Flavoxate HCl Tablets 100 mg

PRESCRIBING INFORMATION

Flavoxate HCl tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 -1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C H NO •HCl. The molecular weight is 427.94. The structural formula appears below: H _{24 25 4}

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.

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.

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.

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.

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

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Nausea, vomiting, dry mouth. Gastrointestinal:

Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness. CNS:

Leukopenia (one case which was reversible upon discontinuation of the drug). Hematologic:

Tachycardia and palpitation. Cardiovascular:

Urticaria and other dermatoses, eosinophilia and hyperpyrexia. Allergic:

Increased ocular tension, blurred vision, disturbance in eye accommodation. Ophthalmic:

Dysuria. Renal:

The oral LD for flavoxate HCl in rats is 4273 mg/kg. The oral LD for flavoxate HCl in mice is 1837 mg/kg. _{50 50}

It is not known whether flavoxate HCl is dialyzable.

NDC:68151-3826-0 in a PACKAGE of 1 TABLET, FILM COATEDS

Manufactured For Perrigo® Minneapolis, MN 55427

Manufactured by: Mikart, INC. Atlanta, GA 30318

Code 917A00

7H700 RC J1

Rev 03-14 A