HOSPIRA PENTAMIDINE ISETHIONATE FOR INJECTION pentamidine isetionate 300mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pentamidine isetionate

Available from:

Hospira Australia Pty Ltd

INN (International Name):

Pentamidine isetionate

Authorization status:

Registered

Patient Information leaflet

HOSPIRA
™
PENTAMIDINE ISETHIONATE
FOR INJECTION
_ _
Pentamidine Isethionate _(pen-TAM-i-deen eye-se-THIO-nate)_
_ _
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
HOSPIRA
™
Pentamidine
Isethionate for 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 or
pharmacist has weighed the risks
of you being given HOSPIRA
™
Pentamidine Isethionate for
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT HOSPIRA
™
PENTAMIDINE
ISETHIONATE FOR
INJECTION IS USED FOR
HOSPIRA
™
Pentamidine
Isethionate for Injection is used to
treat an infection called
_Pneumocystis carinii_ pneumonia
(PCP). This kind of pneumonia
occurs commonly in patients
whose immune system is not
working normally, such as cancer
patients, transplant patients, or
patients with acquired immune
deficiency syndrome (AIDS).
HOSPIRA
™
Pentamidine
Isethionate for Injection can also
be used to treat other types of
protozoal infections, such as
Leishmaniasis and
Trypanosomiasis.
Your doctor may have prescribed
HOSPIRA
™
Pentamidine
Isethionate for Injection for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that
HOSPIRA
™
Pentamidine
Isethionate for Injection is
addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOSPIRA
™
PENTAMIDINE
ISETHIONATE FOR
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
HOSPIRA
™
PENTAMIDINE
ISETHIONATE FOR INJECTION IF YOU
HAVE AN ALLERGY TO PENTAMIDINE.
Symptoms of an allergic reaction
to pentamidine may include:
•
shor

Summary of Product characteristics

Product Information – Australia
HOSPIRA
™ PENTAMIDINE ISETHIONATE FOR INJECTION
NAME OF THE MEDICINE
Pentamidine isethionate
CAS registry number: 140-64-7
DESCRIPTION
Hospira
™
Pentamidine Isethionate for Injection is a white or almost white,
odourless or almost
odourless hygroscopic powder. Each 4 mg of pentamidine isethionate is
equivalent to 2.3 mg
pentamidine base.
PHARMACOLOGY
Pentamidine isethionate exhibits antiprotozoal activity against
_Pneumocystis carinii_
,
_Leishmania_
and
some species of
_Trypanosoma_
.
The exact mechanism of antiprotozoal action of pentamidine has not
been fully elucidated. Several
mechanisms of action may be involved, and the role of the mechanism(s)
may vary among the
different types of protozoa (e.g. trypanosome, sporozoons). Most
information on the antiprotozoal
activity of pentamidine has been derived from studies involving
trypanosomes.
_In vitro_
studies
indicate that the drug interferes with nuclear metabolism.
PHARMACOKINETICS
Limited information is available concerning the pharmacokinetics of
pentamidine isethionate.
Following a single 4 mg/kg IV dose of pentamidine isethionate (given
as a 2 hour infusion), peak
plasma pentamidine concentrations averaged 612 nanogram/mL after
completion of the IV infusion.
DISTRIBUTION
Distribution of pentamidine into human body tissues and fluids has not
been well characterised, but
the drug appears to be rapidly and extensively distributed and/or
bound to tissues. Pentamidine has a
distribution half life of 5 to 15 minutes after intravenous
administration. Following parenteral
administration, highest concentrations have been found in the liver,
followed by the kidneys, adrenals,
spleen, lungs and pancreas. Pentamidine penetrates the CNS only very
poorly after prolonged therapy.
Version 0.1
Page 1
Product Information – Australia
_In vitro_
, pentamidine is reportedly 69% bound to serum proteins.
It is not known whether pentamidine isethionate crosses the placenta
or is distributed into breast milk.
ELIMINATION
Little is known abo