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.
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.
Each tablet taken orally contains 20mg 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:
- 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.
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.
Safety and effectiveness in pediatric patients has not been established.
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.
Oral: 10 to 20 mg, three or four times daily.
Isoxsuprine HCl tablets, USP 20 mg
Bottles of 1000 NDC 63549-919-53
Isoxsuprine HCl 20mg tablets: These tablets contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate (vegetable), microcrystalline cellulose.
St. Joseph, MO 64507
PRINCIPAL DISPLAY PANEL — 20 mg Tablet Bottle Label
| ISOXSUPRINE HYDROCHLORIDE |
isoxsuprine hydrochloride tablet
|Labeler — Vedco dba Valdar (021634266)|
Revised: 01/2012 Vedco dba Valdar
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