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![ISOXSUPRINE HYDROCHLORIDE TABLET [ECI PHARMACEUTICALS LLC]](https://medic.hrt.org//dailymed/images/6baec489-724b-4184-9529-7b9ca3573025/isoxsuprine-03.jpg)
| NDC | 51293-605-01, 51293-605-10, 51293-606-01, 51293-606-10 |
| Set ID | 6baec489-724b-4184-9529-7b9ca3573025 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | ECI Pharmaceuticals LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:
C18H23NO3 ∙ HCl
p-Hydroxy-α[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.Quantitative Ingredient Information: Each tablet taken orally contains 10 or 20 mg Isoxsuprine HCl
Pharmacological Class: Peripheral Vasodilator -
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 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 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 are white, round, biconvex tablets identified as "I10" debossed on one side and bisected on the other.
Bottle of 100 NDC 51293-606-01 Bottle of 1000 NDC 51293-606-10 Isoxsuprine HCl Tablets, USP 20 mg are white, round, biconvex tablets identified as "20" debossed on one side and bisected on the other.
Bottle of 100 NDC 51293-605-01 Bottle of 1000 NDC 51293-605-10 - COMPOSITION
- SPL UNCLASSIFIED SECTION
- 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:51293-606 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 Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code I10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51293-606-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2011 09/30/2024 2 NDC:51293-606-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2011 09/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/02/2011 09/30/2024 ISOXSUPRINE HYDROCHLORIDE
isoxsuprine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51293-605 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 Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51293-605-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/23/2011 03/31/2025 2 NDC:51293-605-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/23/2011 03/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/23/2011 03/31/2025 Labeler - ECI Pharmaceuticals LLC (962476029)
