ISOXSUPRINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Isoxsuprine hydrochloride (UNII: V74TEQ36CO) (Isoxsuprine - UNII:R15UI3245N)

Available from:

Vista Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Based on a review of this drug by the National Academy of Sciences -National Research Council and / or other information, the FDA has classified the medications as follows : Possibly Effective : 1. For the relief of symptoms associated with cerebral vascular 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. Oral There are no known contraindications to oral use when administered in recommended doses. Should not be given immediately postpartum or in the presence of arterial bleeding.

Product summary:

Isoxsuprine HCI tablets, USP are supplied in HDPE bottles. 20 mg Bottles of 1,000's: NDC61971-065-10 Manufactured in India by Vista Pharmaceuticals, Limited. For Vista Pharmaceuticals, Inc. Revised:07/2017

Authorization status:

unapproved drug other

Summary of Product characteristics

ISOXSUPRINE HYDROCHLORIDE- ISOXSUPRINE HYDROCHLORIDE TABLET
VISTA PHARMACEUTICALS, INC.
_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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ISOXSUPRINEHYDROCHLORIDE TABLETS, USP
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA._
CAUTION: Federal Law prohibits dispensing without prescription
DESCRIPTION
Isoxsuprine HCI occurs as a white odorless, crystalline powder, having
a bitter
taste, It has a following structural formula
INDICATIONS
Based on a review of this drug by the National Academy of Sciences
-National Research Council and /
or other information, the FDA has classified the medications as
follows :
Possibly Effective :
1. For the relief of symptoms associated with cerebral vascular
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
Each tablet contains lsoxsuprine HCI 20 mg.
These tablets contain the following inactive ingredients: dibasic
calcium phosphate (anhydrous),
lactose, magnesium stearate. microcrystalline cellulose, povidone k30,
and sodium starch glycolate.
DOSAGEANDADMINISTRATION
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. 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 occurrences 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