AUSGEM Gemfibrozil 600mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemfibrozil, Quantity: 600 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: polysorbate 80; sodium lauryl sulfate; crospovidone; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; croscarmellose sodium; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 8000; triacetin; polydextrose

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AUSGEM is indicated as an adjunct to diet and other therapeutic measures for the following conditions: -Severe hypertiglyceridamia (types IV and V) in those who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. -Dyslipidaemia associated with diabetes. -Reduction of risk of coronary heart disease in patients with Type IIa and IIb hypercholesterolaemia. Beacause of potential toxicity such as malignancy, gallbladder disease, abnormal pain leading to appendectomy and other abdominal surgeries, an increased incidence in non-coronary mortality and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefits of gemfibrozil in treating Type IIa patients with elevation of LDL-cholesterol only are not likely to outweigh the risks. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (>1.2mmol/L), both gemfibrozil and placebo subgroups had similar incidences of serious coronary events. NOTE: AUSGEM is indicated when exercise, weight loss and specific dietary or other non-drug measures, for example, limiting alcohol intake have failed. Other medical disorders such as hypothyroidism and diabetes should be controlled as much as possible. Periodic determinations of serum lipids should be obtained during treatment with AUSGEM. The drug should be withdrawn or additional therapy instituted if the lipid response is deemed inadequate after 3 months.

Product summary:

Visual Identification: White, oval, biconvex, film-coated tablet scoreline on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1997-12-16

Patient Information leaflet

AUSGEM- Consumer Medicine Information
Page 1 of 3
_ _
AUSGEM
_gemfibrozil _
CONSUMER MEDICINE INFORMATION (CMI)
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about _AUSGEM_. 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 taking gemfibrozil
against the benefits this medicine is
expected to have for you.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IS AUSGEM USED
FOR
The name of your medicine is
_AUSGEM_. It contains the active
ingredient, gemfibrozil.
_AUSGEM_ belongs to group of
medicines known as fibric acid
derivatives. _AUSGEM_ is used to
help regulate cholesterol and
triglycerides which are fat-like
substances in the blood.
Everyone has cholesterol in their
blood. It is a type of blood fat
needed by the body for many things,
such as making bile acids (which
help digest food) and some
hormones. However, having too
much cholesterol in the blood can
contribute to the development of
heart disease.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body does not balance
the amount of cholesterol it needs
with the amount of cholesterol you
obtain from your food, then your
cholesterol becomes too high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
When you have high levels of
cholesterol, this fat may “stick” to the
inside of your blood vessels instead
of being carried to the parts of the
body where it is needed.
Over time, this can form hard areas
(called a “plaque”) on the lining of
your blood vessels, making it more
difficult for the blood to flow. This
blocking of your blood vessels can
lead to heart disease (such as heart
attack and angina), and stroke.
There are different types of
cholesterol, called LDL and HDL.
LDL cholesterol is the harmful or
“bad” cholesterol that can block your
blood

Summary of Product characteristics

AUSGEM- Product Information
Page 1 of 10
PRODUCT INFORMATION
AUSGEM
NAME OF THE MEDICINE
AUSGEM
®
(Gemfibrozil)
Empirical formula: C
15
H
22
O
3
. MW: 250.35. CAS No: [25812-30-0]
_ _
_ _
DESCRIPTION
Gemfibrozil is a nonhalogenated phenoxypentanoic acid with the
chemical name of 5-(2,5-
dimethylphenoxy)-2,2-dimethylpentanoic acid.
It is a white, waxy powder with a melting point of 58
º
C to 61°C. The solubility in water and
acid is 0.0019% (w/v). The solubility in dilute base is over 1%.
AUSGEM tablets contain gemfibrozil 600 mg and the excipients;
povidone, polysorbate 80,
crospovidone, pregelatinised maize starch, microcrystalline cellulose,
colloidal anhydrous
silica, croscarmellose sodium, magnesium stearate and sodium lauryl
sulphate.
The tablet coating contains polydextrose, hydroxypropyl
methylcellulose, titanium dioxide,
triacetin and polyethylene glycol.
PHARMACOLOGY
PHARMACODYNAMICS
Gemfibrozil
is
a
lipid
regulating
agent
which
decreases
serum
triglycerides
and
total
cholesterol and very low density lipoprotein cholesterol (VLDL), and
increases high density
lipoprotein cholesterol (HDL-cholesterol). The lipid lowering changes
occur primarily in the
very low density lipoprotein (VLDL) fraction rich in triglycerides and
to a lesser extent in the
AUSGEM- Product Information
Page 2 of 10
low density lipoprotein (LDL) fraction rich in cholesterol. AUSGEM
treatment of patients
with elevated triglycerides due to Type IV hyperlipoproteinaemia may
cause a rise in LDL
cholesterol.
Gemfibrozil
increases
the
HDL-cholesterol
subfractions,
HDL
2
and
HDL
3
,
as
well
as
apolipoproteins AI and AII.
Gemfibrozil’s exact mechanism of action is still unknown. In humans,
gemfibrozil inhibits
peripheral lipolysis and decreases the hepatic extraction of free
fatty acids, thus reducing
hepatic triglyceride production. Gemfibrozil also inhibits synthesis
and increases clearance of
apolipoprotein B, which is a carrier of VLDL, leading to a decrease in
VLDL production.
While modest decreases in total and LDL-cholesterol may b