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Fosfomycin (Oral route)

Pronunciation:

fos-foe-MYE-sin troe-METH-a-meen

Brand Names:

  • Monurol

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Uses of This Medicine:

Fosfomycin is used to treat urinary tract infection and cystitis (bladder infection) in women. This medicine is an antibiotic. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fosfomycin in children 12 years of age and below. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fosfomycin in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving fosfomycin.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea—Use with caution. May make this condition worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

If your symptoms do not improve within 2 or 3 days or if they become worse, check with your doctor.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
Blood in the urine
burning while urinating
cough or hoarseness
difficult or painful urination
fever or chills
lower back or side pain
painful or difficult urination
Incidence not known
Abdominal or stomach pain or tenderness
black, tarry stools
bloating
chest pain
clay-colored stools
constipation
dark urine
diarrhea
difficulty with swallowing
dizziness
fast heartbeat
headache
hives
itching
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
nausea or vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rash
severe abdominal or stomach cramps and pain
shortness of breath
sores, ulcers, or white spots on the lips or in the mouth
swollen or painful glands
tightness in the chest
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood
watery and severe diarrhea, which may also be bloody
wheezing
worsening of asthma
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Itching of the vagina or genital area
pain during sexual intercourse
thick, white vaginal discharge with no odor or with a mild odor
Less common
Acid or sour stomach
back pain
belching
body aches or pain
congestion
dryness or soreness of the throat
heartburn
heavy bleeding
indigestion
lack or loss of strength
pain
painful menstruation
runny or stuffy nose
skin rash
sneezing
sore throat
stomach discomfort or upset
tender, swollen glands in the neck
trouble with swallowing
voice changes
weakness
Rare
Abnormal stools
absent missed or irregular menstrual periods
blindness
blue-yellow color blindness
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
decreased vision
difficulty with moving
dry mouth
excess air or gas in the stomach or intestines
eye pain
full feeling
headache, severe and throbbing
joint pain
loss of appetite
muscle aching or cramping
muscle pains or stiffness
nervousness
passing gas
sleepiness or unusual drowsiness
sleeplessness
stopping of menstrual bleeding
swollen joints
swollen, painful, or tender lymph glands in the neck, armpit, or groin
trouble sleeping
unable to sleep
weight loss
Incidence not known
Hearing loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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