Carbinoxamine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sree Teja Yelamanchili, MBBS [2]
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Overview
Carbinoxamine is a H1-blocking agent that is FDA approved for the 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, and dermatographism. Common adverse reactions include epigastric pain, coordination problem, dizziness, sedation, somnolence, and excessive bronchial secretions.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- 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.
Dosage
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 adult 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:
Tablets
Usual Adult Dosage:
- 1 or 2 tablets (4 to 8 mg) 3 to 4 times daily.
Oral Solution
Usual Adult Dosage:
- 1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Carbinoxamine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Carbinoxamine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
- 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.
Dosage
Tablets
Usual Child’s Dosage:
- Six to eleven years – 1/2 to 1 tablet (2 to 4 mg) 3 to 4 times daily.
Oral Solution
Usual Child’s Dosage:
- Approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 doses
- Six to eleven years – 1/2 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 1/4 to 1/2 teaspoonful (1 to 2 mg) 3 to 4 times daily.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Carbinoxamine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Carbinoxamine in pediatric patients.
Contraindications
Carbinoxamine maleate is contraindicated in:
- Children younger than 2 years of age.
- Nursing mothers.
- Patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy.
Warnings
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.
Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Carbinoxamine Clinical Trials Experience in the drug label.
Postmarketing Experience
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.
Drug Interactions
There is limited information regarding Carbinoxamine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Carbinoxamine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Carbinoxamine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Carbinoxamine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Carbinoxamine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Carbinoxamine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Carbinoxamine in geriatric settings.
Gender
There is no FDA guidance on the use of Carbinoxamine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Carbinoxamine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Carbinoxamine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Carbinoxamine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Carbinoxamine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Carbinoxamine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Carbinoxamine Administration in the drug label.
Monitoring
There is limited information regarding Carbinoxamine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Carbinoxamine and IV administrations.
Overdosage
There is limited information regarding Carbinoxamine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Carbinoxamine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Carbinoxamine Mechanism of Action in the drug label.
Structure
There is limited information regarding Carbinoxamine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Carbinoxamine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Carbinoxamine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Carbinoxamine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Carbinoxamine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Carbinoxamine How Supplied in the drug label.
Storage
There is limited information regarding Carbinoxamine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Carbinoxamine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Carbinoxamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Carbinoxamine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Carbinoxamine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.