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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Content
Overview
Chlorphenamine is an anti- allergic agent that is FDA approved for the treatment of allergic rhinitis, common cold. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Allergic rhinitis
Dosing Information
The dosage of chlorpheniramine depends on the product. Use the following guidelines: 4-hour allergy tablet - 1 tablet (4 mg) every 4 to 6 hours up to a maximum of 6 tablets in 24 hours; 8-hour allergy tablet - 1 tablet (8 mg) every 8 to 12 hours up to 3 tablets in 24 hours; 12-hour tablet - 1 tablet (12 mg) every 12 hours up to 2 tablets in 24 hours.
For the prevention of allergic rhinitis symptoms, administer chlorpheniramine 4 mg (syrup or plain, uncoated tablet) and increase 3 times daily every 3 days as tolerated until reaching 8 mg 3 times daily. Start before the allergy season (for ragweed - August 1st) and continue until inhalant allergen is gone (first frost in ragweed areas). Most patients develop tolerance to the sedative effect if dose is started low and increased in small increments (only when previous lower dose is tolerated).
Common cold
Dosing Information
For cough, 2 teaspoonfuls of Codeprex(TM) (10 mL; equivalent to codeine 40 mg and chlorpheniramine maleate 8 mg) ORALLY every 12 hours; maximum dose 4 teaspoonfuls in 24 hours.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
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There is limited information regarding Off-Label Guideline-Supported Use of Chlorphenamine in adult patients.
Non–Guideline-Supported Use
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Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorphenamine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Allergic rhinitis
Dosing Information
Reports of infant deaths have been associated with over-the-counter (OTC) cough and cold medications, and chlorpheniramine is commonly used as an antihistamine, alone or in combination with a cough suppressant, a decongestant, and/or an expectorant in the OTC cough and cold products. In January 2008, the US Food and Drug Administration issued a public health advisory recommending that cough and cold products not be used in children younger than 2 years due to the risk of serious and life-threatening effects.
Common cold
Dosing Information
Reports of infant deaths have been associated with over-the-counter (OTC) cough and cold medications, and chlorpheniramine is commonly used as an antihistamine, alone or in combination with a cough suppressant, a decongestant, and/or an expectorant in the OTC cough and cold products. In January 2008, the US Food and Drug Administration issued a public health advisory recommending that cough and cold products not be used in children younger than 2 years due to the risk of serious and life-threatening effects.
Important Note:
Chlorpheniramine may cause excitability in children. It is not recommended to give the 8-hour or 12-hour allergy tablets to children younger than 12 years and the 4-hour allergy tablets to children younger than 6 years. Codeprex(TM) is not recommended for children younger than 6 years.
The dose for children ages 6 to 11 years, using the 4-hour allergy tablet, is half of the recommended adult dose. Therefore, 2 mg (break the 4 mg tablet in half) every 4 to 6 hours up to 12 mg in 24 hours. The 8-hour and 12-hour allergy tablets are not recommended.
Oral:
To treat children with allergic rhinitis, start with 2 mg and increase progressively to 12 mg/day.
For cough, allergic rhinitis, and hay fever in children 12 years or older: 2 teaspoonfuls of Codeprex(TM) (10 mL; equivalent to codeine 40 mg and chlorpheniramine maleate 8 mg) ORALLY every 12 hours; maximum dose 4 teaspoonfuls in 24 hours.
For cough, allergic rhinitis, and hay fever in children 6 to 12 years of age: 1 teaspoonful of Codeprex(TM) (5 mL; equivalent to codeine 20 mg and chlorpheniramine maleate 4 mg) ORALLY every 12 hours; maximum dose 2 teaspoonfuls in 24 hours.
Maximum Dose:
The maximum recommended dose for oral chlorpheniramine in children 6 to 11 years old is 12 mg/day.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Chlorphenamine in pediatric patients.
Non–Guideline-Supported Use
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Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorphenamine in pediatric patients.
Contraindications
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Warnings
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See full prescribing information for complete Boxed Warning.
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Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Chlorphenamine in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Chlorphenamine in the drug label.
