Caverject Impulse

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alprostadil 25.6ug equivalent to maximum dose of 20 mcg after reconstitution

Available from:

Pfizer New Zealand Limited

INN (International Name):

Alprostadil 25.6 µg (= maximum dose of 20 mcg after reconstitution)

Dosage:

20 mcg

Pharmaceutical form:

Powder for injection

Composition:

Active: Alprostadil 25.6ug equivalent to maximum dose of 20 mcg after reconstitution Excipient: Alfadex Hydrochloric acid Lactose monohydrate Sodium citrate dihydrate Sodium hydroxide Benzyl alcohol Water for injection

Prescription type:

Prescription

Manufactured by:

Pharmacia & Upjohn Company LLC

Therapeutic indications:

The treatment of erectile dysfunction in adult males. May be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Product summary:

Package - Contents - Shelf Life: Syringe, Glass dual chamber cartridge - 2 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2012-10-17

Patient Information leaflet

CAVERJECT
®
IMPULSE
1
CAVERJECT
® IMPULSE
_Alprostadil, Prostaglandin E1 (PGE1) 10 and 20 micrograms _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CAVERJECT
Impulse.
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
Impulse against the expected benefits
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CAVERJECT
IMPULSE IS USED FOR
CAVERJECT Impulse may be
prescribed by your doctor for the
treatment of erectile dysfunction
(inability to maintain an erection to
have sexual intercourse).
CAVERJECT Impulse may also be
used to help in the diagnosis of
erectile dysfunction.
CAVERJECT Impulse contains
alprostadil as the active ingredient.
Alprostadil is also known as
prostaglandin E1 (PGE1) and is
found naturally in many parts of your
body.
CAVERJECT Impulse works by
increasing the blood flow to your
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 Impulse is injected
into the side of the penis and should
produce an erection in 5 to 20
minutes. The erection should last for
about 30 to 60 minutes.
CAVERJECT Impulse is available
only with a doctor's prescription.
Your doctor may have prescribed
CAVERJECT Impulse for another
reason. Ask your doctor if you have
any questions about why
CAVERJECT Impulse has been
prescribed for you.
BEFORE YOU USE
CAVERJECT IMPULSE
_WHEN YOU MUST NOT USE _
_CAVERJECT IMPULSE _
DO NOT USE CAVERJECT IMPULSE
IF YOU:

have an allergy to alprostadil, the
active ingredient in CAVERJECT
Impulse, or to any of the other
ingredients listed at the end of
this leaflet

have a penis whic

Summary of Product characteristics

Version: pfdcaviv10119
Supersedes: pfdcaviv10416
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CAVERJECT
®
IMPULSE 10 and 20 microgram powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Caverject Impulse dual chamber syringe is available in two strengths,
10 and 20 micrograms.
Each 0.5 mL cartridge delivers a maximum dose of 10 micrograms or 20
micrograms of
alprostadil.
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 and has a molecular weight of 354.49. Alprostadil is
practically insoluble in water
with a solubility of 8,000 micrograms in 100 mL double distilled water
at 35°C. The
structural formula is as follows:
CHEMICAL STRUCTURE
EXCIPIENT(S) WITH KNOWN EFFECT
Each mL of reconstituted solution contains 8.04 mg of benzyl alcohol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for Injection for intracavernous use.
Dual
chamber
glass
cartridge
containing
a
white
lyophilised
powder
and
diluent
for
reconstitution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intracavernosal alprostadil (PGE
1
) is indicated for the treatment of erectile dysfunction in
adult males. Intracavernosal alprostadil may be a useful adjunct to
other diagnostic tests in
the diagnosis of erectile dysfunction.
Version: pfdcaviv10119
Supersedes: pfdcaviv10416
Page 2 of 12
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
GENERAL INFORMATION
Caverject Impulse is administered by direct intracavernosal injection.
A 13 mm, 27 to 30
gauge, needle is recommended. The dose of Caverject Impulse should be
individualised by
careful titration under a physician’s supervision.
In order to increase dosage flexibility, each syringe is capable of
delivering 25% dosage
increments:
Caverject Impulse 10 micrograms: 2.5, 5.0, 7.5, 10 micrograms.
Caverject Impulse 20 micrograms: 5.0, 10, 15, 20 micrograms.
The first injections of Caverject Impulse must be done at the
physician's offi