CADUET

Valsts: Indonēzija

Valoda: indonēziešu

Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktīvā sastāvdaļa:

ATORVASTATIN CALCIUM, AMLODIPINE BESILATE

Pieejams no:

PFIZER INDONESIA - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

ATORVASTATIN CALCIUM, AMLODIPINE BESILATE

Deva:

10.85 MG /13.87 MG

Zāļu forma:

TABLET SALUT SELAPUT

Vienības iepakojumā:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Ražojis:

PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany

Autorizācija datums:

2021-07-22

Produkta apraksts

Generic Name: Amlodipine/Atorvastatin
Trade Name: CADUET
CDS Effective Date: December 15, 2020
Supersedes: January 24, 2020
Approved by BPOM:
2020-0064301
Page 1 of 35
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Amlodipine/Atorvastatin
Trade Name: CADUET
CDS Effective Date: December 15, 2020
Supersedes: January 24, 2020
NAME OF THE MEDICINAL PRODUCT
CADUET
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients: amlodipine besilate, atorvastatin calcium
The tablets for oral administration contain amlodipine besilate and
atorvastatin calcium equivalent
to 5 mg/10 mg, 5 mg/20 mg, 10 mg/10 mg, 10 mg/20 mg,
amlodipine/atorvastatin dosage strengths
respectively.
PHARMACEUTICAL FORM
Tablets
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
CADUET (amlodipine and atorvastatin) is indicated in patients for whom
treatment with both
amlodipine and atorvastatin is appropriate.
Amlodipine is indicated for treatment of hypertension and can be used
as the sole agent to control
blood pressure (BP) 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
adrenoreceptor
blocking
agent,
or
an
angiotensin-converting enzyme inhibitor.
Amlodipine is indicated for treatment of myocardial ischemia, whether
due to fixed obstruction
(stable angina) and/or vasospasm/vasoconstriction (Prinzmetal’s or
variant angina) or coronary
vasculature.
Amlodipine
may
be
used
where
the
clinical
presentation
suggests
a
possible
vasospastic/vasoconstriction
has
not
been
confirmed.
Amlodipine
may
be
used
alone,
as
monotherapy, or in combination with other antianginal drugs in
patients with angina that is refractory
to nitrates and/or adequate doses or beta-blockers.
Atorvastatin is indicated as an adjunct to diet for the reduction of
elevated total cholesterol (total-C),
low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B),
and triglycerides (TG) in
patients with primary hy