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![ISOXSUPRINE HYDROCHLORIDE TABLET [BI-COASTAL PHARMACEUTICAL CORPORATION]](https://medic.hrt.org//dailymed/images/47134a96-77d0-4211-90b8-e2a857586d7b/isoxsuprine-02.jpg)
![ISOXSUPRINE HYDROCHLORIDE TABLET [BI-COASTAL PHARMACEUTICAL CORPORATION]](https://medic.hrt.org//dailymed/images/47134a96-77d0-4211-90b8-e2a857586d7b/isoxsuprine-03.jpg)
| NDC | 42582-100-10, 42582-200-10, 42582-200-20 |
| Set ID | 47134a96-77d0-4211-90b8-e2a857586d7b |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Bi-Coastal Pharmaceutical Corporation |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
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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
- PRECAUTIONS
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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
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HOW SUPPLIED
Isoxsuprine HCl tablets, USP 10 mg
Bottles of 100 NDC 42582-100-10Isoxsuprine HCl tablets, USP 20 mg
Bottles of 1000 NDC 42582-200-20Isoxsuprine HCl tablets, USP 20 mg
Bottles of 100 NDC 42582-200-10 - PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label
- PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label
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INGREDIENTS AND APPEARANCE
ISOXSUPRINE HYDROCHLORIDE
isoxsuprine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength isoxsuprine hydrochloride (UNII: V74TEQ36CO) (Isoxsuprine - UNII:R15UI3245N) isoxsuprine hydrochloride 10 mg Inactive Ingredients Ingredient Name Strength Lactose Monohydrate (UNII: EWQ57Q8I5X) Magnesium Stearate (UNII: 70097M6I30) Cellulose, Microcrystalline (UNII: OP1R32D61U) Starch, Corn (UNII: O8232NY3SJ) Product Characteristics Color WHITE (White) Score 2 pieces Shape ROUND (Tablet) Size 8mm Flavor Imprint Code I10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42582-100-10 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/02/2011 ISOXSUPRINE HYDROCHLORIDE
isoxsuprine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-200 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 Monohydrate (UNII: EWQ57Q8I5X) Magnesium Stearate (UNII: 70097M6I30) Cellulose, Microcrystalline (UNII: OP1R32D61U) Starch, Corn (UNII: O8232NY3SJ) Product Characteristics Color WHITE (White) Score 2 pieces Shape ROUND (Tablet) Size 8mm Flavor Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42582-200-10 100 in 1 BOTTLE 2 NDC:42582-200-20 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/02/2011 Labeler - Bi-Coastal Pharmaceutical Corporation (808397079) Establishment Name Address ID/FEI Business Operations ECI Pharmaceuticals, LLC 962476029 MANUFACTURE(42582-100, 42582-200) , LABEL(42582-100, 42582-200) , ANALYSIS(42582-100, 42582-200)
