FLAVOXATE HYDROCHLORIDE

INDICATIONS AND USAGE Flavoxate HCl 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 HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

ADVERSE REACTIONS 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.

CONTRAINDICATIONS Flavoxate HCl tablets are 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.

DESCRIPTION Flavoxate HCl 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 C 24 H 25 NO 4 •HCl. The molecular weight is 427.94. The structural formula appears below: Flavoxate HCl is supplied in tablets for oral administration. Each round, white, film-coated Flavoxate HCl tablet is debossed "PAD" and "0115" on one side and plain on the other side and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of colloidal silicon dioxide, ethyl acrylate, hypromellose, lactose monohydrate, magnesium stearate, methyl methacrylate, microcrystalline cellulose, nonoxynol 100 and sodium starch glycolate. Film coating is composed of hypromellose 2910 6cP and polyethylene glycol. Chemical Structure

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.

WARNINGS Flavoxate HCl should be given cautiously in patients with suspected glaucoma.

OVERDOSAGE The oral LD 50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD 50 for flavoxate HCl in mice is 1837 mg/kg. It is not known whether flavoxate HCl is dialyzable.

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 HCl was excreted in the urine within 24 hours.

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FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE FLAVOXATE SILICON DIOXIDE ETHYL ACRYLATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHYL METHACRYLATE MICROCRYSTALLINE CELLULOSE NONOXYNOL-100 SODIUM STARCH GLYCOLATE TYPE A POTATO HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL, UNSPECIFIED PAD;0115

Carcinogenesis, Mutagenesis, Impairment of Fertility: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate HCl have not been performed.

ANDA076831

FLAVOXATE HYDROCHLORIDE

FLAVOXATE HYDROCHLORIDE

0574-0115

HUMAN PRESCRIPTION DRUG

ORAL

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle NDC 0574- 0115 -01 Rx Only Flavoxate HCl Tablets 100 mg 100 Tablets The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. label serialization-template.jpg

PRESCRIBING INFORMATION

Information for Patients: 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.

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 HCl is administered to a nursing woman.

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

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.

HOW SUPPLIED Flavoxate HCl Tablets, 100 mg, are supplied as round, white, film-coated tablets debossed "PAD" and "0115" on one side and plain on the other side, in bottles of 100. 100 mg 100's: NDC 0574- 0115 -01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Manufactured For Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 05-23 7H700 RC PH3 Code 917A00

PRECAUTIONS Information for Patients: 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of 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 flavoxate HCl is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.