카르비녹사민말레산염

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 )

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)]. Children younger than 2 years of age (4) Patients with known hypersensitivity to the drug or any of the inactive ingredients (4) Monoamine oxidase inhibitors (MAOI) (4)

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 …

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) 8.1 Pregnancy Risk Summary Published data over decades of use of antihistamines, including carbinoxamine, have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, published data specifically evaluating the risk of carbinoxamine were not found. Animal reproductive studies have not been …