Dexchlorpheniramine Maleate

FDA Drug Profile — Corphena, RYCLORA

Dexchlorpheniramine Maleate is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including Corphena, RYCLORA. Available dosage forms: solution, concentrate, powder, liquid.

Drug Details

Generic Name
Dexchlorpheniramine Maleate
Brand Names
Corphena, RYCLORA
Application Number
ANDA202520
Sponsor
BluCrest Pharmaceuticals LLC
NDC Codes
6
Dosage Forms
SOLUTION, CONCENTRATE, POWDER, LIQUID
Routes
ORAL
Active Ingredients
DEXCHLORPHENIRAMINE MALEATE

Indications and Usage

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.

Warnings

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 RYCLORA™ 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.