Fosmidex 1

Indonesia • Dexa Medica

Indication

Prevention of infections in abdominal surgery.

Composition

Each vial contains Fosfomycin sodium bulk equivalent to Fosfomycin base 1 g.

Package

Box, 10 vial @ 1g

Dosage Forms

Powder for Injection

ATC Classification

J01X

Warning

Pregnancy
Caution
This item may not be safe for use during pregnancy. Use with caution and after consultation with your doctor.
Lactation
Caution
This item may not be safe for use during lactation. Use with caution and after consultation with your doctor.
Precaution

When FOSMIDEX FOR IV USE is dissolved, heat may be released. This does not adversely affect the drug or its activity and is not a cause for concern.

This drug should be administered with caution in patients with liver disorders.

Use in Pregnancy
The safety of this drug during pregnancy has not yet been established. Therefore, it is advisable to avoid using this drug in women who are pregnant or may become pregnant.

Precautions for Administration
FOSMIDEX FOR IV USE should be administered only via the intravenous route. Whenever possible, administration should be performed by intravenous drip infusion.

Phlebitis and vascular pain (angialgia) may occur following intravenous administration. Therefore, careful attention should be given to the selection of the injection site, administration technique, and injection rate. The drug solution should be injected as slowly as possible.

Other Precautions
For patients receiving long-term therapy with this drug, periodic liver function tests, kidney function tests, and hematological examinations are recommended.

FOSMIDEX FOR IV USE contains 14.5 mEq of sodium per gram (base). Caution is advised when administering to patients requiring sodium restriction, such as those with heart failure, kidney failure, or hypertension.

Dosage

Intravenous Drip Infusion
The usual daily dosage of FOSMIDEX FOR IV USE is:

  • Adults: 2–4 g (base) per day
  • Children: 100–200 mg (base)/kg body weight per day

Both are administered by intravenous drip infusion in 2 divided doses. Each dose should be dissolved in 100–500 mL of intravenous fluid and infused over a period of 1–2 hours.

For Acute and Elective Abdominal Surgery
Adults and children over 12 years:
8 g as a single intravenous infusion administered 0.5–1 hour before surgery.

Depending on the degree of contamination and the duration of surgery, the dose may be repeated.

FOSMIDEX should be administered in combination with an aerobic antibiotic.

Renal Insufficiency
Repeated doses should not be administered in patients with creatinine clearance below 20 mL/minute.

For patients with creatinine clearance of 20–40 mL/minute, the dosing interval should be 16 hours.

Preparation and Administration
8 g of FOSMIDEX should be mixed with 500 mL isotonic glucose infusion solution.

The infusion should be administered at a rate of 10–15 mL/minute.

Heat may be generated when FOSMIDEX is dissolved. Other antibiotics or medications should not be added to the solution.

* For detailed product information, see package insert.
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