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Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Memantine, sold under the brand name Namenda among others, is a medication used to slow the progression of moderate-to-severe Alzheimer's disease. [10] [11] [8] It is taken by mouth. [10] [8] Common side effects include headache, constipation, sleepiness, and dizziness. [10] [11] Severe side effects may include blood clots, psychosis, and heart ...
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
While estimates vary, some studies suggest that 1 in 5 prescriptions of common medications involves an off-label use. Skip to main content. 24/7 Help. For premium support please call: 800-290 ...
Modafinil is a central nervous system (CNS) stimulant medication used to treat sleepiness due to narcolepsy, shift work sleep disorder, and obstructive sleep apnea. It is often used off-label as a nootropic. Prazosin (Minipress) for nightmares: prazosin is approved for the use of hypertension. A 2012 systematic review showed a small benefit for ...
Memantine/donepezil, sold under the brand name Namzaric among others, is a fixed dose combination medication used for the treatment of dementia of the Alzheimer's type. [1] It contains memantine, as the hydrochloride, a NMDA receptor antagonist; and donepezil as the hydrochloride, an acetylcholinesterase inhibitor. [1] It is taken by mouth. [1]
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 ...
Off label indications often have some clinical significance to back the use, but they have not gone through the extensive testing required by the FDA to have an official labeled indication. Drug companies can not provide any official medication information (e.g. package inserts) for off label indications. [2]