CP PHARMA CETIRIZINE 10 MG TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CETIRIZINE HYDROCHLORIDE

Boleh didapati daripada:

ALLPAC SOLUTIONS SDN. BHD.

INN (Nama Antarabangsa):

CETIRIZINE HYDROCHLORIDE

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CP PHARMA CETIRIZINE 10 MG TABLET
Cetirizine Hydrochloride BP (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What CP Pharma Cetirizine is used
for
2.
How CP Pharma Cetirizine works
3.
Before you use CP Pharma
Cetirizine
4.
How to use CP Pharma Cetirizine
5.
While you are using CP Pharma
Cetirizine
6.
Side effects
7.
Storage and Disposal of CP
Pharma Cetirizine
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT CP PHARMA CETIRIZINE IS USED
FOR
CP Pharma Cetirizine is used for adults
and children of 2 years and above to
treat seasonal allergic rhinitis (pollen
allergic), perennial allergic rhinitis (hay
fever) and urticaria (hives) of allergic
origin.
HOW CP PHARMA CETIRIZINE WORKS
CP Pharma Cetirizine contains
Cetirizine Hydrochloride which is an
antihistamine agent. Antihistamine can
help to relieve the symptoms of some
allergies and itchy skin rashes.
BEFORE YOU USE CP PHARMA CETIRIZINE
_ _
_- When you must not use it _
Do not take this medicine if:
•
You have ever had an allergic
reaction to antihistamines or to any
of the other ingredients (listed in
later part of this leaflet).
•
You have severe kidney problems.
If you are not sure whether you should
start taking this medicine, talk to your
pharmacist or doctor.
_- Before you start to use it _
Tell your doctor if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription, as they
may interact with CP Pharma Cetirizine.
_ _
_- Taking other medicines_
Consumption of alcohol at the same
time may reduce the alertness and
impairment of performance.
Other interactions not stated may occur.
Talk to your doctor or pharmacist if
you have any other concerns.
HOW TO USE CP PHARMA CETIRIZINE
_- How much to use_
Swallow CP Pharma Cetirizine with
water at the recommended dose as
follows:
•
_Adults:_
10 mg (1 tablet) once daily.
A 5 mg starting dose (half of the
tablet) may be proposed if this
leads to satisfactory

Ciri produk

CETIRIZINE 10MG TABLET
VICETxx-0_2
DESCRIPTION
Oblong, white to off-white film-coated tablet, bevel edged, shallow
convex and scored on one face. This tablet can be broken into two.
COMPOSITION
Each tablet contains Cetirizine HCl BP 10 mg.
PHARMACODYNAMICS
Cetirizine, a human metabolite of hydroxyzine, is a potent and
selective antagonist of peripheral H1-receptors. In addition to its
anti-H1 effect, cetirizine was shown to display anti-allergic
activities
at a dose of 10 mg once or twice daily, it inhibits the late phase
recruitment of eosinophils, in the skin and conjunctiva of atopic
subjects submitted to allergen challenge.
At the recommended dosage, cetirizine has demonstrated that it
improves the quality of life of patients with perennial and seasonal
allergic rhinitis.
PHARMACOKINETICS
ABSORPTION
The steady-state peak plasma concentration is approximately 300
ng/ml and is achieved within 1.0 ± 0.5 h. The extent of absorption
of
cetirizine
is
not
reduced
with
food,
although
the
rate
of
absorption is decreased. The extent of bioavailability is similar when
cetirizine is given as solutions, capsules or tablets.
DISTRIBUTION
The apparent volume of distribution is 0.50 l/kg. Plasma protein
binding of cetirizine is 93 ± 0.3 %. Cetirizine does not modify the
protein binding of warfarin.
METABOLISM AND ELIMINATION
Cetirizine does not undergo extensive first pass metabolism. About
two-thirds of the dose is excreted unchanged in urine. The terminal
half-life is approximately 10 hours and no accumulation is observed
for cetirizine following daily doses of 10 mg for 10 days. Cetirizine
exhibits linear kinetics over the range 5 to 60 mg.
SPECIAL PATIENT POPULATIONS
Children
The half-life of cetirizine was about 6 hours in children of 6-12
years
and 5 hours in children 2-6 years.
Elderly
Following a single 10 mg oral dose, half-life increased by about 50 %
and clearance decreased by 40 % in elderly compared to the
younger. The decrease in cetirizine clearance in these elderly
appeared to be related to their decrea