Caverject

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alprostadil 23ug equivalent to 20 µg/ml after reconstitution.; Alprostadil 23ug equivalent to 20 µg/ml after reconstitution.

Available from:

Pfizer New Zealand Limited

INN (International Name):

Alprostadil 23 µg (= 20 µg/ml after reconstitution.)

Dosage:

20 mcg

Pharmaceutical form:

Powder for injection

Composition:

Active: Alprostadil 23ug equivalent to 20 µg/ml after reconstitution. Excipient: Hydrochloric acid Lactose monohydrate Sodium citrate dihydrate Sodium hydroxide Benzyl alcohol Water for injection Active: Alprostadil 23ug equivalent to 20 µg/ml after reconstitution. Excipient: Alfadex Hydrochloric acid Lactose monohydrate Sodium citrate dihydrate Sodium hydroxide

Units in package:

Combination pack, 1x(vial+diluent syringe), 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pharmacia & Upjohn Company LLC

Therapeutic indications:

CAVERJECT is indicated for the treatment of erectile dysfunction. CAVERJECT may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Product summary:

Package - Contents - Shelf Life: Combination pack, 1x(vial+diluent syringe) - 1 dose units - 24 months from date of manufacture stored at or below 25°C 0 hours reconstituted, use immediately - Syringe, 1x1ml - 1 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, 1x20?g - 20 ?g - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1994-02-24

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 other parts of the

Summary of Product characteristics

DATA SHEET
CAVERJECT
®
ALPROSTADIL
10 MICROGRAMS AND 20 MICROGRAMS POWDER FOR INJECTION
PRESENTATION
Caverject
is
a
white
crystalline
powder
containing
10 micrograms
or
20 micrograms
alprostadil in a 5 mL clear glass vial.
USES
ACTIONS
Alprostadil is the naturally occurring form of prostaglandin E
1
(PGE
1
). Alprostadil has a
wide variety of pharmacological actions; vasodilation and inhibition
of platelet aggregation
are among the most notable of these effects. In most animal species
tested, alprostadil
relaxed 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 PGF
2
α
_in vitro_
. 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.
Alprostadil induces erection by relaxation of trabecular smooth muscle
and by dilation of
cavernosal arteries. This leads to expansion of lacunar spaces and
entrapment of blood by
compressing the venules against the tunica albuginea, a process
referred to as the corporal
veno-occlusive mechanism.
PHARMACOKINETICS
_ABSORPTION _
For the treatment of erectile dysfunction, alprostadil is administered
by injection into the
corpora cavernosa. The absolute bioavailability of alprostadil has not
been determined.
_DISTRIBUTION _
Following intracavernosal injection of 20 micrograms alprostadil, mean
peripheral plasma
concentrations of alprostadil at 30 and 60 minutes after injection (89
and 102 picograms/mL,
respectively) were not significantly greater than baseline levels of
endogenous alprostadil
(96 picograms/mL). Alprostadil is bound in plasma primarily to albumin
(81% bound) and to
a lesser extent
α
-globulin IV-4 fraction (55% bound). No significant binding to
erythrocytes
or white blood cells was observed.
_BIOTRANSFORMATION OR METABOLISM _
Alprostadil
is