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

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

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

제공처:

Medis Pharma Pty Ltd

약제 형태:

Tablet, film coated

구성:

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

관리 경로:

Oral

패키지 단위:

10, 30

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

CAMDIS (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.

제품 요약:

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

승인 상태:

Registered

승인 날짜:

2018-04-02

제품 특성 요약

CAMDIS PI ver003 10-16
Page 1 of 34
PRODUCT INFORMATION
CAMDIS 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
CAMDIS amlodipine (as besilate) and atorvastatin (as calcium) 5
mg/10mg, 5 mg/20mg,
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.
CAMDIS 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:
CAMDIS 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
CAMDIS tablet contains the following inactive ingredients:
calcium carbonate, croscarmellose sodium, microcrystalline cellulose,
pregelatinised maize
starch, polysorbate 80, hyprolose, colloidal anhydrous silica,
magnesium stearate, Opadry II
White complete film coating sy