Drug Facts
Composition & Profile
Identifiers & Packaging
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; PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle NDC 0574- 0115 -01 Rx Only Flavoxate HCl Tablets 100 mg 100 Tablets label
- 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
- PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle NDC 0574- 0115 -01 Rx Only Flavoxate HCl Tablets 100 mg 100 Tablets label
Overview
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
Indications & 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.
Dosage & 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 & Precautions
WARNINGS Flavoxate HCl should be given cautiously in patients with suspected glaucoma.
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.
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.
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