[Levothyroxine and the problem of interchangeability of drugs with narrow therapeutic index].
نویسنده
چکیده
The exchange of a prescribed drug by other similar, by generic products and even by custom products has become common practice in our country, often ignoring basic tenets of bioequivalence, interchangeability, stability and characteristics of the pharmaceutical compounds. In the case of drugs of narrow therapeutic index, such as levothyroxine, these problems are intensified, putting the effectiveness of treatment and patient health at serious risk. We review the pertinent legislation, emphasizing the characteristics of levothyroxine and adverse effects that limit the interchangeability of the compound.
منابع مشابه
Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation
The calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are the mainstay of immunosuppression in solid organ transplantation. Generic formulations of these drugs are now available. With increasing pressure on healthcare budgets and the consequent need to match health expectations to available resources, substitution with a generic product appears an attractive option to reduce costs. App...
متن کاملA Review on Therapeutic Drug Monitoring of Immunosuppressant Drugs
Immunosuppressants require therapeutic drug monitoring because of their narrow therapeutic index and significant inter-individual variability in blood concentrations. This variability can be because of factors like drug-nutrient interactions, drug-disease interactions, renal-insufficiency, inflammation and infection, gender, age, polymorphism and liver mass. Drug monitoring is widely practiced ...
متن کاملGeneric substitution: issues for problematic drugs.
The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for...
متن کاملPatterns and predictors of generic narrow therapeutic index drug use among older adults.
OBJECTIVES To ascertain predictors of initiation of brand-name versus generic narrow therapeutic index (NTI) drugs. DESIGN Retrospective cohort study. SETTING Data from CVS Caremark were linked to Medicare claims and to U.S. census data. PARTICIPANTS Individuals aged 65 and older who initiated an NTI drug in 2006 and 2007 (N = 36,832). MEASUREMENTS Demographic, health service utilizatio...
متن کاملBrand and generic medications: are they interchangeable?
BACKGROUND AND OBJECTIVES Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety, and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concer...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Arquivos brasileiros de endocrinologia e metabologia
دوره 55 7 شماره
صفحات -
تاریخ انتشار 2011