Label: ISOXSUPRINE HYDROCHLORIDE- isoxsuprine hydrochloride tablet

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 28, 2017

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  • SPL UNCLASSIFIED SECTION

    Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

    CAUTION: Federal Law prohibits dispensing without prescription

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  • DESCRIPTION

    Isoxsuprine 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.

    These tablets contain the following inactive ingredients: dibasic calcium phosphate (anhydrous), lactose, magnesium stearate. microcrystalline cellulose, povidone k30, and sodium starch glycolate.

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  • DOSAGEANDADMINISTRATION

    Oral:10 to 20 mg three or four times daily

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  • CONTRAINDICATIONS AND CAUTIONS

    Oral
    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 occasion, oral administration of the drug has been associated in time with the occurrences of hypotension, tachycardia, chest pain, 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 refuted.

    β-Adrenergic receptor stimulants such as isoxsuprine hydrochloride have been used to inhibit pre-term labor. Maternal and fetal tachycardia may occur under such use. Hypocalcemia, hypoglycemia, hypotension and ileus have been reported to occur in infants whose mothers received isoxsuprine. Pulmonary edema has been reported in mothers treated with β-stimulants. Isoxsuprine HCl tablets, USP is neither approved nor recommended for use in the treatment of premature labor.

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  • HOW SUPPLIED

    Isoxsuprine HCI tablets, USP are supplied in HDPE bottles.

    20 mg Bottles of 1,000's: NDC61971-065-10

    Manufactured in India by
    Vista Pharmaceuticals, Limited.

    For
    Vista Pharmaceuticals, Inc.
    Revised:07/2017

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  • INGREDIENTS AND APPEARANCE
    ISOXSUPRINE HYDROCHLORIDE 
    isoxsuprine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61971-065
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Isoxsuprine hydrochloride (UNII: V74TEQ36CO) (Isoxsuprine - UNII:R15UI3245N) Isoxsuprine hydrochloride 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    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; Type 0: Not a Combination Product 09/19/1997
    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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