Label: FLAVOXATE HYDROCHLORIDE tablet
- NDC Code(s): 42806-058-01, 42806-058-10
- Packager: Epic Pharma, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 7, 2019
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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 24H 25NO 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, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.
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 hydrochloride was excreted in the urine within 24 hours.
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.
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 hydrochloride have not been performed.
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.
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.
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.
- DOSAGE AND ADMINISTRATION
Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ Є58” on one side and plain on the other side, and are available as follows:
NDC 42806-058-01 Bottles of 100
NDC 42806-058-10 Bottles of 1000
Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container.
Epic Pharma, LLC
Laurelton, NY 11413
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 100ct
INGREDIENTS AND APPEARANCE
flavoxate hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLAVOXATE HYDROCHLORIDE (UNII: 9C05J6089W) (FLAVOXATE - UNII:3E74Y80MEY) FLAVOXATE HYDROCHLORIDE 100 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code E58 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42806-058-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2011 2 NDC:42806-058-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/21/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076835 02/21/2011 Labeler - Epic Pharma, LLC (827915443) Registrant - Epic Pharma, LLC (827915443) Establishment Name Address ID/FEI Business Operations Epic Pharma, LLC 827915443 manufacture(42806-058)