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FDA Approves Karbinal ER (Carbinoxamine Maleate) for Allergic Rhinitis in Children

First sustained-release histamine receptor blocker for this indication (Apr. 3)

The FDA has approved Karbinal ER (carbinoxamine maleate, Tris Pharma, Inc.) extended-release oral suspension (4 mg/5 mL) for the treatment of seasonal and perennial allergic rhinitis in children aged 2 years and older. The drug is the first sustained-release histamine (H1) receptor blocker indicated for use in this setting.

According to the product’s developer, approximately 30% of allergic rhinitis patients do not receive adequate relief from nonsedating antihistamines. Before 2006, carbinoxamine — a mildly sedating antihistamine — was widely used with dozens of carbinoxamine-containing combination products, including extended-release solid-dose medications.However, nearly all of these products had not gone through the FDA’s approval process. Following the Drug Efficacy Study Implementation (DESI) review, the FDA removed all unapproved carbinoxamine products from the market, with the exception of two immediate-release formulations, thus creating a need for an extended-release formulation.

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is an H1-receptor antagonist indicated for the symptomatic treatment 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
  • Amelioration of the severity of allergic reactions to blood or plasma

Karbinal ER is dosed once every 12 hours.

Source: Tris Pharma; April 3, 2013.

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