Non-sedating Antihistamines - Index

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

  • Revision history
    • July 26, 2024
    • July 2022
    • June 2020
    • June 2018
    • July 2016
    • May 2016
    • Sept. 2014
    • Dec. 2012
    • March 2011
    • Feb. 2011
    • Jan. 2011
    • Jan. 2008
    • April 2003
    • April 2002
    • April 2001
    • April 2000
    • March 1999
    • March 1998
    • Aug. 1997
    • March 1997 (Initially developed)

Non-sedating Antihistamines - Dosage - Index

Oral non-sedating antihistamines are FDA-approved for managing urticaria and allergic rhinitis. Nasal non-sedating antihistamines as monotherapy and combination therapy are FDA-approved for treating allergic rhinitis and vasomotor rhinitis. The oral non-sedating antihistamines desloratadine and acrivastine are available only by prescription. Inhalational non-sedative antihistamines are also available; olopatadine (Patanase) and azelastine (Astepro) are available by prescription and azelastine (Astepro Allergy) are available now over the counter.

1.1. Adults

Maximum recommended daily dosages for available non-sedating antihistamines are summarized in Tables 1 and 2. Dosages identified in Texas Medicaid patient profiles exceeding these recommendations will be reviewed.

Table 1. Adult Maximum Recommended Daily Dosages for Non-sedating Antihistamines – Monotherapy 1-12
Drug NameDosage Form/StrengthTreatment IndicationMaximum Recommended Dosage 
azelastine (Astepro, Astepro Allergy, generics)**0.15% nasal solution – 205.5 mcg/sprayseasonal or perennial allergic rhinitis2 sprays per nostril twice daily
azelastine (generics)0.1% nasal solution – 137 mcg/sprayperennial allergic rhinitis2 sprays per nostril twice daily
azelastine (Astepro, generics) seasonal allergic rhinitis2 sprays per nostril twice daily
azelastine (generics) vasomotor rhinitis2 sprays per nostril twice daily
cetirizine (Zyrtec, generics)

**tablets, chewable tablets – 5 mg, 10 mg

**orally disintegrating tablets - 10 mg

**liquid filled capsule – 10 mg

**solution – 1 mg/mL

syrup – 1 mg/ mL

perennial or seasonal allergic rhinitis10 mg once daily
cetirizine (Zyrtec, generics)

**liquid filled capsule – 10 mg

**solution – 1 mg/mL

syrup – 1 mg/mL

**tablets, chewable tablets – 5 mg, 10 mg

chronic idiopathic urticaria10 mg once daily
desloratadine (Clarinex, generics)

tablets – 5 mg

rapidly disintegrating tablets - 2.5 mg, 5 mg

chronic idiopathic urticaria5 mg once daily
desloratadine (Clarinex, generics) perennial or seasonal allergic rhinitis5 mg once daily
fexofenadine (Allegra, generics, Allegra ODT)

**tablets – 30 mg, 60 mg, 180 mg

**orally disintegrating tablets - 30 mg

**suspension – 30 mg/5 mL

allergic rhinitis60 mg twice daily; 180 mg once daily (tablets only)
fexofenadine (Allegra, generics, Allegra ODT) chronic idiopathic urticaria60 mg twice daily or 180 mg once daily
levocetirizine (Xyzal, generics)

**tablet – 5 mg

**oral solution – 2.5 mg/5 mL

allergic rhinitis5 mg once daily in evening
levocetirizine (Xyzal, generics) chronic idiopathic urticaria5 mg once daily in evening
loratadine (Claritin, Alavert, Claritin Children’s, Claritin RediTabs, generics)

