ISOXSUPRINE HYDROCHLORIDE tablet

ISOXSUPRINE HYDROCHLORIDE by

Drug Labeling and Warnings

ISOXSUPRINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

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

1. For the relief of symptoms associated with cerebrovascular 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.

CONTRAINDICATIONS

There are no known contraindications to oral use when administered in recommended doses.

Isoxsuprine Hydrochloride, USP should not be given immediately postpartum or in the presence of arterial bleeding.

PRECAUTIONS

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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

Oral: 10 to 20 mg, three or four times daily.

HOW SUPPLIED

Isoxsuprine HCl tablets, USP 10 mg
Bottles of 100 NDC: 42582-101-10

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 1000 NDC: 42582-201-20

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 100 NDC: 42582-201-10

COMPOSITION

Isoxsuprine HCl 10mg and 20mg tablets: These tablets contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate (vegetable), microcrystalline cellulose.

Distributed By:
Bi-Coastal Pharma International LLC
Red Bank, NJ 07701

Iss. 11/14

PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

Bi-Coastal Pharma International LLC

NDC: 42582-101-10

Isoxsuprine
Hydrochloride
Tablets, USP

10 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label

Bi-Coastal Pharma International LLC

NDC: 42582-201-10

Isoxsuprine
Hydrochloride
Tablets, USP

20 mg

Rx only

100 Tablets

INGREDIENTS AND APPEARANCE

ISOXSUPRINE HYDROCHLORIDE 
isoxsuprine hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42582-101
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)
MICROCRYSTALLINE CELLULOSE (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: 42582-101-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2011

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 tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42582-201
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)
MICROCRYSTALLINE CELLULOSE (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: 42582-201-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2011
2	NDC: 42582-201-20	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/02/2011

Labeler - BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY (078397428)