Texas Health and Human Services Commission
sign up for e-mail updates

Criteria for Outpatient Use Guidelines

Disclaimer

The information contained at this site and available for download is for the convenience of the public. Some documents are made available in specific file formats to respond to specific requests.

The Texas Health and Human Services Commission is not responsible for any errors in transmission or any errors or omissions in the documents.

Nonsedating Antihistamines

[Criteria developed, March 1997; Revised, August 1997; March 1998; March 1999; April 2000; April 2001; April 2002; April 2003; January 2008]

Information on indications for use or diagnosis is assumed to be unavailable.All criteria may be applied retrospectively; prospective application is indicated with [*].

Printable version (PDF)

1.*Dosage

Adults
Maximum recommended daily doses for available nonsedating antihistamines are summarized in Table 1. Dosages identified in Texas Medicaid patient profiles exceeding these recommendations will be reviewed.

TABLE 1
Maximum Recommended Daily Doses for Nonsedating Antihistamines in Adults
DRUG MAXIMUM DAILY DOSE
Azelastine (Astelin®) spray - 137 mcg/spray 2 sprays per nostril twice daily
+Cetirizine (Zyrtec®) tablets, chewable tablets - 5 mg, 10 mg
+Cetirizine (Zyrtec®) syrup - 5 mg/5 ml 		10mg once daily
+Cetirizine/pseudoephedrine (Zyrtec-D®) 12 hour tablets
(cetirizine 5 mg/pseudoephedrine 120 mg/tablet) 		1 tablet twice daily
Fexofenadine (Allegra®, generics) tablets - 30 mg, 60 mg, 180 mgFexofenadine orally disintegrating (Allegra ODT®) tablets- 30 mg
Fexofenadine (Allegra®) suspension - 6 mg/ml 		60 mg twice daily or 180 mg once daily
Fexofenadine/pseudoephedrine (Allegra-D®) 12 hour tablets (fexofenadine 60 mg/pseudoephedrine 120 mg/tablet) 1 tablet twice daily
Fexofenadine/pseudoephedrine (Allegra-D®) 24 hour tablets(fexofenadine 180 mg/ pseudoephedrine 240 mg/tablet) 1 tablet once daily
Desloratidine (Clarinex®) tablets - 5 mg Desloratadine rapidly disintegrating (Clarinex RediTabs®) tablets - 2.5 mg, 5 mgDesloratadine (Clarinex®) syrup - 2.5 mg/5ml 5 mg once daily
Desloratadine/pseudoephedrine (Clarinex-D®) 24 hour tablets (5 mg desloratadine/ 240 mg pseudoephedrine) 1 tablet once daily
Levocetirizine (Xyzal®) tablet – 5 mg 5 mg once daily in evening
**Loratadine (Claritin®, Tavist ND®, generics) tablets -10 mg Loratadine chewable (Claritin Children’s®) tablets - 5 mg
**Loratadine rapidly disintegrating (Claritin RediTabs®, Alavert®, generics) tablets - 5 mg, 10 mg
**Loratadine (Claritin®) syrup - 5 mg/5 ml 		10 mg once daily
**Loratadine/pseudoephedrine (Claritin D® 12 Hour) tablets
(loratadine 5mg/pseudoephedrine 120 mg/tablet) 		1 tablet twice daily
**Loratadine/pseudoephedrine extended-release (Claritin D® 24 Hour) tablets
(loratadine 10 mg/pseudoephedrine 240 mg/tablet) 		1 tablet once daily

+ Cetirizine tablets, chewable tablets, and syrup as well as cetirizine/pseudoephedrine tablets will now be available over the counter for adults and children 6 years of age and older to manage hay fever and other respiratory allergies as well as hives.
**now OTC

Pediatrics
Nonsedating antihistamines are FDA-approved for use in pediatric patients for allergic rhinitis and chronic urticaria. Maximum recommended dosages for available nonsedating antihistamines are summarized in Table 2. Dosages identified in Texas Medicaid patients exceeding these recommendations will be reviewed.

