Label: ISOXSUPRINE HYDROCHLORIDE- isoxsuprine hydrochloride tablet
- NDC Code(s): 61971-065-10
- Packager: Vista Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated July 28, 2017
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- SPL UNCLASSIFIED SECTION
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 prescriptionClose
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.Close
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.Close
Oral:10 to 20 mg three or four times dailyClose
- 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.
- ADVERSE REACTIONS
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.Close
- HOW 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.
- INGREDIENTS AND APPEARANCE
isoxsuprine hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61971-065 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isoxsuprine hydrochloride (UNII: V74TEQ36CO) (Isoxsuprine - UNII:R15UI3245N) Isoxsuprine hydrochloride 20 mg Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 20;VISTA065 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61971-065-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/19/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/19/1997 Labeler - Vista Pharmaceuticals, Inc. (943932806) Establishment Name Address ID/FEI Business Operations Vista Pharmaceuticals, Limited. 916648541 manufacture(61971-065) , analysis(61971-065)