Atorvastatin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Atorvastatin calcium trihydrate 10.825mg equivalent to atorvastatin 10 mg

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Name):

Atorvastatin calcium trihydrate 10.825 mg (equivalent to atorvastatin 10 mg)

Dosage:

10 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Atorvastatin calcium trihydrate 10.825mg equivalent to atorvastatin 10 mg Excipient: Butylated hydroxyanisole Colloidal silicon dioxide Croscarmellose sodium Sepifilm LP 010 Magnesium stearate Mannitol Microcrystalline cellulose Purified water Sodium carbonate Sodium laurilsulfate

Prescription type:

Prescription

Manufactured by:

Ind-Swift Laboratories Limited

Therapeutic indications:

Indicated as an adjunct to diet to reduce elevated total-C, LDL-C and TG levels in patients with primary hypercholesterolaemia or mixed dyslipidaemia where the primary abnormality is either elevated cholesterol or triglycerides when response to diet and other non-pharmacological measures is inadequate. Atorvastatin tablet is also indicated to reduce total-C and LDL-C in patients with heterozygous and homozygous familial hypercholesterolaemia.

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu-Alu cold form laminate & aluminium foil, calendar pack of 4 x 7 strips - 28 tablets - 18 months from date of manufacture stored at or below 25°C

Authorization date:

2016-07-05

Patient Information leaflet

ATORVASTATIN 10mg, 20mg, 40mg, 80mg film-coated tablets (Pharmacare®)
1
ATORVASTATIN 10MG, 20MG, 40MG & 80MG FILM-COATED
TABLETS (PHARMACARE®)
_Atorvastatin (as Atorvastatin calcium)_
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
Atorvastatin.
It does not contain all of 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 Atorvastatin
against the benefits he/she
expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT
ATORVASTATIN
IS USED FOR
Atorvastatin is used to lower
high
cholesterol levels.
Atorvastatin is also used to
help
reduce the risk of having a heart
attack or stroke in people who have
high blood pressure and coronary
heart disease (CHD) or who are at
risk of CHD. Examples of risk
factors for CHD include diabetes, a
history of stroke, or small blood
vessel disease.
_WHAT IS CHOLESTEROL?_
Everyone has cholesterol in their
blood. It is a type of blood fat
needed by the body for many things,
such as building the cell lining,
making bile acids (which help to
digest food) and some hormones.
However, too much cholesterol can
be a problem.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body makes too much
cholesterol or you have too much
cholesterol in your diet, then your
level becomes too high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
There are different types of
cholesterol. LDL, or low-density
lipoprotein, is the 'bad' cholesterol
that can block your blood vessels.
HDL, or high density lipoprotein,
cholesterol is the 'good' cholesterol
that is thought to remove the bad
cholesterol from the blood vessels.
When you have high levels of 'bad'
cholesterol i

Summary of Product characteristics

Page 1 of 24
NEW ZEALAND
DATA SHEET
ATORVASTATIN 10MG, 20MG, 40MG & 80MG FILM-COATED TABLETS
(PHARMACARE®)
(AS A
TORVASTATIN
CALCIUM)
NAME OF MEDICINE
Atorvastatin 10mg, 20mg, 40mg & 80mg film-coated Tablets
(Pharmacare®)
(as Atorvastatin calcium)
Atorvastatin 10mg, 20mg, 40mg & 80mg film-coated Tablets
(Pharmacare®) contain
the
active
ingredient
atorvastatin calcium.
The
structural
formula
of atorvastatin calcium is shown below:
NHC
N
O
CH
CH
3
CH
3
CH
2
CH
2
CH
2
CH
2
CH
CH
C
O
O
-
F
•Ca
•3H O
2
2+
OH
OH
Chemical name:
Molecular formula:
Molecular weight:
2
[R-(R*,R*)]-2-(4-fluorophenyl)-ß,

-dihydroxy-5-(1-
methylethyl)-3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole-1-
heptanoic acid, calcium salt (2:1)
(C
33
H
34
FN
2
O
5
)
2
Ca.3H
2
O
1209.42
CAS registry number:
134523-03-8
DESCRIPTION
Atorvastatin calcium is a white to off-white crystalline powder that
is practically insoluble in
a q u e o u s
s o l u t i o n s
o f
pH 4
a n d
below. Atorvastatin
c a l c i u m
i s
very slightly soluble
in
distilled water, pH 7.4 phosphate buffer and acetonitrile, slightly
soluble in ethanol and freely
soluble in methanol.
A t o r v a s t a t i n
1 0 m g ,
2 0 m g ,
4 0 m g
&
8 0 m g
f i l m - c o a t e d
t a b l e t s
( P h a r m a c a r e ® )
contain
10 mg,
20 mg,
40 mg
o r
80 mg
o f
atorvastatin (as atorvastatin calcium), and the following
inactive ingredients:
Bulk tablets: Mannitol, Sodium lauryl sulphate, Colloidal anhydrous
silica, Anhydrous sodium
carbonate, Butyl hydroyanisole, Microcrystalline cellulose,
Croscarmellose sodium and
Magnesium stearate. Film coat: Hypromellose, Microcrystalline
cellulose and Stearic acid.
Page 2 of 24
PHARMACOLOGY
PHARMACODYNAMICS
Atorvastatin and its metabolites are responsible for pharmacological
activity in humans. The
liver is its primary site of action and the principal site of
cholesterol synthesis and LDL
clearance. Drug dose rather than systemic drug concentration
correlates better with LDL-C
reduction.
Individualisation of drug dose should be based on therapeutic