Isoxsuprine Tablets 20 mg (1000 ct)

$27.89

Isoxsuprine Tablets are orally administered peripheral vasodilator used in the treatment of navicular syndrome in horses.

Categories: , Tag: Prescription Required

Description

Isoxsuprine Tablets are orally administered peripheral vasodilator used in the treatment of navicular syndrome in horses. Made by Bi-Coastal Pharma International.

Additional information

Weight 1 lbs
Dimensions 3 x 3 x 6 in

More Details

Isoxsuprine Tablets requires a prescription from your veterinarian.

Isoxsuprine hydrochloride is a drug labeled for human use that has been used extra-label in veterinary medicine principally for the treatment of navicular disease in horses.

Formulations

Isoxsuprine Tablets is available in 10 mg and 20 mg tablets in 100 ct and 1000 ct bottles.

Administration

Use as directed by your veterinarian.

Typical dosage recommendations 1.2 mg/kg orally every 8- 12 hours initially, and then time between dosages is increased to once a day and then every other day.

Precautions

Bioavailability was shown to be low after oral administration in horses (Mathews 1986), probably due to a high first-pass effect.

Isoxsuprine Tablets should not be administered to animals immediately post-partum or in the presence of arterial bleeding.

Adverse effects are unlikely after oral administration but hypotension, tachycardia, and GI effects are possible.

Matthews, H. (1986). Cardiovascular and pharmacokinetic effects of isoxsuprine in the horse. Am J Vet Res 47 (10): 2110-3.

Manufacturer Product Information

ISOXSUPRINE HYDROCHLORIDE- isoxsuprine hydrochloride tablet 
BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Isoxsuprine Hydrochloride Tablets, USP

Rx Only


DESCRIPTION

Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:

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

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