IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
RYCLORA™ (dexchlorpheniramine maleate) Oral Solution, USP is a prescription liquid antihistamine indicated for:
- 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
- As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
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 AND PRECAUTIONS
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.
RYCLORA™ Oral Solution 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
MAO inhibitors prolong and intensify the anticholinergic (drying effects) of antihistamines.
- 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.
- I. System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
- U. System: Urinary frequency, difficult urination, urinary retention, early menses.
- Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
Call your doctor for medical advice about side effects.
Healthcare providers and patients are encouraged to report adverse events taking RYCLORA™ Oral Solution to Carwin Pharmaceutical Associates at 1-844-700-5011 or at firstname.lastname@example.org. You may voluntarily report negative side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Antihistamine overdosage reactions 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.
Please see the full Prescribing Information for additional important safety information.