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USP DI Vol. II - FLAVOXATE (Systemic)

FLAVOXATE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Urispas

In Canada?

  • Urispas

Category

  • Antispasmodic, urinary tract

Description

Flavoxate (fla-VOX-ate) belongs to the group ofmedicines called antispasmodics. It is taken by mouth to help decrease musclespasms of the bladder and relieve difficult urination.

Flavoxate is available only with your doctor's prescription, in the followingdosage form:

    Oral
  • Tablets (U.S. and Canada)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to flavoxate. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Flavoxate has not been studied in pregnant women.However, flavoxate has not been shown to cause birth defects or other problemsin animal studies.

Breast-feeding?It is not known whether flavoxate passes into breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast-feeding. Mothers who are taking thismedicine and who wish to breast-feed should discuss this with their doctor.

Children?Studies on this medicine have been done only in adultpatients and in children over 12 years of age. Flavoxate is not recommendedfor children younger than 12 years of age because safety and efficacy havenot been established.

Older adults?Confusion may be especially likely to occur in elderlypatients, who are usually more sensitive than younger adults to the effectsof flavoxate.

Other medicines?Although certain medicines should not be usedtogether at all in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of flavoxate. Make sure you tell your doctor ifyou have any other medical problems, especially:

  • Bleeding (severe) or
  • Glaucoma or
  • Intestinal blockage or other intestinal or stomach problems or
  • Urinary tract blockage?Use of flavoxate may make these conditionsworse
  • Enlarged prostate?Use of flavoxate may cause difficult urination

Proper Use of This Medicine

This medicineis usually taken with water on an empty stomach. However, your doctor maywant you to take it with food or milk to lessen stomach upset.

Take this medicine only as directed. Do nottake more of it, do not take it more often, and do not take it for a longertime than your doctor ordered. To do so may increase the chance of side effects.

Dosing?The dose of flavoxate will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage dose of flavoxate. If your dose is different,do not change it unless your doctor tells you to do so. The numberof tablets that you take depends on the strength of the medicine.

  • Adults and children 12 years of age and older: 100 to 200 milligramsthree or four times a day.
  • Children up to 12 years of age: Use and dose must be determined bythe doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Thismedicine may cause your eyes to become more sensitive to light than they arenormally. Wearing sunglasses may help lessen the discomfort from bright light.

This medicine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine beforeyou drive, use machines, or do anything else that could be dangerous if youare not alert or able to see well.

Flavoxate may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exerciseor hot weather while you are taking this medicine, since overheatingmay result in heat stroke. Also, hot baths or saunas may make you feel dizzyor faint while you are taking this medicine.

Your mouth and throat may feel very dry while you are taking this medicine.For temporary relief of mouth dryness, use sugarless candy or gum, melt bitsof ice in your mouth, or use a saliva substitute. However, if your mouth continuesto feel dry for more than 2 weeks, check with your medical doctor or dentist.Continuing dryness of the mouth may increase the chance of dental disease,including tooth decay, gum disease, and fungus infections.


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 mayneed medical attention.

Check with your doctor as soon as possibleif any of the following side effects occur:

    Rare

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

    Symptoms of overdose

      Clumsiness or unsteadiness; dizziness(severe); drowsiness (severe); fever; flushing or redness of face; hallucinations (seeing, hearing, or feeling things that are notthere); shortness of breath or troubled breathing; unusual excitement, nervousness, restlessness,or irritability

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

    More common

      Drowsiness; dryness of mouth and throat

    Less common or rare

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

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Revised: 02/23/2000