Chlorphenamine

Chlorphenamine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: 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

Condition1

• 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 adult patients.

Non–Guideline-Supported Use

Condition1

• 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

Condition1

• 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

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorphenamine in pediatric patients.

Contraindications

• Condition1

Warnings

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: 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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chlorphenamine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Chlorphenamine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Chlorphenamine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Chlorphenamine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Chlorphenamine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Chlorphenamine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Chlorphenamine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Chlorphenamine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Chlorphenamine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Chlorphenamine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Chlorphenamine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Chlorphenamine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Chlorphenamine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Chlorphenamine in the drug label.

Pharmacology

There is limited information regarding Chlorphenamine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Chlorphenamine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Chlorphenamine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Chlorphenamine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Chlorphenamine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Chlorphenamine in the drug label.

How Supplied

Storage

There is limited information regarding Chlorphenamine 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 Patient Counseling Information of Chlorphenamine in the drug label.

Precautions with Alcohol

• Alcohol-Chlorphenamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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