Karbinal ER

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Karbinal ER 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 Karbinal ER is 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 .3): 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 .4): 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 Karbinal ER 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 Karbinal ER by the oral route only. Measure Karbinal ER 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 correct dose. Shake Karbinal ER 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 administered orally 4 years to 5 years: Administer 3.75 mL to 10 mL (3 mg to 8 mg) orally every 12 hours administered orally 6 years to 11 years: Administer 7.5 mL to 15 mL (6 mg to 12 mg) orally every 12 hours administered orally 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, Karbinal ER is contraindicated in children younger than 2 years of age. 5.2 Somnolence and Impaired Mental Alertness Karbinal ER 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 Karbinal ER. Avoid concurrent use of Karbinal ER with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur. 5.3 Concomitant Medical Conditions Karbinal ER 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 prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction. 5.4 Allergic Reactions due to Sulfites, including Anaphylaxis Karbinal ER contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Su