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URISPAS
(flavoxate hydrochloride) Tablet, Film Coated
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.
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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 is Flavoxate Hydrochloride and how is it used?
Flavoxate is used to treat bladder symptoms such as frequent urination, urgent urination, increased nighttime urination, bladder pain, and leakage of urine.
What are side effects of Flavoxate Hydrochloride?
Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.
Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H-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.
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Each tablet for oral administration contains 100 mg flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.
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.
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 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
Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
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.
Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ ∈58” on one side and plain on the other side, and are available as follows:
NDC 42806-058-01 Bottles of 100
NDC 42806-058-10 Bottles of 1000
Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container.
Distributed by: Epic Pharma, LLC, Laurelton, NY 11413. Revised: May 2018.
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.
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
Nausea, vomiting, dry mouth.
Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.
Leukopenia (one case which was reversible upon discontinuation of the drug).
Tachycardia and palpitation.
Urticaria and other dermatoses, eosinophilia and hyperpyrexia.
Increased ocular tension, blurred vision, disturbance in eye accommodation.
Dysuria.
No Information provided
URISPAS® (flavoxate HC1) should be given cautiously in patients with suspected glaucoma.
Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of URISPAS® (flavoxate HC1) have not been performed.
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.
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.
Safety and effectiveness in children below the age of 12 years have not been established.
Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate hydrochloride have not been performed.
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 hydrochloride. 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.
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.
Safety and effectiveness in children below the age of 12 years have not been established.
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.
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.
The oral LD50 for flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD50 for flavoxate hydrochloride in mice is 1837 mg/kg.
It is not known whether flavoxate hydrochloride is dialyzable.
Flavoxate hydrochloride 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 HC1 was excreted in the urine within 24 hours.
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 hydrochloride 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.
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.
