PAPAVERINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PAPAVERINE HYDROCHLORIDE (UNII: 23473EC6BQ) (PAPAVERINE - UNII:DAA13NKG2Q)

Available from:

American Regent, Inc.

INN (International Name):

PAPAVERINE HYDROCHLORIDE

Composition:

PAPAVERINE HYDROCHLORIDE 30 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Papaverine is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic. Intravenous injection of papaverine is contraindicated in the presence of complete atrioventricular heart block. When conduction is depressed, the drug may produce transient ectopic rhythms of ventricular origin, either premature beats or paroxysmal tachycardia. Papaverine Hydrochloride is not indicated for the treatment of impotence by intracorporeal injection. The intracorporeal injection of papaverine hydrochloride has been reported to have resulted in persistent priapism requiring medical and surgical intervention. Drug dependence resulting from the abuse of many of the selective depressants, includin

Product summary:

Papaverine Hydrochloride Injection, USP, 30 mg/mL 0517-4002-25              2 mL Vial                                packaged in boxes of 25 0517-4010-01              10 mL Multiple Dose Vial*    packaged individually *The 10 mL Multiple Dose Vial contains chlorobutanol 0.5% as a preservative. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN4002 Rev. 1/09

Authorization status:

unapproved drug other

Summary of Product characteristics

PAPAVERINE HYDROCHLORIDE- PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION
AMERICAN REGENT, 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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PAPAVERINE HYDROCHLORIDE INJECTION, USP
RX ONLY
This product is to be used by or under the direction of a physician.
Each vial contains a sufficient amount to permit withdrawal and
administration of the
volume specified on the label.
DESCRIPTION
Papaverine Hydrochloride, USP, is the hydrochloride of an alkaloid
obtained from opium
or prepared synthetically. It belongs to the benzylisoquinoline group
of alkaloids. It does
not contain a phenanthrene group as do morphine and codeine.
Papaverine Hydrochloride, USP, is 6,7-dimethoxy-1-
veratrylisoquinoline hydrochloride
and contains, on the dried basis, not less than 98.5% of C
H
NO •HCI. The molecular
weight is 375.85. The structural formula is as shown.
Papaverine Hydrochloride occurs as white crystals or white crystalline
powder. One
gram dissolves in about 30 mL of water and in 120 mL of alcohol. It is
soluble in
chloroform and practically insoluble in ether.
Papaverine Hydrochloride Injection, USP, is a clear, colorless to
pale-yellow solution.
Papaverine Hydrochloride, for parenteral administration, is a
smooth-muscle relaxant
that is available in vials containing 30 mg/mL. Each vial also
contains edetate disodium
0.005%. The 10 mL vials also contain chlorobutanol 0.5% as a
preservative. pH may be
adjusted with sodium citrate and/or citric acid.
CLINICAL PHARMACOLOGY
The most characteristic effect of papaverine is relaxation of the
tonus of all smooth
20
21
4
muscle, especially when it has been spasmodically contracted.
Papaverine Hydrochloride
apparently acts directly on the muscle itself. This relaxation is
noted in the _vascular_
_system _and _bronchial musculature _and in the _gastrointestinal,
biliary _and _urinary tracts_.
The main actions of papaverine are exerted on