Cytisine for cessation

Posted 4 Dec, 2024

A final decision has been made on proposed amendments to the Poisons Schedule in relation to cytisine. The delegate of the Secretary of the Department of Health and Aged Care (the Delegate) made the decision to create new entries for cytisine in Schedules 3 and 4 and Appendix H. Currently there are no cytisine products on the Australian Register of Therapeutic Goods.

Cytisine is a partial nicotine receptor agonist that belongs to the same class of medicine as varenicline. It is a plant-derived oral smoking cessation aid that is used to reduce nicotine withdrawal symptoms. Cytisine has been used in many European countries for years, and it has become available in Canada, UK and Ireland recently.  

A final decision has recently been made on proposed amendments to the Poisons Schedule in relation to cytisine. The Delegate’s decision was to create new entries for cytisine: 

Schedule 4 – New entry  
Cytisine except when included in Schedule 3 

Schedule 3 – New entry 
Cytisine in divided oral and oromucosal preparations with a recommended daily dose of 9mg or less of cytisine as an aid in withdrawal from tobacco smoking in adults 

Appendix H – New entry 
Cytisine 

Currently, there are no cytisine products on the Australian Register of Therapeutic Goods. 

Further information:

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