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Desloratadine

Pronunciation

Pronunciation: DES-lor-A-ta-deen
Class: Peripherally selective piperidine, Antihistamine

Trade Names

Clarinex
- Syrup 2.5 mg per 5 mL
- Tablets 5 mg

Clarinex Reditabs
- Tablets, rapidly disintegrating 2.5 mg
- Tablets, rapidly disintegrating 5 mg

Aerius (Canada)
Aerius Kids (Canada)

Pharmacology

Long-acting histamine antagonist with selective H 1 -receptor histamine antagonist activity.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Pharmacokinetics

Absorption

T max is approximately 3 h. C max is approximately 4 ng/mL. AUC is approximately 56.9 ng•h/mL.

Distribution

82% to 87% protein bound.

Metabolism

Metabolized to 3-hydroxydesloratadine (active).

Elimination

The half-life is 27 h. Approximately 87% is excreted in urine and feces.

Onset

1 h.

Duration

24 h.

Special Populations

Renal Function Impairment

AUC and C max are increased. Dosage adjustment is recommended.

Hepatic Function Impairment

AUC and half-life are increased. Dosage adjustment is recommended.

Elderly

C max and AUC are 20% higher. The half-life is 33.7 h.

Children

Desloratadine plasma concentrations are similar to those achieved in adults.

Indications and Usage

Relief of nasal and nonnasal symptoms of seasonal and perennial allergic rhinitis; relief of symptoms of pruritus and reduction in number and size of hives in chronic idiopathic urticaria.

Contraindications

Hypersensitivity to any components of the product or to loratadine.

Dosage and Administration

Adults and Children 12 yr of age and older

PO 5 mg once daily.

Children 6 to 11 yr of age

PO 2.5 mg once daily.

Children 12 mo to 5 yr of age

PO 1.25 mg once daily.

Children 6 to 11 mo of age

PO 1 mg once daily.

Renal/Hepatic Impairment Adults

PO 5 mg every other day.

General Advice

Advise patients to take with or without food.

Administer syrup with a commercially available measuring dropper or syringe that is calibrated.

Administer orally disintegrating tablets with or without water. Place on tongue and allow to disintegrate before swallowing. Tablet should be taken immediately after opening the blister.

The use of orally disintegrating tablets is for patients 6 yr of age and older.

Storage/Stability

Store at 59° to 86°F. Do not remove orally disintegrating tablet from blister until just prior to administration.

Drug Interactions

None well documented.

Laboratory Test Interactions

May prevent or diminish otherwise positive reactions to skin tests.

Adverse Reactions

Cardiovascular

Palpitations, tachycardia (postmarketing).

CNS

Headache (14%); irritability (12%); somnolence (9%); fatigue, insomnia (5%); dizziness (4%); emotional liability (3%); psychomotor hyperactivity, seizure (postmarketing).

Dermatologic

Erythema, maculopapular rash (3%).

EENT

Otitis media (6%); pharyngitis, rhinorrhea (5%); dry mouth, epistaxis (3%).

GI

Diarrhea (20%); vomiting (6%); anorexia, nausea (5%); appetite increased, dyspepsia (3%).

Genitourinary

UTI (4%); dysmenorrhea (2%).

Hepatic

Elevated liver enzymes, including bilirubin, and, very rarely, hepatitis (postmarketing).

Respiratory

Upper respiratory tract infection (21%); cough (11%); bronchitis (6%).

Miscellaneous

Fever (17%); varicella (4%); myalgia, parasitic infection (3%); hypersensitivity, including anaphylaxis, dyspnea, edema, pruritus, rash, urticaria (postmarketing).

Precautions

Monitor

Assess patient for allergy symptoms (eg, hives, itching, nasal congestion, rhinitis, sneezing, watery eyes) before starting therapy and periodically throughout therapy. Monitor patient for dizziness and excessive drowsiness. If noted, hold therapy.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established in children younger than 6 mo of age (tablets and syrup). Desloratadine orally disintegrating tablets are intended for children 6 yr of age and older.

Elderly

Select dose with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and comorbidity.

Renal Function

Dosage adjustment is recommended.

Hepatic Function

Dosage adjustment is recommended.

Phenylketonurics

Orally disintegrating tablets contain phenylalanine 2.9 mg per 5 mg tablet or 1.4 mg per 2.5 mg tablet.

Overdosage

Symptoms

Increased heart rate and QT interval; somnolence.

Patient Information

  • Advise patient to take dose daily as prescribed and to not stop taking or change the dose unless advised by health care provider.
  • Ensure patient understands how to store and take the orally disintegrating tablet.
  • Advise patient to take without regard to meals, but to take with food if stomach upset occurs.
  • Advise patient not to increase the dose of medication or frequency of use if allergy symptoms are not controlled, but to inform health care provider. Inform patient that larger or more frequent dosing does not increase effectiveness and may cause drowsiness.
  • Caution patient to avoid alcohol and other CNS depressants (eg, sedatives) while using this medication.
  • Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to take frequent sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
  • If patient is to have allergy skin testing, advise patient not to take the medication for at least 4 days before the skin testing.
  • Instruct patient to stop taking drug and report persistent dizziness or excessive drowsiness to health care provider.

Copyright © 2009 Wolters Kluwer Health.

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