Table 2
Pediatric Maximum Recommended Dosages for Nonsedating Antihistamines
DRUG MAXIMUM DAILY DOSE
Azelastine nasal spray 5 to 11 years of age:1 spray per nostril twice daily
12 years and older:2 sprays per nostril twice daily
Cetirizine tablets, chewable tablets, syrup 6 months to 11 months of age:2.5 mg once daily
12 months to 5 years of age:5 mg once daily
+6 years to 11 years of age:10 mg once daily
+12 years and older:10 mg once daily
Cetirizine/pseudoephedrine 12 hour tablets +12 years and older:1 tablet twice daily
Desloratadine tablets, rapid tablets, syrup 6 months to 11 months of age:1 mg once daily
12 months to 5 years of age:1.25 mg once daily
6 years to 11 years of age:2.5 mg once daily
12 years and older:5 mg once daily
Desloratadine/pseudoephedrine 24 hour tablets 12 years and older:1 tablet once daily
Fexofenadine tablets, ODT, suspension 6 months to 23 months (chronic urticaria only):15 mg twice daily
2 years to 11 years of age: 30 mg twice daily
12 years and older: 60 mg twice daily or 180 mg once daily
Fexofenadine/pseudoephedrine 12 hour tablet 12 years and older:1 tablet twice daily
Fexofenadine/pseudoephedrine 24 hour tablet 12 years and older:1 tablet once daily
Levocetirizine tablet 6 years to 11 years of age:2.5 mg once daily in evening
12 years and older:5 mg once daily in evening
**Loratadine tablets, chew tabs, rapid tablets, syrup 2 years to 5 years of age:5 mg once daily
6 years and older:10 mg once daily
**Loratadine/pseudoephedrine 12 hour tablet 12 years and older:1 tablet twice daily
**Loratadine/pseudoephedrine 24 hour tablet 12 years and older:1 tablet once daily

+ Cetirizine tablets, chewable tablets, and syrup as well as cetirizine/pseudoephedrine tablets will now be available over the counter for adults and children 6 years of age and older to manage hay fever and other respiratory allergies as well as hives.

**Now available OTC

2.Duration of Therapy

There is no basis for limiting the duration of treatment for nonsedating 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 nonsedating antihistamines is not recommended. Additional therapeutic benefit is not experienced when several antihistamines are administered in combination. Patient profiles containing concurrent prescriptions for multiple nonsedating antihistamines will be reviewed.

References

  1. Drug facts and comparisons.Facts and Comparisons 4.0 [database online].St. Louis, MO:Wolters Kluwer Health, Inc.; 2007.Available at: http://online.factsandcomparisons.com.Accessed January 22nd, 2008.
  2. May JR, Smith PH.Allergic rhinitis. In:DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy.a pathophysiologic approach. 6th ed.New York: McGraw-Hill, 2005.
  3. Hansten PD, Horn JR, eds. Hansten and Horn's Drug Interactions Analysis and Management. St. Louis, MO: Wolters Kluwer Health, Inc., 2007.
  4. Tatro DS, ed. Drug Interaction Facts.St. Louis, MO: Wolters Kluwer Health, Inc., 2008.
  5. Morgan MM. Khan DA. Nathan RA. Treatment for allergic rhinitis and chronic idiopathic urticaria: focus on oral antihistamines. Ann Pharmacother. 2005;39:2056-64.
  6. Kaliner MA. A novel and effective approach to treating rhinitis with nasal antihistamines.Ann Allergy, Asthma, & Immunol. 2007;99:383-90.
  7. Physicians' Desk Reference (electronic version), Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com. Accessed January 22nd, 2008.
  8. (December 8th, 2000) Doctor’s Guide to Medical & Other News.FDA approves antihistamine Claritin (loratadine) for treatment of allergy symptoms in children.http://www.docguide.com.(Information retrieved April 3rd, 2001).
  9. (December 2nd, 2002) Doctor’s Guide.FDA approves over-the-counter Claritin (loratadine). http://www.docguide.com (Information retrieved April 22nd, 2003).
  10. Anonymous. Levocetirizine (Xyzal) for allergic rhinitis and urticaria.Med Lett Drugs Ther. 2007;49:97-9.
  11. FDA News.FDA approves Zyrtec for nonprescription use in adults and children.Available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01750.html .Accessed January 22nd, 2008.

Prepared by:Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin.