Stocrin

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Efavirenz 50mg

から入手可能:

Merck Sharp & Dohme (New Zealand) Limited

INN（国際名）:

Efavirenz 50 mg

投薬量:

50 mg

医薬品形態:

Film coated tablet

構図:

Active: Efavirenz 50mg Excipient: Carnauba wax Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 03B12896 Sodium laurilsulfate

パッケージ内のユニット:

Bottle, HDPE bottle with plastic cap 30 tablets, 30 tablets

クラス:

Prescription

処方タイプ:

Prescription

製:

F.I.S. Fabbrica Italiana Sintetici SpA

製品概要:

Package - Contents - Shelf Life: Bottle, HDPE bottle with plastic cap - 30 tablets - 36 months from date of manufacture stored at or below 30°C

承認日:

2005-11-29

情報リーフレット

STOCRIN

_efavirenz _
50 mg, 200 mg & 600 mg tablets
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. 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
•
you are breast-feeding or plan to breast-feed.
You should not breast-feed if you are taking STOCRIN because of the
possibility that
your baby can be infected with HIV through your

製品の特徴

NEW ZEALAND DATA SHEET
1 PRODUCT NAME
STOCRIN
®
50 mg tablet
STOCRIN
®
200 mg tablet
STOCRIN
®
600 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
STOCRIN is an HIV-1 specific, non-nucleoside, reverse transcriptase
inhibitor (NNRTI).
STOCRIN is chemically described as (S) -6-
chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-
(trifluoromethyl)-2H-3,1-benzoxazin-2-one.
Its empirical formula is C
14
H
9
ClF
3
NO
2
and its structural formula is:
STOCRIN is a white to slightly pink crystalline powder with a
molecular mass of 315.68. It is
practically insoluble in water (<10 µg/mL).
ACTIVE INGREDIENTS
_STOCRIN 50 mg tablet: _
Each tablet contains 50 mg of efavirenz.
_STOCRIN 200 mg tablet: _
Each tablet contains 200 mg of efavirenz.
_STOCRIN 600 mg tablet: _
Each tablet contains 600 mg of efavirenz.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
STOCRIN 50 mg tablet
A yellow round shaped tablet engraved with “113” on one side and
plain on the other.
STOCRIN 200 mg tablet
A yellow round shaped tablet engraved with “223” on one side and
plain on the other.
O
N
O
Cl
H
F
3
C
STOCRIN 600 mg tablet
A yellow modified capsular shaped tablet with “225” engraved on
one side and plain on the
other.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
STOCRIN is indicated in antiviral combination treatment of HIV-1
infected adults,
adolescents and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
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.
STOCRIN may be taken with or without food, as desired.
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).
Adolescents and Children