Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price.
However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease time to relapse or might lead to a therapeutic failure; on the other hand, a higher drug concentration 2008 antibiotic generic drugs list expose patients to an increased risk of dose-dependent side-effects, 2008 antibiotic generic drugs list.
In the last years, several generic drugs have been introduced in Italy in agreement with the Finance Law of Law n. In this contest, at least at a physiological level, generic medicines behave very similarly to their originator counterparts; therefore, theoretically, they may show a similar efficacy.
In fact, an interesting study comparing single-dose clinical bioequivalence studies of orally administered generic medicine products approved by the Food and Drug Administration FDAfrom 2008 antibiotic generic drugs listdemonstrated that the products did not significantly differ.
In agreement, other authors documented that treatment with generic drugs or the switch from brand to generic formulation is not related to significant clinical failure or development of adverse drug reactions. On the other hand, while generic drugs are tested for bioequivalence within a certain range compared to innovator drugs, safety and efficacy testing is not required; therefore, generic drugs are not necessarily therapeutically equivalent to branded drugs.
In particular, in agreement with the above reported law, bioequivalence study is not necessary in the presence of injectable formulations. Moreover, in the presence of drugs with sustained release or narrow therapeutic index, clinical studies performed in 12 young health volunteers from 18 to year-old are necessary.
However, these studies evaluate the bioequivalence of these formulations, performing a pharmacokinetic and not a pharmacodynamic evaluation. Therefore, no data concerning the efficacy and safety are recorded. In fact, other authors documented the development of side-effects or clinical failure after the switch from brand to generic formulation, 2008 antibiotic generic drugs list.
In this case-review, we report the lack of efficacy during treatment with generic formulations of fluoroquinolones and discuss the relative reasons also considering the limitations of this legal approach. A year-old woman presented with a history of recurrent urinary infections was admitted on July 10,to her general practitioner GP for the development of painful burning sensation when urinating. 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 2008 antibiotic generic drugs list pH [ Table 1 ]. Moreover, urine had a strong smell and appeared cloudy. During the follow-up performed on 20 July, the persistence of cystitis induced a new microbiological evaluation that revealed, 2008 antibiotic generic drugs list, 3 days later, an infection sustained from E.
Cardiovascular and abdominal relieves were normal. Clinical evaluation documented the presence of wheezing, coughing with green mucus and shortness of breath. Six days later, patient returned to the GP for the worsening of symptoms fever No side-effects appeared during drug treatment.
A year-old man with 4 days of pain, tenderness, swelling and pressure around the eyes presented to his medical practitioner for clinical evaluation. Examination revealed the presence of fever During the follow-up, 3 days later, clinical evaluation revealed the persistence of symptoms with a worsening of the fever The change from generic to brand formulation taussig cancer pharmacy and phone a complete resolution of symptoms in about 10 days.
Therefore, in these cases a lack of efficacy during treatment with generic formulations may be hypothesized. Several mechanisms could be involved in both lack of efficacy and development of side-effects:. This difference could play a role in the effectiveness of drugs and it is very relevant during treatment with antibiotic drugs. It is excreted by active tubular secretion. The efficacy of fluoroquinolones in bacterial infections is determined by the possibility to obtain appropriate values of pharmacokinetic and pharmacodynamic indexes: Previous study suggested that a possible explanation in clinical difference between brand formulation and a generic one might be represented by the difference in excipients.
Moreover, several studies documented that a difference in excipients is related with the loss of response during treatment with the generic formulations. Other studies reported the development of an allergic reaction to croscarmellose sodium used as excipient in a generic furosemide preparation in a patient who had previously been taking branded furosemide.
This factor has been previously reported to affect the bioavailability of the drug and therefore, its therapeutic efficacy. In this light, the switch from brand to generic formulation might not always be considered 2008 antibiotic generic drugs list according to cost-effectiveness. In fact, a retrospective study, that evaluated the effect of generics on price and consumption of ciprofloxacin in primary health-care, has demonstrated a significant increase in the total consumption of oral ciprofloxacin and an increased resistance of E.
