Atlantic Lab


Atlantic Pharma


Atlantic Pharma
Full Prescribing Info
Fosfomycin trometamol 5.631 g (equiv to fosfomycin 3 g).
Each sachet contains Fosfomycin Trometamol 5.631 g equivalent to Fosfomycin 3 g.
Pharmacology: Pharmacodynamics: As a phosphonic acid derivative, fosfomycin inhibits bacterial wall synthesis (bactericidal) by inactivating the enzyme, pyruvyl transferase, which is critical in the synthesis of cell walls by bacteria; the trometamol salt is preferable to the calcium salt due to its superior absorption.
It is active in vitro against a range of gram-positive and gram-negative bacteria including Staphylococcus aureus, some streptococci, most Enterobacteriaceae, Haemophilus influenzae, Neisseria spp., and some strains of Pseudomonas aeruginosa although some are resistant. Bacteroides spp. are not sensitive.
Phamacokinetics: Absorption: Well absorbed.
Bioavailability: 34% to 58%.
Distribution: Vd: 2 L/kg; high concentrations in urine; well into other tissues; crosses maximally into CSF with inflamed meninges.
Protein binding: <3%.
Half-life elimination: 4-8 hours; Clcr <10 mL/minute: 50 hours.
Time to peak, serum 2 hours.
Excretion: Urine (as unchanged drug); high urinary levels (100 mcg/mL) persist for >48 hours.
Single oral dose in the treatment of acute uncomplicated urinary tract infections in women due to susceptible strains of Escherichia coli.
Dosage/Direction for Use
Recommended Dose: Oral, single dose of 3 g in 120 ml of water.
Dosing adjustment in hepatic impairment: No dosage decrease needed.
Dosing adjustment in renal impairment: Dosage adjustment not necessary.
Mode of Administration: Always mix with water before ingesting; do not administer in its dry form; pour contents of envelope into 90-120 ml of water (not hot), stir to dissolve and take immediately. Fosfomet can be taken with or without food.
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. Symptomatic and supportive treatment is recommended in the event of an overdose.
Known hypersensitivity to fosfomycin or any ingredient in the formulation.
Special Precautions
Retreatment: Do not use more than a single dose to treat a single episode of acute cystitis; repeated daily doses do not enhance efficacy and increase incidence of adverse events.
Selection and use of anti-infectives: Obtain urine specimens for culture and in vitro susceptibility testing before and after completion of therapy.
To reduce development of drug-resistant bacteria and maintain and maintain effectiveness of fosfomycin and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.
Use In Pregnancy & Lactation
Pregnancy: Category B.
Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Lactation: Enters breastmilk, not recommended.
Adverse Reactions
Gastrointestinal disturbances including nausea and diarrhea, transient increases in serum concentrations of aminotransferases, headache, visual disturbances, and skin rashes have been reported after use of fosfomycin. Eosinophilia and, rarely, angioedema, aplastic anemia, exacerbation of asthma, cholestatic jaundice, hepatic necrosis, and toxic megacolon, have also occurred.
Store below 30°C.
MIMS Class
ATC Classification
J01XX01 - fosfomycin ; Belongs to the class of other antibacterials. Used in the systemic treatment of infections.
Powd for oral liqd (sachet) 3 g (white to off-white granules) x 1's.
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