Monurol

fosfomycin

(foss-foe-mye-sin) ,

Monurol

(trade name)

Classification

Therapeutic: anti infectives
Pregnancy Category: B

Indications

Uncomplicated urinary tract infections in women (acute cystitis).

Action

Inactivates an enzyme crucial for bacterial cell wall synthesis.
Decreases adherence of bacteria to uroepithelial cells.

Therapeutic effects

Bactericidal action against susceptible bacteria.
Active against: Enterococcus faecalis and Escherichia coli.

Pharmacokinetics

Absorption: Rapidly absorbed and converted to fosfomycin, its active component, resulting in 37% bioavailability.
Distribution: Distributes to kidneys and bladder wall; crosses the placenta.
Metabolism and Excretion: Excreted unchanged in urine (38%) and feces (18%).
Half-life: 5.7 hr.

Time/action profile (bactericidal urine levels†)

ROUTEONSETPEAKDURATION
POrapid2–4 hrunknown
†Symptoms may take 24–48 hr to subside

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Pyelonephritis; Lactation: Lactation.
Use Cautiously in: Obstetric / Pediatric: Pregnancy or children <12 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache
  • weakness

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea
  • dyspepsia
  • nausea

Genitourinary

  • vaginitis

Interactions

Drug-Drug interaction

Urinary excretion and blood levels are decreased by metoclopramide.

Route/Dosage

Oral (Adults and Children ≥18 yr) 3 g single dose.

Availability

Sachet: 3 g

Nursing implications

Nursing assessment

  • Assess patient for signs and symptoms of cystitis (frequency, urgency, painful urination).
  • Obtain urine specimen for culture and sensitivity before administration.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.

Potential Nursing Diagnoses

Risk for infection (Indications)
Acute pain (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Oral: Do not take medication in dry form. Pour entire contents of single sachet into 3–4 oz (½ cup) water and stir to dissolve. Do not use hot water. Drink immediately after mixing. May be administered with or without food.

Patient/Family Teaching

  • Instruct patient on correct preparation of sachet.
  • Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
  • Advise patient to notify health care professional if symptoms have not improved or persist more than 2–3 days after treatment.

Evaluation/Desired Outcomes

  • Improvement in symptoms of acute cystitis within 2–3 days.

Monurol

® Fosfomycin tromethamine Infectious disease A single dose antibiotic for treating uncomplicated UTIs. See Urinary tract infection.
References in periodicals archive ?
Mayne Pharma Group Limited is pleased to announce it has received TGA approval for Monurol (fosfomycin trometamol) (3g) granules and has recently launched Urorec (silodosin) (8mg) capsules in Australia.
Monurol is an antibiotic for the treatment of urinary tract infections which is estimated to impact one in two women over their lifetime with 13% of adult women estimated to be diagnosed each year3 .
During the symposium, a breakthrough prescription drug called Monurol (generic name is Fosfomycin trometamol) was introduced.
Its important products are Celexa (depression), Aerobid (asthma), Lorcet (pain), Tiazac (hypertension), Monurol (urinary tract infection) and generic drugs using controlled-release technology.
Under the agreement with Forest, Snyder Healthcare Sales will provide national sales detailing and field management for multiple Forest drugs, including Aerobid, an inhaled steroid for the treatment of asthma; Tiazac, a cardiovascular drug; and Monurol, an antibiotic.
In the prescription arena Monurol from Forest Laboratories has been cleared by the Food and Drug Administration as what a spokeswoman calls the first onetime, one-dose antibiotic for uncomplicated UTI.
As a drug that is taken one time and one time only, Monurol is the most convenient antibiotic for uncomplicated urinary tract infection and should have an extremely high rate of compliance among its users," notes Forest Laboratories medical director Harvey Schneier.
A single oral dose of Monurol provides a urinary concentration of the active ingredient that remains effective for more than three and a half days, well over the minimum necessary to destroy the most common urinary tract disease-causing bacteria, escherichia coli, the spokeswoman says.
An orange-flavor, water-soluble powder, Monurol starts destroying the harmful bacteria in the bladder in two to four hours, she notes.
Monurol is the first one-time, one-dose antibiotic for uncomplicated urinary tract infection, as well as the first product of a new class of antibiotics.
The approval of Monurol represents a unique option for the treatment of uncomplicated urinary tract infection, and the first new treatment for cystitis in nearly three years.
Available in Europe since 1988, Monurol has been used to treat more than 11 million uncomplicated urinary tract infections in Germany, Italy, France, Spain and other countries.