ISENTRESS raltegravir 100 mg chewable tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

raltegravir potassium, Quantity: 108.6 mg (Equivalent: raltegravir, Qty 100 mg)

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Raltegravir potassium

Pharmaceutical form:

Tablet, chewable

Composition:

Excipient Ingredients: hyprolose; sucralose; saccharin sodium; sodium citrate dihydrate; mannitol; sodium stearylfumarate; magnesium stearate; iron oxide yellow; crospovidone; iron oxide red; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides; sorbitol; ammonium glycyrrhizinate; fructose; Flavour; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

60 chewable tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ISENTRESS or ISENTRESS HD, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents and children from the age of 2 years.,This indication is based on analyses of plasma HIV-1 RNA levels in controlled studies of ISENTRESS (see Section 5.1).,The indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24 weeks in a multicentre, open label, noncomparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,The use of other active antiretroviral agents in combination with ISENTRESS is associated with a greater likelihood of treatment response (see Section 5.1).,There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.

Product summary:

Visual Identification: Pale orange, oval shaped tablet scored on both sides: one side is imprinted with the MSD logo and '477' on either side of the score.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-02-06

Patient Information leaflet

ISENTRESS
® AND
ISENTRESS HD
®
_raltegravir_
CONSUMER MEDICINE INFORMATION
THE FOLLOWING INFORMATION IS APPLICABLE TO ISENTRESS (400 MG TABLET,
25 MG AND 100 MG CHEWABLE TABLET) AND
ISENTRESS HD (600 MG TABLET)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the ISENTRESS
product range.
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 ISENTRESS
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 ISENTRESS IS
USED FOR
ISENTRESS is used in combination
with other anti-HIV medicines to
treat adults, adolescents and children
2 years of age and older who are
infected with HIV. The children and
adolescents (2 - 18 years of age) who
participated in the ISENTRESS
studies had previously taken HIV
medicines.
ISENTRESS belongs to a group of
medicines called integrase inhibitors.
It works by blocking HIV integrase,
one of the enzymes that is needed
during the replication process for
HIV to make more virus. When
integrase is blocked by ISENTRESS,
the virus is not able to reproduce
normally. This helps reduce the
amount of virus in the blood.
When used with other anti-HIV
medicines, ISENTRESS helps reduce
the amount of HIV virus in your
blood (called "viral load") and
increase the number of CD4 (T)
cells.
ISENTRESS may not have these
effects in all patients.
ISENTRESS DOES NOT CURE HIV
INFECTION OR AIDS.
It is very important that you stay
under the care of your doctor during
treatment with ISENTRESS.
BEFORE YOU TAKE
ISENTRESS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ISENTRESS IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
raltegravir
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reactio

Summary of Product characteristics

WPC-MK0518-MF-012018
AUS-2018-017933
AUSTRALIAN PRODUCT INFORMATION
ISENTRESS
®
and ISENTRESS HD
®
(raltegravir potassium) tablets
1 NAME OF THE MEDICINE
ISENTRESS (raltegravir) 400 mg tablet, 25 mg chewable tablet and 100
mg chewable tablet.
ISENTRESS HD (raltegravir) 600 mg tablet.
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
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. The pKa is 6.6 in water.
The octanol/water partition at pH 7.4 is 2.80.
ISENTRESS HD 600 MG TABLET
Each film-coated tablet of ISENTRESS HD contains 600 mg of raltegravir
(as potassium salt).
ISENTRESS 400 MG TABLET
Each film-coated tablet of ISENTRESS contains 400 mg of raltegravir
(as potassium salt).
ISENTRESS 100 MG CHEWABLE TABLET
Each chewable tablet contains 100 mg of raltegravir (as potassium
salt).
ISENTRESS 25 MG CHEWABLE TABLET
Each chewable tablet contains 25 mg of raltegravir (as potassium
salt).
For the full list of excipients, see Section 6.1 List of excipients.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ISENTRESS or ISENTRESS HD, in combination with other antiretroviral
agents, is indicated for the
treatment of human immunodeficiency virus (HIV-1) infection in adults,
adolescents and children from
the age of 2 years.
This indication is based on analyses of plasma HIV-1 RNA levels in
controlled studies of ISENTRESS
(see Section 5.1).
The indication in paediatric patients is based on the evaluation of
safety, tolerability, pharmacokinetic
parameters and efficacy of ISENTRESS through at least 24 weeks in a
multicentre, open label, non-
comparative study in HIV-1 infected, treatment-experienced children
and adolescents 2 to 18 years of
age.
The use of other active antiretroviral agents in combination with
ISENTRESS is associated with a
greater likelihood of treatment response (see Section 5.1).
WPC-MK0518-MF-012018
AUS-2018-017933
There are no study results