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Desloratadine

Classification: A

Drug products: Aerius, Aerius®, Azomyr, Dasselta, Desloratadin ABECE, Desloratadin Apofri, Desloratadin Mylan, Desloratadin STADA, Desloratadine Actavis, Desloratadine Glenmark, Desloratadine ratiopharm, Desloratadine Sandoz, Desloratadine Teva, Flynise

ATC code: R06AX27

Substances: desloratadine

Summary

Desloratadine improve rhinitis symptoms equally effective in men and women.

Adverse events have been reported more frequently by women, especially headaches.
 
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.

Additional information

Pharmacokinetics and dosing

Women treated with oral desloratadine 7.5 mg daily for two weeks had 10% and 3% higher Cmax and AUC values than men (24 men, 24 women; ages 19-45 years). The authors considered the variations to be of no clinically relevance and therefore, no dosage adjustment based on sex is deemed necessary. The Cmax and AUC of the active metabolite 3-hydroxydesloratadine was 45% and 48% higher in women [1]. No sex differentiation in dosing is recommended by the manufacturer [2].

Effects

In a clinical study conducted by the manufacturer, 924 patients with seasonal allergic rhinitis and concomitant asthma received oral desloratadine 5 mg once daily for two weeks. Desloratadine improved rhinitis symptoms and the authors reported that no sex differences in effectiveness of desloratadine were observed [3].

Adverse effects

In an open-label multiple-dose study in healthy volunteers (24 men, 24 women) receiving oral desloratadine 7.5 mg daily for two weeks, women reported more adverse events than men (9 (38%) vs. 2 (8%)). Headache was the most common adverse event, and only reported by women [1].

No differences in adverse events between men and women were reported from the  placebo-controlled trials conducted by the manufacturer [3].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2016-08-10

References

  1. Affrime M, Banfield C, Gupta S, Cohen A, Boutros T, Thonoor M et al. Effect of race and sex on single and multiple dose pharmacokinetics of desloratadine. Clin Pharmacokinet. 2002;41 Suppl 1:21-8. PubMed
  2. Aerius (desloratadine). Summary of Product Characteristics. European Medicines Agency (EMA); 2015.
  3. Clarinex (desloratadine). DailyMed [www]. US National Library of Medicine. [updated 2016-11-16, cited 2016-08-10]. länk
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-08-22.] Socialstyrelsens statistikdatabas

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson