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:

Bi-Coastal Pharmaceutical Corporation

INN (International Name):

isoxsuprine hydrochloride

Composition:

isoxsuprine hydrochloride 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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: - For the relief of symptoms associated with cerebrovascular insufficiency. - 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. 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.

Product summary:

Isoxsuprine HCl tablets, USP 10 mg Bottles of 100 NDC 42582-100-10 Isoxsuprine HCl tablets, USP 20 mg Bottles of 1000 NDC 42582-200-20 Isoxsuprine HCl tablets, USP 20 mg Bottles of 100 NDC 42582-200-10 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 Pharmaceutical Corp. ® Red Bank, NJ 07701 Iss. 1/12

Authorization status:

unapproved drug other

Summary of Product characteristics

ISOXSUPRINE HYDROCHLORIDE- ISOXSUPRINE HYDROCHLORIDE TABLET
BI-COASTAL PHARMACEUTICAL CORPORATION
_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:
C
H NO • 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
18
23
3
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