Carbinoxamine

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. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods.

Carbinoxamine is an H1 receptor antagonist (antihistamine) that exhibits anticholinergic (drying) and sedative properties. Antihistamines compete with histamine for receptor sites on effector cells.

Adults and Adolescents 12 years of age and older: 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 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

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. patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Carbinoxamine Maleate Extended-Release Oral Suspension. patients who are taking monoamine oxidase inhibitors (MAOI). Children younger than 2 years of age. Patients with known hypersensitivity to the drug or any of the inactive ingredients. Monoamine oxidase inhibitors (MAOI)

Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. 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. Contains sodium metabisulfite, a sulfite that may cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals.

The following clinically significant adverse reactions are described elsewhere in the labeling: Somnolence and Impaired Mental Alertness Allergic Reactions due to Sulfites, including Anaphylaxis The most frequent adverse reactions include: sedation, sleepiness, dizziness, disturbed coordination, epigastic distress, and thickening of bronchial secretions. In clinical use, younger children and older adults may be particularly sensitive to adverse reactions. The following adverse reactions, listed by body system, have been identified in case reports and during the use of carbinoxamine in observational studies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Do not use Carbinoxamine Maleate extended-release oral suspension in patients who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Avoid use of Carbinoxamine Maleate extended-release oral suspension with alcohol and other CNS depressants (hypnotics sedatives, tranquilizers, etc.) due to additive effects. Monoamine oxidase inhibitors (MAOIs): Prolong and intensify the anticholinergic (drying) effects. (4 and 7) Alcohol and CNS depressants (hypnotics sedatives, tranquilizers, etc.): Avoid concomitant use due to additive adverse effects.

Store at 25ºC (77ºF), excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).