Cetirizine (Zyrtec, and others) and cetirizine/pseudoephedrine (Zyrtec-D) are becoming available without a prescription this month for treatment of allergic rhinitis and urticaria in adults and children. Cetirizine is the second of the second-generation H1-antihistamines to become available over the counter. Loratadine (Claritin, and others) was the first.Cetirizine has been shown to be more effective than loratadine in suppressing histamine-induced wheals in healthy volunteers (W Carey et al. Drugs Exp Clin Res 2002; 28:243), but no well-controlled clinical trials have established that any...

Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6 months old. Oral formulations of cetirizine (Zyrtec, and others) have been for sale over the counter for years. Quzyttir is the first parenteral formulation of a second-generation H1-antihistamine to become available in the US; parenteral formulations of two first-generation H1-antihistamines, diphenhydramine (Benadryl, and others) and hydroxyzine (Vistaril, and others), have been available for many...

A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.

Olopatadine 0.6% nasal spray (Patanase - Alcon) has been approved by the FDA for treatment of seasonal allergic rhinitis in patients ≥ 12 years old. An H1-antihistamine with mast-cell stabilizing activity, olopatadine is already marketed for treatment of allergic conjunctivitis in a 0.1% solution as Patanol and in a 0.2% solution as Pataday. Azelastine (Astelin), another H1-antihistamine with mast-cell stabilizing activity, has been available for intranasal treatment of allergic rhinitis since 1997.

Azelastine hydrochloride, a histamine-H1 receptor antagonist, has been marketed as a 0.1% nasal spray (Astelin - Wallace) for treatment of seasonal allergic rhinitis. Corticosteroid and cromolyn sodium nasal sprays are also available for this indication (Medical Letter, 37:5, 1995). Cromolyn sodium (Nasalcrom) has now been approved for over-the-counter use.

An intranasal spray formulation of the corticosteroid fluticasone propionate (floo tik a sone; Flonase - Allen & Hanburys) has been approved by the US Food and Drug Administration for treatment of seasonal and perennial allergic rhinitis in adults and children more than 12 years old.

In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and others) in many OTC formulations when access to pseudoephedrine-containing products was restricted in an effort to reduce their use in the synthesis of methamphetamine.CLINICAL STUDIES — In a randomized, open-label,...

Epinastine HCl, an H₁-receptor antagonist and mast cell stabilizer, has been approved by the FDA for use in a 0.05% ophthalmic solution (Elestat - Allergan/Inspire) for prevention of itching associated with allergic conjunctivitis. The drug is available orally in Europe and Asia.

Acrivastine/Pseudoephedrine (Semprex-D) for Seasonal Allergic Rhinitis (Burroughs-Wellcome), a combination of acrivastine with pseudoephedrine hydrochloride, has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis. Acrivastine is a new H 1 -receptor antagonist with a chemical structure similar to that of triprolidine (Actidil, and others) (RN Brogden and D McTavish, Drugs, 41:927, 1991). Pseudoephedrine is an α -adrenergic agonist. The combination is available only by prescription.

Montelukast (Singulair - Merck) is an oral cysteinyl leukotriene D₄ receptor antagonist originally marketed for treatment of asthma. It was approved by the FDA in 2003 for treatment of seasonal allergic rhinitis and recently for use in perennial allergic rhinitis in adults and children ≥ 6 months old. Intranasal corticosteroids have generally been considered the most effective drugs available for prevention and treatment of allergic rhinitis.