Jungheon Varenicline Salicylate Tablet 0.5 mg

Adult dose

Patients should set a quit date and begin taking this medicine 1 week before that date. Alternatively, they may start trying to quit between day 8 and day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dosage of this medicine is as follows: after dose titration over 1 week, take 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 Patients who cannot tolerate the adverse reactions of this medicine may temporarily or permanently reduce the dose. The treatment period is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be continued for an additional 12 weeks to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Reduce smoking by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by an additional 50% over the next 4 weeks; continue to reduce smoking so that complete cessation is achieved by 12 weeks. Continue this medicine for an additional 12 weeks, for a total treatment period of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. Patients who fail to quit smoking after the first 12 weeks of treatment, or who resume smoking after treatment, should review the reasons for failure and try again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who failed to quit during the initial 12 weeks or resumed smoking after treatment. No dose adjustment is necessary 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. No dose adjustment is necessary in patients with hepatic impairment. In elderly patients, renal function is more likely to be reduced, so care should be taken when selecting the dose; monitoring renal function may be useful.

Child dose

Patients under 18 years of age: Administration is not recommended because the safety and efficacy of this medicine in children have not been established.

This medication is used to assist smoking cessation and may pose the risk of neuropsychiatric symptoms, including suicidal tendencies, during its use. Care should be taken. Should symptoms like depression, anxiety, hallucinations, or aggressive behavior occur while on this medication, discontinue use immediately and consult a physician. If there is a history of psychiatric disorders, inform the doctor beforehand and closely monitor mental status before and during treatment. This medication should not be administered to patients with allergic reactions or hypersensitivity. Pregnant and nursing women should use this medication with caution and consult a physician considering its effects on the fetus or infant. Common side effects during use may include nausea, headache, insomnia, and abnormal dreams, most of which are mild to moderate. Caution is advised while driving or operating machinery due to the potential for drowsiness or impaired concentration. Patients with cardiovascular diseases may experience cardiac-related abnormal symptoms while using this medication, and should notify their doctor immediately in such cases. Although drug interactions are relatively few, combining with alcohol may increase side effects, so alcohol consumption should be avoided or minimized. Elderly patients or those with decreased kidney function may require dosage adjustments and should consult a physician prior to use. There have been no specific cases of overdose, but if unusual symptoms occur, seek medical attention immediately. This medication should be stored out of the reach of children and kept in its original container to maintain quality and safety.

• Suicidal ideation
• suicidal behavior
• suicide
• changes in behavior or thoughts
• depression
• mania
• mood swings
• psychosis
• aggressive behavior
• hallucinations

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperature between 1°C and 30°C. Proper storage will help preserve the efficacy and safety of the medication.

Appearance

White or grayish white, double convex, rectangular film-coated tablet

Package unit

11 tablets (11 tablets/BlisterX1)