Carbinoxamine Maleate Extended-Release Oral Suspension
Generic: CARBINOXAMINE MALEATE
Basic Information
Manufacturer
Neos Therapeutics, LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
199f46e5-6288-5627-e063-6294a90ae086
Indications & Usage
1 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 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 )
Adverse Reactions
6 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.
Most common adverse reactions are: sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics at 1-855-298-8246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Most common adverse reactions are: sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics at 1-855-298-8246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.