Label: ISOXSUPRINE HYDROCHLORIDE - isoxsuprine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 61971-065-10
  • Packager: Vista Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 12/12

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  • SPL UNCLASSIFIED SECTION

    CAUTION: Federal Law prohibits dispensing without prescription

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  • DESCRIPTION

    lsoxsuprine HCI occurs as a white odorless, crystalline powder, having a bitter
    taste, It has a following structural formula

    chemical structure

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  • INDICATIONS

    Based on a review of this drug by the National Academy of Sciences -National Research Council and / or other information, the FDA has classified the medications as follows :

    Possibly Effective :
    1. For the relief of symptoms associated with cerebral vascular insufficiency
    2. In peripheral vascular disease of arteriosclerosis obliterans, thromboangitis obliterans (Buerger's Disease) and Raynaud's disease.

    Final classification of the less than - effective indications requires further investigation.

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  • COMPOSITION

    Each tablet contains lsoxsuprine HCI 20 mg.

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  • CONTRAINDICATIONS AND CAUTIONS

    There are no known contraindications to oral use when administered in recommended doses. Should not be given immediately postpartum or in the presence of arterial bleeding.

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  • ADVERSE REACTIONS

    On rare occasions oral administration of the drug has been associated in time with the occurrences of hypotension, tachycardia, nausea, vomiting, dizziness, abdominal distress, and severe rash.  If rash appears the drug should be discontinued.
    Although available evidence suggests a temporal association of these reactions with Isoxsuprine, a casual relationship can be neither confirmed nor refused.

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  • DOSAGE AND ADMINISTRATION

    10 to 20mg three or four times daily

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  • HOW SUPPLIED

    lsoxsuprine HCI 20mg tablets are supplied in HDPE containers of 1,000's

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  • SPL UNCLASSIFIED SECTION

    Manufactured in India by
    Vista Pharmaceuticals, Limited.

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  • INGREDIENTS AND APPEARANCE
    ISOXSUPRINE HYDROCHLORIDE  
    isoxsuprine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61971-065
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Isoxsuprine hydrochloride (Isoxsuprine) Isoxsuprine hydrochloride 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    CELLULOSE, MICROCRYSTALLINE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    POVIDONE K30  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code 20;VISTA065
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61971-065-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/19/1997
    Labeler - Vista Pharmaceuticals, Inc. (943932806)
    Establishment
    Name Address ID/FEI Business Operations
    Vista Pharmaceuticals, Limited. 916648541 manufacture(61971-065), analysis(61971-065)
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