ISOXSUPRINE HYDROCHLORIDE

ISOXSUPRINE HYDROCHLORIDE- isoxsuprine hydrochloride tablet
Vedco dba Valdar

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

DESCRIPTION

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

C₁₈ H₂₃ NO₃ • HCl

p-Hydroxy-α[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.

QUANTITATIVE INGREDIENT INFORMATION

Each tablet taken orally contains 20mg Isoxsuprine Hydrochloride.

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

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

Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

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.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Isoxsuprine HCl tablets, USP 20 mg

Bottles of 1000 NDC 63549-919-53

COMPOSITION

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

Manufactured For:
Valdar
St. Joseph, MO 64507

PRINCIPAL DISPLAY PANEL — 20 mg Tablet Bottle Label

NDC 63549-919-53

Isoxsuprine
Hydrochloride
Tablets
USP
20 mg

1000 Tablets

Rx Only

VALDAR

ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63549-919 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength isoxsuprine hydrochloride (Isoxsuprine) isoxsuprine hydrochloride 20 mg

Inactive Ingredients Ingredient Name Strength Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Starch, Corn

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63549-919-53 1000 TABLET (TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/23/2011

Labeler — Vedco dba Valdar (021634266)

Revised: 01/2012 Vedco dba Valdar