**tablets – 10 mg

**chewable tablets (Claritin Children’s) – 5 mg

**rapidly disintegrating tablets (Claritin RediTabs, Alavert) 10 mg

**liquid-gel capsule – 10 mg

**solution – 5 mg/5 mL

perennial or seasonal allergic rhinitis    10 mg once daily
loratadine (Claritin, Alavert, Claritin Children’s, Claritin RediTabs, generics) chronic idiopathic urticaria10 mg once daily
olopatadine (Patanase, generics)0.6% nasal solutionseasonal allergic rhinitis2 sprays per nostril twice daily

Legend:

  • **now over-the-counter
  • ODT = orally disintegrating tablet
Table 2. Adult Maximum Recommended Daily Dosages for Non-sedating Antihistamines - Combination Therapy1,2,12-19
Drug NameDosage Form/StrengthTreatment IndicationMaximum Recommended Dosage
azelastine/fluticasone (Dymista, generics)nasal suspension – 137 mcg/ 50 mcg per actuationseasonal allergic rhinitis1 spray per nostril twice daily
**cetirizine/ pseudoephedrine (Zyrtec-D, generics)12-hour tablets (cetirizine 5 mg/ pseudoephedrine 120 mg/ tablet)perennial or seasonal allergic rhinitis1 tablet twice daily
**fexofenadine/ pseudoephedrine (Allegra-D, generics)12-hour tablets (fexofenadine 60 mg/ pseudoephedrine 120 mg/ tablet)seasonal allergic rhinitis1 tablet twice daily
**fexofenadine/ pseudoephedrine (Allegra-D, generics)24-hour tablets (fexofenadine 180 mg/ pseudoephedrine 240 mg/ tablet)seasonal allergic rhinitis1 tablet once daily
desloratadine/ pseudoephedrine (Clarinex-D 12 hour, generics)12-hour tablets (2.5 mg desloratadine/ 120 mg pseudoephedrine/ tabletseasonal allergic rhinitis1 tablet twice daily
**loratadine/ pseudoephedrine (Claritin D 12 Hour, Alavert-D, generics)12-hour tablets (loratadine 5 mg/ pseudoephedrine 120 mg/ tablet)seasonal allergic rhinitis1 tablet twice daily
**loratadine/pseudoephedrine extended-release (Claritin D 24 Hour, generics)24-hour tablets (loratadine 10 mg/pseudoephedrine 240 mg/tablet)seasonal allergic rhinitis1 tablet once daily

Legend:

  • **now over-the-counter

1.2. Pediatrics

Oral non-sedating antihistamines are FDA-approved for use in pediatric patients for allergic rhinitis and chronic urticaria. Cetirizine and levocetirizine are FDA-approved for use in children 6 months of age and older with urticaria and seasonal allergic rhinitis. Desloratadine is FDA-approved for use in children 6 months of age and older with chronic idiopathic urticaria and perennial allergic rhinitis and 2 years of age and older for seasonal allergic rhinitis, and fexofenadine and loratadine are FDA-approved for use in children 2 years and older for allergic rhinitis. The nasal non-sedating antihistamine, azelastine 0.1% solution, is FDA-approved for use in children 2 years and older for seasonal allergic rhinitis treatment, while olopatadine, another nasal non-sedating antihistamine, is indicated for use in children 6 years and older for seasonal allergic rhinitis therapy. Azelastine 0.15% solution is approved for use in children 5 years and older for perennial allergic rhinitis; azelastine 0.1% is FDA-approved for perennial allergic rhinitis treatment in children 6 months to 11 years. Azelastine 0.1% solution is also indicated for use in pediatric patients 12 years and older with vasomotor rhinitis. Safety and efficacy of oral non-sedating antihistamine/decongestant combination products have not been established in children less than 12 years of age. Maximum recommended pediatric dosages for available non-sedating antihistamines are summarized in Tables 3 and 4. Dosages identified in Texas Medicaid patients exceeding these recommendations will be reviewed.

