DESCRIPTION
Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Drops is an antihistaminic and decongestant drop for oral administration.
Each dropperful (1 mL) contains:
Chlorpheniramine Maleate, USP.............. 0.8 mg
Pseudoephedrine HCl, USP........................ 9 mg
Inactive Ingredients
Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Red #40, Cherry Flavor, Purified Water.
Chlorpheniramine maleate is an antihistamine having the chemical name, 2-[p-Chloro--[2-(dimethylamino)ethyl]benzyl]pyridine maleate(1:1), with the following structure:
Pseudoephedrine hydrochloride is a decongestant having the chemical name, (Benzenemethanol, -[1-(methylamino)ethyl]-,[S-(R*,R*)]-,hydrochloride) with the following structure:
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CLINICAL PHARMACOLOGY
Antihistaminic and decongestant actions.
Chlorpheniramine Maleate
Chlorpheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines compete with histamine for receptor sites on effector cells. Chlorpheniramine also has mild anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue.
Chlorpheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration reached in 2 to 6 hours in adults. Urinary excretion is the major route of elimination, mostly as products of biodegradation. The liver is assumed to be the main site of metabolic transformation.
Pseudoephedrine Hydrochloride
Pseudoephedrine hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults. The serum half-life in adults for pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one-half of the administered dose is excreted in the urine.
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