CONTRAINDICATIONS SECTION.

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.

DESCRIPTION SECTION.

DESCRIPTION. Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:C18H23NO3 HClp-Hydroxy-[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. Chemical Structure.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Isoxsuprine HCl Tablets, USP 10 mg are white, round, biconvex tablets identified as I10 debossed on one side and bisected on the other.Bottle of 100NDC 51293-606-01Bottle of 1000NDC 51293-606-10Isoxsuprine HCl Tablets, USP 20 mg are white, round, biconvex tablets identified as 20 debossed on one side and bisected on the other.Bottle of 100NDC 51293-605-01Bottle of 1000NDC 51293-605-10.

INDICATIONS & USAGE SECTION.

INDICATIONS. Based on 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. For the relief of symptoms associated with cerebrovascular insufficiency.In peripheral vascular disease of arteriosclerosis obliterans, thromboangitis obliterans (Buergers disease) and Raynauds disease. Final classification of the less-than-effective indications requires further investigation.. For the relief of symptoms associated with cerebrovascular insufficiency.. In peripheral vascular disease of arteriosclerosis obliterans, thromboangitis obliterans (Buergers disease) and Raynauds disease.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL- 10 mg Bottle Label. ECI PharmaceuticalsNDC 51293-606-01IsoxsuprineHydrochlorideTablets, USP10 mgRx only100 Tablets. PRINCIPAL DISPLAY PANEL- 10 mg Bottle Label.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PRECAUTIONS SECTION.

PRECAUTIONS. Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS SECTION.

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 temporal association of these reactions with Isoxsuprine Hydrochloride, causal relationship can be neither confirmed nor refuted.Beta 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 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.