Ryclora Prescribing Information
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 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.
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)
- 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.
Drug Interaction:
MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Each 5 mL (teaspoonful) contains:
Dexchlorpheniramine Maleate, USP ............. 2 mg
Dexchlorpheniramine Maleate, USP, an antihistamine agent, is a white, odorless crystalline powder that is freely soluble in water. The molecular formula is C 16H 19ClN 2 • C 4H 4O 4, designated chemically as (+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1).
M.W. = 390.86
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.
POLMON Oral Solution is supplied as a red colored, cherry flavored liquid in the following sizes:
4 fl oz (118 mL), NDC 64543-600-04
16 fl oz (473 mL), NDC 64543-600-16
Storage and Handling
Store at 20° to 25°C (68° to 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
Manufactured For:
Capellon Pharmaceuticals, LLC
Fort Worth, TX 76118
500403-01
REV. 04/2015
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:
POLMON 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.