ALUVIA

Country: Indonesia

Language: Indonesian

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

Active ingredient:

LOPINAVIR, RITONAVIR

Available from:

ABBOTT INDONESIA - Indonesia

INN (International Name):

LOPINAVIR, RITONAVIR

Dosage:

200 Mg /50 Mg

Pharmaceutical form:

TABLET SALUT SELAPUT

Units in package:

BOTOL PLASTIK @ 120 TABLET SALUT SELAPUT

Manufactured by:

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

Authorization date:

2020-12-03

Summary of Product characteristics

Page 1 of 45
ALUVIA 200 & 100 mg
Posology Update 16032020
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:
DISETUJUI OLEH BPOM : 22/05/2020
218245429 - 218245430
Page 2 of 45
ALUVIA 200 & 100 mg
Posology Update 16032020
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