Flavoxate HCl (Urispas)
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Flavoxate HCl (Urispas)

URISPAS
(flavoxate hydrochloride) Tablet, Film Coated

DRUG DESCRIPTION

URISPAS® (flavoxate HC1) tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C24H25NO4• HCl. The molecular weight is 427.94. The structural formula appears below.

URISPAS (flavoxate hydrochloride) Structural Formula Illustration

URISPAS® is supplied in tablets for oral administration. Each round, white, film-coated URISPAS® tablet is debossed with the product name URISPAS® and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, hypromellose, magnesium stearate, polyethylene glycol, starch and talc.

What are the possible side effects of flavoxate (Urispas)?

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.

Stop using flavoxate and call your doctor at once if you have any of these serious side effects:

  • hot, dry skin and extreme thirst;
  • confusion;
  • pounding heartbeats, fluttering in your chest; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth;
  • blurred vision;
  • nausea, vomiting;
  • drowsiness,...

Read All Potential Side Effects and See Pictures of Urispas »

What are the precautions when taking flavoxate hcl (Urispas)?

Before taking flavoxate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: stomach/intestinal blockage (e.g., pyloric/duodenal obstruction, ileus), bleeding from the stomach or intestines, bladder blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., fast/irregular heartbeat, heart failure), a certain eye condition (glaucoma), kidney problems, a certain muscle disease...

Read All Potential Precautions of Urispas »

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

URISPAS® (flavoxate HC1) is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. URISPAS® is not indicated for definitive treatment, but is compatible with drugs used for the treatment of urinary tract infections.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

URISPAS® (flavoxate HC1), 100 mg, is supplied as round, white, film-coated tablets, debossed with the product name URISPAS® in bottles of 100.

100 mg 100's: NDC 17314-9220-1

Store between 15° and 30°C (59° and 86°F).

Manufactured by Cardinal Health, Winchester, Kentucky 40391. Distributed by Ortho-Mcneil Pharmaceutical, Inc. Raritan, New Jersey 08869

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

Read the Urispas (flavoxate hcl) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

URISPAS® (flavoxate HC1) should be given cautiously in patients with suspected glaucoma.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of URISPAS® (flavoxate HC1) have not been performed.

Pregnancy

Teratogenic Effects-Pregnancy Category B.

Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HC1. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when URISPAS® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 years have not been established.

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The oral LD50 for flavoxate HC1 in rats is 4273 mg/kg. The oral LD50 for flavoxate HC1 in mice is 1837 mg/kg. It is not known whether flavoxate HC1 is dialyzable.

CONTRAINDICATIONS

URISPAS® (flavoxate HC1) 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.

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes.

57% of the flavoxate HC1 was excreted in the urine within 24 hours.

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Urispas Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FLAVOXATE - ORAL

(flay-VOX-ate)

COMMON BRAND NAME(S): Urispas

USES: This medication is used to treat certain bladder/urinary tract symptoms. Flavoxate is a smooth-muscle relaxant. It works by relaxing the muscles in the bladder. Flavoxate helps to reduce leaking of urine, feelings of needing to urinate right away, frequent trips to the bathroom, and bladder pain. This medication does not treat the cause of your bladder symptoms (e.g., urinary tract/bladder/prostate infection or inflammation).

HOW TO USE: Take this medication by mouth, usually 3-4 times a day or as directed by your doctor. Take with food if stomach upset occurs.

The dosage is based on your medical condition and response to therapy. Your doctor may lower your dose after your symptoms have improved. The length of treatment depends on the cause of the problem.

Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of side effects may be increased.

Tell your doctor if your condition persists or worsens.

Disclaimer

Urispas Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, dry mouth, headache, drowsiness, dizziness, blurred vision, and nervousness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (e.g., stimulant-type with stool softener).

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: mental/mood changes (e.g., confusion), eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain, fast/pounding heartbeat, signs of infection (e.g., fever, persistent sore throat), stomach/intestinal blockage (e.g., persistent nausea/vomiting, long-lasting constipation), difficult/painful 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, 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.

