Norvir Tablets 100 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ritonavir

Available from:

ABBVIE PTE. LTD.

ATC code:

J05AE03

Dosage:

100.0 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Ritonavir 100.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

AbbVie Deutschland GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2013-01-15

Patient Information leaflet

Page 1 of 19 
NORVIR® 
(ritonavir tablets) 
(ritonavir capsules) 
(ritonavir oral solution) 

WARNING CO-ADMINISTRATION OF NORVIR WITH CERTAIN NONSEDATING 
ANTIHISTAMINES, SEDATIVE HYPNOTICS, ANTIARRHYTHMICS, OR ERGOT ALKALOID 
PREPARATIONS MAY RESULT IN POTENTIALLY SERIOUS AND/OR LIFE-THREATENING 
ADVERSE EVENTS DUE TO POSSIBLE EFFECTS
OF NORVIR ON THE HEPATIC METABOLISM 
OF
CERTAIN DRUGS. SEE CONTRAINDICATIONS AND PRECAUTIONS SECTIONS. 

DESCRIPTION 
Ritonavir is an inhibitor of HIV protease with activity against
the Human Immunodeficiency Virus (HIV). 
Ritonavir is a white to light
tan powder and has a bitter metallic taste. It
is freely soluble in methanol and 
ethanol, soluble in isopropanol
and practically insoluble in water. 
Ritonavir is chemically designated 10-Hydroxy-2-methyl-5-(1-methylethyl)1-[2-(1-methylethyl) -4-thiazolyl]-
3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12tetraazatridecan-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 molecular weight is 720.95. Ritonavir has 
the following structure: 

Ritonavir is supplied as
a film coated tablet, oral solution and as a soft
gelatin capsule. 

Ritonavir film coated tablets are available for oral administration in a strength of 100 mg with the following 
inactive ingredients: copovidone, dibasic
calcium phosphate anhydrous / calcium hydrogen phosphate 
anhydrous, sorbitan monolaurate, colloidal silicon dioxide /
colloidal anhydrous silica and sodium stearyl 
fumarate. The following are the ingredients in the film coating: hypromellose, titanium dioxide E171, 
polyethylene glycol 400 / macrogol type 400, hydroxylpropyl
cellulose, talc, polyethylene glycol 3350 / 
macrogol type 3350, colloidal silicon dioxide /
colloidal silica anhydrous and polysorbate 80. 

Ri

Summary of Product characteristics

Page 1 of 19
NORVIR®
(ritonavir tablets)
WARNING CO-ADMINISTRATION OF NORVIR WITH CERTAIN NONSEDATING
ANTIHISTAMINES, SEDATIVE HYPNOTICS, ANTIARRHYTHMICS, OR ERGOT ALKALOID
PREPARATIONS MAY RESULT IN POTENTIALLY SERIOUS AND/OR LIFE-THREATENING
ADVERSE EVENTS DUE TO POSSIBLE EFFECTS OF NORVIR ON THE HEPATIC
METABOLISM
OF CERTAIN DRUGS. SEE CONTRAINDICATIONS AND PRECAUTIONS SECTIONS.
DESCRIPTION
Ritonavir is an inhibitor of HIV protease with activity against the
Human Immunodeficiency Virus (HIV).
Ritonavir is a white to light tan powder and has a bitter metallic
taste. It is freely soluble in methanol and
ethanol, soluble in isopropanol and practically insoluble in water.
Ritonavir is chemically designated
10-Hydroxy-2-methyl-5-(1-methylethyl)1-[2-(1-methylethyl)
-4-thiazolyl]-
3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12tetraazatridecan-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 molecular weight is 720.95. Ritonavir has
the following structure:
Ritonavir is supplied as a film coated tablet.
Ritonavir film coated tablets are available for oral administration in
a strength of 100 mg with the following
inactive ingredients: copovidone, dibasic calcium phosphate anhydrous
/ calcium hydrogen phosphate
anhydrous, sorbitan monolaurate, colloidal silicon dioxide / colloidal
anhydrous silica and sodium stearyl
fumarate. The following are the ingredients in the film coating:
hypromellose, titanium dioxide E171,
polyethylene glycol 400 / macrogol type 400, hydroxylpropyl cellulose,
talc, polyethylene glycol 3350 /
macrogol type 3350, colloidal silicon dioxide / colloidal silica
anhydrous and polysorbate 80.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_
Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1
and HIV-2 aspartyl proteases. Inhibition of
HIV protease renders the enzyme incapable of processing the gag-pol
polyprotein precursor which leads to the
production of HIV particles with immature morphology that are unable
to initiate new ro