Polmon

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.

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 Solutionis supplied as a red colored, cherry flavored liquid in the following sizes:

4 fl oz (118 mL),NDC64543-600-04
16 fl oz (473 mL),NDC64543-600-16

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.

Manufactured For: Capellon Pharmaceuticals, LLCFort Worth, TX 76118. Revised: Nov 2020

SIDE EFFECTS

1. General:Urticaria, drug rash,anaphylactic shock,photosensitivity, excessiveperspiration, chills, dryness of mouth, nose and the throat.
2. Cardiovascular System:Hemolytic anemia,thrombocytopenia,agranulocytosis.
3. Hematologic System:Hemolyticanemia, thrombocytopenia, agranulocytosis.
4. Nervous System:Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness,tremor, irritability, insomnia,euphoria, paresthesias, blurred vision,diplopia,vertigo,tinnitus, acutelabyrinthitis, hysteria, neuritis, convulsions.
5. G.I. System:Epigastric distress,anorexia, nausea, vomiting, diarrhea, constipation.
6. G.U. System:Urinary frequency,difficult urination, urinary retention, early menses.
7. Respiratory System:Thickening of bronchial secretions, tightness of chest andwheezing,nasalstuffiness.

DRUG INTERACTIONS

MAO inhibitors prolong and intensify theanticholinergic(drying) effects ofantihistamines.

警告

Antihistamines should be used with considerable caution in patients with:

• Narrow angleglaucoma

Stenosingpeptic ulcer

Pyloroduodenal obstruction

Symptomatic prostatichypertrophy

Bladderneck 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, andhypotensionin elderly patients.

PRECAUTIONS

POLMON Oral Solution has anatropine-like action and, therefore, should be used with caution in patients with:

History of bronchialasthma
Increased intraocular pressure
Hyperthyroidism
Cardiovascular disease
Hypertension

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 spontaneouslythe patient should be induced tovomit. 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 againstaspirationmust be taken, especially in infants and children.

Saline cathartics,such asmilk of magnesia, draw water into the bowel by osmosis and therefore, are valuable for their action in rapid dilution of bowel content.

Stimulantsshouldnotbe 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

Antihistaminesshould NOTbe 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 structureMonoamine oxidase inhibitortherapy (SeeDRUG INTERACTIONsection)

CLINICAL PHARMACOLOGY

Dexchlorpheniramine maleate is an antihistamine with anticholinergic (drying) andsedativeside effects. Antihistamines appear to compete withhistaminefor cell receptor sites on effector cells.

PATIENT INFORMATION

No information provided. Please refer to the警告ANDPRECAUTIONSsections.