DOSAGE AND ADMINISTRATION
Oral
Children
(2-6 years)
5 ml (half measure) once daily.
Children
above 6 years
5 -10 ml (half to one measure) once daily. In individual cases the 10 ml daily
dose can be administered as 5 ml in the morning and 5 ml in the evening.
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
Health
2000 Cetirizine 5 mg syrup is indicated in the treatment of
perennial and seasonal allergic rhinitis, pruritus, allergic asthma, allergic
conjunctivitis and urticaria
(iii) DESCRIPTION OF DOSAGE FORM
Cetirizine is a highly potent long-acting peripheral H1-receptor antagonist which acts both on the early and late allergic response.
(iv) CONTRAINDICATIONS
Hypersensitivity or idiosyncrasy to cetirizine or its parent compound, hydroxyzine.
WARNINGS AND PRECAUTIONS
DRUG
INTERACTIONS
To date there are no known interactions of cetirizine with other drugs.
PREGNANCY
Should be used in pregnancy only if the potential benefit justifies the potential
risk to the foetus.
NURSING
MOTHERS
Not recommended for use by nursing mothers.
PAEDIATRIC
USE
Not recommended for use by children under two years of age.
OTHERS
Although investigations indicate that the effect of alcohol is not intensified,
it is advisable to avoid alcohol consumption. Patients are advised not to
exceed the recommended dose if driving or operating machinery.
(v) SIDE EFFECTS
There have been occasional reports of mild and transient side effects such as headache, sedation, dizziness, dry mouth and gastrointestinal discomfort.
Overdosage
Drowsiness can be a symptom of overdosage. In case of massive overdosage gastric
lavage should be performed with the usual supportive measures.
(vi) TOXIC EFFECTS
MUTAGENICITY, CARCINOGENICITY, TERATOGENICITY
Carcinogenicity
studies over 24 months showed increased incidences of benign liver tumors
in male mice (at the maximum dose of 16 mg/kg/day), but not in female mice
or in rats. These benign tumors in mice are commonly found with compounds
which cause liver enzyme induction. Since Cetirizine does not induce liver
enzymes in non-rodents and humans, this may be considered to be a species
specific phenomenon.Cetirizine was devoid of mutagenic activity in a series
of in vitro and in vivo assays.
Studies in animals are inadequate or may be lacking, but available data show
no evidence of an increased occurrence of fetal damage. Clinical data for
Cetirizine or other compounds of the class are inadequate to establish safety
in pregnancy.
Until such data are available, Cetirizine should be used in pregnancy only
if the expected benefits clearly outweigh potential risks to mother and fetus.