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A package insert from 1970, with Ovrette brand contraception pills A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications , the insert is technical , providing information for medical professionals about how to prescribe the drug.
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
The Physicians' Desk Reference (PDR), renamed Prescriber's Digital Reference after its physical publication was discontinued, is a compilation of manufacturers' prescribing information (package insert) on prescription drugs, updated regularly and published by ConnectiveRx. [citation needed]
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user-- the person who will take the ...
Simnotrelvir/ritonavir is a combination drug of simnotrelvir, an inhibitor of SARS-CoV-2 3CL pro, and ritonavir, [3] a CYP3A inhibitor. It was developed by Simcere Pharmaceutical and conditionally approved in China by the National Medical Products Administration (NMPA) in January 2023. [ 4 ]
Common side effects of dolutegravir in clinical trials included insomnia and headache. Serious side effects included allergic reactions and abnormal liver function in patients who were also infected with hepatitis B or C. [15] The package insert warns against a mean rise in serum creatinine of 0.11 mg/dL due to inhibition of tubular secretion of creatinine and does not affect GFR.