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Isoxsuprine Hydrochloride Prescribing Information

Package insert / product label
Dosage form: tablet
Drug class: Peripheral vasodilators

Medically reviewed by Last updated on Jun 7, 2023.

Rx Only

Isoxsuprine Hydrochloride Description

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

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 and Usage for Isoxsuprine Hydrochloride

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.


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.


Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions/Side Effects

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.

Keep this and all medications out of the reach of children.

Isoxsuprine Hydrochloride Dosage and Administration

Oral: 10 to 20 mg, three or four times daily.For additional dosage recommendations, and other important prescribing information, see accompanying package insert.

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 100 NDC 42582-201-10

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


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


lsoxsuprine HCI 10mg and 20mg tablets:

These tablets contain the fdlowing inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose.

Storage and Handling

Store between 15° and 20°C (59° and 86°F).

Keep container tightly closed. Dispense in a tight container as defined in the USP.

Distributed By:

Bi-Coastal Pharma International LLC, Red Bank, NJ 07701

Manufactured By:

Syntho Pharmaceuticals, Inc.
Farmingdale, NY 11735
Rev. 05/19




NDC 66576-201-10

Isoxsuprine Hydrochloride Tablets, USP

20 mg

Rx only

100 Tablets


isoxsuprine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66576-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
isoxsuprine hydrochloride (UNII: V74TEQ36CO) (Isoxsuprine - UNII:R15UI3245N) isoxsuprine hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Product Characteristics
ColorWHITE (White) Score2 pieces
ShapeROUND (Tablet) Size8mm
FlavorImprint CodeI10
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66576-201-10100 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/11/2020
Labeler - Syntho Pharmaceuticals Inc. (088797407)
Registrant - Syntho Pharmaceuticals Inc. (088797407)
NameAddressID/FEIBusiness Operations
Syntho Pharmaceuticals Inc.088797407manufacture(66576-201)