dexchlorpheniramine maleate 0.4 MG/ML Oral Solution

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.

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.

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 CORPHENA Oral Solution 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.

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)

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.