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
- Monoamine oxidase inhibitors (MAOI)
WARNINGS AND PRECAUTIONS
- Activities requiring mental alertness: 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.
- 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.
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.1113-A KER HCP ISI