ISOXSUPRINE HYDROCHLORIDE- isoxsuprine hydrochloride tablet
BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY
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:
Chemical Structure
(click image for full-size original)
C18 H23 NO3 � HCl
p-Hydroxy-?[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.
Quantitative Ingredient Information
Each tablet taken orally contains 10 or 20 mg Isoxsuprine HCl
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.
PRECAUTIONS
Pediatric Use
Safety and effectiveness in pediatric patients have 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 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.
DOSAGE AND ADMINISTRATION
Oral: 10 to 20 mg, three or four times daily.
