STOCRIN efavirenz 30mg/mL oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

efavirenz

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

Authorization status:

Registered

Patient Information leaflet

STOCRIN
®
_Efavirenz_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about STOCRIN. 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 STOCRIN
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 AIDS COUNCIL.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT STOCRIN IS
USED FOR
STOCRIN is used to help treat HIV
(Human Immunodeficiency Virus)
infection. It is used in combination
with other appropriate medicines
used to treat the HIV virus. Examples
include protease inhibitors such as
indinavir (Crixivan*) and nelfinavir
(Viracept*). They also include
nucleoside analogue reverse
transcriptase inhibitors (NRTIs) such
as zidovudine (AZT, Retrovir*) or
lamivudine (3TC).
STOCRIN belongs to a group of
medicines called non-nucleoside
reverse transcriptase inhibitors
(NNRTIs). It works by interrupting
the formation of new HIV particles in
already infected cells. When HIV is
attacked by STOCRIN, the virus is
not able to reproduce normally. This
helps reduce the amount of virus in
the blood. Although STOCRIN helps
reduce the amount of virus in the
blood and thus increases the CD4
count, it has not yet been shown to
improve survival or slow the
progression of the disease.
You may continue to develop
infections or other illnesses
associated with HIV disease while
you are taking STOCRIN.
BEFORE YOU TAKE
STOCRIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE STOCRIN IF:
•
YOU HAVE AN ALLERGY TO
STOCRIN 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.
•
YOU ARE BREAST FEEDING OR PLAN
TO BREAST FEED
It is po

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
STOCRIN
®
(efavirenz) Tablets and Oral Solution
1 NAME OF THE MEDICINE
Efavirenz
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Efavirenz is a white to slightly pink crystalline powder.
STOCRIN is available as tablets for oral administration. Each STOCRIN
tablet contains 50, 200, 300
or 600 mg of efavirenz. STOCRIN is also available as an oral solution
containing 30 mg efavirenz per
mL.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
STOCRIN is indicated for use in combination with other antiviral
agents for the treatment of HIV-1
infection in adults and children (See section 5.1; Use in Children).
4.2 DOSE AND METHOD OF ADMINISTRATION
STOCRIN should be taken in the fasted state, preferably at bedtime.
Food increases the
bioavailability of STOCRIN and this may be associated with a higher
frequency of side effects.
In order to improve the tolerability of nervous system side effects,
bedtime dosing is recommended
during the first two to four weeks of therapy and in patients who
continue to experience these
symptoms (see section 4.8).
Concomitant Antiretroviral Therapy:
STOCRIN must be given in combination with other antiretroviral
medications (see section 4.5).
Adults:
The recommended dosage of STOCRIN in combination with a protease
inhibitor and/or nucleoside
analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally,
once daily when using the tablets
or 24 mL orally once daily when using the oral solution.
Adolescents and Children (17 years and under):
The recommended dose of STOCRIN in combination with a protease
inhibitor and/or NRTIs for
patients 17 years of age and under is described in the table below.
STOCRIN tablets should only be
administered to children who are able to reliably swallow tablets.
STOCRIN tablets or oral solution
have not been adequately studied in children under the age of 3 years
or children weighing less than
13 Kg (see section 4.4, USE IN CHILDREN).
P