ISOXSUPRINE HYDROCHLORIDE - isoxsuprine hydrochloride tablet 
Vista Pharmaceuticals, Inc.

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.

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ISOXSUPRINE HYDROCHLORIDE TABLETS, USP

CAUTION: Federal Law prohibits dispensing without prescription

DESCRIPTION

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

chemical structure

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.

COMPOSITION

Each tablet contains lsoxsuprine HCI 20 mg.

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.

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.

DOSAGE AND ADMINISTRATION

10 to 20mg three or four times daily

HOW SUPPLIED

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

Manufactured in India by
Vista Pharmaceuticals, Limited.

Bottle label
ISOXSUPRINE HYDROCHLORIDE  
isoxsuprine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:61971-065
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Isoxsuprine hydrochloride (Isoxsuprine) Isoxsuprine hydrochloride20 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
CELLULOSE, MICROCRYSTALLINE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 20;VISTA065
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61971-065-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/19/1997
Labeler - Vista Pharmaceuticals, Inc. (943932806)
Establishment
NameAddressID/FEIBusiness Operations
Vista Pharmaceuticals, Limited.916648541manufacture(61971-065), analysis(61971-065)

Revised: 12/2012
Document Id: 3da92ae2-eef2-4f93-bb7c-0edc451c783b
Set id: e6582e24-9414-43b8-ac6f-b1422e3197cf
Version: 5
Effective Time: 20121205
 
Vista Pharmaceuticals, Inc.