FLAVOXATE HYDROCHLORIDE- flavoxate hydrochloride tablet, film coated
Impax Generics
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FLAVOXATE HYDROCHLORIDE TABLETS, 100 mg
DESCRIPTION
Flavoxate HCl 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.
Each tablet for oral administration contains 100 mg flavoxate hydrochloride. The tablet contains the following inactive ingredients: cellulose acetate phthalate aqueous dispersion, dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch. The film-coating material contains hypromellose and macrogol.
CLINICAL PHARMACOLOGY
Flavoxate HCl 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.
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 is compatible with drugs used for the treatment of urinary tract infections.
CONTRAINDICATIONS
Flavoxate HCl 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.
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.
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.
OVERDOSAGE
The oral LD50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD50 for flavoxate HCl in mice is 1837 mg/kg.
It is not known whether flavoxate HCl is dialyzable.
HOW SUPPLIED
Flavoxate Hydrochloride Tablets, 100 mg—Each off-white, film-coated, round, convex tablet debossed with "G" on one side and "181" on the other side.
| Bottles of 100 | NDC 0115-1811-01 |
| Bottles of 500 | NDC 0115-1811-02 |
| FLAVOXATE HYDROCHLORIDE
flavoxate hydrochloride tablet, film coated |
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| Labeler - Impax Generics (079832487) |