WHAT ARE THE SIDE EFFECTS OF HIPREX® (methenamine hippurate tablets USP)?

Tell your doctor immediately if any of these serious side effects occur:

  • an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives
  • lower back or side pain
  • blood in urine
  • increasingly painful or difficult urination

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.

In addition, tell your doctor immediately if you have any of the following symptoms:

  • nausea
  • vomiting
  • diarrhea
  • abdominal cramps
  • loss of appetite

You may experience painful or difficult urination when you are taking Hiprex.  Report these side effects to your doctor, who may need to lower your dose of Hiprex or change your treatment to make your urine less acidic.

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.

Taking higher than recommended doses of Hiprex may cause bladder irritation, painful/frequent urination, and bloody/pink urine. Tell your doctor right away if you have any of these symptoms.

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Validus Pharmaceuticals LLC at 1-866-982-5438.

OVERDOSAGE:

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

IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

Hiprex® (methenamine hippurate tablets USP)

WHAT IS HIPREX USED FOR?

Hiprex® (methenamine hippurate tablets USP) are used to prevent or control recurring urinary tract infections caused by certain bacteria. Hiprex is not used to treat an active infection; Hiprex should only be used after the infection has been treated with other antibiotics.

WHEN SHOULD I NOT TAKE THE DRUG?

You should not take Hiprex if you are allergic to methenamine hippurate, formaldehyde, or any of the other ingredients in the drug, or if you are taking a sulfonamide drug.

You should not take Hiprex unless your doctor has confirmed that your infection is caused by bacteria that is susceptible to Hiprex. Hiprex is effective only against bacterial infections in the urinary tract. It will not work for other types of bacterial infections or for viral infections (such as the common cold or flu). Unnecessary use of Hiprex can lead to its decreased effectiveness and the development of antibiotic-resistant bacteria.

You should not take Hiprex if you have kidney failure, severe liver insufficiency, or you are severely dehydrated.

WHAT WARNINGS SHOULD I KNOW ABOUT HIPREX?

Large doses of Hiprex (8 pills/day for 3-4 weeks) can cause bladder irritation, painful and frequent urination, cause protein to leak into the urine, and cause blood in the urine.

You should also be aware that taking Hiprex before a bacterial infection has been confirmed increases the risk of developing drug resistant bacteria.

When taking Hiprex:

Hiprex should only be used to treat bacterial infections. Hiprex will not treat a viral infection (such as the common cold)

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

WHAT OTHER MEDICATIONS MIGHT INTERACT WITH HIPREX?

WHAT ARE THE SIDE EFFECTS OF HIPREX?

A very serious allergic reaction to this drug is rare. 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, or trouble breathing.

Most side effects have been mild and reported in < 3.5% of people taking Hiprex.

These minor side effects have included:

Large doses of Hiprex (8 pills daily for 3-4 weeks) have caused bladder irritation, painful and frequent urination, excess protein in the urine and blood in the urine. If you experience any of these side effects, contact your doctor immediately.

WHAT IF I OVERDOSE?

There is no specific treatment for suspected overdose.

Seek emergency help. Supportive measures should be taken.

Call the Poison Control Hotline (1-800-222-1222).

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch