COCAINE HYDROCHLORIDE Solution Ref.[9265] Active ingredients: Cocaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Aurum Pharmaceuticals Ltd, Bampton road, Harold hill, Romford, Essex, RM3 8UG

Product name and form

Cocaine Hydrochloride Solution 10% w/v.

Pharmaceutical Form

Sterile oromucosal solution 10% w/v.

Sterile nasal spray, solution 10% w/v.

Qualitative and quantitative composition

Cocaine Hydrochloride Ph Eur 10% w/v.

Active Ingredient Description
Cocaine

Cocaine is a tropane alkaloid with central nervous systems (CNS) stimulating and local anesthetic activity. Cocaine binds to the dopamine, serotonin, and norepinephrine transport proteins and inhibits the re-uptake of dopamine, serotonin, and norepinephrine into pre-synaptic neurons. This leads to an accumulation of the respective neurotransmitters in the synaptic cleft and may result in increased postsynaptic receptor activation. The mechanism of action through which cocaine exerts its local anesthetic effects is by binding to and blocking the voltage-gated sodium channels in the neuronal cell membrane. By stabilizing neuronal membranes, cocaine inhibits the initiation and conduction of nerve impulses and produces a reversible loss of sensation.

List of Excipients

Dilute hydrochloric acid
Water for injections

Pack sizes and marketing

8ml type 1 clear glass bottle, with chlorobutyl rubber stopper and plastic screw cap, containing 2.5ml of a 10% w/v Cocaine Hydrochloride solution for topical application.

Marketing authorization holder

Aurum Pharmaceuticals Ltd, Bampton road, Harold hill, Romford, Essex, RM3 8UG

Marketing authorization dates and numbers

12064/0016

14th April 1999

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