Label: AVC VAGINAL- sulfanilamide cream

  • NDC Code(s): 66663-103-00, 66663-103-04
  • Packager: Jazz Pharmaceuticals Commercial Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 10/12

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  • SPL UNCLASSIFIED SECTION

    AVC ® (sulfanilamide)

    Cream

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  • DESCRIPTION

    AVC ® is a preparation for vaginal administration for the treatment of Candida albicans infections and available in the following forms:

    AVC Cream

    Each tube contains:

    Sulfanilamide............................................................................................................................15.0%
    in a water-miscible, non-staining base made from lactose, propylene glycol, stearic acid, diglycol stearate, methylparaben, propylparaben, trolamine, and water; buffered with lactic acid to an acid pH of approximately 4.3.

    Sulfanilamide is an anti-infective agent. It is p-amino-benzenesulfonamide with the chemical structure:

    chemical structure

    Sulfanilamide occurs as a white odorless crystalline powder with a slightly bitter taste and sweet aftertaste. It is slightly soluble in water, alcohol, acetone, glycerin, propylene glycol, hydrochloric acid, and solutions of potassium and sodium hydroxide. It is practically insoluble in chloroform, ether, benzene, and petroleum ether.

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  • CLINICAL PHARMACOLOGY

    Sulfanilamide has been a useful ingredient of vaginal formulations for about four decades. It blocks certain metabolic processes essential for the growth of susceptible bacteria. In AVC, the sulfanilamide is in a specially compounded base buffered to the pH (about 4.3) of the normal vagina to encourage the presence of the normally occurring Döderlein’s bacilli of the vagina.

    The use of AVC for the treatment of vulvovaginitis caused by Candida albicans is supported by three clinical investigations. The three studies show AVC with sulfanilamide to be significantly more effective (p ≤ 0.01) than placebo as follows:

    In Study I, the ratio of effectiveness was 71% for the AVC with sulfanilamide versus 49% for placebo with 30 days of treatment;

    In Study II, the percentages were 48% and 24%, respectively, with 15 days of treatment;

    In Study III, the percentages were 66% versus 33%, respectively, with 30 days of treatment.

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  • INDICATIONS AND USAGE

    For the treatment of vulvovaginitis caused by Candida albicans. (See CLINICAL PHARMACOLOGY.)

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  • CONTRAINDICATIONS

    AVC should not be used in patients known to be sensitive to this product or to the sulfonamides.

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  • PRECAUTIONS

    General

    Because sulfonamides are absorbed from the vaginal mucosa, the usual precautions for oral sulfonamides apply. Patients should be observed for skin rash or evidence of systemic toxicity, and if these develop, the medications should be discontinued.

    Deaths associated with administration of oral sulfonamides have reportedly occurred from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias.

    Goiter production, diuresis, and hypoglycemia have reportedly occurred rarely in patients receiving oral sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has reportedly produced thyroid malignancies in this species.

    Vaginal applicators or inserters should be used with caution after the seventh month of pregnancy.

    Information For Patients

    The doctor should advise the patient that in the event unusual local itching and burning occur, or other unusual symptoms develop, medication should be discontinued and not restarted without further consultation.

    Drug Interactions

    Drug interactions have not been documented with AVC.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No data are available on long-term potential of AVC for carcinogenicity, mutagenicity, or impairment of fertility in animals or humans.

    Pregnancy

    Teratogenic Effects. Pregnancy Category C: Animal reproductive studies have been conducted with sulfonamides, including sulfanilamide (see below). It is not known whether AVC can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. AVC should be given to a pregnant woman only if clearly needed.

    Sulfonamides, including sulfanilamide, readily pass through the placenta and reach fetal circulation. The concentration in the fetus is from 50-90% of that in the maternal blood and if high enough, can cause toxic effects. The safe use of sulfonamides, including sulfanilamide, in pregnancy has not been established. The teratogenic potential of most sulfonamides has not been thoroughly investigated in either animals or humans. However, a significant increase in the incidence of cleft palate and other bony abnormalities of offspring has been observed with certain sulfonamides of the short-, intermediate- and long-acting types (including sulfanilamide) when given to pregnant rats and mice at high oral doses (seven to 25 times the human therapeutic oral dose.)

