EXEFEN SUMMARY
Pseudoephedrine hydrochloride is an adrenergic (vasoconstrictor).
Guaifenesin is an expectorant.
Each immediate-release tablet for oral administration contains:
Pseudoephedrine HCl 60 mg Guaifenesin 400 mg
EXEFEN-IR Tablets are indicated for the relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis. To promote nasal or sinus drainage; for the relief of Eustachian tube congestion; for adjunctive therapy in serous otitis media; for the symptomatic relief of respiratory conditions characterized by dry, non-productive cough and in the presence of tenacious mucus and/or mucus plugs in the respiratory tract.
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NEWS HIGHLIGHTS
Published Studies Related to Exefen (Pseudoephedrine / Guaifenesin)
[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution] [2010.03] CONCLUSION: Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.
[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution]. [2010.03] CONCLUSION: Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.
Safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for adjunctive symptom relief of acute respiratory infections. [2009.05] Acute bacterial respiratory infections (ABRIs) require treatment with antibiotics.
A randomized, double-blind, parallel-group, multicenter, placebo-controlled study of the safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief as an adjunctive therapy to antibiotic treatment of acute respiratory infections. [2008.07] PURPOSE: This study assessed the efficacy and safety of guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg extended-release bilayer tablets in providing relief of acute respiratory symptoms when used as an adjunct to antibiotics in patients with an acute respiratory infection (ARI).Conclusions: As adjunctive therapy for symptom relief for patients taking antibiotics for ARIs, guaifenesin/pseudoephedrine shortened time to relief and improved bothersome respiratory symptoms better than placebo, with greatest effects seen for nasal congestion and sinus headache.
A new technique for spectrophotometric determination of pseudoephedrine and guaifenesin in syrup and synthetic mixture. [2011.05] The accuracy in predicting different chemometric methods was compared when applied on ordinary UV spectra and first order derivative spectra. Principal component regression (PCR) and partial least squares with one dependent variable (PLS1) and two dependent variables (PLS2) were applied on spectral data of pharmaceutical formula containing pseudoephedrine (PDP) and guaifenesin (GFN)...
Clinical Trials Related to Exefen (Pseudoephedrine / Guaifenesin)
Phase 4 Study - Mucinex D as Adjunct Therapy [Completed]
The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in
providing symptom relief when administered as an adjunct to antibiotic therapy in patients
with acute respiratory infection.
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI [Completed]
The purpose of this study is to determine if treatment with Mucinex D lowers the use of
antibiotics in the treatment of upper respiratory infection when compared to placebo
Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy [Completed]
The purpose of the study is to evaluate the efficacy (effect on grip strength and
disability) and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor
Neuropathy.
Preventing Frequent Sinus Infections in HIV-Infected Patients [Withdrawn]
To evaluate the additional effectiveness of an anti-inflammatory nasal spray (
beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over
decongestant ( Deconsal II ) alone, when these agents are given individually or in
combination for the prevention of recurrent paranasal sinus infection in patients with HIV
infection. To compare the clinical utility of paranasal sinus radiographs with computed
tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent
paranasal sinus infection. To determine relevant prognostic factors and the microbiologic
etiology of maxillary sinusitis in this patient population.
Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory
to traditional therapy, particularly in patients with advanced immunosuppression. An
intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears
to be warranted.
Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections [Not yet recruiting]
Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms
during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the
mucosa more reactive to infectious agents and potentiates mucus production.
The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits
antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this
product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in
promoting mucus elimination in atopic patients with viral infections of the upper
respiratory tract.
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