Karbinal

Karbinal ER is indicated for adults and pediatric patients 2 years of age and older 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

2 to 3 years: 3.75 mL to 5 mL (3 to 4 mg) every 12 hours administered orally

4 to 5 years: 3.75 mL to 10 mL (3 to 8 mg) every 12 hours administered orally

6 to 11 years: 7.5 mL to 15 mL (6 to 12 mg) every 12 hours administered orally

Extended-release oral suspension: 4 mg carbinoxamine maleate per 5 mL

• Lactation: Advise not to breastfeed. (
  8.2)
  
• Contraindicated in children younger than 2 years of age. (
  
  4 CONTRAINDICATIONS

  Karbinal ER is contraindicated in:

  • children younger than 2 years of age because deaths have been reported in this age group
    (see Warnings and Precautions (5.1)]
    • patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Karbinal ER
      [see Warnings and Precautions (5.1)]
  • patients who are taking monoamine oxidase inhibitors (MAOI)
    [see Drug Interactions(7)].

  • Children younger than 2 years of age
  • Patients with known hypersensitivity to the drug or any of the inactive ingredients
  • Monoamine oxidase inhibitors (MAOI)
  and
  
  8.4 Pediatric Use

  Karbinal ER is contraindicated in pediatric patients younger than 2 years of age becuase deaths have been reported in this patient population who were taking carbinoxamine-containing drug products.

  The safety and effectiveness of Karbinal ER in pediatric patients aged 2 years and older hve been established and I based on demonstration of bioequivalence to the immediate-release reference product

  [see Clinical Phamacology (12.3)]

  . Carbinoxamine may diminish mental alertness or produce sedation in children. Paradoxical reactions with excitation are more likely in younger children.
  )
  
• May cause sedation or excitation in young children. (
  
  8.4 Pediatric Use

  Karbinal ER is contraindicated in pediatric patients younger than 2 years of age becuase deaths have been reported in this patient population who were taking carbinoxamine-containing drug products.

  The safety and effectiveness of Karbinal ER in pediatric patients aged 2 years and older hve been established and I based on demonstration of bioequivalence to the immediate-release reference product

  [see Clinical Phamacology (12.3)]

  . Carbinoxamine may diminish mental alertness or produce sedation in children. Paradoxical reactions with excitation are more likely in younger children.
  )
  
• May cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation. (
  
  8.5 Geriatric Use

  Karbinal ER may cause dizziness, hypotension, confusion, or over-sedation in the elderly. Start elderly patients on lower doses and observe closely.
  )