Desloratadine
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From MedlinePlus, U.S. National Library of Medicine
Histamine-1 Receptor Antagonist
Dosing in kidney impairment
Adults with Hepatic or Renal Impairment In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology ].
Dosing in liver impairment
Hepatic Impairment Dosage adjustment for patients with hepatic impairment is recommended [see Dosage and Administration and Clinical Pharmacology ].
Preparation and administration
2 DOSAGE AND ADMINISTRATION Although the oral solution and the orally disintegrating tablet formulation of desloratadine may be available in the marketplace, CLARINEX ® Oral Solution and CLARINEX ® RediTabs ® Tablets are no longer marketed. CLARINEX Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals.
Place CLARINEX (desloratadine) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister. The age-appropriate dose of CLARINEX Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon) .
Dosage (by age): Adults and Adolescents 12 Years of Age and Over: CLARINEX Tablets - one 5 mg tablet once daily or CLARINEX RediTabs Tablets - one 5 mg tablet once daily or CLARINEX Oral Solution - 2 teaspoonfuls (5 mg in 10 mL) once daily Children 6 to 11 Years of Age: CLARINEX Oral Solution - 1 teaspoonful (2.5 mg in 5 mL) once daily or CLARINEX RediTabs Tablets - one 2.5 mg tablet once daily Children 12 Months to 5 Years of Age: CLARINEX Oral Solution - ½ teaspoonful (1.25 mg in 2.5 mL) once daily Children 6 to 11 Months of Age: CLARINEX Oral Solution - 2 mL (1 mg) once daily 2.1 Adults and Adolescents 12 Years of Age and Over The recommended dose of CLARINEX Tablets or CLARINEX RediTabs Tablets is one 5-mg tablet once daily.
Drug interactions
Check desloratadine against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3) .]
7.2 Fluoxetine In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3) .]
7.3 Cimetidine In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3) .]
Contraindications
Tablets, RediTabs, and Oral Solution are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ]. Hypersensitivity ( 4 , 6.2 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary The limited available data with CLARINEX in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are no adequate and well-controlled studies in pregnant women. Desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (AUC)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (RHD) of 5 mg/day. Desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the AUC-based exposures of desloratadine approximately 230 times that at the RHD.
Desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of F 1 pups at the summed AUC-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Desloratadine was given orally during organogenesis to pregnant rats at doses of 6, 24 and 48 mg/kg/day (approximately 50, 200 and 320 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). No fetal malformations were present. Reduced fetal weights and skeletal variations noted at doses of 24 and 48 mg/kg/day were likely secondary to the maternal toxicities of reduced body weight gain and food consumption observed at the same doses. Desloratadine was also given orally during organogenesis to pregnant rabbits at doses of 15, 30 and 60 mg/kg/day (approximately 30, 70 and 230 times the AUC-based exposure of desloratadine at the RHD).
No adverse effects to the fetus were noted. Reduced maternal body weight gain was noted in rabbits at 60 mg/kg/day. In a peri- and post-natal development study, desloratadine was given to rats orally during the peri-natal (Gestation Day 6) through lactation periods (Postpartum Day 21) at doses of 3, 9 and 18 mg/kg/day. Reduced body weight and slow righting reflex were reported in F 1 pups at doses of 9 mg/kg/day or greater (approximately 70 times or greater than the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Desloratadine had no effect on F 1 pup development at 3 mg/kg/day (approximately 10 times the summed…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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