Urispas

Before taking flavoxate,

• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins.
• tell your doctor if you have or have ever had glaucoma, ulcers, paralytic ileus, or obstructive disease (blockage) of the stomach, kidneys, or intestines.
• tell your doctor and pharmacist if you are allergic to flavoxate or any other drugs.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking flavoxate, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking flavoxate.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

You should not use flavoxate if you are allergic to it, or if you have:

• blockage in your digestive tract (stomach or intestines);

• stomach or intestinal bleeding; or

• bladder obstruction or if you are unable to urinate.

To make sure flavoxate is safe for you, tell your doctor if you have:

• glaucoma; or

• urination problems.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether flavoxate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Flavoxate is not approved for use by anyone younger than 12 years old.

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Genitourinary antispasmodic.a b

Absorption

Bioavailability

Appears to be well absorbed from the GI tract. a

Onset

Following oral administration in healthy males, onset of action was 55 minutes.a

Duration

Following oral administration in healthy males, peak effect occurred at 112 minutes.a

Distribution

Extent

Not known whether flavoxate is distributed into milk.a

Elimination

Elimination Route

57% of an oral dose of flavoxate is excreted in urine within 24 hours.a b

Special Populations

Not known whether flavoxate is dialyzable.a

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Urispas® (flavoxate HCl) is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Adults and children over 12 years of age:

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

Applies to flavoxate: oral tablet

Along with its needed effects, flavoxate (the active ingredient contained in Urispas) 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 as soon as possible if any of the following side effects occur while taking flavoxate:

• Confusion
• eye pain
• skin rash or hives
• sore throat and fever

• Clumsiness or unsteadiness
• dizziness (severe)
• drowsiness (severe)
• fever
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• shortness of breath or troubled breathing
• unusual excitement, nervousness, restlessness, or irritability

Some side effects of flavoxate 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:

• Drowsiness
• dryness of mouth and throat

• Blurred vision
• constipation
• difficult urination
• difficulty concentrating
• dizziness
• fast heartbeat
• headache
• increased sensitivity of eyes to light
• increased sweating
• nausea or vomiting
• nervousness
• stomach pain