Isoxsuprine HCL 40Mg (Sustain Release) Tablet

Some medical conditions may interact with isoxsuprine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have bleeding problems

Some MEDICINES MAY INTERACT with isoxsuprine. However, no specific interactions with isoxsuprine are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if isoxsuprine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

In addition to its needed effects, some unwanted effects may be caused by isoxsuprine. In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking isoxsuprine, check with your doctor or nurse as soon as possible:

Rare

• Chest pain
• dizziness or faintness (more common for injection)
• fast heartbeat (more common for injection)
• shortness of breath
• skin rash

Minor Side Effects

Some of the side effects that can occur with isoxsuprine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

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.

C18H23NO3 • HCl

p-Hydroxy-α[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.