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Isoxsuprine Hydrochloride

Dosage Form: tablet

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.

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

Isoxsuprine Hydrochloride Description

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

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.

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

DOSAGEANDADMINISTRATION

Oral:10 to 20 mg three or four times daily

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.

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.

How is Isoxsuprine Hydrochloride 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

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
1 NDC:61971-065-10 1000 TABLET 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 Operations
Vista Pharmaceuticals, Limited. 916648541 manufacture(61971-065), analysis(61971-065)
Revised: 07/2017
 
Vista Pharmaceuticals, Inc.
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