DBL PAPAVERINE HYDROCHLORIDE 120mg/10mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

papaverine hydrochloride, Quantity: 12 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intracavernosal

Units in package:

5x10mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Papaverine hydrochloride injection is indicated for the treatment of erectile dysfunction.

Product summary:

Visual Identification: A clear colourless to pale yellow solution free from visible particulate matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DBL™ PAPAVERINE HYDROCHLORIDE INJECTION
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DBL PAPAVERINE HYDROCHLORIDE INJECTION?
DBL Papaverine Hydrochloride Injection contains the active ingredient
papaverine hydrochloride. DBL Papaverine Hydrochloride
Injection is used to produce erections in impotent men.
For more information, see Section 1. Why am I using DBL Papaverine
Hydrochloride Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DBL PAPAVERINE HYDROCHLORIDE
INJECTION?
Do not use if you have ever had an allergic reaction to papaverine
hydrochloride or any of the ingredients listed at the end of the
CMI.
Talk to your doctor if you have any other medical conditions and/or
take any other medicines.
For more information, see Section 2. What should I know before I use
DBL Papaverine Hydrochloride Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Papaverine Hydrochloride
Injection and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DBL PAPAVERINE HYDROCHLORIDE INJECTION GIVEN?
Your doctor will decide what dose of papaverine you will receive. This
depends on your medical condition and whether or not you
are taking any other medicines. A doctor or trained nurse will give
you the first injection. If you will be self-administering papaverine
your doctor will provide you with proper training and instruction.
More instructions can be found in Section 4. How is DBL Papaverine
Hydrochloride Injection given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DBL PAPAVERINE HYDROCHLORIDE INJECTION?
THINGS YOU
MUST DO
•
Call your doctor straight away if the erection lasts for longer than 4
hours, or if it becomes painful.
•
Remind any doctor, nurse, pharmaci

Summary of Product characteristics

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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 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.
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Dosage
adjustment
should
be
made
carefully,
based
on
the
degree
and
duration
of
tumescence achieved with the previous dose.
METHOD OF ADMINISTRATION
DBL Papaverine