Levocet syrup 0.5mgml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOCETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

Asumed Biotech Sdn. Bhd.

INN (Nama Antarabangsa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

1 BOTTLE; 20 BOTTLE

Dikeluarkan oleh:

Chen Ho Pharmaceutical Co., Ltd. Sinying Plant

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
LEVOCET SYRUP 0.5MG/ML
_ _
Levocetirizine Dihydrochloride 0.5mg
P a g e 1
WHAT IS IN THIS LEAFLET
1.What Levocet Syrup 0.5mg/ml is used
for
2.How Levocet Syrup 0.5mg/ml works
3.Before
you
use
Levocet
Syrup
0.5mg/ml
4. How to use Levocet Syrup 0.5mg/ml
5. While you are using it
6. Side effect
7.Storage
and
Disposal
of
Levocet
Syrup 0.5mg/ml
8. Product description
1.
WHAT LEVOCET SYRUP 0.5MG/ML IS
USED FOR
Levocetirizine
dihydrochloride
is
the
active
ingredient
of
Levocet
syrup
0.5mg/ml.
Levocetirizine
is
an
antiallergic medication.
2. HOW
LEVOCET
SYRUP
0.5MG/ML
WORKS
Levocet Syrup 0.5 mg/ml works for the
treatment of signs of illness (symptoms)
associated with:
- allergic rhinitis
- nettle rash (urticaria)
3.
BEFORE
YOU
USE
LEVOCET
SYRUP
0.5MG/ML
WHEN YOU MUST NOT USE IT
-
If
you
allergic
to
levocetirizine
dihydrochloride,
cetirizine,
hydroxyzine
or
any
of
the
other
ingredients of this medicine.
-
If
you
have
severe
impairment
of
kidney function (severe renal failure
with
creatinine
clearance
below
10ml/min).
BEFORE YOU START TO USE IT
-You should be cautious if you take
Levocetirizine at the same time with
alcohol as it may cause a reduction in
alertness
and
impairment
of
performance.
-If
you
have
epilepsy
or
at
risk
of
convulsion, please ask your doctor for
advice as use of Levocetirizine may
cause seizure aggravation.
-If you are likely to be unable to empty
your bladder (with conditions such as
spinal cord injury or enlarge prostate)
please ask your doctor for advice as
levocetirizine may increase the risk of
urinary retention.
-If
you
are
scheduled
for
allergy
testing, ask your doctor if you should
stop taking Levocetirizine for several
days before testing as this medicine
may affect your allergy test result.
TAKING OTHER MEDICINES
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
-
If you are taking 400mg of theophylline
once a day, a small decrease in the
cetirizine
clearance
was
observed,
while the

Ciri produk

Page
1
of
3 LEVOCET SYRUP 0.5MG/ML
COMPOSITION
Active Ingredient:
Excipients:
Sodium citrate
11mg/ml
Sucralose
0.35mg/ml
D-Sorbitol Solution (70%)
350mg/ml
Grape Flavor
1mg/ml
Citric Acid
3.5mg/ml
Sodium Benzoate
1mg/ml
Purified water
Added to 1ml
DOSAGE FORM
Oral Solution
PRODUCT DESCRIPTION
Levocet syrup 0.5mg/ml is a colorless to pale yellow clear solution. A
sweet taste of sugar,
with grape flavor and a smell of grape note.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: Antihistamines for systemic use, piperazine
derivatives.
Mechanism of action
Levocetirizine, the (R) enantiomer of cetirizine, is a potent and
selective antagonist of
peripheral H1-receptors.
Binding studies revealed that levocetirizine has high affinity for
human H1-receptors (Ki =
3.2 nmol/l). Levocetirizine has an affinity 2-fold higher than that of
cetirizine (Ki = 6.3
nmol/l).
Levocetirizine dissociates from H1-receptors with a half-life of 115
± 38 min.
After single administration, levocetirizine shows a receptor occupancy
of 90% at 4 hours
and 57% at 24 hours.
PHARMACOKINETICS
Absorption
Levocetirizine is rapidly and extensively absorbed following oral
administration. In adults,
peak plasma concentrations are achieved 0.9 h after dosing. Steady
state is achieved after
two days. Peak concentrations are typically 270 ng/ml and 308 ng/ml
following a single and
a repeated 5 mg o.d. dose, respectively. The extent of absorption is
dose-independent and is
not altered by food, but the peak concentration is reduced and
delayed.
Distribution
No tissue distribution data are available in humans, neither
concerning the passage of
levocetirizine through the blood-brain-barrier. In rats and dogs, the
highest tissue levels are
found in liver and kidneys, the lowest in the CNS compartment.
In
humans,
levocetirizine
is
90%
bound
to
plasma
proteins.
The
distribution
of
levocetirizine is restrictive, as the volume of distribution is 0.4
l/kg.
Biotransformation
The extent of metabolism of levocetirizine in humans is less than 14%
of the