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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 ...
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.
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 ...
Indications and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called "off-label uses").
Some turn to online pharmacies to get an off-label prescription. ... and has been approved by the U.S. Food and Drug Administration for weight loss in people with obesity or weight-related health ...
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]
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]
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...