AMLODIPINE/ATORVASTATIN-AS 10/20 amlodipine (as besilate) 10 mg and atorvastatin (as calcium) 20 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg); atorvastatin calcium trihydrate, Quantity: 21.7 mg (Equivalent: atorvastatin, Qty 20 mg)

Available from:

Medis Pharma Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMLODIPINE/ATORVASTATIN-AS (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,The indications for amlodipine are:,1. Hypertension: Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,The indications for atorvastatin are:,1. Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Product summary:

Visual Identification: Film-coated tablet, oval, biconvex, blue, "A24" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-04-02

Patient Information leaflet

AMLOPDOPINE/ATORVASTATIN-AS CMI ver002 06-16
Page 1 of 13
AMLODIPINE/ATORVASTATIN-AS
_Amlodipine Besilate and Atorvastatin Calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
Amlodipine/Atorvastatin-AS. 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
Amlodipine/Atorvastatin-AS against the benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT AMLODIPINE/ATORVASTATIN-AS IS USED FOR
Amlodipine/Atorvastatin-AS is used to treat high blood pressure and
high cholesterol (fat in
the blood). Amlodipine/Atorvastatin-AS can also be used for angina (a
certain type of chest
pain). Amlodipine/Atorvastatin-AS can be used in people who have high
blood pressure and
coronary heart disease (CHD) or who are at risk of CHD (for example,
if they have diabetes,
a history of stroke, or small blood vessel disease). In these people,
Amlodipine/Atorvastatin-
AS is used to help reduce the risk of having a heart attack or stroke.
_WHAT IS HIGH BLOOD PRESSURE? _
_ _
There are usually no symptoms of high blood pressure (hypertension).
The only way of
knowing that you have hypertension is to have your blood pressure
checked on a regular
basis. If high blood pressure is not treated it can lead to serious
health problems.
_WHAT IS CHOLESTEROL? _
_ _
Everyone has cholesterol in their blood. It is a type of blood fat
needed by the body for things
such as building 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 take too much cholesterol in your
diet, then your level
becomes too high.
AMLOPDO

Summary of Product characteristics

AMLOPDOPINE/ATORVASTATIN-AS PI ver003 10-16
Page 1 of 34
PRODUCT INFORMATION
AMLODIPINE/ATORVASTATIN-AS 5/10, 5/20, 5/40, 5/80, 10/10, 10/20,
10/40 AND 10/80
(AMLODIPINE BESILATE AND ATORVASTATIN CALCIUM)
NAME OF THE MEDICINE
AMLODIPINE/ATORVASTATIN-AS amlodipine (as besilate) and atorvastatin
(as calcium)
5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20
mg, 10 mg/40 mg
and 10 mg/80 mg tablets.
AMLODIPINE/ATORVASTATIN-AS contains the active ingredients amlodipine
besilate and
atorvastatin calcium.
AMLODIPINE BESILATE
Amlodipine besilate is a dihydropyridine derivative and has the
following structural formula
and enantiomer:
Chemical name:
3-ethyl, 5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-
chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
benzene sulphonate
Molecular formula:
C
20
H
25
ClN
2
O
5
C
6
H
6
O
3
S
Molecular weight:
567.1 (free base 408.9)
CAS registry number:
111470-99-6.
ATORVASTATIN CALCIUM
Atorvastatin calcium has the following structural formula:
AMLOPDOPINE/ATORVASTATIN-AS PI ver003 10-16
Page 2 of 34
Chemical name:
[R-(R*,R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-
3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole -1-heptanoic
acid, calcium salt (2:1)
Molecular formula:
(C
33
H
34
FN
2
O
5
)
2
Ca.3H
2
O
Molecular weight:
1209.42
CAS registry number:
134523-03-8.
DESCRIPTION
Amlodipine besilate and atorvastatin calcium are white to off white
crystalline powders.
Amlodipine besilate is slightly soluble in water and sparingly soluble
in ethanol. Atorvastatin
calcium is practically insoluble in aqueous solutions of pH 4 and
below. Atorvastatin calcium
is very slightly soluble in distilled water, pH 7.4 phosphate buffer
and acetonitrile, slightly
soluble in ethanol, and freely soluble in methanol.
In addition to the active ingredients amlodipine besilate and
atorvastatin calcium, each
AMLODIPINE/ATORVASTATIN-AS tablet contains the following inactive
ingredients:
calcium carbonate, croscarmellose sodium, microcrystalline cellulose,
pregelatinised maize