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DBL™ Papaverine cmi.doc
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DBL™ 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 DBL™
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 DBL™
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 DBL™
PAPAVERINE
HYDROCHLORIDE
INJECTION
_WHEN YOU MUST NOT USE IT _
DO NOT USE DBL™
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 atrioventricular
block (a heart condition
char
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Version: 7.0
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION –
DBL
TM
PAPAVERINE HYDROCHLORIDE
INJECTION (PAPAVERINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Papaverine Hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Papaverine Hydrochloride Injection is supplied in ampoules
containing 30 mg/1 mL
or 120 mg/10 mL of papaverine hydrochloride BP in water for injection
BP/USP.
3.
PHARMACEUTICAL FORM
DBL™ Papaverine Hydrochloride Injection is a sterile, clear,
colourless to pale-yellow
solution of papaverine hydrochloride in water for injections.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL™
Papaverine
Hydrochloride
Injection
is
indicated
for
the
treatment
of
erectile
dysfunction.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The lowest effective dose should be determined for each patient. In
general most patients
respond to doses in the range of 2.5 to 60 mg of papaverine
hydrochloride.
A starting dose of 15 mg is recommended for patients with erectile
dysfunction due to most
causes. Patients with psychogenic erectile dysfunction are likely to
respond to lower doses,
while those with vasculogenic erectile dysfunction are likely to
require higher doses. Patients
who do not respond to a dose of 60 mg should be changed to alternative
therapy.
A starting dose of 5 mg is recommended for men with erectile
dysfunction due to spinal cord
injury.
Erection usually occurs within 10 minutes of injection of the drug and
may persist for one to
several hours. Tolerance to papaverine hydrochloride may occur during
long-term use and
may require an increase in dosage.
The dose should be reduced if erections persist for longer than four
hours. Early studies using
doses of up to 80 mg papaverine hydrochloride resulted in high
proportion patients requiring
assisted detumescence.
Version: 7.0
Page 2 of 11
Dosage
adjustment
should
be
made
carefully,
based
on
the
degree
and
duration
of
tumescence achieved with the previous dose.
METHOD OF ADMINISTRATION
DBL™ Papaverine Hydrochloride Injection should only be pres
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