Monurol (Oral)

Fosfomycin is used to treat urinary tract infections and cystitis (bladder infections) in women. This medicine is an antibiotic. It works by killing bacteria or stopping them from growing. However, this medicine will not work for colds, flu, or other viral infections.

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

If your symptoms do not improve within 2 or 3 days or if they get worse, contact your doctor.

This medicine may cause diarrhea, which can sometimes be severe. It can happen 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 worsens, contact your doctor.

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

In deciding to use a medicine, you and your doctor will evaluate the risks and benefits. For this medicine, please consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on the effects of fosfomycin in children aged 12 years and below. Safety and effectiveness have not been established.

Geriatric

Studies to date have not shown any specific problems in older adults that would limit the use of fosfomycin in this age group. However, older adults are more likely to have age-related kidney, liver, or heart issues, which may require caution and a dose adjustment for patients taking fosfomycin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Cholera Vaccine, Live
• Methotrexate

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor about any other medical problems, especially:

• Diarrhea—Use with caution. This condition may worsen.

• Kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may need medical attention.

Check with your doctor right away 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. Your health care professional may also tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Monurol

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

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.

• How long do antibiotics take to work?
• What antibiotics are used to treat UTI?