Each vial contains: Fosfomycin sodium equivalent to Fosfomycin 1 g (Potency).
Fosfomycin sodium equivalent to Fosfomycin 2 g (Potency).
Pharmacology: Antibacterial Activity: Fosfomycin acts bactericidally on gram-positive and gram-negative pathogens. It is especially highly active against Pseudomonas aeruginosa, Proteus sp, Serratia marcescens, and multi-drug resistant strains of Staphylococcus aureus and E. coli.
Mode of Action: The mode of action of fosfomycin is very unique. It is taken into bacterial cells in high concentration via the active transport system against a concentration gradient, and inhibits the initial stage of cell wall synthesis (β-lactam antibiotics inhibits the final stage of cell wall synthesis).
Prevention of infections in abdominal surgery.
Intravenous Drip Infusion: The usual daily dosage of Focyn for I.V. use is 2 to 4 g (base) for adults and 100 to 200 mg (base)/kg for children; both of these are given by intravenous drip infusion in 2 divided dose. Each dose is dissolved in 100 to 500 mL of intravenous fluid and infused over a period of one to 2 hours.
For acute and elective abdominal surgery: Adults and children over 12 years: 8 g as a single dose infused intravenous 0.5-1 hour preoperative. Depending on the level of contamination and the length of the surgery, this dose can be repeated. Focyn should be given in combination with an aerobic antibiotics.
Renal insufficiency: Repeated doses should not be given at creatinine clearance below 20 mL/minute.
The dose interval should be 16 hours at 20-40 mL/minute. 8 g of Focyn to be mixed with 500 mL isotonic glucose infusion liquid and to be given at an infusion rate 10-15 mL/minute. Heat is generated when Focyn is resolved. Other Antibiotics or medicaments shall not be added.
This drug should be administered with care to patients with liver disorders.
Precaution in Application: Focyn for I.V. use should be administered only by the intravenous route. In addition, it is desirable for the administration to be performed by intravenous drip infusion whenever possible.
It is known that phlebitis and angialgia may occur following the intravenous administration of this drug. Therefore, sufficient care should be taken with regard to the selection of the injection site and the technique to be employed for the administration, and the rate at which the drug solution is injected should be as slow as possible.
Other Precautions: In the case of patients who are put on longterm therapy using this drug, it is desirable to periodically perform liver and kidney function tests, as well as hematological test.
Focyn for I.V. use contains 14.5 mEq of sodium per g (base); accordingly, care should be taken when administering it to patients who need to reduce their sodium intake due to heart failure, kidney failure, hypertension, etc.
Usage in Pregnancy: The safety of this drug for administration during the course of pregnancy has not yet been established. Therefore, it is desirable to avoid the use of this drug in females who are, or may be, pregnant.
The safety of this drug for administration during the course of pregnancy has not yet been established. Therefore, it is desirable to avoid the use of this drug in females who are, or may be, pregnant.
Liver: Occasionally the values for S-GOT, S-GPT and ALP, LDH, gamma-GTP 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: A 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 this drug. Moreover, in the case of administration of large doses, spasms may occasionally occur.
Hematological Disorders: On rare occasions, agranulocytosis may develop, and occasionally patients develop signs of anemia, eosinophilia, granulocytopenia and thrombocytopenia.
Gastrointestinal Tract: Such side effects as stomatitis, nausea, vomiting, abdominal pain, diarrhea and anorexia may occasionally develop.
Skin: Rarely develop eruption, urticaria, erythema, and itching.
Injection Site: Phlebitis develops on rare occasions, and angialgia may occasionally occur.
Others: There are occurrences of dull headache, oral dryness, vertigo and chest discomfort, and occasionally patients may experience a feeling of pressure on the chest.
Reconstitution administrations: Powder for injection in vial dissolved with 20 mL water for injection or 5% dextrose injection and then reconstitution solution injected in 100 to 500 mL of 5% dextrose solution for infusion.
Use within 3 hours at temperature below 25°C after reconstituted with water for injection or 5% dextrose injection.
Use within 24 hours at temperature below 25°C and at 2°-8°C after reconstituted solution injected to 5% dextrose solution for infusion.
When Focyn for I.V. use is dissolved, heat is released; this has no detrimental effect on the drug or its activity, and is therefore no cause for worry.
J01XX01 - fosfomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Focyn powd for inj 1 g
2 × 1's
Focyn powd for inj 2 g
2 × 1's
Sign Out
