HOSPIRA PAPAVERINE HYDROCHLORIDE INJECTION papaverine hydrochloride 30 mg/1 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

papaverine hydrochloride

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Papaverine hydrochloride

Authorization status:

Registered

Patient Information leaflet

Hospira
TM
Papaverine Hydrochloride Injection CMI
Page 1
HOSPIRA
TM PAPAVERINE
HYDROCHLORIDE INJECTION
Papaverine Hydrochloride (pa-PAV-er-een)
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Hospira
TM
Papaverine
Hydrochloride Injection. It does
not contain all the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor weighed the
risks of you using papaverine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HOSPIRA
TM
PAPAVERINE
HYDROCHLORIDE
INJECTION IS USED FOR
This medicine is used to produce
erections in impotent men.
It belongs to a group of medicines
called vasodilators.
When papaverine is injected into
the penis (called ‘intracavernosal’
injection) it works by increasing
blood flow to the penis, which
results in an erection.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
PRODUCT HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription.
There is not enough information
to recommend the use of this
medicine for children and
newborn babies.
BEFORE YOU USE
HOSPIRA™ PAPAVERINE
HYDROCHLORIDE
INJECTION
_WHEN YOU MUST NOT USE IT _
DO NOT USE HOSPIRA™
PAPAVERINE HYDROCHLORIDE
INJECTION IF YOU HAVE AN ALLERGY
TO:

any medicine containing
papaverine

any of the ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue
or other parts of the body; rash,
itching or hives on the skin.
DO NOT USE THIS MEDICINE IF YOU
HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:

complete at

Summary of Product characteristics

Product Information – Australia
Version 1.0
Page 1 HOSPIRA™ PAPAVERINE HYDROCHLORIDE INJECTION
NAME OF MEDICINE
Papaverine hydrochloride
The chemical structure is shown below.
CAS registry number
:
61-25-6
DESCRIPTION
Papaverine hydrochloride is the hydrochloride of an alkaloid obtained
from opium or prepared
synthetically. It belongs to the benzylisoquinoline group of
alkaloids. The chemical name for
papaverine hydrochloride is 6,7-dimethoxy-1-veratrylisoquinoline
hydrochloride. The molecular
weight of papaverine hydrochloride (C
20
H
21
NO
4
,HCl) is 375.9.
Hospira™ Papaverine Hydrochloride Injection is a sterile, clear,
colourless to pale-yellow solution of
papaverine hydrochloride in water for injections. It is supplied in
ampoules containing 30 mg or 120
mg of papaverine hydrochloride BP and water for injection BP/USP. The
pH of the injection ranges
between 3.0 and 5.0.
PHARMACOLOGY
The principal therapeutic action of papaverine hydrochloride is its
relaxant effect on smooth muscles,
which leads to penile erection. It may induce erections by arteriolar
relaxation, increased blood flow
and volume due to relaxation of the sinusoidal wall of the corpora
cavernosa and subsequent
compression of venous channels between the sinusoids and the tunica
albuginea.
The spasmolytic effect of papaverine hydrochloride is most pronounced
on the vascular system,
including coronary, cerebral, pulmonary and peripheral vasodilation;
it also relaxes the bronchial,
gastrointestinal, biliary and urinary tract smooth muscles. Papaverine
hydrochloride has also been
reported to have direct cardiac inotropic effects, leading to
increased myocardial oxygen consumption,
which can outstrip the effect of increased coronary blood flow if
hypotension is also present. It can
depress myocardial excitability, prolong the refractory period and
depress myocardial conduction. In
the presence of depressed conduction due to other causes (eg AV
block), papaverine hydrochloride
may produce transient ventricular arrhythmias. Papaverine
hydrochlor