Cezti 10 film-coated tablet (Cetirizine dihydrochloride 10mg)

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

CETIRIZINE DIHYDROCHLORIDE

Доступна с:

STADPHARM SDN. BHD.

ИНН (Международная Имя):

CETIRIZINE DIHYDROCHLORIDE

Штук в упаковке:

50Tablet Tablets

Производитель:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

тонкая брошюра

_ Consumer Medication Information Leaflet (RiMUP) _
C
EZTI 10 FILM-COATED TABLET
Cetirizine Dihydrochloride 10 mg
Page no. 1
WHAT IS IN THIS LEAFLET
1. What Cezti 10 film-coated tablet is used
for
2. How Cezti 10 film-coated tablet works
3. Before you use Cezti 10 film-coated
tablet
4. How to use Cezti 10 film-coated tablet
5. While you are using it
6. Side effects
7. Storage and Disposal of Cezti 10 film-
coated tablet
8. Product description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT CEZTI 10 FILM-COATED TABLET IS USED
FOR
Cezti 10 film-coated tablet is used in adults
and children of 3 years or above to treat
swelling and irritation inside the nose
that can occur during specific seasons
(seasonal rhinitis) or occur year round
(perennial allergic rhinitis) and urticaria
of allergic origin (a common allergic
disorder in which a red, itchy, lumpy
skin rash appears).
HOW CEZTI 10 FILM-COATED TABLET WORKS
Cetirizine is a drug that inhibits the actions
of histamine (an amine found in all body
tissues) by competitive binding to the H1
receptor. Histamine is responsible for
many of the symptoms caused by allergies.
Cetirizine does not inhibit the actions of
cholinergic and serotonin (two types of
major neurotransmitter systems). So
these effects are obtained without sedation
nor behavioral changes.
Cetirizine also inhibits the skin reaction
induced by some peptides that are believed
to take part in the allergic reaction.
BEFORE YOU USE CEZTI 10 FILM-COATED
TABLET
_- When you must not take it _
If you are known allergy to any of its
ingredients.
_- Before you start to use it _
_If any of the situations mentioned below _
_apply to you, you should tell your doctor _
_before taking this drug:_ _ _
-
If you do activities requiring mental
alertness._ _
-
The safety and effectiveness of
Cetirizine in pediatric patients under the
age of 2 years have not been established. _ _
-
Caution should be exercised in patients
with mild to moderate renal impairment
or impaired liver function_ _
_- Taking oth

Характеристики продукта

COMPOSITION
Active ingredient:
One Cezti 10 film-coated tablet contains Cetirizine dihydrochloride 10
mg.
PHARMACODYNAMICS
In experimental animals, Cetirizine has been shown to be an anti-H1
agent devoid of any significant
anticholinergic or antiserotonin effects. At pharmacologically active
doses, it induces neither sedation nor
behavioral changes. This may be explained by the fact that Cetirizine
does not cross the blood-brain barrier.
It was shown in human pharmacology studies that Cetirizine would
inhibit certain effects produced by
endogenous histamine released
by an agent, e.g. 48/80.
_in vivo_
Finally, it inhibits the cutaneous reaction induced by VIP (Vasoactive
Intestinal Polypeptide) and substance P,
neuropeptides that are believed to take part in the allergic reaction.
Cetirizine markedly reduces bronchial
hyper-reactivity to histamine in the asthmatic patients. It also
reduces the allergic reaction induced by specific
allergens.
These effects are obtained without any central effects being
demonstrated either by psychometric test or by a
quantified EEG.
PHARMACOKINETICS
Peak blood levels of the order of 0.3
µ
g/ml are reached between 30 and 60 minutes after administration of
a 10 mg dose of Cetirizine. Its plasma half - life is approximately 11
hours.
Absorption is very consistent from one subject to the next. Its renal
clearance is 30 ml/minute and the
excretion half-life is approximately 9 hours. Cetirizine is strongly
bound to plasma proteins.
INDICATIONS
Adult and children of 3 years or above: Symptomatic treatment of
seasonal rhinitis, perennial allergic
rhinitis and urticaria of allergic origin.
DOSAGE AND ADMINISTRATION
ADMINISTRATION
Cezti 10 need to be swallowed with a glass of liquid.
DOSAGE
The recommended dosage in children aged between 3 and 6 years old is 5
mg daily, either 2.5 mg twice
daily or 5 mg once daily.
Adults and adolescents over 12 years of age: 1 tablet (10 mg) once
daily.
If drowsiness occurs, the tablets can be administered in the evening.
Children 6-12 years: 1 tablet (10