In other words, newly diagnosed epileptic patients starting 2008 antibiotic generic drugs list anticonvulsant treatment with a specific formulation should be maintained on the same identical drug.
Overall, it is advisable to well evaluate the effects of generic formulations during the therapeutic treatment. National Center for Biotechnology InformationU.
Journal List J Pharmacol Pharmacother v. This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3. This article has been cited by other articles in PMC. Abstract Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product.
Antibiotics, bioequivalence, brand, clinical efficacy, generic, safety. Table 1 Laboratory findings in urinary samples for case 1. Open in a separate window. Case 4 A year-old man with 4 days of pain, tenderness, swelling and pressure around the eyes presented to his medical practitioner for clinical evaluation, 2008 antibiotic generic drugs list.
Comments In these cases, it is important to underline that: The switch from brand drug to generic formulation has been suggested by the pharmacist, 2008 antibiotic generic drugs list.
All factors related to the lack of efficacy, e. The development of resistance may be excluded because 2008 antibiotic generic drugs list the first case microbiological evaluation revealed a high sensibility of bacteria to antibiotic; however, in all patients treatment with brand formulations induced an improvement in both clinical and laboratory findings without the development of side effects.
2008 antibiotic generic drugs list the exception of the first case, in all other cases reported, the lack of effects cannot be completely confirmed since the patients continued with the same drug; so, it could be argued that also continuing with the generic drug a therapeutic effect might have been observed.
In any case, the lack of an early efficacy during treatment is controversial and further studies are warranted. Difference in excipients Previous study suggested that a possible explanation in clinical difference between brand formulation and a generic one might be represented by the difference in excipients.
CONCLUSION In conclusion, 2008 antibiotic generic drugs list, the use of generic drugs could be related with an increased days of disease time to relapse or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.
Footnotes Source of Support: Nil Conflict of Interest: Black Book — The Long View: Similarities to and differences from brand-name drugs. Comparing generic and innovator drugs: Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: A systematic review and meta-analysis. Efficacy of substituting innovator propafenone for its generic formulation in patients with atrial fibrillation.
Health authority opportunity or nightmare? Expert Rev Pharmacoecon Outcomes Res. Generic medications in ophthalmology. Lack of efficacy during the switch from brand to generic allopurinol. J Forensic Leg Med. Skin rash during the treatment with generic itraconazole: Description of a case.
Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: A reappraisal of generic bisphosphonates in osteoporosis.
Treatment failure in osteoporosis. Investigation and management of loss of efficacy of an antiepileptic medication using carbamazepine as an example. J R Soc Med. Current controversies and future directions. Adverse drug reactions to antibiotics observed in two pulmonology divisions of catanzaro, Italy: A six-year retrospective study.
Bilateral skin ulceration after injection of pegylated interferon-alpha-2b in a patient with chronic hepatitis C. Levofloxacin-induced taste perversion, blurred vision and dyspnoea in a young woman. 2008 antibiotic generic drugs list possible drug-food interaction induced generalised urticaria in a young woman. Venlafaxine-propafenone interaction resulting in hallucinations and psychomotor agitation. Hepatotoxicity induced by methimazole in a previously healthy patient.
A case of neuroleptic malignant syndrome induced by risperidone in a schizophrenic woman, 2008 antibiotic generic drugs list. Prospective randomized double-blind trial of racecadotril compared with loperamide in elderly people with gastroenteritis living in nursing homes. Eur J Clin Pharmacol. A case of adverse drug reaction induced by dispensing error. Pharmacovigilance and drug safety in Calabria Italy: J Res Med Sci.
Fluoroquinolones and Gram-negative bacteria: Antimicrobial activity and mechanisms of resistance. Interactions among low dose of methotrexate and drugs used in the treatment of rheumatoid arthritis. Adv Pharmacol Sci Role of CYP3A5 in abnormal clearance of methadone. Rosuvastatin-induced rhabdomyolysis probably via 2008 antibiotic generic drugs list saturation.
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