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
Adults and Adolescents 12 years of age and older (2.3):
7.5 mL to 20 mL (6 to 16 mg) every 12 hours
Pediatric patients 2-11 years of age (approximately 0.2 to 0.4 mg/kg/day) (2.4):
2 to 3 years – 3.75 mL to 5 mL (3 to 4 mg) every 12 hours
4 to 5 years – 3.75 mL to 10 mL (3 to 8 mg) every 12 hours
6 to 11 years – 7.5 mL to 15 mL (6 to 12 mg) every 12 hours
Extended-release oral suspension: 4 mg carbinoxamine maleate per 5 mL
Lactation: Advise not to breastfeed. (8.2)
Contraindicated in children younger than 2 years of age. (4 and 8.4)
May cause sedation or excitation in young children. (8.4)
May cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation. (8.5)
Carbinoxamine Maleate Extended-Release Oral Suspension is contraindicated in:
children younger than 2 years of age because deaths have been reported in this age group [see Warnings and Precautions (5.1)].
patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Carbinoxamine Maleate Extended-Release Oral Suspension [see Warnings and Precautions (5.4)].
patients who are taking monoamine oxidase inhibitors (MAOI) [see Drug Interactions (7)].
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)
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available