【Description】

 

Fomsina is white crystalline powder and the chemical name is Disodium [(2R,3S)-3-methyloxiran-2-yl]-dioxido-oxo-λ⁵-phosphane.

 

Chemical structure:

 

Molecular Formula：C₃H₅Na₂O₄P Molecular Weight: 182.02

 

【Indications】

 

For the treatment of respiratory tract infections, skin and soft tissue infections, intestinal tract infections, urinary tract infections, septicemia, peritonitis, meningitis, osteomyelitis, adnexitis, intra-uterine infection and pelvic inflammation etc induced by sensitive bacteria. Combined administration with other antibiotics can treat severe infections induced by sensitive bacteria. It can treat MRSA infection combined with vancomycin.

 

【Pharmacokinetics】

 

The mean maximum serum concentration (Cmax) achieved were 28 mg/L, 46 mg/L and 90 mg/L, respectively, when administrated single dose of 28 mg/L, 46 mg/L and 90 mg/L by intravenous drip. The serum concentration will reduce to around 50% within 1 hour after administration. The mean half-life for elimination (t_1/2β) is 3~5 hours. Fosfomycin distributes abroad in vivo. The concentration in kidney is highest, secondly high in heart, lung and liver etc. Fosfomycin also can distribute to chest, abdominal cavity, bronchia secretion and aqueous humor. It can pass through the placental barrier and blood-cerebrospinal fluid barrier. Fosfomycin is mainly excreted in kidney, and 90% will be excreted from urine within 24 hours after intramuscular or intravenous administration. Also with the feces and latex excretion.

 

【Pharmacology】

 

Fosfomycin Sodium is a broad-spectrum antibiotic. It has antibacterial action on Staphylococcus aureus, Staphylococcus epidermidis and Gram-positive Enterococcus faecium. Fosfomycin Sodium also has a strong antibacterial activity for Escherichia coli, Serratia marcescens, Shigella SPP, Yersinia and Pseudomonas aeruginosa bacteria, Klebsiella pneumoniae, Enterobacter, Vibrio SP and Aeromonas gram-negative bacteria. Fosfomycin Sodium works by disabling affected cells from generating the cell membrane. It inhibits bacterial cell wall biogenesis by inactivating the enzyme known as MurA.

 

【Usage and Dosage】

 

Intravenous drip. Solving in quantum of sterile water for injection, and diluted in 250 to 500 ml of 5% glucose injection or sodium chloride injection for intravenous drip.

Adults: 4 to 12 g per day divided into 2-3 times by intravenous drip, and the dose should be raised to 16g per day for severe infection.

 Children: 0.1 to 0.3 g/kg, divided into 2-3 times by intravenous drip.

 Slow drip speed is recommended, time for i.v. drip once should be more than 1~2 hours.

 

【Adverse reactions】

 

1. The most frequently reported adverse events were mild gastrointestinal reaction, such as nausea, cholestatic, ill epigastrium, watery feces or mild diarrhea. Generally it will not affect medication.

 

2. Rarely it behaves tetter, EOS increase, transient reduce of peripheral erythrocyte and haematoblast, leucocyte decrease, transient rise of serum transaminase, swirl and headache etc.

 

3. Occasionally phlebitis when i.v. drip at large dose or drip quickly.

 

4. Really seldom shock.

 

Keep the doctor informed to the adverse reactions which occur during the use of Fomsina.

 

【Contraindications】

 

Fomsina is contraindicated in patients with known hypersensitivity to the drug.

 

【Precautions】

 

1. The patients with hypohepatia and renal insufficiency should take it cautiously.

 

2. It should be administrated combined with other antibiotics such as β-lactam or aminoglycoside for the treatment of severe infection, and larger dose is also needed.

 

3. Combined use is recommended for treating the infection of staphylococcus aureus.

 

4. Liver function should be monitored as large dose be taken.

 

5. It has inhibition effect on haematoblast agglutination mediated by ADP in vitro. The effect will be more significant at large dose, but no report in clinical application.

 

【Pregnant women and lactating women】

 

1. The pregnant women or probably pregnant women should take it cautiously or consult your doctor for information

 

2.As it can be excreted through latex, women in lactation should take it cautiously.

 

【Children】

 

The newborn and infant with low weight should be administrated cautiously, for lack of correlative data to evaluate safety for children.

 

【Elder】

 

As the physiological function of the old patients has reduced, they are easier to appear adverse reaction. Take care of the dose for the old patient who is restricted to ingest sodium for the diseases of hypohepatia and renal insufficiency, high pressure etc.

 

【Drug interactions】

 

 1. It has synergistic action for SA (including SA drug-fast to methicillin sodium) and pseudomonas aeruginosa, when combined with β-lactam antibiotics.

 

 2. It has synergistic action combined with aminoglycoside.

 

 3. Its antibacterial activity in vitro easy to be weakened affected by glucose or (and) phosphate in substrate. Its activity will be strengthened by adding glucose-6-phosphate.

 

【Overdose】

 

Still not confirm.

 

【Strength】

 

1.0 g; 2.0 g; 4.0 g

 

【Storage】

 

Keep in well-closed container, protect from light, stored in cool and dry place, not exceeding 20 ℃.

 

【Package】

 

1 g×10 vials/box; 2 g x 10 vials/box; 4 g x 2 vials/box.

 

【shelf life】

 

24 Months

 

 

Features

 

1.    High efficiency, no drug resistance and cross resistance

 

2.    High safety, no need for hypersensitive test

 

3.    Stable antibacterial activity, keeping antibacterial activity for 30 years

 

 

Advantages

 

1.    Supply-chain advantage. As the leading manufacturer of raw material of Fosfomycin Sodium , Northeast Pharm can guarantee stable supply and sales flexibility.

 

2.    An all-around support service provided by our professional marketing team.

 

3.    Complete dossiers available.