Monograph: |
Chlorpheniramine Maleate
Indications: Allergy, blood, adjunct; Allergy, plasma, adjunct; Anaphylaxis, adjunct; Angioedema; Conjunctivitis, allergic; Dermographism; Rhinitis, perennial allergic; Rhinitis, seasonal allergic; Rhinitis, vasomotor; Urticaria
DESCRIPTION:
Chlorpheniramine maleate is an antihistaminic agent. It is a white, odorless, crystalline powder, the solutions of which have a pH between 4 and 5.
CLINICAL PHARMACOLOGY:
Chlorpheniramine maleate is an antihistaminic drug which possesses anticholinergic and sedative effects.
INDICATIONS AND USAGE:
Chlorpheniramine maleate is indicated for the following conditions:
1. Perennial and seasonal allergic rhinitis.
2. Vasomotor rhinitis.
3. Allergic conjunctivitis due to inhalant allergens and foods.
4. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
5. Amelioration of allergic reactions to blood or plasma.
6. Dermographism.
7. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
CONTRAINDICATIONS:
This drug should not be used in newborn or premature infants.
Antihistamines should NOT be used to treat lower respiratory symptoms.
Do Not Use This Drug in Patients With:
Hypersensitivity to preparation
Asthmatic attack
Narrow-angle glaucoma
Prostatic hypertrophy
Stenosing peptic ulcer
Pyloroduodenal obstruction
Bladder neck obstruction
Patients receiving monoamine oxidase inhibitors
WARNINGS:
This drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. This drug may impair mental alertness in children. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Patients should be warned accordingly.
Usage In Pregnancy: Although there is no evidence that the use of this drug is detrimental to the mother or fetus, the use of any drug in pregnancy should be carefully deliberated. This product may cause an inhibition of lactation.
Usage In Children: In infants and children particularly, antihistamines in overdosage may produce convulsions and/or death.
PRECAUTIONS:
Chlorpheniramine maleate has an atropine-like action and should be used with caution in patients who may have increased intraocular pressure, hyperthyroidism, cardiovascular disease, hypertension or in patients with a history of bronchial asthma.
ADVERSE REACTIONS:
The Following Adverse Reactions Have Been Reported: Drowsiness; confusion; nervousness; restlessness; nausea; vomiting; diarrhea; blurring of vision; diplopia; headache; insomnia; urticaria; epigastric distress; nasal stuffiness; difficulty in urination; constipation; tightness of the chest and wheezing; thickening of bronchial secretions; dryness of mouth, nose, and throat; tingling, heaviness, and weakness of hands; vertigo; palpitation; drug rash; hemolytic anemia; hypotension; anaphylaxis.
DOSAGE AND ADMINISTRATION:
Adults: The usual adult dose is 4 mg three or four times daily.
Children: For children over 20 pounds the usual dose is 2 mg three or four times daily.
Storage: Store at controlled room temperature 15-30Β°C (59-86Β°F).
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