Read the Urispas (flavoxate hcl) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking flavoxate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: stomach/intestinal blockage (e.g., pyloric/duodenal obstruction, ileus), bleeding from the stomach or intestines, bladder blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., fast/irregular heartbeat, heart failure), a certain eye condition (glaucoma), kidney problems, a certain muscle disease (myasthenia gravis), enlarged prostate gland, stomach/intestinal problems (e.g., infection, acid-reflux disease, chronic constipation, ulcerative colitis), overactive thyroid (hyperthyroidism).

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

This medication can cause decreased sweating. To reduce the risk of a serious reaction to too much heat (heatstroke), avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially confusion.

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

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Urispas Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because a very serious interaction may occur: pramlintide.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting flavoxate.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic drugs (e.g., atropine, belladonna alkaloids, scopolamine, benztropine, trihexyphenidyl), antispasmodic drugs (e.g., clidinium, dicyclomine), bisphosphonate drugs (e.g., alendronate, etidronate, risedronate), potassium tablets/capsules.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, hallucination, seizures, loss of consciousness.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

This medication may relieve the symptoms of a bladder infection, urinary tract infection (UTI), or prostate infection. However, it does not treat an infection. An antibiotic may be needed if you have an infection.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Urispas Patient Information Including Side Effects

Brand Names: Urispas

Generic Name: flavoxate (Pronunciation: flah VOX ate)

What is flavoxate (Urispas)?

Flavoxate reduces muscle spasms of the bladder and urinary tract.

Flavoxate is used to treat bladder symptoms such as frequent or urgent urination, increased night-time urination, bladder pain, and incontinence (urine leakage). These bladder symptoms are often caused by overactive bladder, prostate enlargement, bladder infections, or irritation of the urethra.

Flavoxate will not treat a bacterial or fungal bladder infection. Infections must be treated with an antibiotic.

Flavoxate may also be used for other purposes not listed in this medication guide.

Flavoxate 100 mg-GLO

round, white, imprinted with G, 181

Urispas 100 mg

round, white, imprinted with URISPAS SKF

What are the possible side effects of flavoxate (Urispas)?

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.

Stop using flavoxate and call your doctor at once if you have any of these serious side effects:

  • hot, dry skin and extreme thirst;
  • confusion;
  • pounding heartbeats, fluttering in your chest; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth;
  • blurred vision;
  • nausea, vomiting;
  • drowsiness, nervousness;
  • spinning sensation;
  • headache; or
  • fever.

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 FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Urispas (flavoxate hcl) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about flavoxate (Urispas)?

You should not use this medication if you are allergic to flavoxate, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using flavoxate, tell your doctor if you have glaucoma or urinary problems.

Flavoxate can cause drowsiness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

There may be other medicines that can interact with flavoxate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, confusion, pounding heartbeats, fluttering in your chest, or if you stop urinating.

Side Effects Centers

Urispas Patient Information including How Should I Take

What should I discuss with my health care provider before taking flavoxate (Urispas)?

You should not use this medication if you are allergic to flavoxate, or have certain conditions. Be sure your doctor knows if you have:

  • a blockage in your stomach or intestines;
  • a history of stomach ulcer or bleeding; or
  • if you are unable to urinate.

Before using flavoxate, tell your doctor if you are allergic to any drugs, or if you have:

  • glaucoma; or
  • urinary problems.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take flavoxate.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether flavoxate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take flavoxate (Urispas)?

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

Take this medicine with water.

Store flavoxate at room temperature away from moisture, heat, and light.

Side Effects Centers

Urispas Patient Information including If I Miss a Dose

What happens if I miss a dose (Urispas)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Urispas)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a flavoxate overdose are not known.

What should I avoid while taking flavoxate (Urispas)?

Flavoxate can cause drowsiness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

What other drugs will affect flavoxate (Urispas)?

Tell your doctor if you are using any other bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare).

There may be other drugs that can interact with flavoxate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about flavoxate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.07. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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