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
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- SPL UNCLASSIFIED SECTION
CAUTION: Federal Law prohibits dispensing without prescriptionClose
lsoxsuprine HCI occurs as a white odorless, crystalline powder, having a bitter
taste, It has a following structural formula
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.Close
Each tablet contains lsoxsuprine HCI 20 mg.Close
- 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.Close
- 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.Close
Although available evidence suggests a temporal association of these reactions with Isoxsuprine, a casual relationship can be neither confirmed nor refused.
- DOSAGE AND ADMINISTRATION
10 to 20mg three or four times dailyClose
- HOW SUPPLIED
lsoxsuprine HCI 20mg tablets are supplied in HDPE containers of 1,000'sClose
- SPL UNCLASSIFIED SECTION
Manufactured in India byClose
Vista Pharmaceuticals, Limited.
- INGREDIENTS AND APPEARANCE
isoxsuprine hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61971-065 Route of Administration ORAL DEA Schedule 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 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)