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PREZISTA
®
TABLETS
_darunavir (da-ROO-nuh-veer) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PREZISTA (pre-
ZIS-ta) tablets. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
PREZISTA against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN PREZISTA ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING PREZISTA.
You may need to read it again.
WHAT PREZISTA IS
USED FOR
PREZISTA is used to treat adults,
and children 6 years of age or above
weighing more than 20 kg, who are
infected by HIV (Human
Immunodeficiency Virus).
PREZISTA is an antiretroviral
medicine. It belongs to a group of
medicines called protease (PRO-tee-
ase) inhibitors. PREZISTA works by
reducing the amount of HIV in your
body. Reducing the amount of HIV
in your blood improves your immune
system, and reduces the risk of
developing illnesses as a result of
HIV infection.
PREZISTA must be taken in
combination with a low dose of
ritonavir (NORVIR), and with other
anti-HIV medicines. Your doctor will
discuss with you which combination
of medicines will work best with
PREZISTA.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PREZISTA
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
PREZISTA
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE PREZISTA:
• if you are allergic
(hypersensitive) to darunavir,
other ingredients of PREZISTA
or to ritonavir.
Symptoms of an allergic reaction
may include rash, itching or hives
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产品特点
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PREZISTA
PRODUCT INFORMATION
NAME OF THE MEDICINE
Darunavir
The
chemical name for darunavir is [(1_S,_2_R_)-3-[[(4-aminophenyl)sulfonyl](2-
methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid
(3_R,_3a_S,_6a_R_)-
hexahydrofuro[2,3-_b_]furan-3-yl ester.
Darunavir has the following chemical structure:
O
O
N
H
OH
N
S
NH
2
O
O
O
O
C
27
H
37
N
3
O
7
S
MW 547.66 daltons
CAS Registry No: 206361-99-1.
DESCRIPTION
Antiviral for systemic use. Darunavir is an
inhibitor of Human Immunodeficiency Virus type 1
(HIV-1) protease.
PREZISTA darunavir is available as 75 mg, 150 mg, 400 mg, 600
mg and 800 mg film-coated
tablets (the 75 mg tablets are not currently marketed).
Each film-coated tablet contains 75 mg,
150 mg, 400 mg, 600 mg or 800 mg of darunavir, as 81.31
mg, 162.62 mg, 325.23 mg, 433.64
mg, 650.46 mg or 867.28
mg of darunavir ethanolate, respectively. Inactive
ingredients:
microcrystalline
cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate,
polyvinyl alcohol – partially hydrolysed, macrogol 3350, titanium dioxide
(E171), talc, and (400
mg, and 600 mg tablets only) sunset yellow FCF (E110). The
800 mg tablet only also contains
hypromellose and iron oxide red (E172).
Darunavir is isolated as darunavir ethanolate, a
pseudo-polymorphic form of darunavir.
Darunavir ethanolate is a white to off-white
powder that is very slightly soluble in water,
sparingly soluble in methanol, slightly soluble in
ethanol, and freely soluble in acetone and
dichloromethane.
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PHARMACOLOGY
PHARMACODYNAMICS
Mechanism of action
Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease. It
selectively inhibits the cleava
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