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DESCRIPTION
Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops is an antihistaminic, antitussive, and decongestant drop for oral administration.
Each dropperful (1 mL) contains:
Chlorpheniramine Maleate, USP.............. 0.8 mg
Dextromethorphan HBr, USP..................... 3 mg
Pseudoephedrine HCl, USP........................ 9 mg
Inactive Ingredients
Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Grape Flavor, FDC Blue #1, FDC Red #40, 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:
Dextromethorphan hydrobromide is an antitussive having the chemical name, (Morphinan,3-methoxy-17-methyl-,(9,13,14)-,hydrobromide, monohydrate), 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, antitussive, 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 allergicresponse (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.
Dextromethorphan Hydrobromide
Dextromethorphan hydrobromide is a nonnarcotic antitussive with effectiveness equal to codeine. It acts in the medulla oblongata to elevate the cough threshold. Dextromethorphan does not produce analgesia or induce tolerance, and has no potential for addiction. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration. At usual doses, it will not depress respiration nor inhibit respiratory cilia activity. Dextromethorphan is rapidly metabolized with trace amounts of the parent compound in blood and urine. About one-half of the administered dose is excreted in the urine as conjugated metabolites.
Pseudoephedrine Hydrochloride
Pseudoephedrine hydrochloride is an oralsympathomimetic 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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