- Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products. Do not give Karbinal ER to children younger than 2 years of age.
- Caution patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination, such as driving or operating machinery.
- 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, or pyloroduodenal obstruction.
- Karbinal ER contains sodium metabisulfite, a sulfite which may cause anaphylaxis and life-threatening or less severe asthmatic episodes in susceptible individuals.
CONTRAINDICATIONS:
- Children younger than 2 years of age.
- Nursing mothers.
- Patients with known hypersensitivity to the drug or any of its inactive ingredients.
- Patients taking monoamine oxidase inhibitors (MAOI).
WARNINGS AND PRECAUTIONS:
- Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products. Do not give Karbinal ER to children younger than 2 years of age.
- Caution patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination, such as driving or operating machinery.
- 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, or pyloroduodenal obstruction.
- Karbinal ER contains sodium metabisulfite, a sulfite which may cause anaphylaxis and life-threatening or less severe asthmatic episodes in susceptible individuals.
ADVERSE REACTIONS:
The most common adverse reactions include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions.
DRUG INTERACTIONS:
- Avoid use of Karbinal ER with monoamine oxidase inhibitors (MAOIs) which prolong and intensify the anticholinergic (drying) effects of antihistamines.
- Avoid use of Karbinal ER with alcohol and CNS depressants (hypnotics, sedatives, tranquilizers, etc.) due to additive adverse effects.
USE IN SPECIAL POPULATIONS:
- 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.
- May cause sedation or excitation in young children.
- May cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation.
Indications for Use
Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension is indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis in children as young as two years of age.
Before prescribing Karbinal ER, please read the Full Prescribing Information.
ADVERSE EVENT REPORTING
To report suspected adverse events or product complaints, please contact Aytu BioPharma at 855-AYTU-BIO; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.