Dexchlorpheniramine

Dexchlorpheniramine
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: Rabin Bista, M.B.B.S. [2]

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Overview

Dexchlorpheniramine is a antihistamine that is FDA approved for the treatment of Perennial and seasonal allergic rhinitis, Vasomotor rhinitis, Allergic conjunctivitis, Mild, uncomplicated allergic skin manifestations of urticaria and angioedema, Amelioration of allergic reactions to blood or plasma, Dermographism.. Common adverse reactions include Diarrhea, Epigastric discomfort, Nausea, Vomiting, Xerostomia, Somnolence ,Nasal mucosa dry.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma Dermographism

As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Dosage

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Recommended Dosage Adults and Children 12 years of age and older: 2 mg (1 teaspoonful)

• Doses are generally given every 4 to 6 hours.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dexchlorpheniramine in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage

Children 6 to 11 years: 1 mg (1/2 teaspoonful) Children 2 to 5 years: 0.5 mg (1/4 teaspoonful)

Doses are generally given every 4 to 6 hours.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Use in Newborn or Premature Infants: This drug should not be used in newborn or premature infants.

Use in Nursing Mothers: Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Use in Lower Respiratory Disease: Antihistamines should NOT be used to treat lower respiratory tract symptoms including asthma.

Antihistamines are also contraindicated in the following conditions:

Hypersensitivity to dexchlorpheniramine maleate or other antihistamines of similar chemical structure

Monoamine oxidase inhibitor therapy

Warnings

Antihistamines should be used with considerable caution in patients with:

Narrow angle glaucoma Stenosing peptic ulcer Pyloroduodenal obstruction Symptomatic prostatic hypertrophy Bladder neck obstruction

Use with CNS Depressants: Dexchlorpheniramine Maleate, USP has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).

Use in Activities Requiring Mental Alertness: Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Precautions

Dexchlorpheniramine Maleate, USP has an atropine-like action and, therefore, should be used with caution in patients with:

History of bronchial asthma Increased intraocular pressure Hyperthyroidism Cardiovascular disease Hypertension

Adverse Reactions

Clinical Trials Experience

General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and the throat. Cardiovascular System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. G.I. System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. G.U. System: Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dexchlorpheniramine in the drug label.

Drug Interactions

• MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

• In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.

Geriatic Use

• Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Dexchlorpheniramine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Dexchlorpheniramine Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

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

Precautions with Alcohol

• Alcohol-Dexchlorpheniramine 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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