Table 3. Pediatric Maximum Recommended Dosages for Non-sedating Antihistamines – Monotherapy1-11
Drug NameDosage Form/StrengthTreatment IndicationMaximum Recommended Dosage
azelastine (Astepro, Astepro Allergy, generics)
  • **0.15% nasal solution – 205.5 mcg/spray
seasonal and perennial allergic rhinitis
  • 6 years to 11 years:
    • 1 spray per nostril twice daily
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily
azelastine (Astepro generics)
  • 0.1% nasal solution – 137 mcg/spray
perennial allergic rhinitis
  • 6 months to 11 years:
    • 1 spray per nostril twice daily
azelastine (Astepro generics) seasonal allergic rhinitis
  • 2 years to 11 years:
    • 1 spray per nostril twice daily
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily
azelastine (generics) vasomotor rhinitis
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily
cetirizine (Zyrtec, generics)
  • **tablets, chewable tablets – 5 mg, 10 mg
  • **orally disintegrating tablets - 10 mg
  • **liquid filled capsule – 10 mg
  • **solution – 1 mg/mL
  • syrup – 1 mg/ mL
perennial or seasonal allergic rhinitis    
  • 6 months to 11 months:
    • 2.5 mg once daily (oral solution only)
  • 12 months to 5 years:
    • 5 mg once daily
  • 6 years to 17 years:
    • 10 mg once daily
cetirizine (Zyrtec, generics)
  • **tablets, chewable tablets – 5 mg, 10 mg
  • **liquid filled capsule – 10 mg
  • **solution – 1 mg/mL
  • syrup – 1 mg/ mL
chronic urticaria
  • 6 months to 11 months:
    • 2.5 mg once daily (oral solution only)
  • 12 months to 5 years:
    • 5 mg once daily
  • 6 years to 17 years:
    • 10 mg once daily
desloratadine (Clarinex, generics)
  • tablets – 5 mg
  • rapidly disintegrating tablets - 2.5 mg, 5 mg
chronic idiopathic urticaria; seasonal and perennial allergic rhinitis    
  • 6 months to 11 months: 1 mg once daily
  • 12 months to 5 years: 1.25 mg once daily
  • 6 years to 11 years: 2.5 mg once daily
  • 12 years to 17 years: 5 mg once daily
  Seasonal allergic rhinitis2 years to 5 years: 1.25 mg once daily
6 to 11 years: 2.5 mg once daily
12 years to 17 years: 5 mg once daily
  chronic idiopathic urticaria6 months to 11 months: 1 mg once daily
12 months to 5 years: 1.25 mg once daily
6 years to 11 years: 2.5 mg once daily
12 years to 17 years: 5 mg once daily 
fexofenadine (Children’s Allegra Allergy suspension, generics)
  • **suspension – 30 mg/5 mL
allergic rhinitis
  • 2 years to 11 years:
    • 30 mg (1 teaspoon) every 12 hours
  • 12 years to 17 years:
    • 60 mg twice daily
fexofenadine (Children’s Allegra Allergy suspension, generics)
  • **suspension – 30 mg/5 mL
allergic rhinitis
  • 2 years to 11 years:
    • 30 mg (1 teaspoon) every 12 hours
  • 12 years to 17 years:
    • 60 mg twice daily
fexofenadine (Children’s Allegra Allergy suspension, generics) chronic idiopathic urticaria
  • 6 months to 2 years:
    • 15 mg twice daily
  • 2 years to 11 years:
    • 30 mg twice daily
  • 12 years to 17 years:
    • 60 mg twice daily or 180 mg once daily
fexofenadine (Children’s Allegra Allergy ODT, generics)
  • **orally disintegrating tablets - 30 mg
allergic rhinitis
  • 6 years to 11 years:
    • 30 mg (1 ODT) on tongue every 12 hours
  • 12 years to 17 years:
    • 60 mg (2 ODTs) on tongue every 12 hours
fexofenadine (Children’s Allegra Allergy ODT, generics) chronic idiopathic urticaria
  • 6 years to 11 years:
    • 30 mg (1 ODT) on tongue every 12 hours
  • 12 years to 17 years:
    • 60 mg (2 ODTs) on tongue every 12 hours
fexofenadine (Allegra, generics)
  • **tablets – 30 mg, 60 mg, 180 mg
allergic rhinitis
  • 12 years to 17 years:
    • 60 mg twice daily or 180 mg once daily
fexofenadine (Allegra, generics) chronic idiopathic urticaria
  • 6 years to 11 years:
    • 30 mg twice daily
  • 12 years to 17 years:
    • 60 mg twice daily or 180 mg once daily
levocetirizine (Xyzal, generics)
  • **tablet – 5 mg
  • **oral solution – 2.5 mg/5 mL
allergic rhinitis
  • 6 months to 5 years:*
    • 1.25 mg once daily in the evening (oral solution only)
  • 6 years to 11 years:
    • 2.5 mg once daily in evening
  • 12 years to 17 years:
    • 5 mg once daily in evening
levocetirizine (Xyzal, generics) chronic idiopathic urticaria
  • 6 months to 5 years:*
    • 1.25 mg once daily in the evening (oral solution only)
  • 6 years to 11 years:
    • 2.5 mg once daily in evening
  • 12 years to 17 years:
    • 5 mg once daily in evening
loratadine (Claritin, Alavert, Claritin Children’s, Claritin RediTabs, generics)
  • **tablets – 10 mg
  • **chewable tablets (Claritin) – 5 mg
  • **rapidly disintegrating tablets (Claritin RediTabs) – 5 mg, 10 mg
  • **liquid-gel capsule – 10 mg
  • **solution - 5 mg/5 mL
perennial or seasonal allergic rhinitis
  • 2 years to 5 years:
    • 5 mg once daily (chewable tablets, solution)
  • 6 years to 17 years:
    • 10 mg once daily or 5 mg every 12 hours
  chronic idiopathic urticaria2 years to 5 years: 5 mg once daily 
6 years to 17 years:
10 mg once daily or 5 mg every 12 hours
 loratadine oral solution 5mg/5mLchronic idiopathic urticaria
  • 6 years to 17 years:
    • 10 mg once daily or 5 mg every 12 hours
olopatadine (Patanase, generics)0.6% nasal solutionseasonal allergic rhinitis
  • 6 years to 11 years:
    • 1 spray per nostril twice daily
  • 12 years to 17 years:
    • 2 sprays per nostril twice daily

Legend:

  • **now over-the-counter
  • *OTC use only indicated in patients 2 years and older
Table 4. Pediatric Maximum Recommended Dosages for Non-sedating Antihistamines – Combination Therapy1,2,12-19
Drug NameTreatment IndicationDosage Form/StrengthMaximum Recommended Dosage
azelastine/ fluticasone (Dymista, generics)seasonal allergic rhinitisnasal suspension – 137 mcg/ 50 mcg per actuation
  • 6 years to 17 years:
    • 1 spray per nostril twice daily
**cetirizine/ pseudoephedrine (Zyrtec-D, generics)perennial or seasonal allergic rhinitis12-hour tablets (cetirizine 5 mg/ pseudoephedrine 120 mg/ tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**fexofenadine/ pseudoephedrine (Allegra-D, generics)seasonal allergic rhinitis12-hour tablets (fexofenadine 60 mg/ pseudoephedrine 120 mg/ tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**fexofenadine/ pseudoephedrine (Allegra-D, generics)seasonal allergic rhinitis24-hour tablets (fexofenadine 180 mg/ pseudoephedrine 240 mg/ tablet)
  • 12 years to 17 years:
    • 1 tablet once daily
desloratadine/ pseudoephedrine (Clarinex-D 12 hour, generics)seasonal allergic rhinitis12-hour tablets (2.5 mg desloratadine/ 120 mg pseudoephedrine/ tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**loratadine/pseudoephedrine (Claritin D 12 Hour, Alavert Allergy and Congestion D- 12 Hour, generics)seasonal allergic rhinitis12-hour tablets
(loratadine 5mg/pseudoephedrine 120 mg/tablet)
  • 12 years to 17 years:
    • 1 tablet twice daily
**loratadine/pseudoephedrine extended release (Claritin D 24 Hour, generics)seasonal allergic rhinitis24-hour tablets (loratadine 10 mg/pseudoephedrine 240 mg/tablet)
  • 12 years to 17 years:
    • 1 tablet once daily

