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DOSAGE
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1 Tab PO BID, do not use more than 2 tab within 24 hours
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GENERIC
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Cetirizine HCl 5 mg/ Pseudoephedrine HCl 120mg
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INDICATIONS
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ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are indicated for the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis in adults and children 12 years of age and older.
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MECHANISM OF ACTION
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Nasal decongestant/Antihistamine
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MICROBIOLOGY
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Cetirizine, a metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of H1 receptors.
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Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis.
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CONTRAINDICATIONS & WARNINGS
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ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are contraindicated in patients with a known hypersensitivity to any of its ingredients or to hydroxyzine.
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Due to its pseudoephedrine component, ZYRTEC-D (cetirizine, pseudoephedrine) Tablets are contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see PRECAUTIONS, Drug Interactions section). It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include insomnia, dizziness, weakness, tremor, or arrhythmias.
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PEDIATRIC USE
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Safety and effectiveness in children below the age of 12 years have not been established.
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PREGNANCY
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Category C In rats, the combination of cetirizine and pseudoephedrine caused developmental toxicity when administered orally at 6/154 mg/kg (approximately 5 times the maximum recommended daily dose in adults on a mg/m2 basis). When rats were dosed throughout pregnancy with oral doses of cetirizine/pseudoephedrine, 6/154 mg/kg increased the number of fetal skeletal malformations (rib distortions) and variants (unossified sternebrae). When dosing was continued through lactation, 6/154 mg/kg also decreased the viability and weight gain of offspring. These effects were not observed at 1.6/38 mg/kg (approximately equivalent to the maximum recommended daily dose in adults on a mg/m2 basis). No embryofetal toxicity was observed when rabbits were dosed throughout organogenesis with oral doses of cetirizine/pseudoephedrine of up to 6/154 mg/kg (approximately 10 times the maximum recommended daily dose in adults on a mg/m2 basis). Because there are no adequate and well-controlled trials in pregnant women, ZYRTEC-D (cetirizine, pseudoephedrine) Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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