Flavoxate

What is Flavoxate?

• Flavoxate (Urispas) is a synthetic urinary tract spasmolytic, used for treatment of urinary incontinence and overactive bladder syndrome.

Flavoxate

What are the uses of this medicine?

• Flavoxate (Urispas) is used for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis.

Limitations of use:

• Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

How does this medicine work?

• Flavoxate (flay vox' ate) is a synthetic quaternary ammonium anticholinergic which inhibits the muscarinic actions of acetylcholine on autonomic nerve endings, decreasing the smooth muscle tone of bladder and gastrointestinal tract.
• Flavoxate has broad activity against muscarinic acetylcholine receptors, but its highly polar quaternary ammonium group makes it less likely to cross lipid membranes such as the blood brain barrier, which is believed to decrease the potential for central nervous system effects.
• Flavoxate increases bladder capacity and decreases urinary frequency and urgency.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Flavoxate was approved for use in the United States in 1970 and continues to be used to treat the symptoms of cystitis and overactive bladder syndrome. Flavoxate is available in tablets of 100 mg in several generic forms and previously under the brand name Urispas.

How should this medicine be used?

Recommended dosage:

In 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.

Administration:

• Flavoxate comes as a tablet.
• Flavoxate usually is taken three or four times a day.
• This drug may be taken with or without food.
• Take flavoxate exactly as directed.
• Do not take more or less of it or take it more often than prescribed by your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet for oral administration contains 100 mg flavoxate hydrochloride.

This medicine is available in fallowing brand namesː

• Urispas

What side effects can this medication cause?

The most common side effects of this medicine include:

• 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.

• Anticholinergic agents can precipitate acute narrow angle glaucoma and acute urinary retention.

What special precautions should I follow?

• Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
• 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.
• 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 flavoxate hydrochloride is administered to a nursing woman.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking flavoxate.
• Alcohol can add to the drowsiness caused by this drug.
• Flavoxate has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• It is not known whether flavoxate hydrochloride is dialyzable.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• 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.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

The active ingredient is flavoxate hydrochloride The inactive ingredients include:

• colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.

Who manufactures and distributes this medicine?

Distributed by:

• Epic Pharma, LLC
• Laurelton, NY

What should I know about storage and disposal of this medication?

• Store at 20° - 25°C (68° - 77°F).
• Dispense contents in a tight, light-resistant container.

Urologic agents

• Overactive bladder syndrome agents - darifenacin, fesoterodine, flavoxate, hyoscyamine, mirabegron, oxybutynin, solifenacin, tolterodine, trospium

• Dailymed label info on Flavoxate
• FDA Flavoxate

Flavoxate Resources
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