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OTC Products: Alaway and Zaditor
otc products
OTC Products: Alaway and Zaditor
reported with the use of ophthalmic ketotifen products include headache, rhinitis, pharyngitis, dry eyes, pain or irritation in the eye or conjunctivae, and influenza.
Yogini Brahmbhatt and Karen W. Lee
Patient information Category: Ophthalmic antihistamine Manufacturer: Bausch & Lomb (Alaway); Novartis (Zaditor) Ingredient: 0.025% ketotifen fumarate ophthalmic solution Use: Allergic conjunctivitis Availability: Eye drops, available in 10 mL (Alaway) and 5 mL (Zaditor) supplies. Discussion: Allergic conditions affect millions in the U.S. annually. Nonprescription ocular antiallergy agents allow those frequently suffering from bothersome symptoms, such as red, itchy, watery eyes, to acquire treatment easily and conveniently. Allergic conjunctivitis is a condition whereby the thin membranes that cover the exposed surfaces of the eyes and eyelids (the conjunctivae) become inflamed following exposure to certain airborne particles.1 Allergic conjunctivitis may manifest as either seasonal allergic conjunctivitis or perennial allergic conjunctivitis.2 Seasonal allergic conjunctivitis is associated with an allergic response to triggers including grass, pollen, and ragweed. Perennial allergic conjunctivitis may occur year round because of allergens such as dust mites and animal dander. Management of allergic conjunctivitis primarily involves avoidance of triggers but often requires additional pharmacologic therapy. Treatment options may include a topical combination antihistamine and vasoconstricting agent for short-term exacerbations and mast cell stabilizers or oral antihistamines if the condition persists. Pharmacologic agents
include both single-entity and combination prescription and OTC products. Ketotifen fumarate is a combination histamine blocker and mast cell stabilizer that works by inhibiting the release of inflammatory mediators involved in hypersensitivity reactions by preventing chemostaxis and the activation of eosinophils. It was a prescription product (Zaditor) until the Food and Drug Administration (FDA) switched it to nonprescription status in October 2006.3 Subsequently, in December 2006, FDA approved Alaway.4 Both products contain identical active and inactive ingredients (benzalkonium chloride 0.01%, glycerin, sodium hydroxide/hydrochloric acid, and purified water). Alaway and Zaditor are indicated for the temporary relief of symptoms associated with allergic conjunctivitis (in particular, itchy eyes).5–7 The recommended dose is one drop into the affected eye(s) twice daily every 8 to 12 hours. Compared with other currently available OTC ocular antiallergy products, Alaway and Zaditor provide a longer duration of action. Other products offer up to 4 hours of relief and must be applied several times a day. Neither ketotifen product contains a vasoconstrictor (i.e., a decongestant), thereby eliminating the potential adverse effects (e.g., rebound redness) associated with continued use of other vasoconstrictorcontaining products. Alaway and Zaditor are not recommended for use in children younger than 3 years of age, and both products are Pregnancy Category C. Adverse reactions commonly
The OTC Products column provides news and information about nonprescription drug and dietary supplement products and medical devices commonly available in pharmacies. Send your suggestions for future installments to Contributing Editor Nicholas G. Popovich, PhD, Professor and Head, Department of Pharmacy Administration, College of Pharmacy, University of Illinois at Chicago, at [email protected].
Journal of the American Pharmacists Association
w w w. p h a r m a c i s t . c o m
n Do not use if sensitive to any ingredient in Alaway/Zaditor. n Do not use if the solution changes color or becomes cloudy. n Do not use to treat contact lens– related irritation. n Remove contact lenses before use and wait 10 minutes after applying drops to reinsert lenses. n Do not touch the tip of the container to any surface to avoid contamination of the product. n Replace the product cap after each use. n Discontinue use and seek medical advice from your physician if the following adverse reactions occur: — Eye pain — Changes in vision — Redness of the eyes — Itching that becomes worse or persists for more than 72 hours Yogini Brahmbhatt, PharmD Clinical Consultant Pharmacist [email protected] Karen W. Lee, PharmD Clinical Consultant Pharmacist Clinical Pharmacy Services University of Massachusetts Medical School Commonwealth Medicine 333 South St. Shrewsbury, MA 01545-4169 [email protected] doi: 10.1331/JAPhA.2007.07535
References
1. American Academy of Allergy, Asthma & Immunology. Allergic conditions: allergic conjunctivitis. Accessed at www. aaaai.org/patients/allergic_conditions/ allergic_conjunctivitis.stm, July 16, 2007. 2. American Academy of Allergy, Asthma & Immunology. Eye allergies. Accessed at www.acaai.org/public/eyeALLERGY/ eyeBrochure.htm, July 16, 2007. 3. Food and Drug Administration. Rx to OTC switch list. Accessed at www.fda. gov/cder/Offices/OTC/rx-to-otc.htm, July 24, 2007.
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otc products 4. Food and Drug Administration. CDER drug and biologic approvals for calendar year 2006: updated through December 31, 2006. Accessed at www. fda.gov/cder/rdmt/InternetNDA06.htm, July 24, 2007.
e28 • JAPhA • 47: 6 • N o v / D e c 2 0 07
5. Bausch & Lomb. Alaway (ketotifen fumarate ophthalmic solution 0.025%) antihistamine eye drops. Accessed at www.bausch.com/en_US/consumer/ visioncare/product/drops/alaway_con. aspx, July 24, 2007.
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6. Novartis. Zaditor (ketotifen fumarate) antihistamine eye drops. Accessed at www.zaditor.com, July 24, 2007. 7. Zaditor [package insert]. Duluth, Ga.: Novartis Ophthalmics; 2002.
Journal of the American Pharmacists Association
OTC Products: Alaway and Zaditor
reported with the use of ophthalmic ketotifen products include headache, rhinitis, pharyngitis, dry eyes, pain or irritation in the eye or conjunctivae, and influenza.
Yogini Brahmbhatt and Karen W. Lee
Patient information Category: Ophthalmic antihistamine Manufacturer: Bausch & Lomb (Alaway); Novartis (Zaditor) Ingredient: 0.025% ketotifen fumarate ophthalmic solution Use: Allergic conjunctivitis Availability: Eye drops, available in 10 mL (Alaway) and 5 mL (Zaditor) supplies. Discussion: Allergic conditions affect millions in the U.S. annually. Nonprescription ocular antiallergy agents allow those frequently suffering from bothersome symptoms, such as red, itchy, watery eyes, to acquire treatment easily and conveniently. Allergic conjunctivitis is a condition whereby the thin membranes that cover the exposed surfaces of the eyes and eyelids (the conjunctivae) become inflamed following exposure to certain airborne particles.1 Allergic conjunctivitis may manifest as either seasonal allergic conjunctivitis or perennial allergic conjunctivitis.2 Seasonal allergic conjunctivitis is associated with an allergic response to triggers including grass, pollen, and ragweed. Perennial allergic conjunctivitis may occur year round because of allergens such as dust mites and animal dander. Management of allergic conjunctivitis primarily involves avoidance of triggers but often requires additional pharmacologic therapy. Treatment options may include a topical combination antihistamine and vasoconstricting agent for short-term exacerbations and mast cell stabilizers or oral antihistamines if the condition persists. Pharmacologic agents
include both single-entity and combination prescription and OTC products. Ketotifen fumarate is a combination histamine blocker and mast cell stabilizer that works by inhibiting the release of inflammatory mediators involved in hypersensitivity reactions by preventing chemostaxis and the activation of eosinophils. It was a prescription product (Zaditor) until the Food and Drug Administration (FDA) switched it to nonprescription status in October 2006.3 Subsequently, in December 2006, FDA approved Alaway.4 Both products contain identical active and inactive ingredients (benzalkonium chloride 0.01%, glycerin, sodium hydroxide/hydrochloric acid, and purified water). Alaway and Zaditor are indicated for the temporary relief of symptoms associated with allergic conjunctivitis (in particular, itchy eyes).5–7 The recommended dose is one drop into the affected eye(s) twice daily every 8 to 12 hours. Compared with other currently available OTC ocular antiallergy products, Alaway and Zaditor provide a longer duration of action. Other products offer up to 4 hours of relief and must be applied several times a day. Neither ketotifen product contains a vasoconstrictor (i.e., a decongestant), thereby eliminating the potential adverse effects (e.g., rebound redness) associated with continued use of other vasoconstrictorcontaining products. Alaway and Zaditor are not recommended for use in children younger than 3 years of age, and both products are Pregnancy Category C. Adverse reactions commonly
The OTC Products column provides news and information about nonprescription drug and dietary supplement products and medical devices commonly available in pharmacies. Send your suggestions for future installments to Contributing Editor Nicholas G. Popovich, PhD, Professor and Head, Department of Pharmacy Administration, College of Pharmacy, University of Illinois at Chicago, at [email protected].
Journal of the American Pharmacists Association
w w w. p h a r m a c i s t . c o m
n Do not use if sensitive to any ingredient in Alaway/Zaditor. n Do not use if the solution changes color or becomes cloudy. n Do not use to treat contact lens– related irritation. n Remove contact lenses before use and wait 10 minutes after applying drops to reinsert lenses. n Do not touch the tip of the container to any surface to avoid contamination of the product. n Replace the product cap after each use. n Discontinue use and seek medical advice from your physician if the following adverse reactions occur: — Eye pain — Changes in vision — Redness of the eyes — Itching that becomes worse or persists for more than 72 hours Yogini Brahmbhatt, PharmD Clinical Consultant Pharmacist [email protected] Karen W. Lee, PharmD Clinical Consultant Pharmacist Clinical Pharmacy Services University of Massachusetts Medical School Commonwealth Medicine 333 South St. Shrewsbury, MA 01545-4169 [email protected] doi: 10.1331/JAPhA.2007.07535
References
1. American Academy of Allergy, Asthma & Immunology. Allergic conditions: allergic conjunctivitis. Accessed at www. aaaai.org/patients/allergic_conditions/ allergic_conjunctivitis.stm, July 16, 2007. 2. American Academy of Allergy, Asthma & Immunology. Eye allergies. Accessed at www.acaai.org/public/eyeALLERGY/ eyeBrochure.htm, July 16, 2007. 3. Food and Drug Administration. Rx to OTC switch list. Accessed at www.fda. gov/cder/Offices/OTC/rx-to-otc.htm, July 24, 2007.
N o v / D e c 2 0 07 • 47: 6 •
JAPhA • e27
otc products 4. Food and Drug Administration. CDER drug and biologic approvals for calendar year 2006: updated through December 31, 2006. Accessed at www. fda.gov/cder/rdmt/InternetNDA06.htm, July 24, 2007.
e28 • JAPhA • 47: 6 • N o v / D e c 2 0 07
5. Bausch & Lomb. Alaway (ketotifen fumarate ophthalmic solution 0.025%) antihistamine eye drops. Accessed at www.bausch.com/en_US/consumer/ visioncare/product/drops/alaway_con. aspx, July 24, 2007.
w w w. j a p h a . o r g
6. Novartis. Zaditor (ketotifen fumarate) antihistamine eye drops. Accessed at www.zaditor.com, July 24, 2007. 7. Zaditor [package insert]. Duluth, Ga.: Novartis Ophthalmics; 2002.
Journal of the American Pharmacists Association