Safety and efficacy of generic drugs with respect to brand formulation
A 70-year-old woman presented with a history of recurrent urinary infections was admitted on July 10, 2012, to her general practitioner (GP) for the development of painful burning sensation when urinating. History revealed the presence of blood hypertension treated with calcium blockers (amlodipine, 10 mg/day) and a previous history of skin reaction after amoxicillin treatment. Clinical evaluation revealed discomfort in the lower abdomen and pain in the pelvic area. Laboratory findings of urinary samples documented the presence of leucocytes and blood, with an acid pH []. Moreover, urine had a strong smell and appeared cloudy.\nOn July 12, 2012, a diagnosis of acute cystitis was performed and a 7 days treatment with ciprofloxacin (Ciproxin, Bayer® 750 mg once daily) was prescribed; on 13 July microbiological evaluation of urine samples revealed the presence of Escherichia coli (2 × 105 colony forming units [CFU]/mL), with a good sensibility to both ciprofloxacin (Minimum inhibitory concentrations [MIC]: 4.9 mcg/mL; range: 0.06-8) and amoxycillin-clavulanate (3.96 mcg/mL; range: 1-16).\nDuring the follow-up performed on 20 July, the persistence of cystitis induced a new microbiological evaluation that revealed, 3 days later, an infection sustained from E. coli (5 × 105 CFU/mL) still ciprofloxacin-sensitive (MIC: 4.9 mcg/mL; range: 0.06-8).\nPharmacological evaluation revealed that the patient took the generic ciprofloxacin (Mylan Generics® 750 mg once daily) instead of the prescribed drug; therefore, the brand formulation of ciprofloxacin (Ciproxin, Bayer®; 750 mg once daily) was prescribed with an improvement of clinical symptoms and laboratory values [] and without the development of side-effects.