This brand name is authorized in United States. It is also authorized in Brazil, Canada, Ecuador, Hong Kong SAR China, Japan, Mexico, New Zealand, Singapore, South Africa.
The drug PRECEDEX contains one active pharmaceutical ingredient (API):
1
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UNII
1018WH7F9I - DEXMEDETOMIDINE HYDROCHLORIDE
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Dexmedetomidine is a selective alpha-2 receptor agonist with a broad range of pharmacological properties. It has a sympatholytic effect through decrease of the release of noradrenaline in sympathetic nerve endings. The sedative effects are mediated through decreased firing of locus coeruleus, the predominant noradrenergic nucleus, situated in the brainstem. |
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Below package inserts are available for further reading:
Document | Type | Information Source | |
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PRECEDEX Solution for injection | MPI, US: SPL/PLR | FDA, National Drug Code (US) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC Group | Classification | |
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N05CM18 | Dexmedetomidine | N Nervous system → N05 Psycholeptics → N05C Hypnotics and sedatives → N05CM Other hypnotics and sedatives |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
BR | Câmara de Regulação do Mercado de Medicamentos | 522717100060208, 522720100090007 |
CA | Health Products and Food Branch | 02339366, 02437147 |
EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 27.771-1-03-12 |
HK | Department of Health Drug Office | 49806, 66360 |
JP | 医薬品医療機器総合機構 | 1129400A1054, 1129400G1022 |
MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 207M2000 |
NZ | Medicines and Medical Devices Safety Authority | 19226, 19258, 19259, 8960 |
SG | Health Sciences Authority | 11333P, 15689P |
US | FDA, National Drug Code | 0409-1434, 0409-1638, 0409-1660, 52584-638 |
ZA | Health Products Regulatory Authority | 34/2.9/0239 |
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