(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Cetirizine 10 mg tablets is indicated in the treatment of perennial and seasonal allergic rhinitis , pruritus, allergic asthama, 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 idiosyncracy to Cetirizine or its parent compound,hydroxyzine.

WARNINGS AND PRECAUTIONS

DRUG INTERACTION
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 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 AND TERATOGENICITY

Carcinogenicity studies over 24 months showed increased incidences of benign liver tumours 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 foetal 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.