PITRESSIN argipressin 20 pressor units/1mL injection ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

argipressin, Quantity: 1 mg

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

argipressin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; acetic acid

Administration route:

Intramuscular, Subcutaneous

Units in package:

10 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pitressin is used in the prevention and treatment of postoperative abdominal distension; in abdominal radiography to dispel interfering gas shadows and in diabetes insipidus.

Product summary:

Visual Identification: A clear colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-06-09

Patient Information leaflet

Pitressin (argipressin)
June 2017
Page 1 of 4
PITRESSIN
(Pi-TRES-sin)
,
Argipressin
____________________________________________________________________
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS CMI
This CMI answers some of the
common questions about
PITRESSIN. 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 possible risks of
taking PITRESSIN against the
benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICATION. YOU MAY WANT
TO READ IT AGAIN.
WHAT PITRESSIN IS
USED FOR
PITRESSIN is a medicine that
contains argipressin, or
antidiuretic hormone.
Argipressin is normally
produced by the pituitary
gland.
Argipressin acts on blood
vessels and the kidney and
reduces the amount of fluids
you pass in the urine.
Argipressin also causes
muscles called ”smooth
muscles” to contract.
If your body does not produce
enough argipressin you can
get a condition called
“diabetes insipidus”.
PITRESSIN is used to treat
deficiency of argipressin in this
disorder. Symptoms of
diabetes insipidus include
passing large volumes of pale
urine and feeling extremely
thirsty. Diabetes insipidus is
not the same as diabetes
mellitus where sugar is passed
in the urine.
Argipressin can also be used
by your doctor to relieve
stomach bloating after you
have had surgery or an X-ray
procedure of the abdomen.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY THIS
MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason. There is no evidence
that PITRESSIN is addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU USE
PITRESSIN
_WHEN YOU MUST NOT _
_USE IT _
DO NOT USE PITRESSIN IF YOU
HAVE AN ALLERGY TO:
•
Any medicine containing
argipressin
•
Any of the ingredients
listed at the end of this
leaflet
•
Any other similar
medicines
S

Summary of Product characteristics

_Page 1 of 5_
AUSTRALIAN PRODUCT INFORMATION - PITRESSIN
®
(ARGIPRESSIN)
1
NAME OF THE MEDICINE
Argipressin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pitressin is a sterile, aqueous solution of synthetic argipressin
(8-arginine argipressin).
Argipressin is a polypeptide hormone having the properties of causing
the contraction of
vascular and other smooth muscles and of antidiuresis. Each 1 mL
ampoule contains 20
pressor units of argipressin.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Sterile solution for injection. A clear colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Pitressin is used in the prevention and treatment of postoperative
abdominal distention; in
abdominal radiography to dispel interfering gas shadows and in
diabetes insipidus.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
Intravenous use of argipressin is NOT recommended. Subcutaneous or
intramuscular dosage
should not exceed 0.75 mL.
Dosage should be appropriately reduced in use in children.
ABDOMINAL DISTENTION
In the average postoperative adult patient, give 0.25 mL (5 units) by
i.m. or s.c. initially,
increasing to 0.5 mL (10 units) at subsequent injections if necessary.
Injections may be
repeated at three or four hourly intervals as required.
Argipressin used in this manner will frequently prevent, or relieve,
postoperative distention.
These recommendations apply also to distention complicating pneumonia
or other acute
toxaemias.
ABDOMINAL RADIOGRAPHY
For the average case, two i.m. or s.c. injections of 0.5 mL each (10
units) are suggested.
These should be given two hours and one half hour, respectively,
before films are exposed.
Many radiologists advise giving an enema prior to the first dose of
argipressin.
DIABETES INSIPIDUS
Argipressin may be given by i.m. or s.c. injections or administered
intranasally on cotton
pledgets, by nasal spray, or by dropper. The dosage by injection is
0.25 to 0.5 mL (5 to 10
units) repeated two or three times daily as needed. When argipressin
is a