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.

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:C18 H23 NO3 HClp-Hydroxy-[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.. PRINCIPAL DISPLAY PANEL 20 mg Tablet Bottle Label. QUANTITATIVE INGREDIENT INFORMATION. Each tablet taken orally contains 20mg Isoxsuprine Hydrochloride.. PHARMACOLOGICAL CLASS. Peripheral Vasodilator.

DOSAGE & ADMINISTRATION SECTION.

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

HOW SUPPLIED SECTION.

HOW SUPPLIED. Isoxsuprine HCl tablets, USP 20 mgBottles of 1000 NDC 63549-919-53.

INACTIVE INGREDIENT SECTION.

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

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 20 mg Tablet Bottle Label. NDC 63549-919-53IsoxsuprineHydrochlorideTabletsUSP20 mg1000 TabletsRx OnlyVALDAR. PRINCIPAL DISPLAY PANEL 20 mg Tablet Bottle Label.

PEDIATRIC USE SECTION.

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

PRECAUTIONS SECTION.

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