NORMETEC

Country: Индонезија

Језик: Индонежански

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

Активни састојак:

AMLODIPINE BESILATE; OLMESARTAN MEDOXOMIL

Доступно од:

PFIZER INDONESIA - Indonesia

INN (Међународно име):

AMLODIPINE BESILATE; OLMESARTAN MEDOXOMIL

Дозирање:

40/10 MG

Фармацеутски облик:

TABLET SALUT SELAPUT

Јединице у пакету:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Произведен од:

PFIZER MANUFACTURING DEUTSCHLAND Gmbh - Germany

Датум одобрења:

2019-06-18

Карактеристике производа

Generic Name: Olmesartan medoxomil-Amlodipine besylate
Trade Name: NORMETEC
CDS Effective Date: May, 2020
Supersedes: June, 2014
Approved by BPOM:
2016-0019627, 2018-0035315, 2020-0060226, 2017-0026039
Page 1 of 22
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Product Document Title: Olmesartan medoxomil-Amlodipine besylate
Trade Name: NORMETEC
CDS Effective Date: May, 2020
Supersedes: June, 2014
DESCRIPTION
NORMETEC is a combination of the angiotensin II receptor blocker (ARB)
olmesartan medoxomil
and the calcium channel receptor blocker (CCB) amlodipine besylate.
Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during
absorption from the
gastrointestinal tract.
Olmesartan medoxomil is chemically described as
2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-
methylethyl)-2-propyl-1-[_p-_(_o-_1_H_-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate,
cyclic 2,3-
carbonate. Its empirical formula is C
29
H
30
N
6
O
6
.
The structural formula for olmesartan medoxomil is:
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl
(±)-2-[(2-aminoethoxy) methyl]-
4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate,
monobenzenesulphonate. Its
empirical formula is C
20
H
25
CIN
2
O
5
• C
6
H
6
O
3
S.
DISETUJUI OLEH BPOM : 02/03/2021
ID : EREG10024112000478
EREG10024112000479
EREG10024112000480
Generic Name: Olmesartan medoxomil-Amlodipine besylate
Trade Name: NORMETEC
CDS Effective Date: May, 2020
Supersedes: June, 2014
Approved by BPOM:
2016-0019627, 2018-0035315, 2020-0060226, 2017-0026039
Page 2 of 22
The structural formula for amlodipine besylate is:
PHARMACEUTICAL FORM
NORMETEC is available for oral use as film-coated tablets in the
following strengths:
• Olmesartan medoxomil 20 mg plus amlodipine 5 mg (20/5 mg). White,
round, film-coated tablet
with C73 debossed on one side.
• Olmesartan medoxomil 40 mg plus amlodipine 5 mg (40/5 mg). Cream,
round, film-coated tablet
with C75 debossed on one side.
• Olmesartan medoxomil 40 mg plus amlodipine 10 mg (40/10 mg).
Brownish-red, round,
film-coat