Each tablet contains Cetirizine Hydrochloride 10 mg.
The principle effects of Cetirizine are mediated via selective inhibition of
peripheral H1 receptors. It is reported to have negligible anticholinergic
and antiserotonergic activity. Cetirizine is an antihistamine reported to be
long acting and with some mast cell stabilizing activity. It inhibits the
histamine-induced early phase of allergic reaction. It also inhibits the
late phase recruitment of eosinophils, neutrophils and basophils associated
with the allergic inflammatory response.
Cetirizine is rapidly absorbed from the gastro-intestinal tract after oral
administration, with peak plasma concentration being attained in
approximately 1 hour in adults. Food had no effect on the extent of
cetirizine absorption but time to maximum concentration (Tmax) was delayed
by 1.7 hours and maximum concentration (Cmax) was decreased by 23% in the
presence of food. Cetirizine is highly bound to plasma proteins and has an
elimination half-life of about 11 hours. The first-pass metabolism is
reported to be low, and excretion is primarily through renal as unchanged
Adezio is indicated for the relief of symptoms associated with seasonal
allergic rhinitis and perennial allergic rhinitis in adults and children
over 2 years of age such as sneezing, rhinorrhea, postnasal discharge, nasal
pruritus, ocular pruritus, tearing and redness of the eyes.
Adezio is also indicated for the treatment of the uncomplicated skin
manifestations of chronic urticaria in adults and children over 2 years of
age. It significantly reduces the occurrence, severity and duration of hives
and significantly reduces pruritus.
DOSAGE AND ADMINISTRATION
Adezio is given as a single daily dose, with or without food. The time of
administration may be varied to suit individual patient needs. To be
Adults and Children
over 12 Years:
5 or 10 mg depending on
1/2 or 1 tablet once
Children 6 to 11
5 or 10 mg depending on
1/2 or 1 tablet once
Children 2 to 5
2.5 mg; can be increased
to a maximum
dose of 5 mg per day
symptom severity and
Recommended for Adezio
Dose Adjustment for Renal and Hepatic Impairment:
In patients 12 years old and older with decreased renal function (creatinine
clearance 11-31 ml/min), patients on hemodialysis (creatinine clearance less
than 7 ml/min), and in hepatically impaired patients, a dose of 5 mg once
daily is recommended.
Similarly, pediatric patients aged 6 to 11 years with impaired renal or
hepatic function should use the lower recommended dose. Because of the
absence of pharmacokinetic and safety information for cetirizine in children
below the age of 6 years with impaired renal or hepatic function, its use in
this impaired patient population is not recommended.
Adezio is contraindicated in those patients with a known hypersensitivity to
it or any of its ingredients or hydroxyzine. It is also contraindicated
Central sedation or antimuscarinic effects do not generally occur with usual
doses of cetirizine. However, the occurrence of somnolence has been reported
in some patients taking cetirizine in clinical trials. Caution should
therefore be exercised when driving a car or operating potentially dangerous
Use in Pregnancy and
Teratogenic studies in animals have not demonstrated any special
malformations. However as a precaution, Adezio should not be administered
during the first trimester of pregnancy.
Cetirizine has been reported to be excreted in human breast milk. Because
many drugs are excreted in human milk, use of cetirizine in nursing mothers
is not recommended.
Use in Paediatric
The safety and effectiveness of cetirizine in pediatric patients under the
age of 2 years have not yet been established.
No clinically significant drug interactions have been reported with other
drugs. However, caution should be exercised when other CNS depressants or
alcohol is taken concurrently.
SIDE EFFECTS/ ADVERSE REACTIONS
Most adverse reactions reported during therapy with cetirizine were mild or
moderate. There have been occasional reports on headache, dizziness,
drowsiness, agitation, dry mouth, gastrointestinal discomfort and
SYMPTOMS AND TREATMENT FOR OVERDOSAGE
Overdosage has been reported with cetirizine. Symptoms reported include
somnolence, restlessness, irritability and drowsiness. Should overdose
occur, treatment should be symptomatic or supportive, taking into account
any concomitantly ingested medications. There is no known specific antidote
to cetirizine. Cetirizine is not effectively removed by dialysis, and
dialysis will be ineffective unless a dialyzable agent has been
The expiry date is indicated on the packaging.
Store in a cool place below 30°C.
White colour, oblong shape, normal convex film-coated tablet, with break
line and "XS" logo.
PACKING / PACK SIZES
10's and 100's in blister packs of 10's.