ZYRTEC Film-coated tablet / Oral drops / Oral solution (2018)

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Name of the medicinal product

Zyrtec.

Qualitative and quantitative composition

Zyrtec tablets, each containing 10 mg cetirizine dihydrochloride. It contains 66.40 mg lactose per film-coated tablet. Zyrtec oral drops containing 10 mg cetirizine dihydrochloride per ml. It contains ...

Pharmaceutical form

Film-coated tablets: White oblong film-coated tablets. Each tablet has a bisect line and a Y-Y logo. Oral drops: The solution is clear and colourless. Oral solution: The solution is ...

Therapeutic indications

For relief of: nasal and ocular symptoms of seasonal and perennial allergic rhinitis; symptoms of chronic idiopathic urticaria.

Posology and method of administration

Children aged from 2 to 6 years 2.5 mg twice daily [5 drops twice daily or 2.5 ml of oral solution twice daily (half of a spoon twice daily)]. Children aged from 6 to 12 years 5 mg [10 drops, or 5 ml oral ...

Contraindications

ZYRTEC is contraindicated during lactation. Hypersensitivity to any of the constituents of the formulation, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment at less ...

Special warnings and precautions for use

Alcohol At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/L). Nevertheless, precaution is recommended if alcohol is taken ...

Interaction with other medicinal products and other forms of interaction

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Neither pharmacodynamic nor significant pharmacokinetic interaction ...

Fertility, pregnancy and lactation

Fertility Limited data is available on human fertility but no safety concern has been identified. Animal data show no safety concern for human reproduction. Pregnancy For cetirizine prospectively collected ...

Undesirable effects

Clinical trial data Clinical studies have shown that cetirizine at the recommended dosage has minor adverse effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical ...

Overdose

Symptoms and signs Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect. Adverse events reported after an ...

Pharmacodynamic properties

Cetirizine (ATC code R06A E07), a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H1-receptors. In vitro receptor binding studies have shown no measurable ...

Pharmacokinetic properties

Absorption The steady-state maximum plasma concentration is approximately 300 ng/ml and is achieved within 1.0 ± 0.5 h. The distribution of pharmacokinetic parameters such as peak plasma concentration ...

List of excipients

Zyrtec Tablet 10 mg: Microcrystalline cellulose, Lactose monohydrate, Colloidal anhydrous silica, Magnesium stearate, Opadry Y-1-7000 which consists of, Hydroxypropylmethylcellulose (E464), Titanium ...

Shelf life

The expiry date is stated on the outer packaging.

Special precautions for storage

Refer to the storage condition on the outer packaging. Keep tablets in a dry place.

Nature and contents of container

Tablet: Boxes containing 10, 50 and 500 film-coated tablets in blister strips. Oral drops: Bottle containing 10 or 20 ml drops. Oral solution: Bottle containing 75 ml solution. Not ...

Marketing authorization holder

Manufacturer for tablets: UCB FARCHIM SA, BULLE SWITZERLAND Manufacturer for oral solution and drops: AESICA PHARMCEUTICALS S.R.L., PIANEZZA (TO) – ITALY

Date of revision of the text

20 April 2018