Composition

Each sachet contains: fosfomycin tromethamine 5.631g equivalent to 3g fosfomycin

DESCRIPTION

Fosfomycin Biomed sachet contains fosfomycin tromethamine, a synthetic, broad-spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin).

Microbiology

Fosfomycin 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

Pharmacokinetics

Absorption: Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3-gm dose of Fosfomycin biomed. The oral bioavailability of fosfomycin is reduced to 30% under fed conditions. Following a single 3-gm oral dose of fosfomycin biomed with a high-fat meal.

Distribution: Fosfomycin is not bound to plasma proteins, it is distributed to the kidneys, bladder wall, prostate, and seminal vesicles. Fosfomycin has been shown to cross the placental barrier Excretion: Fosfomycin is excreted unchanged in both urine and feces. Approximately 38% of a 3-gm dose of Fosfomycin biomed is recovered from urine, and 18% is recovered from feces, the mean half-life for elimination (t 1/2) is 5.7 (± 2.8) hours.

INDICATIONS AND USAGE

Fosfomycin Biomed  is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Aerobic gram-negative microorganisms (Escherichia coli) and Aerobic garm-positive microorganisms (Enterococcus faecalis). Fosfomycin biomed is not indicated for the treatment of pyelonephritis or perinephric abscess.

If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin, other therapeutic

agents should be selected

CONTRAINDICATIONS

Fosfomycin Biomed is contraindicated in patients with known hypersensitivity to fosfomycin or any of the other constituents.

WARNINGS

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin. and may range in severity from mild diarrhea to fatal colitis Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

• Do not use more than one single dose of Fosfomycin Biomed to treat a single episode of acute cystitis. Repeated  daily doses of Fosfomycin did not improve the clinical success or microbiological eradication rates compared to single dose therapy, but did increase the incidence of adverse events.
• Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy.

The symptoms should improve in two to three days after taking Fosfomycin biomed. if not improved, the patient should contact her health care provider.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

-  Metoclopramide: When coadministered with Fosfomycin Biomed, metoclopramide, (a drug which increases gastrointestinal motility), lowers the serum concentration and urinary excretion of fosfomycin.                             

- Cimetidine: Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with Fosfomycin biomed.

Pregnancy

Pregnancy Category B: There are, however, no adequate and well-controlled studies in pregnant women. this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether fosfomycin trometamine is excreted in human milk. a decision should be made whether to discontinue nursing or to not administer the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children age 12 years and under have not been established in adequate and well-controlled studies.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Insufficiency

The percent of fosfomycin recovered in urine decreased from 32% to 11% indicating that renal impairment significantly decreases the excretion of fosfomycin

ADVERSE REACTIONS

the most frequently adverse events occurring in > 1 % are: diarrhea, headache, vaginitis, nausea, rhinitis, back pain, dysmenorrhea, pharyngitis, dizziness, abdominal pain, dyspepsia, asthenia, and rash. at a rate of less than 1%,:abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder, fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy, menstrual disorder, migraine, myalgia, nervousness, pruritus, SGPT increased, skin disorder, somnolence, and vomiting.

Laboratory Changes

Significant laboratory changes occur include: increased eosinophil count, increased or decreased WBC count, increased bilirubin, increased SGPT, increased SGOT, increased alkaline phosphatase, decreased hematocrit, decreased hemoglobin, increased and decreased platelet count.

OVERDOSAGE

The following events have been observed in patients who have taken Fosfomycin in overdose: vestibular loss, impaired hearing, metallic taste, and general decline in taste perception. In the event of over dosage, treatment should be symptomatic and supportive.

DOSAGE AND ADMINISTRATION

The recommended dosage for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet of Fosfomycin Biomed. Fosfomycin Biomed should be taken orally. Pour the entire contents of a single-dose sachet of Fosfomycin Biomed into 1/2 cup of water and stir to dissolve, do not use hot water, it should be taken immediately after dissolving in water, and may be taken with or without food. It should not be taken in its dry form. always mix it with water before ingesting.

Presentation

Box contains single dose sachet containing the equivalent of 3 g fosfomycin

Storage

Store at 25°C