Urispas (flavoxate HCl) 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 C₂₄H₂₅NO₄HCl.The molecular weight is 427.94, with the following structure:

Urispas is supplied in tablets for oral administration. Each round, white, film-coated Urispas tablet is debossed URISPAS SKF and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, castor oil, cellulose acetate phthalate, magnesium stearate, polyethylene glycol, starch and talc.

Urispas (flavoxate HCl) 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.

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.

Urispas (flavoxate HCl), 100 mg, is supplied as round, white, film-coated tablets debossed with the product name URISPAS and SKF, in bottles of 100 and in Single Unit Packages of 100 (intended for institutional use only).

100 mg 100's: NDC 0007-5290-20
100 mg SUP 100's: NDC 0007-5290-21

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

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.

No information provided.

Urispas (flavoxate HCl) should be given cautiously in patients with suspected glaucoma.

Information for Patients

See PATIENT INFORMATION section.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Urispas (flavoxate HCl) 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 HCl. 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.

The oral LD₅₀ for flavoxate HCl in rats is 4273 mg/kg. The oral LD₅₀ for flavoxate HCl in mice is 1837 mg/kg.

It is not known whether flavoxate HCI is dialyzable.

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.

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 HCl was excreted in the urine within 24 hours.

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.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

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.

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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking flavoxate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

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 and cause blurred vision. Use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. 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.

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 August 2008 Copyright(c) 2008 First DataBank, Inc.