Crixivan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Indinavir sulfate 500mg equivalent to 400 mg indinavir;  ;  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Indinavir sulfate 500 mg (equivalent to 400 mg indinavir)

Dosage:

400 mg

Pharmaceutical form:

Capsule

Composition:

Active: Indinavir sulfate 500mg equivalent to 400 mg indinavir     Excipient: Gelatin Lactose Magnesium stearate TekPrint green SB-4020

Units in package:

Blister pack, Al/Al foil, 42 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck Sharp & Dohme Corp

Therapeutic indications:

Indicated for the treatment of adults with HIV-1 infection. Clinical studies demonstrated: · reduced risk of progression to an AIDS-defining illness or death · increased overall survival · durable reduction in serum viral RNA · durable increase in CD4 cell counts

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al foil - 42 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, 10 oz. HDPE - 90 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, 14oz. HDPE - 180 capsules - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1996-03-11

Patient Information leaflet

CRIXIVAN
®
_indinavir sulfate _
200 mg & 400 mg capsules
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CRIXIVAN. 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 taking
CRIXIVAN against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor,
pharmacist or
treatments officer at your local NZ AIDS Foundation.
Keep this leaflet with the medicine. You may need to read it again.
WHAT CRIXIVAN IS USED FOR
CRIXIVAN, a protease inhibitor, is used to help treat HIV (Human
Immunodeficiency
Virus) infection. It should be used in combination with other
appropriate medicines used
to treat the HIV virus, including zidovudine (AZT, Retrovir),
didanosine (ddI, Videx) or
lamivudine (3TC).
CRIXIVAN belongs to a group of medicines called HIV protease
inhibitors. It works in a
different way to the other medicines used to treat HIV. CRIXIVAN works
by interrupting
the formation of new HIV particles in already infected cells. When HIV
is attacked by
CRIXIVAN, the virus is not able to reproduce normally. This helps
reduce the amount of
virus in the body and helps protect new cells from infection.
CRIXIVAN helps reduce the amount of virus in the body and thus
increases the CD4
count, it also improves survival and slows the progression of the
disease.
You may continue to develop infections or other illnesses associated
with HIV disease
while you are taking CRIXIVAN.
BEFORE YOU TAKE CRIXIVAN
WHEN YOU MUST NOT TAKE IT
Do not take CRIXIVAN if:
•
you have an allergy to CRIXIVAN or any of the ingredients listed at
the end of this
leaflet
•
the packaging is torn or shows signs of tampering
•
the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not
work.
If you are not sure whether you should start taking CRIXIVAN, talk to
your doctor.
Do not give CRIX

Summary of Product characteristics

NAME OF MEDICINE
CRIXIVAN
®
_indinavir sulfate _
200 mg & 400 mg capsules
PRESENTATION
CRIXIVAN 200 mg: A #1 white semi-translucent capsule with
‘CRIXIVAN™ 200 mg’
printed in blue ink. Each capsule contains 200 mg of indinavir (250 mg
indinavir
sulphate). Dimensions are approximately 19.4 mm in length and 6.91 mm
in diameter.
CRIXIVAN 400 mg: A #00 white semi-translucent capsule with
‘CRIXIVAN™ 400 mg’
printed in green ink. Each capsule contains 400 mg of indinavir (500
mg indinavir sulfate).
Dimensions are approximately 25.3 mm in length and 8.53 mm in
diameter.
THERAPEUTIC CLASS
CRIXIVAN (indinavir sulfate) is a specific protease inhibitor active
against the Human
Immunodeficiency Virus (HIV-1).
INDICATIONS
CRIXIVAN is indicated for the treatment of adults with HIV-1
infection. Clinical studies
demonstrated:
•
reduced risk of progression to an AIDS-defining illness or death
•
increased overall survival
•
durable reduction in serum viral RNA
•
durable increase in CD4 cell counts
DOSAGE AND ADMINISTRATION
The recommended dosage of CRIXIVAN is 800 mg (usually given as two 400
mg
capsules) orally every 8 hours. Therapy with CRIXIVAN must be
initiated at the
recommended dose of 2.4 gm/day.
It should be noted that the decrease in suppression of viral RNA
levels was seen more
frequently when therapy with indinavir was initiated at doses lower
than the recommended
oral dose of 2.4 gm/day. Therefore, therapy with indinavir should be
initiated at the
recommended dose to increase suppression of viral replication and
therefore inhibit the
emergence of resistant virus.
CRIXIVAN should be used:
•
in combination with approved antiretroviral agents (e.g. nucleoside
and non-nucleoside
reverse transcriptase inhibitors), for the treatment of adult patients
with HIV-1 infection.
Since CRIXIVAN must be taken at intervals of 8 hours, a schedule
convenient for the
patient should be developed. For optimal absorption, CRIXIVAN should
be administered
without food but with water 1 hour before or 2 hours after a mea