Cetirizine; Pseudoephedrine (Zyrtec-D) Contraindications and Precautions
- acute myocardial infarction
- angina
- breast-feeding
- cardiac arrhythmias
- hydroxyzine hypersensitivity
- MAOI therapy
- myocardial infarction
- tachycardia
- urinary retention
- cardiac disease
- cardiomyopathy
- children
- closed-angle glaucoma
- coronary artery disease
- diabetes mellitus
- dialysis
- driving or operating machinery
- elderly
- ethanol intoxication
- GI obstruction
- heart failure
- hepatic disease
- hypertension
- hyperthyroidism
- increased intraocular pressure
- infants
- peptic ulcer disease
- pregnancy
- renal disease
- renal failure
- renal impairment
Cetirizine; Pseudoephedrine (Zyrtec-D) Contraindications and Precautions
NOTE: This monograph discusses the contraindications and precautions of cetirizine and pseudoephedrine combination products for the relief of nasal congestion and allergic rhinitis. Clinicians may wish to consult the individual cetirizine or pseudoephedrine drug monographs for more specific information.
Cetirizine is contraindicated for use in patients with a known hypersensitivity to the drug, to any of the formulation components or who have a known hydroxyzine hypersensitivity. Cetirizine is a known human metabolite of hydroxyzine. Additionally, pseudoephedrine is contraindicated in patients with a known hypersensitivity or idiosyncratic reaction to it or other adrenergic agents. Examples of idiosyncratic reactions to pseudoephedrine include insomnia, dizziness, weakness, tremor or cardiac arrhythmia.
Cetirizine; pseudoephedrine should be used cautiously in patients with renal disease, renal failure, renal impairment, undergoing dialysis or with hepatic disease; dosage adjustments are required in these groups (see Dosage). Elderly patients are at a particular risk for renal or hepatic disease. While advanced age alone does not necessitate dose adjustment, lower initial doses and renal monitoring may be particularly prudent in this population.
Well-controlled hypertensive adult patients receiving pseudoephedrine at recommended doses (240 mg/day PO) generally do not appear at risk for significant elevations in blood pressure; however, small increases in blood pressure and heart rate may occur. Although considered safe in the general population of controlled hypertensives, increased blood pressure (especially systolic hypertension) has been reported in individual patients receiving pseudoephedrine. When pseudoephedrine is used at higher than recommended doses, when combined with a MAOI therapy (see Drug Interactions), or when used in the setting of substance abuse or overdosage, it may result in hypertension or hypertensive crisis. Since pseudoephedrine is a vasoconstrictor and may increase heart rate and blood pressure via sympathomimetic effects, it should be avoided in patients with uncontrolled or severe hypertension, acute cardiac arrhythmias (tachycardias), or severe coronary artery disease (including acute myocardial infarction, angina, or history of myocardial infarction). Considerable caution should be used in patients with controlled or mild hypertension, heart failure, cardiomyopathy, or other cardiac disease.
Pseudoephedrine is also relatively contraindicated in patients with hyperthyroidism, diabetes mellitus, closed-angle glaucoma, stenosing peptic ulcer disease, GI obstruction (pyloroduodenal obstruction), increased intraocular pressure or urinary retention due to prostatic hypertrophy, because sympathomimetics can exacerbate these conditions.
Patients should assess the effects of cetirizine; pseudoephedrine prior to driving or operating machinery or performing other activities that require mental alertness or are considered hazardous. Because the effects of ethanol or other CNS depressants may be additive with antihistamines, ethanol intoxication should be avoided.
The combination of cetirizine; pseudoephedrine is classified in FDA pregnancy risk category C. Animal studies with the combination product have demonstrated teratogenic effects, but there are no adequate and well controlled studies in pregnant women. Fetal skeletal malformations in rats have been noted at doses 5 times the maximum recommended dose; no malformations were noted at doses equal to the maximum recommended daily dose. Rabbit studies have not revealed malformations. Cetirizine; pseudoephedrine should be used in pregnancy only when the potential benefit clearly outweighs the risk to the fetus.
Cetirizine and pseudoephedrine are both excreted into human milk. Because there is a lack of information on safety during lactation, the manufacturer recommends against the use of cetirizine during breast-feeding. While pseudoephedrine is considered safe for the breast-feeding infant by the American Academy of Pediatrics (AAP), no recommendations are available from AAP for cetirizine. Rat studies utilizing doses 5 times the maximum recommended daily dose of cetirizine; pseudoephedrine have noted reduced viability and weight gain of offspring.
The safety and efficacy of cetirizine; pseudoephedrine has not been established in children < 12 years of age or infants. Zyrtec-D® contains 120 mg of extended-release pseudoephedrine per tablet which exceeds the recommended dose for children < 12 years of age. The adverse effects of sympathomimetics such as pseudoephedrine can be severe, especially in infants and toddlers. CNS stimulation, increased blood pressure and tachycardia may occur.
[ Last revised: 8/14/2003 3:00:00 PM ]
References
. Coates ML, et al. Does pseudoephedrine increase blood pressure in patients with controlled hypertension? J Fam Pract 1995;40:22 - 6.
. Chua SS, Benrimoj SI. Non-prescription sympathomimetic agents and hypertension. Med Toxicol Adverse Drug Exp 1988;3:387 - 417.
. Gunn VL, Taha SH, Liebelt EL et al. Toxicity of over-the counter cough and cold medications. Pediatrics 2001;108:1 - 5.
. Beck RA, Mercado DL, Seguin SM, et al. Cardiovascular effects of pseudoephedrine in medically controlled hypertensive patients. Arch Intern Med 1992;152:1242 - 5.
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