STOCRIN® 50mg TABLET

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Efavirenz

Fáanlegur frá:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC númer:

J05AG03

Skammtar:

50.0 mg

Lyfjaform:

TABLET

Samsetning:

Efavirenz 50.0 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Leyfisstaða:

ACTIVE

Leyfisdagur:

2008-07-31

Upplýsingar fylgiseðill

STOCRIN 

SG-MK0831-MF-112013 
(efavirenz) 

PRODUCT CIRCULAR 

TABLETS 
STOCRIN
®

(EFAVIRENZ) 

I.  THERAPEUTIC CLASS 

STOCRIN
* [/sg_wm_1296.html#1]
  [/sg_wm_1296.html#1]is a non-nucleoside reverse transcriptase
inhibitor of human immunodeficiency virus type 1 
(HIV-1). 

II.  INDICATIONS 

STOCRIN is indicated in antiviral combination treatment  of HIV-1
infected adults, adolescents and 
children. 

III.  DOSAGE AND 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.  It is 
recommended that STOCRIN be taken on an empty stomach. 

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 SIDE EFFECTS). 

CONCOMITANT ANTIRETROVIRAL THERAPY: STOCRIN must be given in
combination with other antiretroviral 
medications (see DRUG INTERACTIONS). 

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 Table 1. STOCRIN tablets should only be administered to children who are able to reliably swallow 
tablets.  It is recommended that STOCRIN be taken on an empty stomach.  STOCRIN has not been 
adequately studied in children under the age of 3
years or children weighing less than 13 kg.   

TABLE 1 
PEDIATRIC DOSE TO BE ADMINISTERED ONCE DAILY

STOCRIN TABLETS 
DOSE (MG) 
BODY  
WEIGHT KG 

13 to <15 
200 
15 to < 20 
250 
20 to < 25 
300 
25 to < 32.5 
350 
32.5 to <

Vara einkenni

STOCRIN
S-SG-MK0831-MF-042020
(efavirenz)
PRODUCT CIRCULAR
Tablets
STOCRIN®
(efavirenz)
I. THERAPEUTIC CLASS
STOCRIN is a non-nucleoside reverse transcriptase inhibitor of human
immunodeficiency virus type 1
(HIV-1).
II. INDICATIONS
STOCRIN is indicated in antiviral combination treatment of HIV-1
infected adults, adolescents and
children.
III. DOSAGE AND 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. It is
recommended that STOCRIN be taken on an empty stomach.
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 SIDE EFFECTS).
Concomitant Antiretroviral Therapy: STOCRIN must be given in
combination with other antiretroviral
medications (see DRUG INTERACTIONS).
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 Table 1.
STOCRIN tablets should only be administered to children who are able
to reliably swallow tablets. It is
recommended that STOCRIN be taken on an empty stomach. STOCRIN tablets
have not been
adequately studied in children under the age of 3 years or children
weighing less than 13 kg (see
PRECAUTIONS and PEDIATRIC USE).
Table 1
Pediatric Dose to be Administered Once Daily
STOCRIN Tablets
Dose (mg)
Body
Weight kg
13 to < 15
200
15 to < 20
250
20 to < 25
300
25 to < 32.5
350
32.5 to < 40
400
≥ 40
600
IV. CONTRAINDICATIONS
STOCRIN
is
contraindicated
in
patients
with
clinically
significant
hypersensitivity
to
any
of
its
components.
STOCRIN is contraindicated with elbasvir/grazoprevir due to the
expected significant decreases in
elbasvir and grazoprevir plasma concentrations (see DRUG
INTERACTIONS). This effect is due to
an induction of CYP3A4 by efavirenz and is expecte