Nicotin Tablet 0.5 mg (Varenicline Ditartrate)

Adult dose

Usual dosage for adults 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. 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 drug in children has not been established; therefore, its use is not recommended.

This medication is used to assist in smoking cessation, and significant neuropsychiatric symptoms may occur during treatment, requiring caution. For example, symptoms such as depression, suicidal thoughts, anxiety, hallucinations, and aggression may appear, so if these symptoms occur, the medication should be discontinued immediately and a physician consulted. Additionally, this medication should not be administered to patients with hypersensitivity, and women who are pregnant or nursing should use it cautiously. During the initial phase of treatment, nausea, headache, insomnia, and abnormal dreams may commonly occur, and in some patients, these symptoms may persist for a long time. This medication may require dose adjustments in elderly patients with reduced kidney function, and patients with a history of seizures should carefully evaluate risks prior to administration. Caution is advised when performing activities requiring vigilance, as drowsiness or dizziness may occur following dosing. Physiological changes due to smoking cessation can alter the effects of other medications, hence it is advisable to consult a doctor or pharmacist when taking other medications. Alcohol consumption may interact with this drug, potentially causing unusual behavior, so it is advisable to avoid or minimize alcohol intake during treatment. Any history of psychiatric disorders or symptoms of depression during the medication should be reported to a physician, and the condition should be closely monitored. If severe hypersensitivity reactions such as angioedema or severe skin rashes occur, the medication should be discontinued immediately, and emergency medical treatment should be sought. Patients with cardiovascular diseases should consider the benefits and risks of potential heart-related issues due to this medication. Should adverse reactions occur, consulting a physician to determine dose adjustments or discontinuation of treatment is important. This medication is not recommended for children, and dosage adjustments may be required for elderly patients based on their kidney function. In cases of overdose, standard treatment should be enacted, and since there is no specific antidote, immediate medical consultation is necessary. Finally, this medication should be stored out of reach of children and in its original container to maintain quality.

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

This medication may be sensitive to air and moisture, therefore it should be stored in a sealed container. The recommended storage temperature is room temperature, between 1 and 30 degrees Celsius. This helps to maintain the medication's effectiveness.

Appearance

White oblong film-coated tablet

Package unit

11 tablets/box [11 tablets/PTP x 1]