One Cetirizin STADA 10mg film-coated tablet contains Cetirizine
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 in vivo by an
agent, e.g. 48/80.
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.
Peak blood levels of the order of 0.3 ug/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.
Adult and children of 3 years or above: Symptomatic treatment of seasonal
rhinitis, perennial allergic rhinitis and urticaria of allergic origin.
DOSAGE AND ADMINISTRATION
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
If drowsiness occurs, the tablets can be administered in the evening.
Children 6-12 years:1 tablet (10 mg) once daily or 1 /2 tablet (5 mg)
taken twice daily (morning and evening).
For children weighing less than 30 kg: 1/2 tablet (5 mg) taken once
Clinical trials in children have not exceeded four weeks.
Cetirizine is contraindicated in patients with severe renal impairment. In
patients with moderate renal impairment the dose should be adjusted to 5 mg
(1/2 tablet). Caution should be exercised in patients with mild to moderate
renal impairment or impaired liver function.
There is no evidence that the dose needs to be modified for healthy elderly
patients. The duration of the treatment may vary depending on the symptoms.
Patients with a history of hypersensitivity of any of Cetirizine's
At therapeutic doses, Cetirizine does not potentiate the effect of alcohol
(at a blood level of 0.8 g/l ). Care should, however be taken.
Activities requiring mental alertness: in clinical trials the occurrence of
somnolence has been reported in some patients taking
Cetirizine: due caution should therefore be exercised when driving a car or
operating potentially dangerous machinery.
The safety and effectiveness of Cetirizine in pediatric patients under the
age of 2 years have not been established.
To date, there are no known interactions with other drugs. Nevertheless,
cetirizine should be used with caution if sedatives are
also being taken.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINE
Studies in healthy volunteers on 20 or 25 mg/day have not revealed effects
on alertness or reaction time. Patient should be advised, however to take
care not to exceed the recommended dose.
USE IN PREGNANCY AND LACTATION
Data on limited number of exposed pregnancies indicate no adverse effect of
cetirizine on pregnancy or on health of foetus/new born child. To date no
other relevant epidemiological data are available. Caution should be
exercised when prescribing to pregnant women. No data concerning the
excretion of cetirizine into human milk are available. Cetirizine should be
avoided during lactation.
When Cetirizine is administered at recommended doses any side effects that
may occur, e.g. agitation, dry mouth, drowsiness or headache, do not differ
significantly from placebo. Very occasionally, symptoms of hypersensitivity
have been reported.
The acute lethal dose of cetirizine in humans is not known. Somnolence was
reported in one adult who ingested 150 mg of cetirizine hydrochloride; no
other adverse effects, including clinical manifestations, abnormal blood
chemistry, or abnormal hematology occurred in this individual. Restlessness
and irritability followed by drowsiness were reported in an 18-month old
child who ingested about 180 mg of cetirizine hydrochloride.
In acute Cetirizine overdosage, treatment should include symptomatic and
supportive measures, taking into account the possibility of any
concomitantly ingested drugs. There is no specific antidote for overdosage
of cetirizine. The drug is not effectively removed by dialysis, and
therefore, dialysis would not be effective in acute overdosage of cetirizine,
unless a drug that is removed by dialysis were ingested about 180 mg of
SHELF - LIFE AND STORAGE INSTRUCTIONS
The expiry date of this pack is printed on the box. Do not use this pack
after this date.
Do not store above 30°C. Store in a dry place.
Protect from light.
Keep all medicines out of reach of children.
PREPARATION AND PACK SIZES
Cetirizin STADA 10 mg appears as a white, caplet-shaped, film-coated tablet,
engraved "STADA" on one side and plain on the other side. Blister packed in
PVC-Aluminium foil and packed in cardboard box (packs of 50's).