severe Multidrug-Resistant Infections – NCBI
• Intravenous Fosfomycin: Clinical Use and Pharmacokinetics – PubMed

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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