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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  03/28/2013
 
Trade Name:  Karbinal ER
 
Generic Name or Proper Name (*):  carbinoxamine maleate
 
Indications Studied:  Relief of seasonal and perennial allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, mild uncomplicated allergic skin manifestations of urticaria and angioedema, dermatographism, as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled, and amelioration of the severity of allergic reactions to blood or plasma
 
Label Changes Summary:  *Approved for use in 2-17 years *Efficacy and safety is based on demonstration of bioequivalence to the immediate release product * Deaths have been reported in children younger than 2 years who were taking carbinoxamine containing drug products. Therefore, Karbinal ER is contraindicated in children younger than 2 years of age and in nursing mothers. *Carbinoxamine may diminish mental alertness or produce sedation in children *Paradoxical reactions with excitation are more likely in younger children *Karbinal ER must be measured with an accurate milliliter measuring device *Information on safety, dosing, and adverse reactions •New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Tris Pharma, Inc.
 
NNPS:  TRUE
 
Therapeutic Category:  Antihistamine
 
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