Active Ingredient: Cytisine
Smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking. The treatment goal of cytisine is the permanent cessation of the nicotine‑containing products use.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 1.5 milligrams cytisine, once every 2 hours, 6 doses in total, over the duration of 3 days. Afterwards, oral, 1.5 milligrams cytisine, once every 2.5 hours, 5 doses in total, over the duration of 9 days. Afterwards, oral, 1.5 milligrams cytisine, once every 3 hours, 4 doses in total, over the duration of 4 days. Afterwards, oral, 1.5 milligrams cytisine, once every 5 hours, 3 doses in total, over the duration of 4 days. Afterwards, oral, 1.5 milligrams cytisine, 1 to 2 times daily, over the duration of 5 days.
The duration of therapy is 25 days.
Cytisine should be taken according to the following schedule:
| Days of treatment | Recommended dosing | Maximum daily dose |
| From the 1st to the 3rd day | 1.5 mg every 2 hours | 9 mg |
| From the 4th to the 12th day | 1.5 mg every 2.5 hours | 7.5 mg |
| From the 13th to the 16th day | 1.5 mg every 3 hours | 6 mg |
| From the 17th to the 20th day | 1.5 mg every 5 hours | 4.5 mg |
| From the 21st to the 25th day | 1.5-3 mg a day | to 3 mg |
Smoking should be stopped no later than on the 5th day of treatment. Smoking should not be continued during treatment as this may aggravate adverse reactions. In case of treatment failure, the treatment should be discontinued and may be resumed after 2 to 3 months.
There is no clinical experience of cytisine in patients with renal or hepatic impairment, therefore the drug product is not recommended for use in this patient population.
Due to limited clinical experience, cytisine is not recommended for use in elderly patients over 65 years of age.
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