Monurol

1-10%

Anorexia

Diarrhea

Epigastric

Discomfort

Headache

Nausea

Rash

Vomiting

<1%

Dizziness

Drowsiness

Fatigue

Pruritus

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MONUROL, 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.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. 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.

• Urinary Tract Infections in Children

Since fosfomycin is used as a single dose, it does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Since fosfomycin is used as a single dose, an overdose is unlikely to occur.

Other drugs may interact with fosfomycin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Antibacterial; phosphonic acid derivative.1

Administration

Oral Administration

Administer orally.1

May be taken with or without food.1

Prepare oral solution by adding contents of a single-dose packet (sachet) containing 3 g of the drug to 90–120 mL of water;1 do not use hot water.1 Ingest immediately after preparation.1

Do not administer as dry granules.1

Dosage

Available as fosfomycin tromethamine; dosage expressed in terms of fosfomycin.1

Adults

3 g as a single dose.1

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.1

Renal Impairment

Dosage adjustment not necessary.6 (See Pharmacokinetics.)

Geriatric Patients

Dosage adjustment not necessary.1 (See Geriatric Use under Cautions.)

Absorption

Bioavailability

Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin.1 Peak serum concentrations attained within 2–4 hours.1

Food decreases oral bioavailability;1 bioavailability is 37% and 30% under fasting and fed conditions, respectively.1

Cumulative amount of drug excreted in urine is similar whether the drug is given with or without food.1

Distribution

Extent

Distributed to kidneys, bladder wall, prostate, and seminal vesicles.1

Crosses the placenta.1

Plasma Protein Binding

Not bound to plasma proteins.1

Elimination

Elimination Route

Eliminated unchanged in urine (38% of an oral dose) and feces (18% of an oral dose).1

Peak urine concentrations achieved within 2–4 hours or 6–8 hours under fasting or fed conditions, respectively; cumulative amount excreted in urine is similar.1

Half-life

5.7 hours.1

Special Populations

Geriatric adults: Pharmacokinetics similar to that reported in younger adults.1

Renal impairment: Decreased elimination and prolonged half-life.1 Half-life ranges up to 50 hours in patients with renal impairment.1

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so, may increase chance for side effects.

Only one dose of this medicine is needed to treat your UTI. The medicine will continue to fight the infection.

You may take this medicine with or without food.

The medicine is an orange-flavored powder that must be mixed with water before using. Never swallow the medicine in its dry form.

To use:

• Open the packet and pour all of the powder into 3 or 4 ounces (1/2 cup) of water. Do not use hot water.
• Stir until the powder is dissolved, and drink the mixture right away.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your bladder working well and help prevent bladder problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder for solution):
  • For treatment of bladder infection:
    • Adults—3 grams (one packet) dissolved in water taken one time.
    • Teenagers 13 to 17 years of age—Dose must be determined by your doctor.
    • Children 12 years of age and below—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.