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Atuss DS Suspension (Dextromethorphan Hydrobromide / Pseudoephedrine Hydrochloride / Chlorpheniramine Maleate) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Each teaspoonful (5 mL) of Atuss® DS Tannate Suspension contains:

Dextromethorphan Hydrobromide. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 30 mg

Pseudoephedrine Hydrochloride. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 30 mg

Chlorpheniramine Maleate. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 4 mg

Atuss® DS Tannate Suspension is used for oral administration only.

Atuss® DS Tannate Suspension contains the following inactive ingredients: Acesulfame K, Artificial Bubblegum Flavor, Artificial Grape Flavor, Aspartame, Bitter Mask, Citric Acid, FDC Blue #1, FDC Red #40, Glycerin, Hydrochloric Acid, Methylparaben, Magnesium Aluminometasilicate, Purified Water, Sodium Citrate Dihydrate, Sodium Hydroxide, Sucralose, Xanthan Gum. Plus tannic acid yielding a tannate suspension.


Dextromethorphan Hydrobromide:
3-Methoxy-17-methyl-9alpha, 13alpha, 14alpha-morphinan.


Pseudoephedrine Hydrochloride:
[S(R*, R*)]- alpha -[1-(methylamino)ethyl] benzenemethanol hydrochloride.


Chlorpheniramine Maleate:
2-[p-chloro- alpha -[2-(dimethylamino) ethyl]-benzyl] pyridine.

CLINICAL PHARMACOLOGY

Dextromethorphan is an antitussive agent which, unlike the isomeric levorphanol, has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage, dextromethorphan does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine.

Pseudoephedrine is an alpha-adrenergic receptor antagonist (sympathomimetic) which produces vasoconstriction by stimulating alpha-receptors within the mucosa of the respiratory tract. Clinically, pseudoephedrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency. The vasoconstriction action of pseudoephedrine is similar to that of ephedrine. In the usual dose it has minimal vasopressor effects. Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. Acidic urine is associated with faster elimination of the drug. The drug is distributed to body tissues and fluids, including the fetal tissue, breast milk and the central nervous system (CNS).

Chlorpheniramine is an alkylamine-type antihistamine. The antihistamine in Atuss® DS Tannate Suspension acts by competing with histamine for H1 histamine receptor sites, thereby preventing the action of histamine on the cell. Clinically, chlorpheniramine suppresses the histamine-mediated symptoms of allergic rhinitis, relieving sneezing, rhinorrhea, and itching of the eyes, nose, and throat.

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