STOCRIN efavirenz 200mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

efavirenz, Quantity: 200 mg

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Efavirenz

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: Carnauba Wax; hyprolose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; lactose monohydrate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

90 tablets

Prescription type:

(S4) Prescription Only Medicine

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 Clinical Trials; use in children).

Product summary:

Visual Identification: Yellow, round shaped tablet with "223" on one side & plain on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-08-22

Patient Information leaflet

STOCRIN
®
S
T
O
C
R
I
N
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING STOCRIN?
STOCRIN contains the active ingredient Efavirenz. 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.
For more information, see Section 1. Why am I using STOCRIN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE STOCRIN?
Do not use if you have ever had an allergic reaction to STOCRIN or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
STOCRIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with STOCRIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE STOCRIN?
Your doctor will tell you how many tablets you need to take each day.
•
For adults and children weighing greater than or equal to 40 kg, the
normal dose is 600 mg once a day. It is important that you
are started and continue on this dose.
•
For children and teenagers 3 to 17 years old, the dose depends on body
weight. Your child's doctor will decide the dose.
More instructions can be found in Section 4. How do I use STOCRIN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING STOCRIN?
THINGS YOU
SHOULD DO
•
Report any changes in your condition to your doctor immediately to
ensure any infections which occur
due to your low immunity are treated promptly.
•
Continue to use safe sexual practices.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking STOCRIN or change the dose without first checking
with your doctor. Do not let
yourself run out of medicine over weekends or on h

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
STOCRIN
®
(efavirenz) Tablets
1 NAME OF THE MEDICINE
Efavirenz
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
List of excipients with known effect: contains sugars (as lactose).
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
STOCRIN 50mg tablets are yellow, round shaped tablets with "113" on
one side and plain on the other.
STOCRIN 200mg tablets are yellow, round shaped tablets with "223" on
one side and plain on the
other.
STOCRIN 300mg tablets are white, capsular film-coated tablets with
"224" in purple ink on both sides.
STOCRIN 600mg tablets are yellow, capsular film-coated tablets with
"225" in purple ink on both sides.
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 Pharmacodynamic
properties 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 Adverse effects (undesirable effects)).
Concomitant Antiretroviral Therapy:
STOCRIN must be given in combination with other antiretroviral
medications (see section 4.5
Interactions with other medicines and other forms of interactions).
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.
Adolescents and Children (17 years and under):
The recommend