Label: FLAVOXATE HYDROCHLORIDE- flavoxate hydrochloride tablet, film coated

  • NDC Code(s): 0574-0115-01
  • Packager: Paddock Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 12, 2018

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  • SPL UNCLASSIFIED SECTION

    PRESCRIBING INFORMATION

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  • 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:

    Chemical Structure

    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.

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  • 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 HCl was excreted in the urine within 24 hours.

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  • 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 are compatible with drugs used for the treatment of urinary tract infections.

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  • CONTRAINDICATIONS

    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.

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  • WARNINGS

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

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  • 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.

    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 HCl is administered to a nursing woman.

    Pediatric Use:

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

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  • 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.

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  • 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.

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  • 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.

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  • HOW SUPPLIED

    Flavoxate HCl Tablets, 100 mg, are supplied as round, white, film-coated tablets debossed "PAD" and "0115" on one side and plain on the other side, in bottles of 100.

    100 mg 100's:
    NDC 0574-0115-01

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

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  • SPL UNCLASSIFIED SECTION

    Manufactured For
    Perrigo®
    Minneapolis, MN 55427

    Manufactured by:
    Mikart, INC.
    Atlanta, GA 30318

    Code 917A00

    7H700 RC J1

    Rev 03-14 A

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  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle

    Rx Only

    NDC 0574-0115-01

    Flavoxate HCl Tablets

    100 mg

    100 Tablets

    7h7-rc-flavoxate-hcl-tablets.jpg

    The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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  • INGREDIENTS AND APPEARANCE
    FLAVOXATE HYDROCHLORIDE 
    flavoxate hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0115
    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)  
    ETHYL ACRYLATE (UNII: 71E6178C9T)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    NONOXYNOL-100 (UNII: A906T4D368)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code PAD;0115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0574-0115-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/22/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076831 12/22/2004
    Labeler - Paddock Laboratories, LLC (967694121)
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