Isoxsuprine Hydrochloride
FDA Label NDC 63549-919

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vedco Dba Valdar for the product Isoxsuprine Hydrochloride (NDC 63549-919). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, quantitative ingredient information, pharmacological class, indications, possibly effective, contraindications, pediatric use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Rx Only

Manufactured For:
Valdar
St. Joseph, MO 64507

Description

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

Principal Display Panel (20 mg Tablet Bottle Label)

Principal Display Panel (20 mg Tablet Bottle Label)

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

  • 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.

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.

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.

Principal Display Panel - 20 Mg Tablet Bottle Label

NDC 63549-919-53

Isoxsuprine
Hydrochloride
Tablets
USP
20 mg

1000 Tablets

Rx Only

VALDAR

Principal Display Panel (20 mg Tablet Bottle Label)

Principal Display Panel (20 mg Tablet Bottle Label)

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