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Table 3 Comparison between PIs of the local and imported products by word counting of 20 criteria

From: Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine

Variable Local Imported P valuea Fold difference in medians
Median [Q1-Q3] Median [Q1-Q3]
Inactive ingredients (excipients) 0.00 [0.00–0.00] 33.50 [20.00–58.50] 0.000 >33.50
Therapeutic class 0.00 [0.00–4.00] 5 [3.5–9.00] 0.016 >5.00
Indications 14.00 [10.00–20.00] 25.00 [18.50–37.00] 0.023 1.78
Drug dose 0.00 [0.00–0.00] 0.00 [0.00–108.5] 0.401
Missing dose 30.00 [15.00–34.70] 30.00 [26.00–34.50] 0.797 1.00
Maximum dose 0.00 [0.00–0.00] 0.00 [0.00–0.00] 0.898
Directions for use 37.00 [20.00–43.00] 33.00 [24.00–71.00] 0.365 1.12
Overdose and management 45.70 [38.00–71.00] 62.50 [44.00–80.00] 0.365 1.37
Warning and precautions 49.00 [36.00–173.00] 161.50 [117.50–322.00] 0.010 2.29
Effect on ability to drive and use machines 0.00 [0.00–20.50] 42.00 [33.00–47.00] 0.002 >42.00
Contraindications 28.33 [9.00–60.50] 89.00 [66.00–126.5] 0.000 3.14
Adverse drug reactions 66.00 [62.00–97.00] 334.00 [235.50–448.50] 0.000 5.06
Drug-drug interactions 57.70 [49.00–73.00] 151.00 [109.00–304.00] 0.001 2.62
Drug-food interactions 0.00 [0.00–13.00] 23.00 [12.00–35.00] 0.001 >23.00
Pregnancy considerations 16.70 [12.00–25.00] 25.00 [20.00–71.00] 0.010 1.50
Lactation considerations 13.00 [8.00–15.70] 16.00 [9.00–21.50] 0.116 1.23
Pediatric considerations 13.00 [6.70–55.00] 62.00 [39.50–72.50] 0.019 4.77
Possibility of tablet splitting 0.00 [0.00–0.00] 7.00 [4.50–12.00] 0.000 >7.00
Possibility of crushing and mixing with food or beverages 5.00 [1.50–5.00] 5.00 [3.00–7.00] 0.270 1.00
Storage 22.00 [15.00–35.00] 55.50 [47.50–59.00] 0.000 2.52
  1. aThe p-values are bold where they are less than the significance level cut-off of 0.05