COMPOSITIONS :
Fosfomycin Sodium Powder for Injection 1 g, each vial contains : Fosfomycin sodium equivalent to Fosfomycin 1 g.
DESCRIPTIONS :
Fosfomycin Sodium contains Fosfomycin sodium (equivalent to Fosfomycin) as active ingredient is available in powder for injection 1 g and 2 g.
INDICATION :
Prevention of infections in abdominal surgery.
DOSAGE AND ADMINISTRATIONS :
Usual daily dosage :
2 – 4 g (potency) for adults and 100 – 200 mg (potency)/kg body weight for children.
IV drip infusion : Doses are given by IV drip infusion in 2 divided doses. Each dose is dissolved in 20 ml of IV fluids (Glucose 5%) until perfectly dissolved, then mix in remaining 100 – 500 ml IV fluid (Glucose 5%), mix until homogeneous and infused over a period of 1 – 2 hours.
Acute and elective abdominal surgery :
Adults and children > 12 years, 8 g as a single dose infused IV 0.5 – 1 hour pre-operative.
Depending on the level of contamination and the length of the surgery, this dose can be repeated. Fosfomycin Sodium should be given in combination with aerobic antibiotics.
Renal insufficiency :
Repeated dose should not be given if creatinine clearance is < 20 ml/minute.
The dose interval should be 16 hours at 20 – 40 ml/minute, 8 g of Fosfomycin Sodium to be mixed with 500 ml isotonic Glucose infusion liquid and to be given at an infusion rate 10 – 50 ml/minute. Heat is generated when Fosfomycin Sodium is dissolved. Other antibiotics or medicaments should not be added.
CONTRAINDICATION :
Patients with known hypersensitivity to any components of this product.
WARNINGS AND PRECAUTIONS :
Fosfomycin should be administered with caution in patients with liver disorders.
Fosfomycin should be administered only by the IV route. In addition, it is desirable for the administration to be performed by IV drip infusion whenever possible.
It is known that phlebitis and angialgia may occur following IV administration of Fosfomycin. Therefore, sufficient care should be taken.
In the case of patients who are on long-term therapy, it is desirable to periodically perform liver and kidney function tests as well as hematological tests.
Fosfomycin contains 14.5 mEq of sodium/g (potency); accordingly, care should be taken when administering it to patients who need to reduce their sodium intake due to heart failure, kidney failure, hypertension.
Use in pregnancy : The safety of Fosfomycin during pregnancy has not yet been established. Therefore, it is advisable to avoid its use in female who are or may be pregnant.
ADVERSE REACTIONS :
Liver : Occasionally, the values for SGOT, SGPT and ALP, LDH, γ-GPT and bilirubin may increase.
Kidney : Proteinuria and abnormalities in the Fishberg test develop in rare cases and occasionally an elevated BUN value and edema may develop.
Respiratory organs : Cough and asthma attacks may develop on rare occasions.
Central and peripheral nervous systems : Occasionally, patients may experience headaches and a feeling of numbness of the lips following the use of Fosfomycin. Moreover, in the case of administration of large doses, spasms may occasionally occurs.
Hematological disorders : On rare occasions, agranulocytosis may develop, and occasionally, patients develop signs of anemia, eosinophilia, granulocytopenia and thrombocytopenia.
Gastrointestinal tract : Stomatitis, nausea, vomiting, abdominal pain, diarrhea and anorexia may occasionally develop.
Skin : Eruption, urticaria, erythema, and itching rarely develop.
Injection site : Phlebitis develops on rare occasions and angialgia may occasionally occurs.
Others : There are occurences of dull headache, oral dyness, vertigo and chest discomfort and occasionally, patients may experience a feeling of pressure on the chest.
PRESENTATIONS :
Fosfomycin Sodium Powder for Injection 1 g Box, 1 vial @ 1 g Reg. No. GKL1402348444A1
STORAGE :
STORE BELOW 30ºC
After reconstitution, Fosfomycin Sodium can be stored for up to 24 hours at temperature below 30°C without undergoing any significant physical or chemical changes.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