    Nursing Mothers

    Sulfanilamide should be avoided in nursing mothers because absorbed sulfonamides will appear in maternal milk and have caused kernicterus in the newborn. Because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug.

    Pediatric Use

    Safety and effectiveness of AVC in pediatric patients have not been established.

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  • ADVERSE REACTIONS

    Local sensitivity reactions such as increased discomfort or a burning sensation have occasionally been reported following the use of topical sulfonamides. With the use of AVC Cream, sensitivity reactions (only local) were reported for 0.2% of the investigational patients.

    Treatment should be discontinued if either local or systemic manifestations of sulfonamide toxicity or sensitivity occur.

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  • DRUG ABUSE AND DEPENDENCE

    Tolerance, abuse, or dependence with AVC have not been reported.

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  • OVERDOSAGE

    There have been no reports of accidental overdosage with AVC.

    The acute oral LD 50 of sulfanilamide is 3700-4200 mg/kg in mice.

    The minimum human lethal dose of AVC has not been established.

    It is not known if AVC is dialyzable.

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  • DOSAGE AND ADMINISTRATION

    One applicatorful (about 6g) intravaginally once or twice daily. Improvements in symptoms should occur within a few days, but treatment should be continued for a period of 30 days.

    Douching with a suitable solution before insertion may be recommended for hygienic purposes.

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  • HOW SUPPLIED

    AVC Cream

    NDC 66663-103-04 4 oz tube with applicator

    Store at room temperature, below 86°F.

    Protect from cold.

    Product darkens with age. Potency is maintained throughout labeled shelf life when stored as directed.

    This leaflet provides a summary of the important information about AVC Cream. You can get more information by calling the toll free number (1-800-890-3098).

    Manufactured for:

    Azur Pharma, Inc.

    1818 Market Street Suite 2350

    Philadelphia, PA 19103, www.azurpharma.com


    Manufactured by:

    DPT Laboratories, Ltd.

    San Antonio, TX 78215

    AVC® is a registered trademark of Azur Pharma International II Limited.

    129712

    AVCCp-11-01

    Rev. 09/11

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  • PRINCIPAL DISPLAY PANEL - PRODUCT CARTON LABEL

    NDC 66663-103-04

    4 ounces vaginal cream with applicator

    AVC ® CREAM
    (sulfanilamide) 15%

    Bottom Carton Label

    Contains: sulfanilamide 15% in a water-miscible, non-staining base made from lactose, propylene glycol, stearic acid, diglycol stearate, methylparaben, propylparaben, trolamine, and water buffered with lactic acid to an acid pH of approximately 4.3.

    Usual dose: 1 applicatorful (about 6 g) intra-vaginally once or twice daily. Improvements in symptoms should occur within a few days, but treatment should be continued for a period of 30 days

    Back Carton Label

    LIFT HERE

    Product Information inside carton.

    Top Carton Label

    Directions for use of applicator are printed under tear-away panel
    of carton.

    Rx only.

    Storage: Store at room temperature (below 86°F). Protect from cold.
    Product darkens with age. Potency is maintained throughout
    labeled shelf-life when stored as directed.

    111747

    Manufactured for: Azur Pharma, Inc.

    1818 Market Street Suite 2350

    Philadelphia, PA 19103, www.azurpharma.com


    Manufactured by: DPT Laboratories, Ltd.

    San Antonio, TX 78215

    AVC® is a registered trademark of Azur Pharma International II Limited.

    AVCCt-11-03

    Product Carton Label

    Product Carton Label

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  • INGREDIENTS AND APPEARANCE
    AVC VAGINAL 
    sulfanilamide cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66663-103
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFANILAMIDE (SULFANILAMIDE) SULFANILAMIDE 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    PROPYLENE GLYCOL  
    STEARIC ACID  
    PEG-2 STEARATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    TROLAMINE  
    WATER  
    LACTIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66663-103-04 1 in 1 CARTON
    1 113 g in 1 TUBE, WITH APPLICATOR
    2 NDC:66663-103-00 1 in 1 CARTON
    2 113 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA006530 06/05/1965
    Labeler - Jazz Pharmaceuticals Commercial Corp. (805611071)
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