Monday, September 25, 2023
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The initial US approval of carbinoxamine maleate was in 1953. It is an H1 receptor antagonist indicated for relief of allergic symptoms related to seasonal and perennial allergic rhinitis; vasomotor rhinitis; allergic conjunctivitis caused by inhalant allergens and foods; and mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It may also be used for dermatographism, for reduction in the severity of allergic reactions to blood or plasma, and as treatment of anaphylactic reactions adjunctive to epinephrine and other standard therapy after the acute symptoms have been controlled.
The new approval by the US Food and Drug Administration (FDA) is for use of the extended-release oral suspension for treatment of seasonal and perennial allergic rhinitis in children at least 2 years old.
Earlier this month, the FDA approved carbinoxamine maleate extended-release (Karbinal ER) to treat seasonal and perennial allergic rhinitis in children 2 years and older. This histamine-H1 receptor blocker is a liquid, extended-release, oral suspension containing 4 mg of carbinoxamine maleate per 5 mL. Twice-daily administration is a convenient option for many patients, especially for school-age children.
The FDA first approved carbinoxamine maleate in 1953 for relief of allergic rhinitis, and subsequently for various other allergic conditions.
Carbinoxamine maleate extended-release is contraindicated in children younger than 2 years, in women who are breast-feeding (because of the higher risk for serious adverse reactions with use of carbinoxamine maleate in infants), in patients with known hypersensitivity to the drug or to any of the inactive ingredients, and in patients taking monoamine oxidase inhibitors.
The most common adverse reactions reported with carbinoxamine maleate are sedation, sleepiness, dizziness, impaired coordination, upper gastrointestinal tract discomfort, and thickening of bronchial secretions. Young children are particularly prone to sedation or excitation, and elderly patients are prone to dizziness, sedation, and hypotension.
Dosage and Administration
For adults and adolescents 12 years and older, the dose of carbinoxamine maleate extended-release is 7.5 to 20 mL (6 - 16 mg) every 12 hours. For children 2 to 11 years old, the recommended dose is approximately 0.2 to 0.4 mg/kg/day. Doses for specific age groups are 3.75 to 5 mL (3 - 4 mg) every 12 hours for children 2 to 3 years old, 3.75 to 10 mL (3 - 8 mg) every 12 hours for children 4 to 5 years old, and 7.5 to 15 mL (6 - 12 mg) every 12 hours for children 6 to 11 years old. Elderly patients should start with lower doses and should be closely monitored for development of confusion and oversedation.
Warnings and Precautions
Patients taking carbinoxamine maleate extended-release should avoid activities requiring mental alertness, such as driving or operating machinery.
Because of the anticholinergic effects of carbinoxamine maleate extended-release, it should be used 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.
Carbinoxamine maleate extended-release contains sodium metabisulfite, which may cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals.
Monoamine oxidase inhibitors prolong and intensify the anticholinergic drying effects of carbinoxamine maleate extended-release. Concomitant use of alcohol or other central nervous system depressants, including hypnotics, sedatives, and tranquilizers, should be avoided because of additive adverse sedating effects.
Clinicians should report suspected adverse reactions to the FDA at 1-800-FDA-1088 or http://www.fda.gov/Safety/MedWatch/default.htm.
More information on the FDA approval of carbinoxamine maleate extended-release is available on the FDA Web site.
