Carbinoxamine Maleate Extended-Release Oral Suspension

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Carbinoxamine Maleate extended-release oral suspension 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 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 Carbinoxamine Maleate extended-release oral suspension is an H1 receptor antagonist indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: Seasonal and perennial allergic rhinitis ( 1 ) Vasomotor rhinitis ( 1 ) Allergic conjunctivitis due to inhalant allergens and foods ( 1 ) Mild, uncomplicated allergic skin manifestations of urticaria and angioedema ( 1 ) Dermatographism (1) As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled ( 1 ) Amelioration of the severity of allergic reactions to blood or plasma ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Adults and Adolescents 12 years of age and older ( 2.2 ): 7.5 mL to 20 mL (6 mg to 16 mg) orally every 12 hours Pediatric patients 2 years to 11 years of age (approximately 0.2 mg/kg/day to 0.4 mg/kg/day) ( 2.3 ): 2 years to 3 years – 3.75 mL to 5 mL (3 mg to 4 mg) orally every 12 hours 4 years to 5 years – 3.75 mL to 10 mL (3 mg to 8 mg) orally every 12 hours 6 years to 11 years – 7.5 mL to 15 mL (6 mg to 12 mg) orally every 12 hours 2.1 General Administration Instructions The dosage of Carbinoxamine Maleate Extended-Release Oral Suspension should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated. Administer Carbinoxamine Maleate Extended-Release Oral Suspension by the oral route only. Measure Carbinoxamine Maleate Extended-Release Oral Suspension with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Shake Carbinoxamine Maleate extended-release oral suspension well before use. 2.2 Recommended Dosage for Adults and Adolescents 12 years of age and older: Administer 7.5 mL to 20 mL (6 mg to 16 mg) orally every 12 hours 2.3 Recommended Dosage for Pediatric Patients 2 years to 11 years of age (approximately 0.2 mg/kg/day to 0.4 mg/kg/day): 2 years to 3 years: Administer 3.75 mL to 5 mL (3 mg to 4 mg) orally every 12 hours 4 years to 5 years: Administer 3.75 mL to 10 mL (3 mg to 8 mg) orally every 12 hours 6 years to 11 years: Administer 7.5 mL to 15 mL (6 mg to 12 mg) orally every 12 hours Warnings and cautions 5 WARNINGS AND PRECAUTIONS Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. (5.2) 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. (5.3) Contains sodium metabisulfite, a sulfite that may cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals. (5.4) 5.1 Pediatric Mortality Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products; therefore, Carbinoxamine Maleate Extended-Release Oral Suspension is contraindicated in children younger than 2 years of age. 5.2 Somnolence and Impaired Mental Alertness Carbinoxamine Maleate Extended-Release Oral Suspension may produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Carbinoxamine Maleate Extended-Release Oral Suspension. Avoid concurrent use of Carbinoxamine Maleate Extended-Release Oral Suspension with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur. 5.3 Concomitant Medical Conditions Carbinoxamine Maleate Extended-Release Oral Suspension has anticholinergic (atropine-like) properties and, therefore, should be used with caution in patients with: increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostati