TYGACIL

Страна: Индонезия

Език: индонезийски

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

Активна съставка:

TIGECYCLINE

Предлага се от:

PFIZER INDONESIA - Indonesia

INN (Международно Name):

TIGECYCLINE

дозиране:

50 MG

Лекарствена форма:

SERBUK INJEKSI

Броя в опаковка:

DUS, 10 VIAL @ 50 MG

Произведено от:

WYETH LEDERLE S.p.A - Italy

Дата Оторизация:

2017-12-12

Данни за продукта

Generic Name: Tigecycline
Trade Name: TYGACIL
TM
CDS Effective Date: December 01, 2020
Supersedes: November 15, 2019
Approved by BPOM:
2020-0065601
Page 1 of 24
PT PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Tigecycline
Trade Name: TYGACIL
TM
CDS Effective Date: December 01, 2020
Supersedes: November 15, 2019
℞ only
DESCRIPTION
TYGACIL (tigecycline) is a glycylcycline antibacterial for intravenous
infusion. The
chemical name of tigecycline is
(4_S_,4a_S_,5a_R_,12a_S_)-9-[2-(_tert_-butylamino)acetamido]-
4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-
dioxo-2-naphthacenecarboxamide. The
empirical
formula
is
C
29
H
39
N
5
O
8
and
the
molecular weight is 585.65.
The following represents the chemical structure of tigecycline:
TYGACIL is an orange lyophilized powder or cake. Each TYGACIL vial
contains
50 mg tigecycline lyophilized powder for intravenous infusion. Each
vial contains
100 mg of lactose monohydrate. The pH is adjusted with hydrochloric
acid, and if
necessary sodium hydroxide.
CLINICAL PHARMACOLOGY
Anti-infective
Glycylcycline antibacterial
ATC code: J01C XXX
PHARMACOKINETICS
The
mean
pharmacokinetic parameters
of
tigecycline
after
single
and
multiple
intravenous doses are summarized in Table 1. Intravenous infusions of
tigecycline were
administered over approximately 30 to 60 minutes.
TABLE 1. MEAN (CV%) PHARMACOKINETIC PARAMETERS OF TIGECYCLINE
Single Dose
100 mg
Multiple Dose
a
50 mg q 12h
C
max
(
µ
g/mL)
b
1.45 (22%)
0.87 (27%)
C
max
(
µ
g/mL)
c
0.90 (30%)
0.63 (15%)
AUC (
µ
g·h/mL)
5.19 (36%)
--
AUC
0-24h
(
µ
g·h/mL)
--
4.70 (36%)
C
min
(
µ
g/mL)
--
0.13 (59%)
DISETUJUI OLEH BPOM: 26/08/2021
ID: EREG10024112100344
Generic Name: Tigecycline
Trade Name: TYGACIL
TM
CDS Effective Date: December 01, 2020
Supersedes: November 15, 2019
Approved by BPOM:
2020-0065601
Page 2 of 24
t
1/2
(h)
27.1 (53%)
42.4 (83%)
CL (L/h)
21.8 (40%)
23.8 (33%)
CL
r
(mL/min)
38.0 (82%)
51.0 (58%)
V
ss
(L)
568 (43%)
639 (48%)
a
100 mg initially, followed by 50 mg every 12 ho