Slideshows Images Quizzes

Polmon

Last reviewed on RxList: 7/26/2018
Drug Description

POLMON
(dexchlorpheniramine maleate) Oral Solution, USP

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).

POLMON (Dexchlorpheniramine Maleate Oral Solution, USP) Structural Formula - Illustration

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.

Indications & Dosage

INDICATIONS

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 (½ teaspoonful)

Children 2 to 5 years: 0.5 mg (1/4 teaspoonful)

Doses are generally given every 4 to 6 hours.

HOW SUPPLIED

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) [s ee USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.

Manufactured For: Capellon Pharmaceuticals , LLC, Fort Worth, TX 76118. Revised: Jul 2018

Side Effects & Drug Interactions

SIDE EFFECTS

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 INTERACTIONS

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

Warnings & Precautions

WARNINGS

Antihistamines should be used with considerable caution in patients with:

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.

PRECAUTIONS

POLMON 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

Overdosage & Contraindications

OVERDOSE

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.

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:

Clinical Pharmacology

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.

Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.