Isoxsuprine

Isoxsuprine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]; Turky Alkathery, M.D. [3]

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Overview

Isoxsuprine is a vasodilator that is FDA approved for the treatment of cerebral vascular insufficiency, arteriosclerosis obliterans, thromboangitis obliterans, and Raynaud's disease. Common adverse reactions include hypotension, tachyarrhythmia, rash, abdominal discomfort, nausea, and dizziness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Cerebral Vascular Insufficiency, Arteriosclerosis Obliterans, Thromboangitis Obliterans, and Raynaud's Disease

• Dosing Information

• 10 to 20 mg three or four times daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isoxsuprine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isoxsuprine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Isoxsuprine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isoxsuprine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isoxsuprine in pediatric patients.

Contraindications

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

Warnings

• Should not be given immediately postpartum or in the presence of arterial bleeding.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Isoxsuprine in the drug label.

Postmarketing Experience

• On rare occasions oral administration of the drug has been associated in time with the occurrences of hypotension, tachycardia, 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 casual relationship can be neither confirmed nor refused.
• 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.

Drug Interactions

There is limited information regarding Drug Interactions of Isoxsuprine in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on the use of Isoxsuprine with respect to pregnant patients.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Isoxsuprine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Isoxsuprine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Isoxsuprine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Isoxsuprine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Isoxsuprine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Isoxsuprine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Isoxsuprine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Isoxsuprine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Isoxsuprine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Isoxsuprine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Isoxsuprine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Isoxsuprine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Isoxsuprine in the drug label.

Overdosage

Acute Overdose

There is limited information regarding Acute Overdose of Isoxsuprine in the drug label.

Chronic Overdose

There is limited information regarding Chronic Overdose of Isoxsuprine in the drug label.

Pharmacology

There is limited information regarding Isoxsuprine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Isoxsuprine Mechanism of Action in the drug label.

Structure

• lsoxsuprine HCI occurs as a white odorless, crystalline powder, having a bitter taste, It has a following structural formula

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Isoxsuprine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Isoxsuprine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Isoxsuprine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Isoxsuprine in the drug label.

How Supplied

• lsoxsuprine HCI 20mg tablets are supplied in HDPE containers of 1,000's.

Storage

There is limited information regarding Isoxsuprine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

Bi-Coastal Pharmaceutical Corp.®

NDC 42582-100-10

Isoxsuprine Hydrochloride Tablets, USP

10 mg

Rx only

100 Tablets

This image is provided by the National Library of Medicine.

Bi-Coastal Pharmaceutical Corp.®

NDC 42582-200-10

Isoxsuprine Hydrochloride Tablets, USP

20 mg

Rx only

100 Tablets

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Isoxsuprine in the drug label.

Precautions with Alcohol

• Alcohol-Isoxsuprine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Vasodilan®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.