Karbinal
(Carbinoxamine Maleate)Karbinal Prescribing Information
| Contraindications, Nursing Mothers (4) | Removed 3/2021 |
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 adjunctiveto 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. ( and
4 CONTRAINDICATIONSKarbinal 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 hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Karbinal ER
- 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)
)8.4 Pediatric UseKarbinal 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. - children younger than 2 years of age because deaths have been reported in this age group
- May cause sedation or excitation in young children. ( )
8.4 Pediatric UseKarbinal 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 UseKarbinal ER may cause dizziness, hypotension, confusion, or over-sedation in the elderly. Start elderly patients on lower doses and observe closely.
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 hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Karbinal ER
- patients who are taking monoamine oxidase inhibitors (MAOI) [see Drug Interactions(7)].