ALUVIA

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

LOPINAVIR, RITONAVIR

Tersedia dari:

ABBOTT INDONESIA - Indonesia

INN (Nama Internasional):

LOPINAVIR, RITONAVIR

Dosis:

200 MG /50 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

BOTOL PLASTIK @ 120 TABLET SALUT SELAPUT

Diproduksi oleh:

ABBVIE DEUTSCHLAND GMBH & CO. KG - Federal Republic of Germany

Tanggal Otorisasi:

2021-12-06

Karakteristik produk

ALUVIA
TM
LOPINAVIR/RITONAVIR TABLETS
PRODUCT NAME
Lopinavir/ritonavir
TRADE NAMES
Aluvia
TM
DESCRIPTION
Lopinavir/ritonavir is a co-formulation of lopinavir and ritonavir.
Lopinavir is an inhibitor of the
HIV-1 and HIV-2 proteases. As co-formulated in Aluvia, ritonavir
inhibits the cytochrome P450
3A (CYP3A)-mediated metabolism of lopinavir, thereby providing
increased plasma levels of
lopinavir.
Lopinavir is a white to light tan powder. It is freely soluble in
methanol and ethanol, soluble in
isopropanol and practically insoluble in water. Lopinavir is
chemically designated as [1S-[1R*,
(R*),
3R*,
4R*]]-N-[4-[[2,6-
dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-
(phenylmethyl)pentyl]tetrahydro-
alpha-(_1_-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its
molecular formula is C
37
H
48
N
4
O
5
, and its molecular weight is 628.80. Lopinavir has the following
structural formula:
Ritonavir
is
chemically
designated
as
10-Hydroxy-2-methyl-5-(1-methylethyl)-1-
[2-(1-
methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic
acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular
formula is C
37
H
48
N
6
O
5
S
2
,
and its molecular weight is 720.95. Ritonavir has the following
structural formula:
Page 1 of 51
ALUVIA 200 & 100 mg
Safety Update ccds 23 21102020
DISETUJUI OLEH BPOM: 15/11/2021
EREG100346VR12100143
Lopinavir/ritonavir film coated tablets are available for oral
administration in a strength of 200
mg of lopinavir and 50 mg of ritonavir or 100 mg of lopinavir and 25
mg of ritonavir with the
following inactive ingredients: copovidone sorbitan laurate, colloidal
anhydrous silica, and
sodium stearyl fumarate.
The following are the ingredients in the film coating:
200/50 mg Tablets:
Strength and
Color
of
Tablet
List of ingredients in the film coating
200/50
mg
Red tablet
Hypromellose, titanium dioxide, macrogols type 400, hydroxypropyl
cellulose,
talc, colloidal anhydrous silica, macrogols type 3350, red ferric
oxide E172, and
polysorbate 80
100/25 mg Tablets: