The Next Level Of Symptomatic Relief
Karbinal™ ER, an H1 receptor antagonist (antihistamine) indicated for children two years of age and older, is the only first generation extended release oral suspension antihistamine available in U.S. Karbinal™ ER provides physicians with an effective and easy to use treatment option for children with seasonal and perennial allergic rhinitis that need symptomatic relief for runny nose, sneezing, and itchy skin.
Important Safety Information
INDICATIONS AND USAGE
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
- 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
- Children younger than 2 years of age
- Nursing mothers
- Patients with known hypersensitivity to the drug or any of the inactive ingredients
- Patients taking monoamine oxidase inhibitors (MAOI)
WARNINGS AND PRECAUTIONS
- Pediatric mortality: Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing products.
- Activities requiring mental alertness: Advise patients to avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery.
- Anticholinergic actions: Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.
- Karbinal ER contains sodium metabisulfite, a sulfite that may cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals.
Most common adverse reactions are: sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions.
- Karbinal ER is contraindicated in patients who are taking MAOIs, which prolong and intensify the anti-cholinergic effects of antihistamines.
- Avoid use of Karbinal ER with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) due to additive effects.
- Because of the higher risk of mortality in infants, Karbinal ER is contraindicated in children younger than 2 years of age and in nursing mothers.
- Karbinal ER may cause sedation or excitation in young children.
Karbinal ER may cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation.
To report SUSPECTED ADVERSE REACTIONS, contact Avadel Pharmaceuticals (USA), Inc. at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.0317 KER HCP ISI