ISENTRESS® 400MG TABLET

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Raltegravir potassium 434.4mg eqv free phenol

זמין מ:

MSD PHARMA (SINGAPORE) PTE. LTD.

קוד ATC:

J05AX08

כמות:

400 mg

טופס פרצבטיות:

TABLET, FILM COATED

הרכב:

Raltegravir potassium 434.4mg eqv free phenol 400 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

Prescription Only

תוצרת:

MSD International GmbH (Ballydine)

מצב אישור:

ACTIVE

תאריך אישור:

2008-11-05

עלון מידע

PRODUCT CIRCULAR  

SG-MK0518-T-102013 
ISENTRESS® Tablets 
(raltegravir 400 mg) 
ISENTRESS® Chewable Tablets 
(raltegravir 25 mg and 100 mg) 

I.  THERAPEUTIC CLASS 

ISENTRESS  (raltegravir)  is  an  HIV  integrase  strand  transfer  inhibitor  active  against  the  Human 
Immunodeficiency Virus (HIV-1).  

II.  CHEMISTRY 

The  chemical  name  for  raltegravir  potassium  is 
N
-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-
methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-
pyrimidinecarboxamide monopotassium salt. 

The empirical formula is C
20
H
20
FKN
6
O
5 
and the molecular weight is 482.51. The structural formula is: 

N
N
H
N
O
H
N
O
O
H
3
C
CH
3
H
3
C
O
N
N
O
H
3
C
F
K

Raltegravir  potassium  is  a  white  to  off-white  powder.  It  is  soluble  in  water,  slightly  soluble  in  methanol, 
very slightly soluble in ethanol and acetonitrile and insoluble in
isopropanol. 

III.  COMPOSITION 

IIIa.  Active Ingredients 

2 

Each film-coated tablet of ISENTRESS contains 434.4 mg of raltegravir (as potassium salt), equivalent to 
400 mg of raltegravir free phenol. 

Each  100  mg  chewable  tablet  of  ISENTRESS  contains  108.6  mg  of  raltegravir  (as  potassium  salt), 
equivalent to 100 mg of raltegravir free phenol.  

Each  25  mg  chewable  tablet  of  ISENTRESS  contains  27.16  mg  of  raltegravir  (as  potassium  salt), 
equivalent to 25 mg of raltegravir free phenol. 

IIIb.  Inactive Ingredients - 400 mg Tablet 

Each  film-coated  tablet  of  ISENTRESS  contains  the  following  inactive  ingredients:  microcrystalline 
cellulose,  lactose  monohydrate,  calcium  phosphate  dibasic  anhydrous,  hypromellose 2208, 
poloxamer 407  (co

מאפייני מוצר

PRODUCT CIRCULAR
SG-MK0518-T-112020
ISENTRESSⓇ HD Tablets
(raltegravir 600 mg)
ISENTRESSⓇ Tablets
(raltegravir 400 mg)
ISENTRESSⓇ Chewable Tablets
(raltegravir 25 mg and 100 mg)
I. THERAPEUTIC CLASS
ISENTRESS
(raltegravir)
is
an
HIV
integrase
strand
transfer
inhibitor
active
against
the
Human
Immunodeficiency Virus (HIV-1).
II. CHEMISTRY
The
chemical
name
for
raltegravir
potassium
is
N
-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-
methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-
pyrimidinecarboxamide monopotassium salt.
The empirical formula is C
20
H
20
FKN
6
O
5
and the molecular weight is 482.51. The structural formula is:
N
N
H
N
O
H
N
O
O
H
3
C
CH
3
H
3
C
O
N
N
O
H
3
C
F
K
Raltegravir potassium is a white to off-white powder. It is soluble in
water, slightly soluble in methanol,
very slightly soluble in ethanol and acetonitrile and insoluble in
isopropanol.
III. COMPOSITION
IIIa. Active Ingredients
Each 600 mg film-coated tablet of ISENTRESS contains 651.6 mg of
raltegravir (as potassium salt),
equivalent to 600 mg of raltegravir free phenol.
Each 400 mg film-coated tablet of ISENTRESS contains 434.4 mg of
raltegravir (as potassium salt),
equivalent to 400 mg of raltegravir free phenol.
Each 100 mg chewable tablet of ISENTRESS contains 108.6 mg of
raltegravir (as potassium salt),
equivalent to 100 mg of raltegravir free phenol.
Each 25 mg chewable tablet of ISENTRESS contains 27.16 mg of
raltegravir (as potassium salt),
equivalent to 25 mg of raltegravir free phenol.
IIIb. Inactive Ingredients – 400 mg Tablet
Each
400 mg
film-coated
tablet
of
ISENTRESS
contains
the
following
inactive
ingredients:
microcrystalline
cellulose,
lactose
monohydrate,
calcium
phosphate
dibasic
anhydrous,
hypromellose 2208, poloxamer 407 (contains 0.01% butylated
hydroxytoluene as antioxidant), sodium
stearyl fumarate, magnesium stearate. In addition, the film coating
contains the following inactive
ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol
3350, talc, red