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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 ...
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]
Nitazoxanide alone has shown preliminary evidence of efficacy in the treatment of chronic hepatitis B over a one-year course of therapy. [17] Nitazoxanide 500 mg twice daily resulted in a decrease in serum HBV DNA in all of 4 HBeAg-positive patients, with undetectable HBV DNA in 2 of 4 patients, loss of HBeAg in 3 patients, and loss of HBsAg in one patient.
Deprescribing is a process of tapering or stopping medications to achieve improved health outcomes by reducing exposure to medications that are potentially either harmful or no longer required. [1] Deprescribing is important to consider with changing health and care goals over time, as well as polypharmacy and adverse effects . [ 2 ]
Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. [10] It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. [10] It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. [10]
The FDA, in its letter on Wednesday, said the company was marketing kits which include certain misbranded piston syringes made by China's Jiangsu Shenli Medical Production and neither had approval ...
Medication discontinuation is the ceasing of a medication treatment for a patient by either the clinician or the patient themself. [1] [2] When initiated by the clinician, it is known as deprescribing. [3]