Legend:

  • **now over-the-counter

2. Duration of Therapy

There is no basis for limiting the duration of treatment for non-sedating antihistamines as patients may suffer from symptoms of allergic rhinitis or other chronic allergic conditions continually.

3. Duplicative Therapy

The concurrent use of two or more non-sedating antihistamines is not recommended20-23 . Additional therapeutic benefit is not experienced when several antihistamines are administered in combination1,2. Patient profiles containing concurrent prescriptions for multiple non-sedating antihistamines will be reviewed.

4. Drug-Drug Interactions

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically significant for non-sedating antihistamines are summarized in Table 5. Only those drug-drug interactions classified as clinical significance level 1/ contraindicated or those considered life-threatening which have not yet been classified will be reviewed.

Table 5. Non-sedating Antihistamine Drug-Drug Interactions1-19, 24, 25
Target Drug Interacting Drug Interaction Recommendation Clinical Significance Level#
fexofenadine antacids adjunctive administration within 15 minutes of each other decreases fexofenadine bioavailability (AUC ↓’d 41%, Cmax ↓’d 43%), may reduce fexofenadine efficacy space administration times Moderate (DrugReax) 3- Moderate (CP)
fexofenadine P-glycoprotein (P-gp) inducers (e.g., rifamycins, carbamazepine, fosamprenavir) co-administration may decrease fexofenadine serum concentrations and reduce fexofenadine efficacy; drugs such as carbamazepine, rifamycins may activate P-gp transport in small intestine (fexofenadine is substrate of this transport) and decrease fexofenadine oral absorption monitor for decreased fexofenadine therapeutic effects 3-moderate (Lexicomp)
fexofenadine P-glycoprotein (P-gp) inhibitors (e.g., etravirine) co-administration may increase fexofenadine serum concentrations, potentially resulting in enhanced pharmacologic and adverse effects monitor for increased fexofenadine pharmacologic effects 3-Minor (CP)
loratadine amiodarone conjunctive administration may result in reduced loratadine metabolism and enhanced loratadine pharmacologic/adverse effects; amiodarone inhibits CYP3A4, loratadine metabolized by CYP3A4; rare reports of QT interval prolongation with drug combination use cautiously together; QT interval monitoring recommended major (DrugReax)

Legend:

