Cetirizine
Regulatory sources consulted
- aemps-cima-ft-66044
- RxNorm rxcui 20610 ↗
Approved indications
- Relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis in adults and pediatric patients from 6 years of age.
- Relief of symptoms of chronic idiopathic urticaria in adults and pediatric patients from 6 years of age.
Contraindications
Absolute
- Hypersensitivity to the active substance, to hydroxyzine, to any piperazine derivatives, or to any of the excipients.
- Patients with end-stage renal disease with a creatinine clearance below 10 ml/min.
Clinical warnings
- Caution is recommended in patients with predisposing factors for urinary retention (e.g., spinal cord lesion, prostatic hyperplasia). — AEMPS CIMA
- Caution should be exercised in epileptic patients and in patients at risk of convulsions. — AEMPS CIMA
Drug interactions
- ModerateAlcohol and other CNS depressants
Mechanism: Additive sedative effects. Although cetirizine is a non-sedating antihistamine, it can potentiate drowsiness in combination.
Recommendation: Caution is advised and alcohol consumption should be avoided.
AEMPS CIMA
Adverse events
Common (≥1%)
somnolence · dizziness · headache · fatigue · dry mouth · nausea
Rare but serious
convulsions · tachycardia · angioedema · anaphylactic reaction · thrombocytopenia
Pregnancy and lactation
Pregnancy: Limited clinical data, animal studies show no harmful effects. Use with caution. Lactation: Excreted in breast milk; its use is not recommended.