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Fluorouracil (5-FU, 5-fluorouracil), sold under the brand name Adrucil among others, is a cytotoxic chemotherapy medication used to treat cancer. [3] By intravenous injection it is used for treatment of colorectal cancer , oesophageal cancer , stomach cancer , pancreatic cancer , breast cancer , and cervical cancer . [ 3 ]
The list of 1997 drug labelling changes can be found on the FDA's website, here. The first patient package insert required by the FDA was in 1968, mandating that isoproterenol inhalation medication must contain a short warning that excessive use could cause breathing difficulties.
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 book was distributed for free to all licensed medical doctors in America; only drugs which drug manufacturers paid to appear, appeared in the PDR, and no generic drugs were listed. The 71st Edition, published in 2017, was the final hardcover edition, weighed in at 4.6 pounds (2.1 kg) and contained information on over 1,000 drugs. [ 1 ]
The "pharmacogenetics" section contains the sentence: "The FDA-approved drug label for fluorouracil states that the drug is contraindicated in patients with known DPD deficiency.[6]" This is not mentioned in the "contraindications" section; should this sentence or similar, or even the section, be added, or moved there (merged or as a subsection ...
The major side effects of tegafur are similar to fluorouracil and include myelosuppression, central neurotoxicity and gastrointestinal toxicity (especially diarrhoea). [3] Gastrointestinal toxicity is the dose-limiting side effect of tegafur. [3] Central neurotoxicity is more common with tegafur than with fluorouracil. [3]
In several major drug classification systems, these four types of classifications are organized into a hierarchy. [4] For example, fibrates are a chemical class of drugs (amphipathic carboxylic acids) that share the same mechanism of action ( PPAR agonist ), the same mode of action (reducing blood triglyceride levels), and are used to prevent ...
An auxiliary label (also called cautionary and advisory label or prescription drug warning label) is a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [1]