Daytime Cold Multi-symptom
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
Levocetirizine dihydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.
Levocetirizine dihydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
History
There is currently no drug history available for this drug.
Other Information
Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride oral solution, is an orally active H1-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C21H25ClN2O3•2HCl. The molecular weight is 461.82 and the chemical structure is shown below:
Levocetirizine dihydrochloride is a white, crystalline powder and is water soluble.
Levocetirizine dihydrochloride 0.5 mg/mL oral solution is formulated as an immediate release, clear, colorless liquid. Inactive ingredients are: sodium acetate trihydrate, glacial acetic acid, maltitol solution, glycerin, methylparaben, propylparaben, saccharin, flavoring (consisting of triacetin, natural & artificial flavors, dl-alpha-tocopherol), purified water.
Sources
Daytime Cold Multi-symptom Manufacturers
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Walgreen Co.
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Daytime Cold Multi-symptom | Perrigo New York Inc
Levocetirizine dihydrochloride is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution. Levocetirizine dihydrochloride can be taken without regard to food consumption.
2.1 Adults and Children 12 Years of Age and OlderThe recommended dose of levocetirizine dihydrochloride is 5 mg (2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1 teaspoon [5 mL] oral solution) once daily in the evening.
2.2 Children 6 to 11 Years of AgeThe recommended dose of levocetirizine dihydrochloride is 2.5 mg (1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults [see Clinical Pharmacology (12.3)].
2.3 Children 6 months to 5 Years of AgeThe recommended initial dose of levocetirizine dihydrochloride is 1.25 mg (1/2 teaspoon oral solution) [2.5 mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg [see Clinical Pharmacology (12.3)].
2.4 Dose Adjustment for Renal and Hepatic ImpairmentIn adults and children 12 years of age and older with:
• Mild renal impairment (creatinine clearance [CL CR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended; • Moderate renal impairment (CL CR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended; • Severe renal impairment (CL CR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended; • End-stage renal disease patients (CL CR < 10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride.No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.
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