OCTREOTIDE SUN octreotide (as acetate) 500 microgram/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

octreotide

Available from:

Sun Pharma ANZ Pty Ltd

Authorization status:

Registered

Patient Information leaflet

OCTREOTIDE SUN CMI V2
Page 1 of 5
OCTREOTIDE SUN
_Octreotide _
CONSUMER HEALTH INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Octreotide SUN. The
information in this leaflet was
last updated on the date listed
on the final page. More recent
information on the medicine
may be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP
TO DATE INFORMATION ON THE
MEDICINE.
Those updates may contain
important information about the
medicine and its use of which
you should be aware. 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 Octreotide SUN
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT OCTREOTIDE SUN
IS USED FOR
Octreotide SUN has three uses:
1.
Octreotide SUN is used to
treat acromegaly.
In people with acromegaly the
body makes too much growth
hormone, which controls the
growth of tissues, organs and
bones. This leads to
enlargement of the bones,
especially of the hands and feet.
Other symptoms include
headaches, increased sweating,
tiredness, numbness of the
hands and feet, pain and
stiffness in the joints and loss of
sexual function. By blocking the
excess growth hormone,
Octreotide SUN can relieve
many of these symptoms.
2.
Octreotide SUN is used to
relieve symptoms of certain
types of cancer such as
carcinoid syndrome and
VIPoma.
By blocking hormones that are
over-produced in these
conditions, Octreotide SUN can
relieve symptoms such as
flushing of the skin and severe
diarrhoea.
3.
Octreotide SUN is used for
people who are having
surgery on the pancreas. This
medicine helps to lower the
chance of complications after
the surgery.
Octreotide SUN contains
octreotide, a man-made
medicine derived from
somatostatin, a substa

Summary of Product characteristics

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OCTEOTRIDE SUN PI V4
PRODUCT INFORMATION
OCTREOTIDE SUN SOLUTION FOR INJECTION
NAME OF THE MEDICINE
Octreotide
Chemical name:
D-Phenylalanyl-L-cysteinyl-L-phenyalanyl-D-tryptophyl-L-Iysyl-L-threonyl-N-[2-hydroxy-1-
(hydroxymethyl)propyl]-L-cysteinamide cyclic (2

7)–disulfide.
DESCRIPTION
Octreotide SUN is octreotide, a synthetic octapeptide analogue of
somatostatin.
where x = 1.4 to 2.5
CAS NUMBER:
79517-01-4. (octreotide acetate)
MW:
1019.3 (free peptide)
Each 1 mL ampoule contains 0.05 mg, 0.1 mg or 0.5 mg octreotide
(present as acetate). The solution is clear and
colourless.
EXCIPIENTS
: (S)-lactic acid, mannitol, sodium bicarbonate, water for injections.
PHARMACOLOGY
PHARMACODYNAMICS
Octreotide is a synthetic octapeptide analogue of naturally occurring
somatostatin with similar pharmacological
effects, but with a considerably prolonged duration of action. It
inhibits the secretion of serotonin and the gastro-
entero-pancreatic peptides: gastrin, vasoactive intestinal peptide,
insulin, glucagon, secretin, motilin, and pancreatic
polypeptide, and of growth hormone (GH). Octreotide, like
somatostatin, decreases splanchnic blood flow.
In animals, octreotide is a more potent inhibitor of growth hormone,
glucagon and insulin release than somatostatin
with greater selectivity for GH-and glucagon-suppression.
In healthy subjects octreotide, like somatostatin, has been shown to
inhibit:

release of growth hormone (GH) stimulated by arginine, exercise and
insulin-induced hypoglycaemia

postprandial release of insulin, glucagon, gastrin, other peptides of
the GEP system, and arginine-stimulated
release of insulin and glucagon

thyrotropin releasing hormone (TRH) stimulated release of thyroid
stimulating hormone (TSH).
Unlike somatostatin, octreotide inhibits GH secretion preferentially
over insulin and its administration is not
followed by rebound hypersecretion of hormones (i.e. GH in patients
with acromegaly).
In patients with acromegaly (including those who have failed to
respond to surgery