DBL PENTAMIDINE ISETHIONATE 300mg powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pentamidine isetionate, Quantity: 300 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1x300mg, 5x300mg(E)

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

Pentamidine isethionate is indicated for intravenous administration in the treatment of the following conditions: . As an alternative first line treatment for Pneumocystis carinii infection in AIDS patients; . As second line treatment for Pneumocystis carinii infection in non-AIDS patients; . As second line treatment of Leishmaniasis (visceral and cutaneous), except Leishmania Aethiopica where it may be used as first line treatment; . As second line treatment for Trypanosomiasis (except for the Trypanosomiasis Rhodesiense strain due to lack of efficacy).

Product summary:

Visual Identification: White to nearly white powder or plug.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DBL™ PENTAMIDINE ISETHIONATE
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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 PENTAMIDINE ISETHIONATE?
DBL Pentamidine Isethionate contains the active ingredient pentamidine
isetionate. DBL Pentamidine Isethionate is used to treat
an infection called pneumocystis carinii pneumonia (PCP). DBL
Pentamidine Isethionate can also be used to treat other types of
protozoal infections, such as Leishmaniasis and Trypanosomiasis.
For more information, see Section 1. Why am I using DBL Pentamidine
Isethionate? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DBL PENTAMIDINE ISETHIONATE?
Do not use if you have ever had an allergic reaction to pentamidine or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take
any other medicines.
DBL Pentamidine Isethionate is Pentamidine is not recommended for use
during pregnancy or breastfeeding. Speak to your doctor if
you are pregnant, plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
DBL Pentamidine Isethionate? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Pentamidine Isethionate 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 DO I USE DBL PENTAMIDINE ISETHIONATE?
•
DBL Pentamidine Isethionate must only be given by a doctor or nurse.
Your doctor will decide what dose of pentamidine you will
receive.
•
DBL Pentamidine Isethionate is given as a slow injection into a vein
(intravenously) over a period of at least 60 minutes.
More instructions can be found in Section 4. How do I use DBL
Pentamidine Isethionate? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DBL PENTAMIDINE ISETHIONATE?
THINGS YOU
SHOULD DO
•
If you become

Summary of Product characteristics

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Page 1 of 12
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™
PENTAMIDINE
ISETHIONATE
FOR
INJECTION
(PENTAMIDINE ISETIONATE)
1.
NAME OF THE MEDICINE
Pentamidine isetionate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DBL
™
Pentamidine Isethionate for Injection contains 300 mg pentamidine
isetionate as a freeze dried powder or plug.
Each 4 mg of pentamidine isetionate is equivalent to 2.3 mg
pentamidine base.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Powder for injection.
DBL
™
Pentamidine Isethionate for Injection is a white or almost white,
odourless or almost
odourless hygroscopic powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pentamidine isetionate is indicated for intravenous administration in
the treatment of the
following conditions:
-
As an alternative first line treatment for
_Pneumocystis carinii_
infection in AIDS patients;
-
As second line treatment for
_Pneumocystis carinii_
infection in non-AIDS patients;
-
As second line treatment of Leishmaniasis (visceral and cutaneous),
except
_Leishmania _
_aethiopica_
where it may be used as first line therapy;
-
As
second
line
treatment
for
Trypanosomiasis
(except
for
the
_Trypanosomiasis _
_rhodesiense_
strain due to lack of efficacy).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The following dosage regimens are recommended.
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Page 2 of 12
_P. CARINII PNEUMONIA _
4 mg/kg bodyweight Pentamidine Isetionate once daily for 14 days,
preferably by slow
intravenous infusion.
_LEISHMANIASIS _
On the basis of current knowledge the following dosage are suggested
however the optimal
treatment regimen has yet to be established.
-
Visceral
_ _
(Kala-azar): 3 to 4 mg/kg bodyweight Pentamidine Isetionate on
alternate days
(3 times a week) to a maximum of 10 injections.
-
Cutaneous: 3 to 4 mg/kg bodyweight Pentamidine Isetionate once or
twice weekly, until
the condition resolves.
_TRYPANOSOMIASIS _
Haemolymphete stage only.
4