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


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

Study of AHIST in Seasonal Allergic Rhinitis Patients [Not yet recruiting]

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.

Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu [Not yet recruiting]
This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours length, characterizing Common Cold and / or Influenza.

After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention).

The outcomes to assess the effectiveness so far consist of the scores of symptoms and to assess the safety of the drug will be accompanied by the emergence of adverse events.

Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome [Recruiting]

The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza. [Not yet recruiting]
This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects [Recruiting]
Paracetamol overdose is the leading cause of acute liver failure in the Western World. N-acetylcysteine (NAC) has been the antidote of choice for over 30 years but its use is associated with adverse effects in 40% of cases. Patients characteristically experience nausea, vomiting and an anaphylactoid ('pseudo-allergic') syndrome. This reaction is clinically similar to true anaphylaxis (allergic reaction) including flushing, rash, constriction of airways, and a fall in blood pressure, but occurs via a different mechanism. Although treatable, these reactions lead to patient distress, commonly cause confusion among treating physicians, and lead to significant delays in antidote administration. The aetiology of these adverse reactions to NAC remains unclear. We hypothesise: i) these reactions result from a dose-dependent release of the chemical histamine, causing dilatation of blood vessels (vasodilatation) and the anaphylactoid syndrome; ii) paracetamol conversely exerts a protective effect on the reaction, with a less severe reaction observed in the presence of higher paracetamol concentrations. We will investigate the mechanisms underlying adverse reactions to NAC in the human forearm model, examining the role of histamine and other markers involved in the inflammatory process. The wider significance is an improved understanding of this poorly delineated phenomenon, with implications for other medications associated with similar reactions, such as non-steroidal anti-inflammatory drugs and opioids such as morphine.

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Page last updated: 2010-01-21

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