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RYCLORA Dailymed

  1. Human Prescription
  2. Antihistamines,alkylamine
  3. CARWIN PHARMACEUTICAL ASSOCIATES, LLC

Generic: dexchlorpheniramine maleate is used for the treatment of Angioedema Asthma Breast Feeding Conjunctivitis, Allergic Rhinitis, Allergic, Seasonal Infant, Newborn Infant, Premature Respiratory Tract Diseases Rhinitis, Allergic, Perennial Rhinitis, Vasomotor Glaucoma, Angle-Closure

RYCLORA solution - image

  1. FDA Adverse Reactions

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Rx only

Description

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 C16H19ClN2 ∙ C4H4O4, designated chemically as (+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl] pyridine maleate (1:1).

M.W. = 390.86

Inactive Ingredients: Citric acid, cherry flavoring, FD&C Red No. 40, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, and sugar.

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.

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.

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


RYCLORAâ„¢ 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.

Precautions


RYCLORAâ„¢ 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 Hypertension

Drug Interaction


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

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.

Call your doctor for medical advice about side effects. You may voluntarily report side effects to FDA at 1-800-FDA-1088. Questions or comments? Call Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.

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.

Dosage And Administration


DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.


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


RYCLORAâ„¢ Oral Solution is supplied as a red colored, cherry flavored liquid in the following sizes:

4 fl oz (118 mL), NDC 15370-150-04 16 fl oz (473 mL), NDC 15370-150-16 0.7 fl oz (20mL), NDC 15370-150-99 (as physician sample)

RECOMMENDED STORAGE


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: Carwin Pharmaceutical Associates, LLC Hazlet, NJ 07730 www.carwinpharma.com

500403-01

REV. 03/2018

Principal Display Panel - 473 Ml Bottle Label


NDC 15370-150-16

RyCloraâ„¢(dexchlorpheniramine maleate)

Oral Solution, USP 2 mg/5 mL

Cherry Flavor

Rx Only 16 fl. oz (473 mL)

carwin PHARMACEUTICAL ASSOCIATES

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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