Monurol (Fosfomycin) is a broad-spectrum antibiotic (a phosphonic acid derivative) that is used in patients with uncomplicated bladder infections (cystitis).

Fosfomycin Uses:

• Acute uncomplicated Cystitis:

  • It is used to treat acute uncomplicated urinary tract (bladder) infections in women caused by susceptible strains of Escherichia coli and Enterococcus faecalis.

• Limitations of use:

  • In patients with pyelonephritis or perinephric abscess, fosfomycin should not be used.
  • Patients who have persistent bacteriuria or a recurrence of the infection following the treatment with fosfomycin, other agents should be used.

• Off Label Use of Fosfomycin in Adults:

  • Complicated Cystitis (Urinary tract infections) in men.

Fosfomycin Dose in Adults

Fosfomycin Dose in the treatment of acute Uncomplicated Cystitis:

• Females:

  • Oral 3 g as a single dose.

Note:

• Although it has been included as a first-line agent in the treatment of acute uncomplicated cystitis, it has a reduced efficacy when compared to other drugs.

Fosfomycin Dose in the treatment of Complicated UTI (off-label):

• Males:

  • Oral 3 gms every 2 to 3 days for a total of 3 doses.

Fosfomycin Dose in the treatment of Prostatitis (off-label):

• Males:

  • Oral 3 gms every 3 days for a total of 21 days.

Fosfomycin Dose in Children:

Not recommended for use in children.

Pregnancy Risk Category: B

• Fosfomycin crosses the placental barrier.
• A single dose of the drug has not been tested in pregnant women, but a three to five-day regimen is recommended.

Fosfomycin use during breastfeeding:

• Fosfomycin can be found in breastmilk.
• Because of possible adverse effects on the infant's development, the manufacturer suggests that you weigh the risks and benefits of treatment during pregnancy.
• In general, antibiotics in breastmilk can alter the bowel flora. Nursing infants should be closely monitored for GI-related adverse effects and oral thrush.

Monurol Dose in Kidney Disease:

The manufacturer has not recommended any adjustment in the dose in patients with kidney disease.

Monurol Dose in Liver disease:

The manufacturer has not recommended any adjustment in the dose in patients with liver disease.

Side Effects of Fosfomycin (Monurol):

• Central Nervous System:

  • Headache
  • Pain
  • Dizziness

• Dermatologic:

  • Skin Rash

• Gastrointestinal:

  • Diarrhea
  • Nausea
  • Abdominal Pain
  • Dyspepsia

• Genitourinary:

  • Vaginitis
  • Dysmenorrhea

• Neuromuscular & Skeletal:

  • Back Pain
  • Weakness

• Respiratory:

  • Rhinitis
  • Pharyngitis

Contraindications to Fosfomycin (Monurol):

Allergy reactions to fosfomycin and any component of this formulation

Warnings and precautions

• Superinfection

  • Long-term antibiotic use can lead to superinfections, including fungal or serious bacterial infections such as C. difficile-associated diarrhea (CDAD), and pseudomembranous collitis. 
  • Even after two months of post-antibiotic treatment, CDAD was still present.

Fosfomycin: Drug Interaction

Monitoring parameters:

• Monitor the clinical features of urinary tract infection.
• Follow urine culture and bacterial sensitivity

How to administer Fosfomycin (Monurol)?

• Before ingesting the drug, mix with 3 to 4 oz (90 to 120 mL) of cool water.
• Mixing the drug with hot water and administration in its dry form should be avoided.
• The medication can be taken without consideration to food.

Mechanism of action of Fosfomycin (Monurol):

It is a bactericidal drug that prevents the growth of bacterial cell walls by deactivating the enzyme pyruvyltransferase, which is essential for their development.

Absorption:

• It is rapidly absorbed

Protein binding:

• None

Bioavailability:

• Fasting: 37%;
• With food: 30%

Half-life elimination:

• 3 to 8 hours;
• CrCl <54 mL/minute: 50 hours;
• hemodialysis patients: 40 hours

Time to peak Serum concentration:

• 2 hours; within 4 hours with a high-fat meal

Excretion:

• Urine (38% as unchanged drug);
• feces (18% as unchanged drug)

International Brands of Fosfomycin:

• Monurol
• JAMP-Fosfomycin
• Efomycin
• Fasapren
• Focin
• Focyn
• Folsmycin
• Fomicyt
• Fosfocil
• Fosfocin
• Fosfocina
• Fosfocine
• Fosfomin
• Fosforal
• Fosforon
• Fosfurol
• Fosmicin
• Fosmicin-S
• Fosmicyn
• Fosmidex
• Fostren
• Fraxemicin-S Kit
• Fu An Xin
• Infectofos
• Monural
• Monuril
• Monurol
• Novellmycin
• Rapidnorm
• Solufos
• Sonomycin
• Ufo
• Uninex
• Uridoz
• Urifos
• Urinex
• Urizone
• Veramina
• Vnikon

Fosfomycin Brand Names in Pakistan: