AHFS Class:

• Second Generation Antihistamines 4:08

Generic Name(s):

• Desloratadine

Associated Monographs

• Antihistamines General Statement

Desloratadine, the active descarboethoxy metabolite of loratadine, is a second generation antihistamine.1,2,3,9

Desloratadine, an active metabolite of loratadine, is used for the management of allergic rhinitis and chronic idiopathic urticaria.1,9 The drug also has been used in patients with seasonal allergic rhinitis who have concomitant mild to moderate asthma.1,2,6,9 For additional information on these and other uses of antihistamines, see Uses in the Antihistamines General Statement 4:00.

Allergic Rhinitis

Desloratadine alone or in fixed combination with pseudoephedrine sulfate is used to provide symptomatic (nasal and nonnasal) relief of seasonal (e.g., hay fever) allergic rhinitis.1,9,18 Desloratadine also is used to provide symptomatic (nasal and nonnasal) relief of perennial (nonseasonal) allergic rhinitis.1 The fixed-combination preparation generally should be used only when both the antihistaminic and nasal decongestant activity of the combination preparation are needed concurrently.18

Antihistamines are not curative and merely provide palliative therapy; since seasonal allergic rhinitis may be a chronic, recurrent condition, successful therapy often may require long-term, intermittent use of these drugs.10,11,12,13 In the treatment of seasonal allergic rhinitis, antihistamines are more likely to be beneficial when therapy is initiated at the beginning of the hay fever season when pollen counts are low.11,13,14,15 Antihistamines are less likely to be effective when pollen counts are high, when pollen exposure is prolonged, and when nasal congestion is prominent.13,16 Chronic nasal congestion and headache caused by edema of the paranasal sinus mucosa often are refractory to antihistamine therapy.11,12,13,17

Safety and efficacy of desloratadine in the management of seasonal allergic rhinitis were established in several randomized, double-blind, placebo-controlled studies of 2-4 weeks' duration in more than 2300 patients (12-75 years of age) with seasonal allergic rhinitis.1,3,4 In these studies, treatment with desloratadine 5 mg daily during the spring or fall allergy season was more effective than placebo in reducing nasal (e.g., rhinorrhea, sneezing, nasal itching, nasal stuffiness/congestion) and nonnasal (e.g., ocular itching or burning, ocular redness or tearing, itching of ears or palate) symptoms (as assessed by reduction in total symptom scores) in patients with seasonal allergic rhinitis.1,2,4,9 Results of several studies indicate that treatment with desloratadine (5 mg daily) for 2-4 weeks also was associated with reduced nasal congestion/stuffiness.2,3,5,9

Desloratadine also appears to be more effective than placebo in improving symptoms in patients with seasonal allergic rhinitis who have concomitant mild to moderate asthma.1,2,6,9 In 2 randomized, controlled studies in 924 patients (15-75 years of age) with seasonal allergic rhinitis and mild to moderate asthma, treatment with desloratadine 5 mg daily for 2-4 weeks improved nasal (e.g., rhinorrhea, sneezing, nasal itching, nasal stuffiness/congestion) and nonnasal (e.g., ocular itching or burning, ocular redness, tearing/watery eyes, itching of ears and/or palate) symptoms without impairing pulmonary function.1,2,6 Limited data indicate that treatment with desloratadine also may improve total asthma symptom score (i.e., sum of individual scores for coughing, wheezing, and breathing difficulties) and/or reduce use of inhaled β₂-agonist bronchodilators.2,6

Safety and efficacy of desloratadine in the management of perennial (nonseasonal) allergic rhinitis were established in 2 randomized, double-blind, placebo-controlled studies of 4 weeks' duration in more than 1300 patients (12-80 years of age) with perennial allergic rhinitis.1 In one of these studies, treatment with desloratadine 5 mg daily was more effective than placebo in reducing nasal and nonnasal symptoms (as assessed by reduction in total symptom scores) in patients with perennial allergic rhinitis.1

In most studies, symptomatic (i.e., nasal and nonnasal) improvement was observed as early as 1 day after initiation of desloratadine therapy and maintained over the 24-hour dosage interval and throughout the entire treatment period.2,4,5,6,9

Safety and efficacy of the extended-release fixed-combination preparation containing desloratadine and pseudoephedrine sulfate were established in two 2-week randomized, parallel-group studies in adults and children 12 years of age and older with seasonal allergic rhinitis.18,19 The fixed combination was more effective in providing symptomatic relief of seasonal allergic rhinitis than either drug alone.18,19 However, the fixed combination generally should be used only when both the antihistaminic and nasal decongestant activity of the combination preparation are needed concurrently.18

Desloratadine also is used to provide symptomatic relief in the treatment of seasonal and perennial allergic rhinitis in pediatric patients.1 Efficacy of the drug for symptomatic relief of seasonal allergic rhinitis in children 2-12 years of age and perennial allergic rhinitis in pediatric patients 6 months of age and older is supported by adequate and well-controlled studies in adults.1 In addition, the course of seasonal and perennial allergic rhinitis and the drug's effects are similar in adults and pediatric patients.1

Chronic Idiopathic Urticaria

Desloratadine is used for the symptomatic treatment of pruritus and urticaria associated with chronic idiopathic urticaria.1 Safety and efficacy of desloratadine were evaluated in several randomized, double-blind, placebo-controlled studies of 6 weeks' duration in more than 400 patients (12-84 years of age) with chronic idiopathic urticaria.1,2,7 In these studies, treatment with desloratadine 5 mg daily was more effective than placebo in decreasing the severity of pruritus, the number of hives, and the size of the largest hive.1,2,7,9 Treatment with the drug also was associated with improved sleep and daytime performance compared with placebo.2,7

Desloratadine also is used for relief of symptoms of chronic idiopathic urticaria (e.g., pruritus, hives) in pediatric patients.1 Efficacy of the drug for symptomatic relief of chronic idiopathic urticaria in pediatric patients 6 months of age and older is supported by adequate and well-controlled studies in adults.1 In addition, the course of chronic idiopathic urticaria and the drug's effects are similar in adults and pediatric patients.1

Administration

Desloratadine is administered orally once daily without regard to meals.1,9,18

Desloratadine orally disintegrating tablets are administered by placing a tablet on the tongue, allowing it to disintegrate, and then subsequently swallowing with or without water.1 Patients receiving desloratadine orally disintegrating tablets should be instructed not to remove a tablet from the blister until just prior to dosing.1 Desloratadine oral solution should be administered using a commercially available dropper or syringe that is calibrated to deliver 2 or 2.5 mL.1 Extended-release tablets containing desloratadine in fixed combination with pseudoephedrine sulfate should be swallowed intact and should not be chewed, broken, or crushed.18

Commercially available desloratadine conventional tablets and oral solution are bioequivalent.1 The currently available reformulated orally disintegrating tablets containing 5 mg of desloratadine are bioequivalent to the original orally disintegrating formulation (no longer commercially available),1 which previously was shown to be bioequivalent to desloratadine conventional tablets and oral solution.20

Dosage

Allergic Rhinitis and Chronic Idiopathic Urticaria

The recommended dosage of desloratadine for symptomatic relief of seasonal allergic rhinitis, perennial allergic rhinitis, or chronic idiopathic urticaria in adults and children 12 years of age and older is 5 mg once daily.1,9 When the fixed combination containing desloratadine and pseudoephedrine sulfate is used for symptomatic relief of seasonal allergic rhinitis in adults and children 12 years of age and older, the recommended dosage is 5 mg of desloratadine once daily.18 Clinical studies in patients with seasonal allergic rhinitis indicate that higher desloratadine dosages (i.e., dosages exceeding 5 mg daily) provide no additional benefit but may increase the risk of adverse effects (e.g., somnolence).1,9

The recommended dosage of desloratadine for symptomatic relief of seasonal allergic rhinitis, perennial allergic rhinitis, or chronic idiopathic urticaria in pediatric patients 6-11 years of age is 2.5 mg once daily (as an oral solution or orally disintegrating tablet).1 For symptomatic relief of seasonal allergic rhinitis in pediatric patients 2-5 years of age, perennial allergic rhinitis in pediatric patients 1-5 years of age, or chronic idiopathic urticaria in pediatric patients 1-5 years of age, the recommended dosage of desloratadine is 1.25 mg once daily (as an oral solution).1 For symptomatic relief of perennial allergic rhinitis or chronic idiopathic urticaria in pediatric patients 6-11 months of age, the recommended dosage of desloratadine is 1 mg once daily (as an oral solution).1

Special Populations

The recommended initial dosage of desloratadine in adults with renal or hepatic impairment is 5 mg every other day.1,18 There are no specific dosage recommendations for pediatric patients with renal or hepatic impairment at this time because of lack of data.1 The manufacturer states that the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate generally should be avoided in patients with hepatic impairment.18

Although peak plasma concentrations and areas under the plasma concentration-time curve (AUCs) of desloratadine reportedly were higher in women, black patients, and geriatric patients, the manufacturer states that these differences do not appear to be clinically important, and that dosage adjustment based on gender, race, or age generally is not necessary.1,3 (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Contraindications

Known hypersensitivity to desloratadine, loratadine, or any ingredient in the formulation.1,18

Warnings/Precautions

General Precautions

Desloratadine shares the toxic potentials of loratadine and other second generation antihistamines, and the usual precautions related to therapy with such drugs should be observed.1

Use of Fixed Combinations

When desloratadine is used in fixed combination with pseudoephedrine sulfate, the usual cautions, precautions, and contraindications associated with pseudoephedrine must be considered in addition to those associated with desloratadine.18

Phenylketonuria

Individuals who must restrict their intake of phenylalanine should be warned that Clarinex^® Reditabs^® contain aspartame, which is metabolized in the GI tract following oral administration, to provide 1.4 or 2.9 mg of phenylalanine per 2.5- or 5-mg tablet, respectively. 1

Specific Populations

Pregnancy

Category C.1,18 (See Users Guide.)

Lactation

Desloratadine is distributed into milk.1,18 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.1,18 Exercise caution if the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate is used in nursing women.18

Pediatric Use

Safety and efficacy have not been established for symptomatic management of seasonal allergic rhinitis in children younger than 2 years of age.1

Safety and efficacy have not been established for symptomatic management of perennial allergic rhinitis or chronic idiopathic urticaria in children younger than 6 months of age.1

Safety and efficacy of the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate for symptomatic management of seasonal allergic rhinitis have not been established in children younger than 12 years of age.18

Overdosage and toxicity (including death) have been reported in children younger than 2 years of age receiving nonprescription (over-the-counter, OTC) preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.22,23 Clinicians should ask caregivers about use of nonprescription cough and cold preparations to avoid overdosage. For additional information on precautions associated with the use of cough and cold preparations in pediatric patients, see Cautions: Pediatric Precautions in the Antihistamines General Statement 4:00.

Geriatric Use

Experience with desloratadine in those 65 years of age and older is insufficient to determine whether they respond differently from younger adults.1,18 In one study, peak plasma concentrations and area under the plasma concentration-time curve (AUC) of desloratadine were increased (by 20%) and plasma elimination half-life was prolonged in geriatric patients compared with younger adults; however, these age-related differences do not appear to be clinically important.1,18 Nevertheless, dosage should be selected with caution because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients.1,18

Hepatic Impairment

In clinical studies, AUC of desloratadine was increased by 2.4-fold in patients with hepatic impairment relative to that in patients with normal hepatic function; decreased clearance and increased elimination half-life also were observed.1 Dosage reduction recommended for patients with hepatic impairment.1 (See Dosage and Administration: Special Populations.) Avoid use of the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate.18

Renal Impairment

Peak plasma concentrations or AUC of desloratadine increased by 1.2- or 1.9-fold, respectively, in patients with mild to moderate renal impairment and by 1.7- or 2.5-fold, respectively, in patients with severe renal impairment or in those who required hemodialysis compared with that in patients with normal renal function.1 Dosage reduction recommended for patients with renal impairment.1,18 (See Dosage and Administration: Special Populations.)

Common Adverse Effects

Adverse effects reported in 2% or more of patients 12 years of age and older receiving desloratadine for management of allergic rhinitis and occurring more frequently than placebo include pharyngitis,1,3,4,9 dry mouth,1,3,4,9 myalgia,1,3,9 fatigue,1,3,9 somnolence,1,3,4,9 and dysmenorrhea.1 Adverse effects reported in at least 2% of patients 12 years of age and older receiving desloratadine for management of chronic idiopathic urticaria and more frequently than placebo include headache,1,7,9 nausea,1 fatigue,1,7 dizziness,1,7 pharyngitis,1,7 dyspepsia,1 and myalgia.1

Adverse effects reported in 2% or more of pediatric patients (2-5 years of age) receiving desloratadine and occurring more frequently than placebo include fever, urinary tract infection, and varicella (chicken pox).1 Adverse effects reported in 2% or more of patients 12-23 months of age and occurring more frequently than placebo include fever, diarrhea, upper respiratory tract infection, coughing, increased appetite, emotional lability, epistaxis, parasitic infection, pharyngitis, and maculopapular rash.1 Adverse effects reported in 2% or more of patients 6-11 months of age and occurring more frequently than placebo include upper respiratory tract infection, diarrhea, fever, irritability, coughing, somnolence, bronchitis, otitis media, vomiting, anorexia, pharyngitis, insomnia, rhinorrhea, erythema, and nausea.1

Adverse effects reported in 2% or more of patients 12 years of age and older receiving the fixed combination of desloratadine and pseudoephedrine sulfate include dry mouth, headache, insomnia, fatigue, pharyngitis, somnolence, nausea, dizziness, nervousness, hyperactivity, and anorexia.18

No formal drug interaction studies have been performed with the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate.18 When using this preparation, consider the drug interactions associated with pseudoephedrine (e.g., monoamine oxidase [MAO] inhibitors).18

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction (increased plasma concentrations of desloratadine and active metabolite) when desloratadine is used with drugs affecting hepatic microsomal enzymes (e.g., azithromycin, cimetidine, erythromycin, fluoxetine, ketoconazole).1,9 No clinically important changes in ECG or laboratory evaluations, vital signs, or adverse effects were reported.1,9

Grapefruit Juice

Pharmacokinetic interaction unlikely.1,3

Pharmacokinetics

Absorption

Bioavailability

Conventional tablets and oral solution are bioequivalent.1 Orally disintegrating tablets (recently reformulated) are bioequivalent to original orally disintegrating formulation (no longer commercially available);1 original formulation previously shown to be bioequivalent to conventional tablets and oral solution.20

Peak plasma concentrations occur at approximately 3 or 6-7 hours following administration of conventional tablets, or fixed-combination extended-release preparation, respectively.1,18

Onset

Following single- and multiple-dose administration, antihistaminic effects occur within 1 hour.1 Symptomatic (nasal and nonnasal) improvement observed as early as 1 day after initiation of therapy.2,4,5,6,9

Duration

Following single- and multiple-dose administration, antihistaminic effects persist for up to 24 hours.1 No evidence of histamine-induced skin wheal tachyphylaxis over 28-day treatment period.1

Food

Food or grapefruit juice does not appear to affect bioavailability following administration as conventional tablets, oral solution,1 or fixed-combination tablets;18 water does not appear to affect bioavailability following administration as orally disintegrating tablets.1

Special Populations

In patients with renal impairment and those who require hemodialysis, peak plasma desloratadine concentrations and AUC are increased.1

Distribution

Plasma Protein Binding

Approximately 82-87% (for desloratadine) and 85-89% (for 3-hydroxydesloratadine).1

Special Populations

Protein binding not altered in patients with renal impairment.1

Elimination

Metabolism

Extensively metabolized to 3-hydroxydesloratadine (active metabolite), which subsequently undergoes glucuronidation; enzyme(s) responsible for metabolism of desloratadine not identified.1

Elimination Route

Approximately 87% excreted as metabolic products in urine and feces in equal proportions.1

Desloratadine and 3-hydroxydesloratadine are poorly removed by hemodialysis.1

Half-life

27 hours for desloratadine and 3-hydroxydesloratadine.1

Special Populations

Approximately 6% of patients are poor metabolizers (decreased ability to form 3-hydroxydesloratadine); higher frequency of poor metabolizers in blacks (17%) than in Caucasians (2%) or Hispanics (2%).1,18 Substantially (approximately sixfold) greater drug exposure in poor metabolizers than in normal metabolizers;1 however, no overall differences in safety observed between these groups.1,18 Nevertheless, an increased risk of adverse effects in poor metabolizers cannot be ruled out.1,18

In patients ≥65 years of age, plasma desloratadine concentrations are increased and elimination half-life is prolonged.1

In patients with hepatic impairment, AUC and elimination half-life are increased and clearance is decreased.1

Description

Desloratadine, the active descarboethoxy metabolite of loratadine, is a long-acting tricyclic antihistamine.1,2,3,9 The drug has been characterized as a specific, selective peripheral H₁-receptor antagonist.1,2,3,4,6,9 Experimental evidence indicates that desloratadine also suppresses the release of histamine from human mast cells.1,9 Because desloratadine does not readily cross the blood-brain barrier,1,2,3 the drug has been referred to as a relatively “nonsedating” or second generation antihistamine.2,5,6,7,9

Desloratadine is commercially available for oral administration as conventional tablets, orally disintegrating tablets, oral solution, and as an extended-release tablet containing desloratadine in fixed combination with pseudoephedrine sulfate.1,18 Desloratadine orally disintegrating tablets recently have been reformulated to improve palatability.9,21

Following oral administration of desloratadine 5 mg once daily for 10 days as conventional tablets, peak plasma concentrations of the drug were achieved in approximately 3 hours.1 Following oral administration of a single 5-mg dose of desloratadine as a fixed-combination, extended-release tablet also containing pseudoephedrine sulfate, peak plasma concentrations of desloratadine were achieved in approximately 6-7 hours.18 Food or grapefruit juice does not appear to affect bioavailability of desloratadine following administration as conventional tablets, oral solution, or extended-release fixed-combination tablets; water does not appear to affect bioavailability of desloratadine following administration as orally disintegrating tablets.1

The manufacturer states that desloratadine conventional tablets and oral solution are bioequivalent.1 The currently available reformulated orally disintegrating tablets containing 5 mg of desloratadine are bioequivalent to the original orally disintegrating formulation (no longer commercially available),1 which previously was shown to be bioequivalent to desloratadine conventional tablets and oral solution.20 The extended-release fixed-combination tablets are not bioequivalent with desloratadine conventional tablets. Following oral administration of the fixed-combination preparation containing 5 mg of desloratadine and 240 mg of pseudoephedrine sulfate, plasma concentrations of desloratadine and 3-hydroxydesloratadine were 15-20% lower than those achieved with the 5-mg conventional tablets.18

Following single- and multiple-dose administration, antihistaminic effects of desloratadine occur within 1 hour and persist for up to 24 hours.1 There is no evidence of histamine-induced skin wheal tachyphylaxis following 28 days of treatment with desloratadine 5 mg daily; the clinical relevance of histamine wheal skin testing has not been established.1

Desloratadine is extensively metabolized to 3-hydroxydesloratadine, an active metabolite that subsequently undergoes glucuronidation; the enzyme(s) responsible for metabolism of desloratadine has not been identified.1,18 Data from clinical trials and pharmacokinetic studies indicate that approximately 6% of patients receiving desloratadine exhibit a decreased ability to form 3-hydroxydesloratadine and, therefore, are classified as poor metabolizers of the drug; the frequency of poor metabolizers appears to be higher in blacks (17%) than in Caucasians (2%) or Hispanics (2%).1,18 Poor metabolizers experience a substantially (approximately sixfold) greater exposure to desloratadine than normal metabolizers; however, no overall differences in safety were observed between these groups.1,18 Nevertheless, the manufacturer states that an increased risk of adverse effects in poor metabolizers cannot be ruled out.1,18

Approximately 87% of a radiolabeled oral dose of desloratadine is excreted as metabolic products in urine and feces in equal proportions.1

Advice to Patients

Importance of adhering to prescribed dosage regimen and directions for use; increase in dosage or dosing frequency not recommended since higher dosages provide no additional benefit but may increase the risk of adverse effects (e.g., somnolence).1

For phenylketonurics, importance of informing them that desloratadine orally disintegrating tablets contain aspartame.1

Importance of advising patients to avoid concomitant use of fixed-combination preparation with OTC antihistamines and/or decongestants.18

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

Importance of informing patients of other important precautionary information. (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

1. Schering Corporation. Clarinex^® (desloratadine) tablets , syrup, RediTabs^® tablets prescribing information. Kenilworth, NJ; 2005 Apr.

