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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. [1] The REMS program was formalized in 2007.
Singer and Bloom acknowledge that the FDA added clozapine to the REMS program in 2015 "because of a rare side effect (less than 3 percent frequency) called agranulocytosis, a reversible but life ...
Clozaril – atypical antipsychotic used to treat resistant schizophrenia Concerta ( methylphenidate ) – an extended release form of methylphenidate Contrave ( naltrexone/bupropion ) – a combination drug used in the treatment of mood and psychotic disorders.
Download QR code; Print/export Download as PDF; ... Clozapine [6] Clozaril ... Text is available under the Creative Commons Attribution-ShareAlike 4.0 License; ...
A DEA number (DEA Registration Number) is an identifier assigned to a health care provider (such as a physician, physician assistant, nurse practitioner, optometrist, podiatrist, dentist, or veterinarian) by the United States Drug Enforcement Administration allowing them to write prescriptions for controlled substances.
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.
Clozapine, sold under the brand name Clozaril among others, is a psychiatric medication and was the first atypical antipsychotic to be discovered. [7] It is used primarily to treat people with schizophrenia and schizoaffective disorder who have had an inadequate response to two other antipsychotics, or who have been unable to tolerate other drugs due to extrapyramidal side effects.
Though prescriber and pharmacy populations have become more familiar with the requirements of the iPLEDGE Program over the years, and some of the initial issues with the system have subsided, the nature of the restrictive distribution program continues to cause inconvenience, added expenses, and interruptions in the course of treatment. [20]