Isoxsuprine Hydrochloride: Package Insert / Prescribing Info

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.

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.

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

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

COMPOSITION

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

MADE IN U.S.A.

PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

Syntho

NDC 66576-201-10

Isoxsuprine Hydrochloride Tablets, USP

20 mg

Rx only

100 Tablets