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REACTINE® important safety information

Pharmacist consulting with a customer.

Indication and clinical use

  • Adults and children 12 years of age and over: REACTINE® (cetirizine hydrochloride) is indicated for the fast relief of nasal and non-nasal symptoms associated with seasonal and perennial allergic rhinitis (i.e., sneezing, rhinorrhea, post-nasal discharge, nasal congestion/stuffiness, tearing and redness of the eyes, itchy nose/throat) and chronic idiopathic urticaria (e.g., pruritus and hives). 

  • Pediatrics - Children 212 years of age: REACTINE® is indicated for the relief of the symptoms associated with seasonal allergic rhinitis. REACTINE® is also indicated for the fast and long-lasting relief of itching due to allergic skin reactions such as hives. The nasal congestion/stuffiness and itchy nose/throat symptoms have not been adequately studied in the pediatric 2–12 years of age patient subset. The effectiveness of REACTINE® in treating symptoms associated with perennial allergic rhinitis and chronic idiopathic urticaria has not been established in this age group. 

  • Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 

Contraindications

  • Patients with: 

    • Known hypersensitivity to cetirizine or to its parent compound, hydroxyzine or to piperazine derivatives 

    • Known hypersensitivity to any other ingredients in the formulation 

  • Severe renal impairment (less than 10 mL/min creatine clearance) 

Relevant warnings and precautions

  • Very rarely, severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), have been reported  

  • If drowsiness occurs, do not drive or operate machinery; and avoid concurrent use with sedating substances 

  • Occasional instances of hepatic transaminase elevations have occurred during REACTINE® therapy, without evidence of jaundice, hepatitis, or other clinical findings 

  • Use with caution in patients with pre-existing liver disease 

  • Starting dose of 5 mg is recommended in patients with moderate hepatic impairment  

  • Should not be used during pregnancy, unless advised otherwise by a physician  

  • Not recommended in nursing women, unless advised otherwise by a physician  

  • Should not be used in children below 2 years of age

For more information

Please consult the Product Monograph at: https://pdf.hres.ca/dpd_pm/00073921.PDF for important information relating to adverse reactions, drug interactions, and dosing information, which has not been discussed in this piece.  

The Product Monograph is also available by calling our medical information department at 1-87-REACTINE.