• NILAY SOLANKI Ramanbhai Patel College of Pharmacy, Department of Pharmacology, CHARUSAT, Changa, Gujarat-388421
  • ALPA GOR Pramukh Swami Medical College, Karamsad, Gujarat
  • BIRAJ PARMAR Ramanbhai Patel College of Pharmacy, Department of Pharmacology, CHARUSAT, Changa, Gujarat-388421


Objective: Many Fix Dose Combinations (FDCs) being introduced in India are usually irrational. The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions, for instance, pediatric formulations of nimesulide+paracetamol. Despite their wide clinical use, their gastro-intestinal toxicity is a major limitation. The aim of the present work was to evaluate the efficacy and safety of FDCs in non-steroidal anti-inflammatory drugs in the orthopedic department at a tertiary care teaching hospital. To study the effectiveness and safety parameters of fixed-dose combinations of Non-Steroidal Anti-inflammatory Drugs.

Methods: This prospective, observational study was conducted among 150 out-patients of the orthopedic ward over a period of July 2013 to December 2013(Each combination with 50 patients). Three fixed-dose combinations utilized were paracetamol+diclofenac, paracetamol+ibuprofen and paracetamol+nimesulide. The effectiveness was analyzed by using Visual Analogue Scale (VAS) and Disease Activity Scale (DAS) and the safety criteria were analyzed by using the WHO probability scale and Naranjo scale. 150 orthopedic patients attending Out Patient Department were included. 50 participants for each of the combinations of fixed-dose combination (FDCs) of NSAIDs.

Results: Out of 150 patients 33 patients developed adverse effects, and 17(51.51%) adverse effects due to the combination of Paracetmol+Nimuselide, 11(33.34%) adverse effects due to the Paracetamol+Ibuprofen and 5 (15.15%) were due to the combination of Paracetamol+Diclofenac. The maximum effectiveness (3.55±0.208) showed in the combination of paracetamol+diclofenac compared to the other two combinations.

Conclusion: It was concluded from this study that the effectiveness and safety profile of PCM+DICLO is better than the other two FDCs.

Keywords: Fix Dose Combinations, Paracetamol diclofenac, Naranjo scale and WHO probability Scale


Download data is not yet available.


1. Shahani S, Nerleker S. Adverse drug reactions in dermatology and a growing need for pharmacovigilance. J Pharmacovig Drug Saf 2009;6:35-7.
2. Gor AP, Saksena M. Adverse drug reactions of non-steroidal anti-inflammatory drugs in orthopedic patients. J Pharmacol Pharmacother 2011;2:26-9.
3. Tsoukas C, Eyster ME, Shingo S. Evaluation of the efficacy and safety of etoricoxib in the treatment of hemophilic arthropathy. Blood 2006;107:1785-90.
4. Raghavendra B, Ullal SD, Kamath R. Trends in prescribing gastroprotective agents with non-steroidal anti-inflammatory drugs in an orthopaedic outpatient unit of a tertiary care hospital. J Clin Diagn Res 2009;3:1553-6.
5. Aletaha D, Smolen J. The simplified disease activity index (SDAI) and the clinical disease activity index (CDAI) a review of their usefulness and validity in rheumatoid arthritis. Clin Exp Rheumatol 2005;23:100–8.
6. Sharma T, Dhasmana SC. Prescribing pattern of NSAIDs in orthopaedic OPD of a tertiary care teaching hospital in Uttaranchal. JK Science 2006;8:160-2.
7. Venkatachalam S, Bhat R. ADR monitoring of NSAIDs among the in-patients of the orthopaedic ward in a tertiary care center: a prospective observational study. J Clin Diagn Res 2012;6:42-6.
8. Shankar PR, Pai R, Dubey AK. Prescribing patterns in the outpatient department in a teaching hospital in Pokhara, western Nepal. Kathmandu University Med J 2007;5:16-21.
9. Uhlig T, Kvien TK, Pincus T. Test-retest reliability of disease activity core set measures and indices in rheumatoid arthritis. Ann Rheum Dis 2009;68:972–5.
10. Radovits BJ, Fransen J, van Riel PL. Influence of age and gender on the 28-joint disease activity score (DAS28) in rheumatoid arthritis. Ann Rheum Dis 2008;67:1127–31.
11. Yadav P, Kanase V, Lacchiramka P. Drug utilization trends in ENT outpatient department in a teaching hospital. Int J Pharm Biol Sci 2010;1:153–60.
12. Gor AP, Shah BK. Evaluation of prescribing pattern and adverse effects of fixed-dose combination of non-steroidal anti-inflammatory drugs. Int J Basic Clin Pharmacol 2016;5:1029-33.
13. Praveen D, Ranadheer C, Rujaswini T. A prospective observational study on safety and efficacy of Hydroxychloroquine against diclofenac in osteoarthritis. Asian J Pharm Clin Res 2018;11:95-7.
14. Kulkarni M, Patil A. Drug utilization study in the orthopedics outpatient department of a tertiary care hospital in Maharashtra. Asian J Pharm Clin Res 2018;7:224-6.
274 Views | 262 Downloads
How to Cite
SOLANKI, N., A. GOR, and B. PARMAR. “EFFECTIVENESS AND SAFETY ASSESSMENT OF FIXED DOSE COMBINATION OF NON-STEROIDAL ANTIINFLAMMATORY DRUGS PRESCRIBED FOR ORTHOPEDIC PATIENTS”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 12, no. 2, Feb. 2020, pp. 70-73, doi:10.22159/ijpps.2020v12i2.35666.
Original Article(s)