CETIRIZINE MYLAN Viatris 10MG BOX OF 7 DRY TABLETS

In adults and children 6 years and older:

- Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

- Cetirizine is indicated for the treatment of symptoms of chronic idiopathic urticaria.

Medical advice is recommended for chronic idiopathic urticaria.

Dosage

Children 6 to 12 years: 5 mg twice daily (half a tablet twice daily).

Adults and adolescents over 12 years of age: 10 mg once daily (one tablet).

The tablet should be swallowed with a drink.

Elderly: no dosage adjustment is necessary in elderly patients with normal renal function.

Moderate to severe renal insufficiency: the available data do not allow to document the benefit/risk ratio in case of renal insufficiency.

Given its essentially renal elimination (see Pharmacokinetics), and if no alternative treatment can be used, cetirizine should be administered in these situations by adjusting the dosage and the interval between doses according to renal clearance as shown in the table below.

Creatinine clearance (CLcr) can be estimated (in ml/min) from the measurement of serum creatinine (in mg/dl) using the following formula:

_LCcr = [140- age (year)] x weight (kg) x (0.85 for women)

72 x serum creatinine (mg/dl)

Dosage adjustment in patients with renal impairment :

In pediatric patients with renal impairment, dosage will be adjusted individually according to renal clearance, age and body weight.

Hepatic impairment: No dose adjustment is necessary in patients with isolated hepatic impairment.

In patients with hepatic impairment associated with renal impairment, dose adjustment is recommended (see "Moderate to Severe Renal Impairment" above).

CETIRIZINE MYLAN PHARMA: What it looks like and how it works

White, scored, oblong film-coated tablet.

CETIRIZINE MYLAN PHARMA: presentation

CETIRIZINE MYLAN PHARMA: how it works

Pharmacotherapeutic class: antihistamines for systemic use/piperazine derivatives, ATC code: R06AE07.

Cetirizine, a metabolite of hydroxyzine, is a potent and selective peripheral H1 receptor antagonist. In vitro receptor binding studies have not revealed any measurable affinity for receptors other than H1 receptors.

In combination with the anti-H1 effects, cetirizine at a dose of 10 mg once or twice daily inhibits the delayed phase of eosinophil recruitment in the skin and connective tissue of atopic subjects after allergen challenge.

Studies in healthy volunteers have shown that cetirizine, at doses of 5 and 10 mg, strongly inhibits erythematopapular reactions induced by high histamine concentrations in the skin. However, the correlation of efficacy with these findings is not established.

In a 35-day study in children aged 5 to 12 years, there was no decrease in the antihistamine effect (inhibition of erythema and papules) of cetirizine. Upon discontinuation of repeated-dose cetirizine therapy, skin reactivity to histamine was restored within 3 days.

In a six-week placebo-controlled study of 186 patients with allergic rhinitis and mild-to-moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms without affecting lung function. This study highlights the safety of cetirizine in allergic patients with mild to moderate asthma.

In a placebo-controlled study, cetirizine 60 mg for 7 days did not significantly prolong the QT interval.

At the recommended dosage, an improvement in quality of life was demonstrated in cetirizine-treated patients with perennial and seasonal allergic rhinitis.