Label: FLAVOXATE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 25, 2012

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    Flavoxate hydrochloride 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.

    Chemical Structure

    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. titanium dioxide and triacetin.

  • CLINICAL PHARMACOLOGY

    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.

  • CONTRAINDICATIONS

    Flavoxate hydrochloride 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.

  • WARNINGS

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

  • 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 hydrochloride 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 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.

    Nursing Mother

    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.

    Pediatric Use

    Safety and effectiveness in children below the age of 12 years have not been established.

  • 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 hydrochloride in rats is 4273 mg/kg. The oral LD50 for flavoxate hydrochloride in mice is 1837 mg/kg.

    It is not known whether flavoxate hydrochloride is dialyzable.

  • 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.

  • HOW SUPPLIED

    Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed "Ɛ58" on one side and plain on the other side, and are available in

    Bottles of 10
    		NDC 54868-6326-1
    Bottles of 90
    		NDC 54868-6326-0

    Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container.

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Epic Pharma, LLC
    Laurelton, NY 11413

    Made in USA

    Distributed by:
    TAGI Pharma
    South Beloit, IL 61080

    Issued 02/11
    MF058ISS02/11
    OE1252



    Relabeling and Repackaging by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • PRINCIPAL DISPLAY PANEL - 100 mg Tablets Bottle Label


    Flavoxate
    Hydrochloride
    Tablets

    100 mg

    Rx Only

    image of package label
  • INGREDIENTS AND APPEARANCE
    FLAVOXATE HYDROCHLORIDE 
    flavoxate hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-6326(NDC:51224-154)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Flavoxate hydrochloride (UNII: 9C05J6089W) (Flavoxate - UNII:3E74Y80MEY) Flavoxate hydrochloride100 mg
    Inactive Ingredients
    Ingredient NameStrength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    starch, corn (UNII: O8232NY3SJ)  
    dibasic calcium phosphate dihydrate (UNII: O7TSZ97GEP)  
    magnesium stearate (UNII: 70097M6I30)  
    hypromelloses (UNII: 3NXW29V3WO)  
    polydextrose (UNII: VH2XOU12IE)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 58
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-6326-090 in 1 BOTTLE
    2NDC:54868-6326-110 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07683501/04/2012
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel, repack
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