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 ?
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.
During the quarter, we began stocking Monurol, our unique single dose antibiotic for treating urinary tract infection, in anticipation of its launch in the current fiscal quarter.
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.
With MONUROL, women take the medication once, which should
infections, MONUROL comes in an educational, "user-friendly"
A single oral dose of Monurol sustains a urinary concentration of
Monurol was extremely well-tolerated in the clinical trials;
Monurol is Forest's single dose antibiotic for the treatment of uncomplicated urinary tract infection.
Forest remains sanguine about the ability of Monurol to obtain marketing approval in the U.
The Advisory Committee's recommendation is non binding and the FDA Center for Drug Evaluation and Research still needs to complete its ongoing review of the Monurol NDA.
Monurol is a unique broad spectrum antibiotic for the treatment of uncomplicated urinary tract infection.