Isentress® Chewable Tablet 100 mg

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Raltegravir Potassium 108.6 mg eqv Raltegravir

זמין מ:

MSD PHARMA (SINGAPORE) PTE. LTD.

קוד ATC:

J05AX08

כמות:

100 mg

טופס פרצבטיות:

TABLET, CHEWABLE

הרכב:

Raltegravir Potassium 108.6 mg eqv Raltegravir 100 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

Prescription Only

תוצרת:

Patheon Pharmaceuticals Inc.

מצב אישור:

ACTIVE

תאריך אישור:

2014-03-07

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®-G Tablets
(raltegravir 400 mg)
ISENTRESS® Chewable Tablets
(raltegravir 25 mg and 100 mg)
I. THERAPEUTIC CLASS
ISENTRESS-G (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 film-coated tablet of ISENTRESS-G 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-G 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, and black
iron oxide.
IIIc. Inactive Ingredients – Chewable Tablets
Each 100 mg chewable tablet of ISENTRESS contains the following
inactive ingredients: hydroxypropyl
cellulose, sucralose, saccharin so