Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Cyclobenzaprine hydrochloride

CAS No.

6202-23-9

Innovator/marketer

Amrix, Flexeril

Polymorphic form

Crystalline, none

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

018317

Drug description:

Cyclobenzaprine hydrochloride is a skeletal muscle relaxant and an anti-cholinergic agent.
Cyclobenzaprine hydrochloride is indicated for treatment of muscle spasm associated with acute, painful musculoskeletal conditions.
It is formulated as film coated tablets for oral route of administration.

Mechanism of action:

Cyclobenzaprine relieves muscle spasms through a central action, possibly at the brain stem level. It shows antagonistic action on serotonin receptor (5-HT2A and 5-HT2C) receptors in the brain stem to reduce tonic somatic motor activity, influencing both gamma and alpha motor neurons.

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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