Flavoxate Hydrochloride 100 MG Oral Tablet
WARNINGS
Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
OVERDOSAGE
The oral LD 50 for flavoxate hydrochloride in rats is 4273 mg/kg.
The oral LD 50 for flavoxate hydrochloride in mice is 1837 mg/kg.
It is not known whether flavoxate hydrochloride is dialyzable.
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 C 24 H 25 NO 4 •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, hypromellose, polydextrose, magnesium stearate, titanium dioxide and triacetin.
Chemical Structure – Flavoxate
HOW SUPPLIED
Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ Є 58 ” on one side and plain on the other side, and are available in bottles of 100 (NDC 60429-290-01) .
Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature].
Dispense contents in a tight, light-resistant container.
Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Marketed/Packaged by: GSMS Inc.
Camarillo, CA 93012 Made in USA Issued 01/11 MF058IS01/11 OE1140
INDICATIONS AND USAGE
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.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in children below the age of 12 years have not been established.
PREGNANCY
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.
NUSRING MOTHERS
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.
INFORMATION FOR PATIENTS
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.
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.