ISOXSUPRINE HYDROCHLORIDE

ECI Pharmaceuticals LLC

Isoxsuprine Hydrochloride Tablets, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• ISOXSUPRINE HYDROCHLORIDE DESCRIPTION
• INDICATIONS
  • Possibly Effective
• ISOXSUPRINE HYDROCHLORIDE CONTRAINDICATIONS
• PRECAUTIONS
  • Pediatric Use
• ISOXSUPRINE HYDROCHLORIDE ADVERSE REACTIONS
• ISOXSUPRINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• COMPOSITION
• PRINCIPAL DISPLAY PANEL- 10 mg Bottle Label
• PRINCIPAL DISPLAY PANEL- 20 mg Bottle Label

FULL PRESCRIBING INFORMATION

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

• For the relief of symptoms associated with cerebrovascular insufficiency.
• 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.

ISOXSUPRINE HYDROCHLORIDE 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.

ISOXSUPRINE HYDROCHLORIDE 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 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.

ISOXSUPRINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION

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

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.

Isoxsuprine HCl Tablets, USP 20 mg are white, round, biconvex tablets identified as "20" debossed on one side and bisected on the other.

COMPOSITION

Isoxsuprine HCl Tablets, 10 mg and 20 mg. These tablets contain the following Inactive Ingredients: Corn Starch, Lactose Monohydrate, Magnesium Stearate (Vegetable), Microcrystalline Cellulose.

Manufactured By:
ECI Pharmaceuticals, LLC
Fort Lauderdale, FL 33309

Iss. 04/12

PRINCIPAL DISPLAY PANEL- 10 mg Bottle Label

ECI Pharmaceuticals

NDC 51293-606-01

Isoxsuprine
Hydrochloride
Tablets, USP

10 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL- 20 mg Bottle Label

ECI Pharmaceuticals

NDC 51293-605-01

Isoxsuprine
Hydrochloride
Tablets, USP

20 mg

Rx only

100 Tablets