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Paper text:
generic drugs are equivalent to brand formulation if they have the same active substance ( with a difference of  5% ) , the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence ( 20% ) with the reference medicinal product ( law no .
even if generic drugs contain the same active ingredients as the branded counterparts , they could be different as far as excipients are concerned .
in addition , it has been estimated that the switch from brand to generic formulation induces benefits in about 30% of the treated patients while about 30% did not experience any benefit , about 10% complained side - effects and about 30% discontinued treatment due to clinical inefficacy or development of side - effects . in agreement
documented that the brand - generic switch may be critical in the presence of drugs with narrow therapeutic index .
three cases of clinical inefficacy after the switch from brand itraconazole to its generic formulation have been reported . in this case
we are reporting on a patient that developed a skin rash during treatment with generic itraconazole .
a 49-year - old woman ( high 155 cm , weight 52 kg ) , without previous history of drug or alcohol abuse or allergies , had been brought to her general practitioner for an infection on her left foot .
clinical and microbiological evaluation documented a  candida  infection , the diagnosis of onychomycosis was performed and an oral treatment with itraconazole ( sporanox 100 mg tablet twice a day for 10 days and then 100 mg / day for 1 month ) was prescribed .
about 20 days later , the patient returned to her general practitioner for the persistence of onychomycosis and the development of skin rash on the body . on examination ,
her blood pressure was 110/70 mm hg , heart rate 65 beats / min , respiratory rate 18 breaths / min and temperature 36.2c .
skin rash examination revealed giant hives associated with sudden itching and an increase in local skin temperature in most of the body parts , regions , especially on the trunk and upper limbs , but without regional positive lymphonodes .
itraconazole was dismissed and betamethasone ( 4 mg/12 h for 3 days ) was started , with a complete remission of skin rash .
about 5 days later , due to the impairment of onychomycosis , the patient takes again itraconazole and develops the skin rash .
history excluded allergic manifestations related to drugs , herbal supplements or contacts with chemical agents .
a detailed pharmacological evaluation revealed that the patient chose the generic itraconazole ( itraconazole mylan generics ) on the advice of the pharmacist .
both the naranjo probability scale and the world health organization ( who ) causality assessment scale , used to evaluate the relationship between adverse drug reaction ( adr ) and drug , documented a probable association between skin rash and itraconazole .
therefore , itraconazole mylan generics was promptly dismissed and a treatment with sporanox+ betamethasone ( 4 mg/12 h ) was started with an improvement of skin rash in few days .
one month later , during the follow - up , a complete remission of onychomycosis was recorded without the development of side - effects .
we are reporting on a case of skin rash occurring during treatment with generic formulation of itraconazole . in our present case , the general practitioner prescribed a branded drug . in agreement with the italian law ( 149/2005 )
, the pharmacist must inform the patient on the availability of a lower price formulation and let the patient choose . in the present case , the pharmacist informed the patient that the lower cost formulation of itraconazole available in pharmacy was  itraconazole mylan generic  and the patient has taken it and developed the skin rash .
several factors may be related to the development of side effects , e.g. , dispensing error , diseases or drug - drug interactions ; in our patient , both history and clinical evaluation suggested to excluded these .
therefore , we postulated that generic formulation of itraconazole may be involved in the development of skin rash .
in fact , the re - challenge with generic - itraconazole induced the development of skin rash while the re - challenge with brand - itraconazole completely improved the onychomycosis without the development of side - effect .
using naranjo probability scale and who causality assessment scale , we showed a probable relationship between skin rash and generic - itraconazole .
controversy remains on whether generic drugs are interchangeable with brand - name drugs as far as efficacy and adrs are concerned .
probably a role in the development of side - effects could be played by pharmaceutical excipients .
recently , it has been reported that pharmaceutical excipients are not inert ingredients and we have recently documented the lack of efficacy after the switch from brand to the generic formulation of allopurinol .
although , we are unable to evaluate the role of each excipient in the development of side - effects , in our patient we can not rule out their involvement in the development of skin rash [ table 1 ] .
this case could represent a first point to define the similarities or differences between branded and generic drugs , even if more data are necessary to validate this observation .
generic drugs have the same active substance , the same pharmaceutical form , the same therapeutic indications and a similar bioequivalence with the reference medicinal product ( branded ) . 
 although a similar efficacy is postulated , some cases of clinical inefficacy during treatment with generic formulations have been reported . in this case 
 , we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole . 
 drug administration and its re - challenge confirmed the association between itraconazole and skin rash . both naranjo probability scale and world health organization causality assessment scale documented a probable association between generic - itraconazole and skin rash . 
 the switch from generic formulation to brand one induced an improvement of symptoms . 
 since we are unable to evaluate the role of each excipient in the development of skin rash , we can not rule out their involvement . however , more data are necessary to better define the similarities or differences between branded and generic formulations .