Monurol

DRUG DESCRIPTION

MONUROL (fosfomycin tromethamine) sachet contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 213 amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows:

MONUROL (fosfomycin tromethamine) Structural Formula Illustration

What are the possible side effects of fosfomycin (Monurol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may be more likely to occur, such as:

  • diarrhea, nausea, stomach pain or upset;
  • headache;
  • dizziness;
  • weakness;
  • stuffy nose, sore throat;
  • menstrual pain;
  • back pain; or
  • vaginal itching or discharge.

Side effects other than those listed here may also...

Read All Potential Side Effects and See Pictures of Monurol

What are the precautions when taking fosfomycin (Monurol)?

Before taking fosfomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the artificial sweetener saccharin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

Do not use more than a single dose (1 packet or sachet) of this medication for each bladder infection. Using more packets will not make the drug work any better and may increase side effects.

If you develop symptoms of a kidney infection (such as pain in side/lower back area, fever, chills), contact your doctor immediately. You may need a different...

Read All Potential Precautions of Monurol


Monurol Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, stomach upset, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vaginal discomfort, stomach/abdominal pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, dark urine, yellowing of the eyes/skin, unusual weakness.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur weeks to months after treatment has stopped. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fosfomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the artificial sweetener saccharin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

Do not use more than a single dose (1 packet or sachet) of this medication for each bladder infection. Using more packets will not make the drug work any better and may increase side effects.

If you develop symptoms of a kidney infection (such as pain in side/lower back area, fever, chills), contact your doctor immediately. You may need a different antibiotic to treat a kidney infection if one develops.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Monurol Patient Information Including Side Effects

Brand Names: Monurol

Generic Name: fosfomycin (Pronunciation: fos foe MYE sin)

  • What is fosfomycin (Monurol)?
  • What are the possible side effects of fosfomycin (Monurol)?
  • What is the most important information I should know about fosfomycin (Monurol)?
  • What should I discuss with my health care provider before taking fosfomycin (Monurol)?
  • How should I take fosfomycin (Monurol)?
  • What happens if I miss a dose (Monurol)?
  • What happens if I overdose (Monurol)?
  • What should I avoid while taking fosfomycin (Monurol)?
  • What other drugs will affect fosfomycin (Monurol)?
  • Where can I get more information?

What is fosfomycin (Monurol)?

Fosfomycin is an antibiotic that fights infection caused by bacteria.

Fosfomycin is used to treat bladder infections.

Fosfomycin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of fosfomycin (Monurol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may be more likely to occur, such as:

  • diarrhea, nausea, stomach pain or upset;
  • headache;
  • dizziness;
  • weakness;
  • stuffy nose, sore throat;
  • menstrual pain;
  • back pain; or
  • vaginal itching or discharge.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fosfomycin (Monurol)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Fosfomycin is usually given in only one dose. Do not take more than a single dose of this medication unless your doctor has told you to.

The usual dose of this medicine is one packet of powder mixed with cold water. Do not use hot water or take the powder in its dry form.

To be sure fosfomycin is the right antibiotic for the type of infection you have, your urine will need to be tested before and after you take this medication. Do not miss any scheduled visits to your doctor.

It may take 2 or 3 days before your symptoms improve. Talk with your doctor if your symptoms do not improve within 3 days after treatment.

Get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Do not share this medicine with anyone else, even if they have the same symptoms you have.

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