Yunhyujeong 0.5 mg (Varenicline Salicylate)

Adult dose

1. Usual dosage in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between day 8 and day 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dosage is as follows: after dose titration over 1 week, administer 1 mg twice daily. Days 1 – 3 0.5 mg once daily Days 4 – 7 0.5 mg twice daily Day 8 – end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking after the first 12 weeks of treatment, an additional 12 weeks of treatment with this medicine is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradually stopping smoking while taking this medicine. Reduce smoking by 50% compared with baseline within the first 4 weeks after starting treatment, and by an additional 50% over the next 4 weeks. Continue to reduce smoking so that complete cessation is achieved by week 12. Continue this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 2. Patients with renal impairment No dose adjustment is required in patients with mild (estimated creatinine clearance > 50 ml/min and ≤ 80 ml/min) to moderate (estimated creatinine clearance ≥ 30 ml/min and ≤ 50 ml/min) renal impairment. In patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended starting dose of varenicline is 0.5 mg once daily. If needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, a maximum dose of 0.5 mg once daily may be administered. 3. Older adults and patients with hepatic impairment No dose adjustment is required in patients with hepatic impairment. Because renal function is more likely to be reduced in older adults, use caution when selecting the dose; monitoring renal function may be useful.

Child dose

The safety and efficacy of this medicine have not been established in children; therefore, administration to patients under 18 years of age is not recommended.

This medication is used to help with smoking cessation. During the course of taking this medication, psychological changes such as depression, anxiety, or thoughts of suicide may occur, so careful monitoring of mental state is necessary. Those with a history of psychiatric disorders must inform their physician, and any abnormal symptoms should be discussed with a doctor immediately. Pregnant or breastfeeding women should use this medication cautiously and consult their physician if necessary. While on this medication, side effects such as nausea, headaches, insomnia, and abnormal dreams may frequently occur, so patients should be aware of this. Those with heart disease or new or worsening cardiovascular symptoms should inform healthcare professionals immediately. This drug has a relatively low interaction potential with other medications, but alcohol consumption may exacerbate side effects, so it is advisable to avoid it. Care should be taken when performing dangerous tasks like driving or operating machinery until the effects of this medication are understood. Children and adolescents under 18 years of age are not recommended to use this medication as its safety and effectiveness have not been established.

• Suicidal thoughts
• suicidal behavior
• suicide
• changes in behavior or thought
• depression
• mania
• mood changes
• psychopathy
• aggressive behavior
• hallucinations

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1°C and 30°C.

Appearance

White or grayish-white, flat, oval-shaped film-coated tablets, bilaterally convex

Package unit

11 tablets (11 tablets/Blister X 1)