Carbinoxamine Maleate (3 brand names, 4 dosage forms, 1 route)
Available dosage forms: TABLET, SOLUTION, ELIXIR, SUSPENSION, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- CARBINOXAMINE MALEATE
- CLISTIN
- KARBINAL ER
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
Contraindications
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)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Somnolence and Impaired Mental Alertness [see Warnings and Precautions (5.2)] Allergic Reactions due to Sulfites, including Anaphylaxis [see Warnings and Precautions (5.4)] 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 [see Pediatric Use (8.4) and Geriatric Use (8.5)]. 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. Body as a Whole: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles. Central Nervous System: Fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, constipation. Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis. Laboratory: Increase in uric acid levels. Respiratory: Tightness of chest and wheezing, nasal stuffiness. Urogenital: Urinary frequency, difficult urination, urinary retention, early menses.
Drug Interactions
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.
Overdosage
Overdosage with carbinoxamine may cause central nervous system depression or stimulation, hallucinations, convulsions, and death. Atropine-like signs and symptoms – dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur. The treatment of overdosage consists of discontinuation of Carbinoxamine Maleate extended-release oral suspension and institution of symptomatic and supportive therapy. Vital signs (including respiration, pulse, blood pressure, and temperature) and EKG should be monitored. Induction of vomiting is not recommended. Activated charcoal should be given and gastric lavage should be considered after ingestion of a potentially life-threatening amount of drug. In the presence of severe anticholinergic effects, physostigmine may be useful. Vasopressors may be used to treat hypotension.