Pharmaceutical Name

Trade (marketing or proprietary) name: Zyrtec, Cetirizine, Alleroff, All-Day Allergy, Zerviate (for ophthalmic use), Reactine, Aller-Tec, Alerid, Cetzine, Cetirin, and Histazine

Generic (nonproprietary or active ingredient) name: Cetirizine Hydrochloride

Indication and Usage

Reason the product has been approved for sale on the market.

FDA has approved this over-the-counter medication for seasonal/perennial allergic rhinitis and chronic urticaria.

Over-the-Counter Labeling

Ingredients

Also known as “excipients” for vaccines.

Varies by product. Check Daily Med for inactive ingredients of specific trade name.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Somnolence, Fatigue, Pharyngitis, Dizziness, Dry mouth, Aggressive reaction, Anaphylaxis, Cholestasis, Convulsions, Glomerulonephritis (kidney inflammation), Hallucinations, Thrombocytopenia, Hemolytic anemia, Hepatitis, Orofacial dyskinesia (involuntary repetitive movements of the mouth and face), Severe hypotension, Stillbirth, Suicidal ideation, and Suicide. Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin has been reported.

Specific Populations

Pregnancy

Pregnancy Category B: Zyrtec should be used during pregnancy only if clearly needed. Antihistamines are efficacious, however, there is still a lack of data regarding use during pregnancy. Although current evidence indicates that antihistamines are well-tolerated during pregnancy, data regarding foetal safety are inconclusive. Most of the maternally exposed, prospective pregnancies resulted in live births (83.7%). “Stillbirth” is also listed as a known potential adverse reaction by the manufacturer.

Breastfeeding

Because many drugs are excreted in human milk, use of Zyrtec in nursing mothers is not recommended. Occasional and small doses of cetirizine are acceptable while breastfeeding. Prolonged use of larger doses may cause a decrease in the milk supply or drowsiness and other adverse effects in the infant, particularly when combined with pseudoephedrine.

Pediatric

According to a meta-analysis, there is moderate to low certainty evidence that cetirizine may improve clinical outcomes and quality of life in children with allergic rhinitis. Cetirizine demonstrates comparably efficacy with other antihistamines and is generally well tolerated, although there is an increased risk of somnolence in the pediatric population. Children taking cetirizine most commonly experience similar side effects as adults taking cetirizine (eg, somnolence, fatigue, and dry mouth). Children, in particular, are more likely than adults to experience headaches while taking cetirizine.

Signs and Symptoms of Overdose: A small number of cases of cetirizine overdose appear in the literature. However, many overdoses of cetirizine in children result from improper medication storage by adults living in the same home. Most overdose incidents in children resolve spontaneously, with drowsiness and sedation being the main adverse effects observed. Drug-induced liver damage is common with numerous medications; there are reports of a small number of cases of cetirizine-induced liver damage.

Confirm Drug Name

Per the NIH, “Cetirizine may be confused with sertraline (look-alike-sound-alike-drugs). Clinicians and pharmacists should be careful while prescribing and dispensing this drug.

Sertraline Hydrochloride (HCl) Capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of Major depressive disorder (MDD) in adults and Obsessive compulsive disorder (OCD) in adults and pediatric patients 6 years and older.

According to AHRQ, “Medication errors are a leading cause of patient harm globally. Look-alike, sound-alike (LASA) medicines are a well-recognized cause of medication errors that are due to orthographic (look-alike) and phonetic (sound-alike) similarities between medicines that can thus be confused. Look-alike medicines appear visually the same with respect to packaging, shape, colour and/or size, while sould-alike medicines are similar int the phonetics of their names, doses, and/or strengths.”

Actions by patients, families, and caregivers:

• Know each medicine prescribed, dispensed and administered, including the name, indication, strengths of medicines dispensed and the dose to be used.
• Be aware of potential errors with LASA medicines, and be vigilant about such errors.
• Learn to label and store medicines appropriately at home to avoid LASA errors with the medicines dispensed to the patient.
• Check with the healthcare provider if in doubt, about a prescribed, dispensed or administered LASA medicine.

Analytical Deep Dive

What is informed consent?

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