2. McClellan K and Jarvis B. Desloratadine. Drugs . 2001; 61:789-96. [PubMed 11398910]

3. Agrawal DK. Pharmacology and clinical efficacy of desloratadine as an anti-allergic and anti-inflammatory drug. Expert Opin Investig Drugs . 2001; 10:547-60. [PubMed 11424898]

4. Meltzer EO, Prenner BM, Nayak A for the Desloratadine Study Group. Efficacy and tolerability of once-daily 5 mg desloratadine, an H₁-receptor antagonist, in patients with seasonal allergic rhinitis assessment during the spring and fall allergy seasons. Clin Drug Invest . 2001; 21:25-32.

5. Nayak AS and Schenkel E. Desloratadine reduces nasal congestion in patients with intermittent allergic rhinitis. Allergy . 2001; 56:1077-80. [PubMed 11703222]

6. Baena-Cagnani CE. Desloratadine activity in concurrent seasonal allergic rhinitis and asthma. Allergy . 2001; 56(Suppl):21-7. [PubMed 11243501]

7. Ring J, Hein R, Gauger A et al. Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study. Int J Dermatol . 2001; 40:1-5. [PubMed 11277944]

8. Gupta S, Banfield C, Kantesaria B et al. Pharmacokinetic and safety profile of desloratadine and fexofenadine when coadministered with azithromycin: a randomized, placebo-controlled, parallel-group study. Clin Ther . 2001; 23:451-66. [PubMed 11318079]

9. Schering, Kenilworth, NJ: Personal communication.

10. Borge PA. Problems in allergic rhinitis. Arzneimittelforschung . 1982; 32:1199-201. [PubMed 6891258]

11. Anon. Treatment of seasonal and perennial rhinitis. BMJ . 1981; 283:808-10. [PubMed 6117350][PubMedCentral]

12. Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antiasthmatic products. [21 CFR 341] Fed Regist . 1976; 41:38312-424.

13. Douglas WW. Histamine and 5-hydroxytryptamine (serotonin) and their antagonists. In: Gilman AG, Goodman LS, Rall TW et al, eds. Goodman and Gilman's the pharmacologic basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:605-38.

14. Cirillo VJ, Tempero KF. The pharmacology and therapeutic use of H1 and H2 antihistamines. In: Miller RR, Greenblatt DJ, eds. Drug therapy reviews. Vol 2. New York: Elsevier/North Holland Inc; 1979:24-47.

15. Church JA. Allergic rhinitis: diagnosis and management. Clin Pediatr (Philadelphia) . 1980; 19:655-9.

16. AMA Division of Drugs. AMA drug evaluations. 5th ed. Chicago: American Medical Association; 1983:1465-79.

17. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; tentative final monograph for OTC antihistamine drug products. [21 FR Part 341] Fed Regist . 1985; 50:2200-18.

18. Schering Corporation. Clarinex-D^® 24-Hour (desloratadine 5 mg and pseudoephedrine sulfate) extended-release tablets prescribing information. Kenilworth, NJ; 2005 Mar.

19. Pleskow W, Grubbe R, Weiss S et al. Efficacy and safety of an extended-release formulation of desloratadine and pseudoephedrine vs the individual components in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol . 2005; 94:348-54. [PubMed 15801245]

20. Schering Corporation. Clarinex^® (desloratadine) tablets, syrup, RediTabs^® tablets prescribing information. Kenilworth, NJ; 2004 Aug.

21. Schering-Plough. FDA approves re-formulated Clarinex^® (desloratadine) RediTabs^® tablets—orally disintegrating prescription antihistamine. Kenilworth, NJ: 2005 Jul 15. Press release. From website. [Web]

22. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep . 2007; 56:1-4. [PubMed 17218934]

23. Food and Drug Administration. Cough and cold medications in children less than two years of age. Rockville, MD; 2007 Jan 12. From FDA website. [Web]