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Chlorphen Mal Dex HBr Pseudoeph (Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride / Dextromethorphan Hydrobromide) - Summary

 
 



SUMMARY

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

Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops is indicated for symptomatic relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
See all Chlorphen Mal Dex HBr Pseudoeph indications & dosage >>

NEWS HIGHLIGHTS

Clinical Trials Related to Chlorphen Mal Dex HBr Pseudoeph (Chlorpheniramine / Pseudoephedrine / Dextromethorphan)

Study of AHIST in Seasonal Allergic Rhinitis Patients [Withdrawn]
Objectives: A) To gather pharmacodynamic measurements and assess blood levels of the active ingredients in AHIST over the dosage interval period of 12 hours. Hypothesis: Hysteresis curves plotting each active ingredient's blood levels over a 12-hour dosage interval will substantiate S5 Symptom Diary scores (IE: evidentiary therapeutic window data); B) To report subjective scores by subjects rating the efficacy of a single dose AHIST in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over a 12-hour dosage interval. Hypothesis: Greater than 66% of subjects will document clinically significant relief over a 12-hour period from one dose of AHIST; C) Report any side effects or adverse drug reactions and rate the severity of any incidence. Hypothesis: Not more than one patient will have an adverse event significant enough to warrant withdrawal; side effects will be mild with the most frequently reported side effect occurring in less than 10% of patients—drowsiness.

Fed Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex� Pennkinetic� Extended Release Oral Suspension [Completed]
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a commercially available extended release oral suspension of chlorpheniramine polistirex/hydrocodone polistirex (Tussionex Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fed conditions.

Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents [Completed]

Fasting Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex� Pennkinetic� Extended Release Oral Suspension [Completed]
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a commercially available extended release oral suspension of chlorpheniramine polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fasting conditions.

StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study [Active, not recruiting]
This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p < 0. 05.

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Page last updated: 2010-01-21

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