FDA Label for Isoxsuprine Hydrochloride
View Indications, Usage & Precautions
Isoxsuprine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Vedco Dba Valdar. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Rx Only
Manufactured For:
Valdar
St. Joseph, MO 64507
Description
Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:
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
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