CAVERJECT alprostadil 20 microgram powder for injection vial with diluent syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alprostadil

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Alprostadil

Authorization status:

Registered

Patient Information leaflet

CAVERJECT
®
1
CAVERJECT
®
_Alprostadil, Prostaglandin E1 (PGE1) 10 and 20 micrograms _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CAVERJECT.
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 has weighed
the risks of you using CAVERJECT
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CAVERJECT IS
USED FOR
WHAT CAVERJECT DOES
CAVERJECT may be prescribed by
your doctor for the treatment of
erectile dysfunction (inability to
maintain an erection to have sexual
intercourse).
CAVERJECT may also be used to
help in the diagnosis of erectile
dysfunction.
CAVERJECT contains alprostadil.
Alprostadil is also known as
prostaglandin E1 (PGE1) and is
found naturally in many parts of your
body.
_HOW CAVERJECT WORKS _
CAVERJECT works by increasing
the blood flow to the penis. The
increased blood flowing into the
penis is trapped in the spongy erectile
tissue of the penis called the corpora
cavernosa. When these chambers fill
with blood they swell and your penis
becomes erect.
CAVERJECT is injected into a
specific area of the penis and should
produce an erection in 5 to 20
minutes. The erection should last for
about 30 to 60 minutes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
CAVERJECT for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
CAVERJECT
_WHEN YOU MUST NOT USE IT _
DO NOT USE CAVERJECT IF YOU
HAVE AN ALLERGY TO:

any medicine containing
alprostadil

any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue
or

Summary of Product characteristics

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PRODUCT INFORMATION
CAVERJECT

(ALPROSTADIL)
NAME OF THE MEDICINE
The Australian Approved Name is Alprostadil, Prostaglandin E
1,
(PGE
1
).
The chemical name is (_11_

,13_E_,15_S_)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid and the CAS
number is 745-65-3.
The molecular weight is 354.49 and the structural formula is:
DESCRIPTION
Alprostadil is the naturally occurring form of PGE
1
.
Alprostadil is a white to off-white crystalline powder with a melting
point between 115°C - 116°C.
Alprostadil has a solubility of 8,000 micrograms in 100 mL double
distilled water at 35°C.
Caverject is available as a sterile freeze-dried powder for
intracavernosal injection only. It is
supplied in clear glass vials delivering either 10 or 20 micrograms of
alprostadil. In addition to
alprostadil,
the
freeze-dried
powder
in
Caverject
also
contains
lactose
monohydrate,
alpha-
cyclodextrin, sodium citrate dihydrate, hydrochloric acid and sodium
hydroxide. The diluent
(bacteriostatic Water for Injections) provided contains Water for
Injections preserved with 9.45
mg/mL benzyl alcohol.
PHARMACOLOGY
PHARMACODYNAMICS
Alprostadil (PGE
1
) is one of a family of naturally occurring acidic lipids.
Vasodilation and
inhibition of platelet aggregation are among the most notable
pharmacological effects. In regard to
the penile structures, in most animal species tested, alprostadil had
relaxant actions on retractor
penis and corpus cavernosum urethrae _ in vitro_. Alprostadil also
relaxed isolated preparations of
human corpus cavernosum and spongiosum as well as cavernous arterial
segments contracted by
either noradrenaline or PGE
2a
. In pigtail monkeys (_Macaca nemestrina_), alprostadil increased
cavernous arterial blood flow _ in vivo._ The degree and duration of
cavernous smooth muscle
relaxation in this animal model was dose-dependent.
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Alprostadil,
when
given
by
intracavernosal
injection,
induces
erection
in
men
wit