Generic Name
Carbinoxamine
Brand Names
Carbzah, RyVent, Karbinal
FDA approval date: May 27, 2011
Classification: Histamine-1 Receptor Antagonist
Form: Tablet, Suspension, Solution
What is Carbzah (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 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.
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Brand Information
CARBZAH (Carbinoxamine Maleate)
1DESCRIPTION
Carbinoxamine maleate is a histamine-H
Each 5 mL (teaspoonful) of oral solution contains 4 mg carbinoxamine maleate and the following inactive ingredients: artificial bubble gum flavor, citric acid (anhydrous), glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate (hydrous) and sorbitol solution.
Carbinoxamine maleate is freely soluble in water. Its structure is:
2-[(4-chlorophenyl)-2-pyridinylmethoxy]-
2INDICATIONS AND USAGE
Carbinoxamine maleate is effective 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
Amelioration of the severity of allergic reactions to blood or plasma.
3CONTRAINDICATIONS
Carbinoxamine maleate is contraindicated in children younger than 2 years of age.
Carbinoxamine maleate is contraindicated in nursing mothers.
Carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy. (See
4WARNINGS
Deaths have been reported in children less than 2 years of age who were taking antihistamines, including carbinoxamine-containing drug products, therefore, carbinoxamine maleate is contraindicated in children younger than 2 years of age (see
Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.
5ADVERSE REACTIONS
The most frequent adverse reactions are underlined:
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.
Hematologic:Hemolytic anemia, thrombocytopenia, agranulocytosis.
Central Nervous System:Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.
Gastrointestinal:Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
Urogenital:Urinary frequency, difficult urination, urinary retention, early menses.
Respiratory:Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
To report SUSPECTED ADVERSE REACTIONS, contact IPG Pharmaceuticals, Inc. at 1-888-711-7116 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch.
6DOSAGE AND ADMINISTRATION
Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see
Carbinoxamine maleate should be taken on an empty stomach with water.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in adults in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily.
Clinical experience suggests the following dosage schedules:
6.1Oral Solution
Usual Adult Dosage:
1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily
Usual Child's Dosage (approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 doses):
Six to eleven years– ½ to 1 teaspoonful (2 to 4 mg) 3 to 4 times daily.
Dosing for children 2 to 5 years of age should be based on weight whenever possible. The usual dosage for children 2 to 5 years of age is
approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 daily doses. In general, this corresponds to a dose of ¼ to ½ teaspoonful (1 to 2 mg) 3
to 4 times daily.
7HOW SUPPLIED
Carbinoxamine Maleate Oral Solution, 4 mg/5 mL is supplied as clear, colorless liquid with a bubble gum aroma, and is supplied in 4 fl. oz. bottles, NDC 71085-080-07 and in 16 fl. oz. bottles, NDC 71085-080-07.
8Product label
