CONCOR AM

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

AMLODIPINE BESILATE; BISOPROLOL FUMARATE

Tersedia dari:

MERCK TBK - Indonesia

INN (Nama Internasional):

AMLODIPINE BESILATE; BISOPROLOL FUMARATE

Dosis:

5 MG / 10 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 3 BLISTER @ 10 TABELT

Diproduksi oleh:

EGIS PHARMACEUTICALS PLC.

Tanggal Otorisasi:

2019-07-02

Karakteristik produk

_Page 1 of 12 _
CONCOR® AM
BISOPROLOL FUMARATE/AMLODIPINE BESILATE
ANTIHYPERTENSIVE
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Concor AM 5 mg/5 mg tablets: 5 mg Bisoprolol fumarate, 5 mg Amlodipine
(as 6.95 mg Amlodipine
besilate) per tablet.
Concor AM 5 mg/10 mg tablets: 5 mg Bisoprolol fumarate, 10 mg
Amlodipine (as 13.9 mg Amlodipine
besilate) per tablet.
Concor AM 10 mg/5 mg tablet: 10 mg Bisoprolol fumarate and 5 mg
Amlodipine (as 6.95 mg Amlodipine
besilate) per tablet.
2.
PHARMACEUTICAL FORM
Tablet.
3.
CLINICAL PARTICULARS
3.1 INDICATIONS
Concor AM is indicated for the treatment of hypertension as
substitution therapy in patients adequately
controlled with the individual products given concurrently at the same
doses level as in the combination,
but as separate tablets.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
Concor AM is indicated in patients whose blood pressure is adequately
controlled with separately
administered
monocomponent
products
of
the
same
doses
as
the
recommended
fixed
dose
combination.
POSOLOGY
Recommended daily dose is one tablet of the given strength.
Treatment must not be abruptly discontinued, as it may lead to
temporary deterioration of clinical
condition. Treatment must not be abruptly discontinued especially in
case of patients suffering from
ischaemic heart disease. Gradual decrease of the dose is recommended.
_Patients with hepatic impairment _
In case of hepatic impairment elimination of Amlodipine may be
elongated. Dosage recommendations
concerning Amlodipine have not been established in patients with mild
to moderate hepatic impairment.
The pharmacokinetics of Amlodipine have not been studied in severe
hepatic impairment. The drug
should therefore be administered with special caution in patients with
hepatic impairment (_see section _
_Special Warnings and Precautions for Use_).
In case of severe hepatic impairment the daily dose of Bisoprolol must
not exceed 10 mg.
_Patients with renal impairment _
No dosage adjustment is required for patients with mild to moderate
renal impai