Cetirizine - Drug Monograph

Comprehensive information about Cetirizine including mechanism, indications, dosing, and safety information.

Introduction

Cetirizine is a second-generation antihistamine medication widely used for the management of allergic conditions. As a selective H1-receptor antagonist, it represents a significant advancement over first-generation antihistamines due to its improved safety profile and reduced sedative effects. First approved by the FDA in 1995, cetirizine has become a mainstay in the treatment of various allergic disorders.

Mechanism of Action

Cetirizine competitively antagonizes histamine at peripheral H1 receptors. Unlike first-generation antihistamines, it has minimal affinity for cholinergic, adrenergic, or serotonin receptors, resulting in fewer anticholinergic side effects. The drug inhibits histamine-mediated early phase allergic responses and may also suppress eosinophil chemotaxis and expression of adhesion molecules, providing anti-inflammatory effects beyond simple histamine blockade.

Indications

  • Perennial and seasonal allergic rhinitis
  • Chronic idiopathic urticaria
  • Allergic conjunctivitis (off-label)
  • Atopic dermatitis (as adjunctive therapy)
  • Mild allergic skin reactions

Dosage and Administration

Adults and children ≥12 years: 5-10 mg orally once daily Children 6-11 years: 5-10 mg orally once daily (5 mg recommended starting dose) Children 2-5 years: 2.5-5 mg orally once daily (2.5 mg recommended starting dose) Renal impairment (CrCl 11-31 mL/min): 5 mg orally once daily Hepatic impairment: 5 mg orally once daily Elderly: Consider reduced dosing if renal impairment present

Pharmacokinetics

Absorption: Rapidly absorbed with peak plasma concentrations occurring within 1 hour. Bioavailability is approximately 70% and not significantly affected by food. Distribution: Volume of distribution is 0.4 L/kg. Plasma protein binding is 93%, primarily to albumin. Metabolism: Minimally metabolized by hepatic cytochrome P450 enzymes (primarily CYP3A4). The majority (70-85%) is excreted unchanged. Elimination: Half-life is approximately 8.3 hours. Excreted primarily in urine (70%) and feces (10%) with 60% excreted within 24 hours.

Contraindications

  • Hypersensitivity to cetirizine, hydroxyzine, or any component of the formulation
  • End-stage renal disease (CrCl <10 mL/min) unless undergoing dialysis
  • History of severe hypersensitivity reactions to any piperazine derivatives

Warnings and Precautions

  • Renal impairment: Dose adjustment required for moderate to severe impairment
  • Sedation: Although less sedating than first-generation agents, somnolence may occur
  • Urinary retention: Use with caution in patients with prostatic hyperplasia
  • Pregnancy: Category B - use only if clearly needed
  • Lactation: Excreted in breast milk; consider alternative feeding options
  • Children <2 years: Safety and efficacy not established

Drug Interactions

  • CNS depressants: Enhanced sedative effects with alcohol, benzodiazepines, opioids
  • Theophylline: May slightly decrease cetirizine clearance (clinically insignificant)
  • Ritonavir: May increase cetirizine concentrations (monitor for increased sedation)
  • Anticholinergic agents: Potential additive effects

Adverse Effects

Common (≥1%):
  • Somnolence (14%)
  • Fatigue (6%)
  • Dry mouth (5%)
  • Pharyngitis (2%)
  • Dizziness (2%)
Less common:
  • Headache
  • Nausea
  • Abdominal pain
  • Diarrhea
  • Epistaxis
Serious (rare):
  • Hypersensitivity reactions (angioedema, bronchospasm)
  • Seizures
  • Hepatitis
  • Tachycardia
  • Thrombocytopenia

Monitoring Parameters

  • Therapeutic response and symptom control
  • Signs of excessive sedation or cognitive impairment
  • Renal function in patients with pre-existing renal disease
  • Adverse effects, particularly in elderly patients
  • Signs of hypersensitivity reactions

Patient Education

  • Take medication as directed, typically once daily in the evening if sedation occurs
  • Avoid alcohol and other CNS depressants while taking cetirizine
  • Report severe drowsiness, difficulty urinating, or palpitations to healthcare provider
  • Use caution when operating machinery or driving until response is known
  • Store at room temperature away from moisture
  • Do not crush or chew extended-release formulations
  • Seek immediate medical attention for signs of allergic reaction (hives, difficulty breathing, swelling)

References

1. Simons FER. Advances in H1-antihistamines. N Engl J Med. 2004;351(21):2203-2217. 2. Cetirizine prescribing information. FDA Orange Book. Accessed January 2023. 3. Church MK, Maurer M, Simons FER, et al. Risk of first-generation H1-antihistamines: a GA²LEN position paper. Allergy. 2010;65(4):459-466. 4. Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2018;73(7):1393-1414. 5. Day JH, Briscoe MP, Rafeiro E, et al. Comparative clinical efficacy of cetirizine and fexofenadine for seasonal allergic rhinitis. Allergy Asthma Proc. 2006;27(5):386-393. 6. Golightly LK, Greos LS. Second-generation antihistamines: actions and efficacy in the management of allergic disorders. Drugs. 2005;65(3):341-384.

Medical Disclaimer

The information provided in this article is for educational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

The content on MedQuizzify is designed to support, not replace, the relationship that exists between a patient and their healthcare provider. If you have a medical emergency, please call your doctor or emergency services immediately.

How to Cite This Article

admin. Cetirizine - Drug Monograph. MedQuizzify [Internet]. 2025 Sep 07 [cited 2025 Sep 08]. Available from: http://medquizzify.pharmacologymentor.com/blog/drug-monograph-cetirizine

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