Fosfomax 4 Powder For Solution For Infusion

✔️ Side Effects:

• Common: Gastrointestinal disturbances, injection site reactions (pain, swelling, redness), hypokalaemia, hypernatraemia
• Rare but Serious: Acute hypersensitivity reactions (e.g., anaphylactic shock), hypotonia, somnolence, thrombocytopenia, hypoprothrombinemia

✔️ Dosage Guidelines: Adults and Adolescents (≥12 years, >40 kg):

• Osteomyelitis: 12–24 g/day in 2–3 divided doses
• Complicated UTIs: 12–16 g/day in 3 divided doses
• Nosocomial lower respiratory tract infections: 12–24 g/day in 2–3 divided doses
• Bacterial meningitis: 16–24 g/day in 3–4 divided doses

Maximum single dose: 8 g
Note: Severe infections caused by resistant bacteria may require higher doses. Doses exceeding 16 g/day require caution due to limited safety data.

✔️ Pediatric Population (<12 years, <40 kg):

• Premature neonates (<40 weeks gestational age): 100 mg/kg/day in 2 divided doses
• Neonates (40–44 weeks): 200 mg/kg/day in 3 divided doses
• Infants (1–12 months, ≤10 kg): 200–300 mg/kg/day in 3 divided doses
• Infants and children (1–12 years, 10–40 kg): 200–400 mg/kg/day in 3–4 divided doses

✔️ Hepatic Impairment:

No dosage adjustment is typically required for patients with liver impairment.

✔️ Renal Impairment:

Adjust dosage based on kidney function. Higher doses should be administered cautiously in patients with impaired renal function.

✔️ Elderly Patients:

The standard adult dosage is appropriate, but higher doses should be used cautiously.

✔️ Administration Instructions:

• Administer via intravenous infusion. For 4 g vials, infusion should last at least 30 minutes.
• Reconstitute with Water for Injections or Glucose Infusion (5% or 10%). Sodium chloride-containing solvents must not be used.
• Shake the vial to loosen the powder, then dissolve 4 g of the drug in 20 ml of solvent.
• Add the reconstituted solution to 80 ml of solvent, resulting in a clear, colorless slightly yellowish infusion solution.
• Use the solution immediately after preparation or store it under refrigeration (2–8°C) for up to 24 hours.

✔️ Duration of Treatment:

The treatment length depends on the type, severity, and clinical response to the infection.

✔️ Overdose Management:

Overdose symptoms may include hypotonia, drowsiness, electrolyte disturbances, thrombocytopenia, and coagulation issues. Symptomatic treatment is recommended.

✔️ Drug Interactions:

No specific drug-drug interaction studies are available for fosfomycin.

✔️ Pregnancy & Lactation

• Pregnancy: Limited clinical data; use only if the benefits outweigh potential risks.
• Breastfeeding: Fosfomycin appears in low concentrations in breast milk; avoid it unless necessary.

✔️ Warnings and Precautions:

• Monitor potassium and sodium levels due to the high sodium load. A low-sodium diet and potassium supplementation may be necessary.
• Use cautiously in patients with cardiac insufficiency, hypertension, hyperaldosteronism, hypernatraemia, or pulmonary edema.
• Discontinue immediately if signs of anaphylactic shock occur.

✔️ Storage:

• Store below 30°C, protected from light and moisture.
• After reconstitution, use immediately or refrigerate (2–8°C) for up to 24 hours.