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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.

Rx Only

Isoxsuprine Hydrochloride Description

Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:

C18H23NO3 • HCl

p-Hydroxy-α[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.

Quantitative Ingredient Information

Each tablet taken orally contains 10 or 20 mg Isoxsuprine HCl

Pharmacological Class

Peripheral Vasodilator

INDICATIONS

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

Possibly Effective

  1. For the relief of symptoms associated with cerebrovascular 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.

Contraindications

There are no known contraindications to oral use when administered in recommended doses.

Isoxsuprine Hydrochloride, USP should not be given immediately postpartum or in the presence of arterial bleeding.

Precautions

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

On rare occasion oral administration of the drug has been associated in time with the occurrence 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 Hydrochloride, a causal relationship can be neither confirmed nor refuted.

Beta Adrenergic receptor stimulants such as Isoxsuprine Hydrocholoride 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 Hydrochloride. Pulmonary edema has been reported in mothers treated with beta stimulants. Isoxsuprine Hydrochloride is neither approved nor recommended for use in the treatment of premature labor.

Isoxsuprine Hydrochloride Dosage and Administration

Oral: 10 to 20 mg, three or four times daily.

How is Isoxsuprine Hydrochloride Supplied

Isoxsuprine HCl tablets, USP 10 mg
Bottles of 100 NDC 42582-101-10

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 1000 NDC 42582-201-20

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 100 NDC 42582-201-10

COMPOSITION

Isoxsuprine HCl 10mg and 20mg tablets: These tablets contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate (vegetable), microcrystalline cellulose.

Distributed By:
Bi-Coastal Pharma International LLC

Red Bank, NJ 07701

Iss. 11/14

PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

Bi-Coastal Pharma International LLC

NDC 42582-101-10

Isoxsuprine
Hydrochloride
Tablets, USP

10 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label

Bi-Coastal Pharma International LLC

NDC 42582-201-10

Isoxsuprine
Hydrochloride
Tablets, USP

20 mg

Rx only

100 Tablets

Isoxsuprine Hydrochloride 
Isoxsuprine Hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42582-101
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Isoxsuprine Hydrochloride (Isoxsuprine) Isoxsuprine Hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate  
Magnesium Stearate  
Cellulose, Microcrystalline  
Starch, Corn  
Product Characteristics
Color WHITE (White) Score 2 pieces
Shape ROUND (Tablet) Size 8mm
Flavor Imprint Code I10
Contains         
Packaging
# Item Code Package Description
1 NDC:42582-101-10 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/02/2011
Isoxsuprine Hydrochloride 
Isoxsuprine Hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42582-201
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 Monohydrate  
Magnesium Stearate  
Cellulose, Microcrystalline  
Starch, Corn  
Product Characteristics
Color WHITE (White) Score 2 pieces
Shape ROUND (Tablet) Size 8mm
Flavor Imprint Code 20
Contains         
Packaging
# Item Code Package Description
1 NDC:42582-201-10 100 TABLET in 1 BOTTLE
2 NDC:42582-201-20 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/02/2011
Labeler - BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY (078397428)
Revised: 06/2012
 
BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY
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