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VASODILAN Label and VASODILAN General Information

View Reported VASODILAN side effects

vasodilan (isoxsuprine hydrochloride)  tablet 
[Bristol-Myers Squibb Company]

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.

COMPOSITION

Vasodilan (isoxsuprine HCl tablets, USP) 10 mg and 20 mg. These tablets contain the following inactive ingredients: acacia, dibasic calcium phosphate, lactose, magnesium stearate, starch (corn), and talc.

DOSAGE AND ADMINISTRATION

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

CONTRAINDICATIONS AND CAUTIONS

Oral

There are no known contraindications to oral use when administered in recommended doses. Vasodilan 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 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, a causal relationship can be neither confirmed nor refuted.

ß-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 ß-stimulants. Vasodilan (isoxsuprine HCl tablets, USP) is neither approved nor recommended for use in the treatment of premature labor.

SUPPLIED

Vasodilan® (isoxsuprine HCl tablets, USP)

10 mg

Bottles of 100         NDC 0087-0543-01

Bottles of 1000       NDC 0087-0543-02

Unit Dose               NDC 0087-0543-05

Vasodilan® (isoxsuprine HCl tablets, USP)

20 mg

Bottles of 100         NDC 0087-0544-01

Bottles of 1000       NDC 0087-0544-06

MeadJohnson Pharmaceuticals

A Bristol-Myers Squibb Company, Princeton, New Jersey 08543 U.S.A.

VASODILAN (isoxsuprine hydrochloride)

PRODUCT INFO Product Code 0087-0543 Dosage Form TABLET Route Of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength isoxsuprine hydrochloride (isoxsuprine) Active 10 MILLIGRAM  In 1 TABLET acacia Inactive   dibasic calcium phosphate Inactive   lactose Inactive   magnesium stearate Inactive   starch (corn) Inactive   talc Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color WHITE (WHITE) Score 1 Shape ROUND (ROUND) Symbol false Imprint Code MJ;543;10 Coating false Size 9MM

PACKAGING # NDC Package Description Multilevel Packaging 1 0087-0543-01 100 TABLET In 1 BOTTLE None 2 0087-0543-02 1000 TABLET In 1 BOTTLE None 3 0087-0543-05 100 TABLET In 1 BLISTER PACK None

VASODILAN (isoxsuprine hydrochloride)

PRODUCT INFO Product Code 0087-0544 Dosage Form TABLET Route Of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength isoxsuprine hydrochloride (isoxsuprine) Active 20 MILLIGRAM  In 1 TABLET acacia Inactive   dibasic calcium phosphate Inactive   lactose Inactive   magnesium stearate Inactive   starch (corn) Inactive   talc Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color WHITE (WHITE) Score 1 Shape ROUND (ROUND) Symbol false Imprint Code MJ;544;20 Coating false Size 10MM

PACKAGING # NDC Package Description Multilevel Packaging 1 0087-0544-01 100 TABLET In 1 BOTTLE None 2 0087-0544-06 1000 TABLET In 1 BOTTLE None

Revised: 09/2006