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isoxsuprine hydrochloride tablet
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----------Isoxsuprine Hydrochloride Tablets, USP
Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:
C H NO – HCl
p-Hydroxy-a[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol 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:
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.
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.
PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label
Revised: 05/2011 Bi-Coastal Pharmaceutical Corporation
Reproduced with permission of U.S. National Library of Medicine
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