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Cough Update: Outcomes on health and safety profile of paracetamol, chlorpheniramine maleate, phenylephrine and amantadine fixed dose combination

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eMediNexus    26 March 2021

Influenza has had a significant impact on society because of the high rates of morbidity or mortality especially in children. There are 16 and 9 types of H and N proteins that are used in combination to label influenza virus strains, such as, H1N1, H3N2, H2N2, H5N1, and so forth. Among these, H1N1 and H3N2 circulate in several parts of the world, including India also where it circulates throughout the year, but generally peaks during monsoon and winters. Early treatment with antivirals agents not only reduces the hospitalization rate, but also prevents the spread of the disease.

The objective of the study is to evaluate the possible impact of a fixed dose combination (FDC) of paracetamol, chlorpheniramine maleate, phenylephrine and amantadine on the health consequence and safety that is arising from the complementary action of amantadine along with the other components.  A Prescription Event Monitoring study was conducted for patients who were assumed to have influenza symptoms and were prescribed this FDC in the real-world clinical settings.  

Questionnaires were sent across to the doctors who later provided data on the health outcomes and safety profile. Adverse effects such as sedation and allergy i.e., rash, were observed in few patients. No major events were reported. Most of the patients (60%) were started on FDC treatment in the first 24 hours of onset of symptoms. A significant proportion of the patients (24.9%) had a concurrent history of allergy including asthma and few patients (4.1%) reported no improvement and were complemented with antibiotics. The fixed dose combination of chlorpheniramine, paracetamol, phenylephrine and amantadine are safe and well-tolerated when administered to patients in the first 24-48 hours of onset of symptoms.

Source: Krishnaprasad K, Manshani P, Karankumar J. Health outcome and safety assessment of a fixed dose combination of Amantadine, Paracetamol, Chlorpheniramine maleate, and Phenylephrine introduction in India: A prescription event monitoring study. Perspect Clin Res. 2012 Apr;3(2):62-5.

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