Flavoxate

What is Urispas and how is it used?

Urispas is a prescription medicine used to treat the symptoms of Overactive Bladder. Urispas may be used alone or with other medications.

Urispas belongs to a class of drugs called Antispasmodic Agents, Urinary.

It is not known if Urispas is safe and effective in children younger than 12 years of age.

What are the possible side effects of Urispas?

Urispas may cause serious side effects including:

• hives,
• difficulty breathing,
• mood changes,
• confusion,
• eye pain, and
• swelling of your face, lips, tongue or throat

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Urispas include:

• nausea,
• vomiting,
• dry mouth,
• headache,
• dizziness,
• drowsiness,
• pounding heartbeats or fluttering in your chest,
• confusion,
• nervousness,
• itching, and
• rash

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Urispas. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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® 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?

• nausea,
• vomiting,
• dry mouth,
• spinning sensation (vertigo),
• headache,
• confusion, especially in the elderly,
• drowsiness,
• nervousness,
• low white blood cell count (leukopenia),
• fast heart rate, palpitations,
• hives and other skin conditions,
• eosinophilia,
• high fever,
• increased ocular tension,
• blurred vision,
• disturbance in visual focusing, and
• painful urination

DESCRIPTION

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.

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.

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

INDICATIONS

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.

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

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.

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.

DRUG INTERACTIONS

No information provided.

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.

DRUG INTERACTIONS

No Information provided

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.

WARNINGS

Flavoxate hydrochloride 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 flavoxate hydrochloride 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 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.

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 flavoxate hydrochloride is administered to a nursing woman.

Pediatric Use

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

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.

OVERDOSE

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.

CONTRAINDICATIONS

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.

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.

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 hydrochloride was excreted in the urine within 24 hours.

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.

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.