  • #CP = Clinical Pharmacology  

5. References

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc; 2024. Available at: http://www.clinicalpharmacology.com. Accessed June 6, 2024.
  2. Azelastine 0.1% nasal spray package insert. AvKare. March 2021.
  3. Azelastine (Astepro Allergy®) 0.15% HCl nasal spray product information. Bayer Healthcare. September 2023.
  4. Azelastine 0.15% nasal spray package insert. Aurobindo Pharma Limited. October 2020.
  5. Cetirizine hydrochloride (Zyrtec® Allergy) film coated tablets product information. Johnson & Johnson Consumer, Inc. May 2023.
  6. Cetirizine hydrochloride (Children’s Zyrtec®) chewable tablet product information. Johnson & Johnson Consumer, Inc. January 2024.
  7. Cetirizine hydrochloride (Children’s Zyrtec® Allergy) oral disintegrating tablet product information. Johnson & Johnson Consumer, Inc. June 2023.
  8. Cetirizine hydrochloride (Zyrtec® Allergy) oral capsule product information. Johnson & Johnson Consumer, Inc. January 2024.
  9. Cetirizine hydrochloride oral solution product information. Amneal Pharmaceuticals, LLC. December 2023.
  10. Cetirizine hydrochloride (Children’s Zyrtec® Allergy) oral syrup product information. Johnson & Johnson Consumer, Inc. March 2023.
  11. Desloratadine tablets (Clarinex®) package insert. Organon, LLC. August 2022.
  12. Desloratadine oral disintegrating tablets package insert. Dr. Reddy’s Laboratories Limited. September 2023.
  13. Fexofenadine hydrochloride (Allegra® Allergy) oral tablets product information. Chattem, Inc. April 2024.
  14. Fexofenadine hydrochloride (Children’s Allegra® Allergy) oral suspension product information. Chattem, Inc. February 2024.
  15. Fexofenadine hydrochloride (Children’s Allegra® Allergy) oral disintegrating tablets product information. Chattem, Inc. August 2022.
  16. Levocetirizine dihydrochloride (Xyzal® Allergy 24 Hours) oral tablets product information. Chattem, Inc. February 2024.
  17. Levocetirizine dihydrochloride (Children’s Xyzal® Allergy) oral solution product information. Chattem, Inc. February 2024.
  18. Loratadine orally disintegrating tablets (Claritin Reditabs®) product information. Bayer Healthcare, LLC. November 2023.
  19. Loratadine oral tablets (Claritin®) product information. Bayer Healthcare, LLC. March 2023.
  20. Loratadine oral capsules (Claritin® Liqui-Gels) product information. Bayer Healthcare, LLC. February 2024.
  21. Loratadine chewable tablets (Claritin® Chewable) product information. Bayer Healthcare, LLC. December 2023.
  22. Loratadine solution (Children Claritin® Allergy) product information. Bayer Healthcare, LLC. November 2023.
  23. Olopatadine nasal spray package insert. Akorn. January 2023.
  24. Azelastine HCl and fluticasone propionate (Dymista®) nasal spray package insert. Meda Pharmaceuticals Inc. August 2022.
  25. Cetirizine HCl and pseudoephedrine HCl (Zyrtec-D®) product information. Johnson and Johnson Consumer Inc. March 2023. 
  26. Fexofenadine HCl and pseudoephedrine HCl (Allegra-D 12 Hour Allergy and Congestion®) product information. Chattem, Inc. August 2021.
  27. Fexofenadine HCl and pseudoephedrine HCl (Allegra-D 24 Hour Allergy and Congestion®) product information. Chattem, Inc. December 2020.
  28. Desloratadine and pseudoephedrine sulfate (Clarinex-D 12 Hour®) package insert. Organon. November 2022.
  29. Loratadine and pseudoephedrine sulfate (Claritin-D 12 hour®) package insert. Bayer Healthcare, LLC. November 2023.
  30. Loratadine and pseudoephedrine sulfate (Claritin-D 24 hour®) package insert. Bayer Healthcare, LLC. November 2023.
  31. Loratadine and pseudoephedrine sulfate (Alavert Allergy Sinus -D®) package insert. Bayer Healthcare. December 2021.
  32. Sur DK, Scandale S. Treatment of allergic rhinitis. Am Fam Physician. 2010; 81(12):1440-6.
  33. Kaliner MA. A novel and effective approach to treating rhinitis with nasal antihistamines. Ann Allergy, Asthma, & Immunol. 2007;99:383-90.
  34. Barr JG, Al-Reefy B, Fox AT, Hopkins C. Allergic rhinitis in children. BMJ. 2014;349:g4153.
  35. Wallace DV, Dykewicz MS, Bernstein DI, et al. for the Joint Task Force on Practice Parameters for Allergy and Immunology. The diagnosis and management of rhinitis: An updated practice parameter. J Allergy Clin Immunol. 2008;122(2)Suppl:S1-S84.