Monograph: |
Isoxsuprine Hydrochloride
Indications: Arteriosclerosis obliterans; Raynaud's disease; Thromboangiitis obliterans
DESCRIPTION:
Isoxsuprine Hydrochloride (abbreviated here as Isoxsuprine HCl) is available in 10 mg and 20 mg tablets. These tablets contain the following inactive ingredients: acacia, dibasic calcium phosphate, lactose, magnesium stearate, starch (corn), and talc.
INDICATIONS AND USAGE:
Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, the FDA has classified the indications as follows:
Possibly Effective:
1. For the relief of symptoms associated with cerebrovascular insufficiency.
2. In the peripheral vascular disease of arteriosclerosis obliterans, thromboangiitis obliterans (Buerger's disease) and Raynaud's disease.
Final classification of the less-than-effective indications requires further investigation.
CONTRAINDICATIONS:
Oral
There are no known contraindications to oral use when administered to recommended doses. Isoxsuprine HCl should not be given immediately postpartum or in the presence of arterial bleeding.
PRECAUTIONS:
See CONTRAINDICATIONS.
ADVERSE REACTIONS:
On rare occasions 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, a casual relationship can neither be confirmed nor refuted.
beta-Adrenergic receptor stimulants such as Isoxsuprine HCl have been used to inhibit preterm 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. Pulmonary edema has been reported in mothers treated with beta-stimulants. Isoxsuprine HCl 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.
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