Nicotin 1 mg Tablet (Varenicline Oxybate)

Adult dose

Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may begin trying to quit smoking between day 8 and day 35 after starting this medication. Take this medication after meals with plenty of water. The recommended dosage is as follows: after dose titration over 1 week, take 1 mg twice daily. 1 – 3 days 0.5 mg once daily 4 – 7 days 0.5 mg twice daily Day 8 – end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions to this medication, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medication 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 medication. Reduce smoking by 50% from the level before starting treatment within the first 4 weeks after starting this medication, and by an additional 50% within the next 4 weeks. Continue to reduce smoking so that complete abstinence is achieved by week 12. Continue this medication 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 initial 12 weeks of treatment or 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 fail to quit smoking during the initial 12 weeks of treatment or resume 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 this medication is 0.5 mg once daily. If needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease undergoing hemodialysis, the maximum dose may be 0.5 mg once daily if well tolerated. No dose adjustment is necessary in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, use caution when selecting the dose; monitoring renal function may be useful.

Child dose

The efficacy of this medication in children has not been established; therefore, its use is not recommended (see section “8. Use in Children” under Precautions for Use).

This medication is used to assist in quitting smoking. Caution is necessary as neuropsychiatric symptoms such as depression, anxiety, agitation, aggression, hallucinations, delusions, etc. may occur during usage. It is important to inform the doctor of any personal or family history of psychiatric disorders before taking this medication, and to monitor changes in mental state during treatment. If there are thoughts of suicide or changes in mood or behavior, discontinue use immediately and consult a physician. During pregnancy or breastfeeding, it is generally advisable not to use this medication; however, use may be warranted in special cases at the discretion of a physician. This medication is commonly associated with side effects such as nausea, headache, insomnia, abnormal dreams, gastrointestinal disturbances, etc. Serious allergic reactions such as angioedema or severe skin reactions may occur infrequently; if such symptoms appear, inform a physician immediately. Patients with cardiovascular disease may experience worsened heart-related symptoms while taking this medication, so caution is needed. Drowsiness or decreased concentration may occur during driving or operating machinery, thus requiring caution. Alcohol consumption during use may worsen symptoms, so it should be avoided if possible. The likelihood of drug interactions is low; however, if other medications are being taken, consult with a physician or pharmacist. In case of overdose, contact a medical institution immediately for appropriate treatment. This medication is not recommended for children or teenagers, and dosage adjustments may be necessary for the elderly considering kidney function. This medication must be taken strictly according to the physician's prescription and instructions; consult a professional immediately if any unusual symptoms occur.

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering and kept at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness over time.

Appearance

Light blue, oblong film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2]