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.

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

• Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in 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

Monitoring

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

IV Compatibility

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

Overdosage

• Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms—dry mouth, fixed, dilated pupils, flushing, and gastrointestinal symptoms may also occur.

• If vomiting has not occurred spontaneously the patient should be induced to vomit. This is best done by having the patient drink a glass of water or milk after which the patient should be made to gag. Precautions against aspiration must be taken, especially in infants and children.

• Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and therefore, are valuable for their action in rapid dilution of bowel content.

• Stimulants should not be used.

• Vasopressors may be used to treat hypotension.

Pharmacology

Mechanism of Action

• Dexchlorpheniramine maleate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

Structure

• Each 5 mL (teaspoonful) contains:

• Dexchlorpheniramine Maleate, USP, an antihistamine agent, is a white, odorless crystalline powder that is freely soluble in water. The molecular formula is C16H19CIN2•C4H4O4, designated chemically as (+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1).

This image is provided by the National Library of Medicine.

Inactive Ingredients

• Citric Acid; Dehydrated Alcohol; FD&C Red No. 40; Glycerin; Liquid Sugar; Menthol; Methylparaben; Natural and Artificial Orange Juice Flavor; Propylene Glycol; Propylparaben and Purified Water. May also contain Sodium Citrate for pH adjustment. The pH range is between 5.0 and 6.5.

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

• Dexchlorpheniramine Maleate Oral Solution, USP 2 mg/5 mL is supplied as a red-orange colored, orange flavored liquid in the following sizes:

• 16 fl oz (473 mL)

Storage

• Store at (20 – 25 )°C ((68 – 77)°F) [See USP Controlled Room Temperature].

• Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

MGP

NDC 60432-539-16

DEXCHLORPHENIRAMINE MALEATE ORAL SOLUTION, USP

2 mg/5 mL

(Contains alcohol not more than 7.0%)

DO NOT USE IF INNER FOIL SEAL PRINTED "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

BULK CONTAINER — NOT FOR HOUSEHOLD USE

Rx Only

NET: 1 Pint (473 mL)

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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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

• Polaramine®

Look-Alike Drug Names

There is limited information regarding Dexchlorpheniramine 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.