【Description】

 

Foneri (fosfomycin tromethamine) contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. The contents are white crystalline powder with taste sweet, and soluble in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl) phosphonic acid, compound with 2- amino-2-(hydroxymethyl)-1,3-propanediol (1:1). Its empirical formula is C₃H₇O₄P.C₄H₁₁NO₃ with a molecular weight of 259.2, and its chemical structure is as follows:

 

 

 

 

【Indications】

 

For the treatment of urinary tract infection caused by sensitive pathogenic bacteria, such as cystitis, urethritis.

 

【Pharmacokinetics】

 

Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. It has high concentration in liver and kidney, and distributes abroad in other viscera and tissue fluid. For a healthy person, the mean maximum serum concentration (Cmax) achieved was 35.6 mg/L within 2 hours after taking 50 mg/kg dose of Foneri. The mean half-life for elimination (t_1/2) is about 3.0 hours. Fosfomycin is mostly excreted through kidney as unchanged drug.

 

【Pharmacology and Toxicology】

 

Fosfomycin (the active component of fosfomycin tromethamine) has in vitro activity against a broad range of gram-positive and gram-negative aerobic microorganisms which are associated with uncomplicated urinary tract infections. Fosfomycin is bactericidal in urine at therapeutic doses. The bactericidal action of fosfomycin is due to its inactivation of the enzyme enolpyruvyl transferase, thereby irreversibly blocking the condensation of uridine diphosphate-N-acetylglucosamine with p-enolpyruvate, one of the first steps in bacterial cell wall synthesis. It also reduces adherence of bacteria to uroepithelial cells. There is generally no cross-resistance between fosfomycin and other classes of antibacterial agents such as beta-lactams and aminoglycosides.

 

【Usage and Dosage】

 

The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is 6 g/time (equivalent to 3 g fosfomycin). Foneri may be taken with or without food. Foneri should not be taken in its dry form. Always mix Foneri with water before ingesting.

 

【Strength】

 

6 g (equivalent to 3 g fosfomycin)

 

【Storage】

 

Seal and store in cool dry place.

 

【Package】

 

1 vial/box; 1 pouch/box

 

【Shelf life】

 

24 months

 

Features

 

1.    The first line drug for uncomplicated acute cystitis ^[1], recurring cystitis in women ^[2], asymptomatic bacteriuria during pregnancy ^[3].

 

2.    High efficiency, effective in a single dose. Improvement in the symptoms can be seen in 2-3 days after taking.

 

3.    Low recurrence rate, high safety, ranked B pregnancy drug by FDA.

 

4.    High bioavailability, urine drug concentration can last 48 h.

 

5.    Convenient, oral powder, good compliance.

 

 

 

Our Advantages

 

1.    High quantity standard. Northeast Pharm launched the product of Fosfomycin Trometamol Granule in Chinese market in 1993. Continuous efforts have been in the past 20 years for the improvement on technology and quality standard.

 

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

 

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

 

4.    Two options of package, bottle and sachet, better satisfy the market demands.

 

5.    Complete dossiers available.

 

 

Reference 

 

[1] Chinese diagnostic guidelines on urology disease, 2011, China.

 

[2] EAU guidelines: urological infections, 2011, Europe.

 

 [3] Guidelines for antimicrobial treatment of acute uncomplicated cystitis in women, 2010, America.

 

 

 

 

Epidemiology

More than 150 million patients in the world are suffered from UTIs every year.

 

 

In the United States, composite data revealed UTI diagnosis and treatment cost approximately $2.47 billion in 2000, excluding the expense of outpatient prescriptions, which were estimated at $218 million in 1995.

 

Causes of urinary tract infections and its treatment

Escherichia coli is the mainly pathogenic bacteria in UTIs.

UTIs are most commonly treated with antibiotics or antimicrobials. At present, the common medicines used in the treatment of UTI include Quinolones, Sulfanilamide, Cephalosporins and Fosfomycin. Quinolones are used extensively in the treatment and prevention of UTI. 

Sulfanilamides and Cephalosporins treating UIT have been rarely used in recent

Escherichiacoli:  Resistance to fluoroquinolones

The WHO global surveillance report highlights an increase in bacterial resistance to Fluoroquinolones used to treat UTIs

Increasing rates of resistance for TMP-SMX treatment regimen for acute uncomplicated cystitis. Increasing rates of resistance for E. coli against ciprofloxacin in South Korea.

FDA warning Restricting fluoroquinolone antibiotic use

Restricting fluoroquinolone antibiotic use for certain uncomplicated infections, such as UITs, because disabling and potentially permanent serious side effects that can occur together.

 

Why Choose Fosfomycin Trometamol?

Rapid Effect：For acute cystitis, after taking FT, one should see improvement in symptoms in 2 to 3 days

High Bioavailability：Urinary concentrations are high and may exceed 2000 mg/L after administration of a single dose (3 g). Urinary levels maintain effective concentration for 48h.

Low Side Effect：Fosfomycin is very well tolerated, only minor, self-limiting adverse effects were observed.

Fosfomycin Trometamol is ranked B pregnancy drug by FDA.

Low Recurrence Rate：The incidence of urinary tract infection was 0.14 infections/patient/year in the FT group and of 2.97 infections/patient/year in the placebo group.

Single Dose Therapy

Single dose daily, suitable for all kinds of people, provide benefits of economy and convenience.

 

Fosfomycin Trometamol gradually become the first-line drug for UTIs

There is a increase trend of drug resistance for Fluoroquinolones and Cephalosporin year after year. Fosfomycin keep stable antimicrobial activity over the years. Therefore, the guidelines suggested to add Fosfomycin Trometamol as the first line drug to treat Uncomplicated Acute Cystitis, and Fluoroquinolones and Cephalosporin degrade the second line drugs.