Dosage Form: tablet
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.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
CAUTION: Federal Law prohibits dispensing without prescription
Isoxsuprine Hydrochloride Description
Isoxsuprine HCI occurs as a white odorless, crystalline powder, having a bitter
taste, It has a following structural formula
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 medications as follows :
Possibly Effective :
1. For the relief of symptoms associated with cerebral vascular insufficiency
2. 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.
Each tablet contains lsoxsuprine HCI 20 mg.
These tablets contain the following inactive ingredients: dibasic calcium phosphate (anhydrous), lactose, magnesium stearate. microcrystalline cellulose, povidone k30, and sodium starch glycolate.
Oral:10 to 20 mg three or four times daily
CONTRAINDICATIONS AND CAUTIONS
There are no known contraindications to oral use when administered in recommended doses. 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 occurrences 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 be neither confirmed nor refuted.
β-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. Pulmonary edema has been reported in mothers treated with β-stimulants. Isoxsuprine HCl tablets, USP is neither approved nor recommended for use in the treatment of premature labor.
How is Isoxsuprine Hydrochloride Supplied
Isoxsuprine HCI tablets, USP are supplied in HDPE bottles.
20 mg Bottles of 1,000's: NDC61971-065-10
Manufactured in India by
Vista Pharmaceuticals, Limited.
Vista Pharmaceuticals, Inc.
Isoxsuprine Hydrochloride tablet
|Labeler - Vista Pharmaceuticals, Inc. (943932806)|
|Vista Pharmaceuticals, Limited.||916648541||manufacture(61971-065), analysis(61971-065)|
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- Drug class: peripheral vasodilators
Other brands: Vasodilan