Dexchlorpheniramine Maleate

Morton Grove Pharmaceuticals, Inc.

DEXCHLORPHENIRAMINE MALEATE ORAL SOLUTION, USP 2 mg/5 mL

FULL PRESCRIBING INFORMATION: CONTENTS*

• DEXCHLORPHENIRAMINE MALEATE DESCRIPTION
  • Inactive Ingredients
• CLINICAL PHARMACOLOGY
• DEXCHLORPHENIRAMINE MALEATE INDICATIONS AND USAGE
• DEXCHLORPHENIRAMINE MALEATE CONTRAINDICATIONS
  • Use in Newborn or Premature Infants:
  • Use in Nursing Mothers:
  • Use in Lower Respiratory Disease:
• WARNINGS
  • Use in Children
  • Use in Pregnancy:
  • Use with CNS Depressants:
  • Use in Activities Requiring Mental Alertness:
  • Use in the Elderly (approximately 60 years or older):
• PRECAUTIONS
  • Drug Interaction:
• DEXCHLORPHENIRAMINE MALEATE ADVERSE REACTIONS
• OVERDOSAGE
• DEXCHLORPHENIRAMINE MALEATE DOSAGE AND ADMINISTRATION
  • Recommended Dosage
• HOW SUPPLIED
  • RECOMMENDED STORAGE
• PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

FULL PRESCRIBING INFORMATION

Rx only

DEXCHLORPHENIRAMINE MALEATE DESCRIPTION

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).

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.

CLINICAL PHARMACOLOGY

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.

DEXCHLORPHENIRAMINE MALEATE INDICATIONS AND USAGE

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.

DEXCHLORPHENIRAMINE MALEATE 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 (See Drug Interaction section)

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 in Children

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.

Use in Pregnancy:

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

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.

Use in the Elderly (approximately 60 years or older):

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

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

Drug Interaction:

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

DEXCHLORPHENIRAMINE MALEATE ADVERSE REACTIONS

• 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.

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.

DEXCHLORPHENIRAMINE MALEATE DOSAGE AND ADMINISTRATION

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)
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.

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)

RECOMMENDED 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.

Rx Only

Product No.: 8539

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

A50-8539-16

REV. 07-05

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)