Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2012 Apr;3(2):62-5.
doi: 10.4103/2229-3485.96447.

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

K Krishnaprasad  1 , P Manshani, J Karankumar
Affiliations

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

K Krishnaprasad et al. Perspect Clin Res. 2012 Apr.

Abstract

To assess the likely impact of a fixed dose combination (FDC) of Amantadine, Paracetamol, Chlorpheniramine maleate, and Phenylephrine on the health outcome and safety profile arising from the complementary action of amantadine and other ingredients, we conducted a Prescription Event Monitoring study for patients with suspected Influenza symptoms who were prescribed this FDC in 'real life clinical settings' or clinical practice. Between August 2010 and March 2011, Questionnaires were sent to doctors who provided data on the health outcome or safety profile. Sedation and allergy, including rash, were noted in few of the patients. None of the patients reported any major events. Most of the patients (60%) were initiated on FDC therapy within the first 24 hours of symptom onset. Even as a significant proportion of the patients (24.9%) had a concurrent history of allergy / rhinitis including asthma, few of them (4.1%) reported lack of improvement and had to be complemented with antibiotics. The FDC of Amantadine, Chlorpheniramine, Paracetamol, and Phenylephrine was found to be safe and well-tolerated when administered to patients within the first 24 to 48 hours of symptom onset.

Keywords: Fixed dose combination; health outcome; prescription-event monitoring; safety.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Percentage of patients showing ‘events’ at the end of the study
Figure 2
Figure 2
Percentage of patients showing physician assessment as ‘effective’
See this image and copyright information in PMC

References

    1. Rao BL, Banerjee K. Influenza surveillance in Pune, India, 1978-90. Bull World Health Organ. 1993;71:177–81. - PMC - PubMed
    1. WHO Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) 2009 and other Influenza Viruses. 2010 Feb;:Part I: Recommendations. - PubMed
    1. Harper SA, Bradley JS, Englund JA, Fill TM, Graven-Stein S, Hayden FG, et al. Expert Panel of the Infections Diseases Society of America.Seasonal influenza in adults and children: Diagnosis, treatment chemoprophylaxis, and institutional outbreak management: Clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2009;48:1003–32. - PMC - PubMed
    1. Mukherjee S, Roy S, Dahake R, Chowdhary A. In-vitro susceptibility of influenza viruses to amantadine hydrochloride. Bull Haffkine Institute. 2011;13:58–9.
    1. Little JW, Hall WI, Douglas RG, Jr, Hyde RW, Speers DM. Amantadine effect on peripheral airways abnormalities in influenza. A study in 15 students with natural influenza. A study in students with natural influenza A infection. Ann Intern Med. 1976;85:177–82. - PubMed