Medication info
Smokelin Tablet 1mg (Varenicline Salicylate)

Smokelin Tablet 1mg (Varenicline Salicylate)

Prescription medicationTabletOral
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
Allico Pharmaceutical Co., Ltd.
Appearance
Light blue, biconvex, rectangular film-coated tablet
Packaging
28 tablets (14 tablets/Alu-AluX2)
Approval status
Active

MFDS item code 201803880 · Approved 2018.10.01

Summary

Main use
Adjunctive treatment for smoking cessation
Who takes it
Adults · Children
Adult dose
Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. Take this medicine after a meal with plenty of water. The recommended dose of this medicine 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 The dose may be reduced temporarily or permanently in patients who cannot tolerate adverse reactions to this medicine. 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 gradual cessation while taking this medicine. Reduce smoking by 50% compared with the amount smoked before treatment 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 week 12. 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 after the first 12 weeks of treatment or resume smoking after treatment should review the reasons for failure before trying again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit during the first 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 varenicline is 0.5 mg once daily. If necessary, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, the maximum dose of 0.5 mg once daily may be administered. No dose adjustment is necessary in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.
Child dose
The safety and efficacy of this medicine in children have not been established; therefore, use in patients younger than 18 years is not recommended.

Ingredients

Manufacturer
Allico Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

This medication is used as an adjunct therapy for smoking cessation. It supports patients who wish to quit smoking in increasing their success rates. It helps alleviate physical withdrawal symptoms and strengthens the will to quit smoking. Therefore, it can be effectively recommended for those who wish to quit smoking.

How to take

Adult dose

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. Take this medicine after a meal with plenty of water. The recommended dose of this medicine 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 The dose may be reduced temporarily or permanently in patients who cannot tolerate adverse reactions to this medicine. 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 gradual cessation while taking this medicine. Reduce smoking by 50% compared with the amount smoked before treatment 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 week 12. 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 after the first 12 weeks of treatment or resume smoking after treatment should review the reasons for failure before trying again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit during the first 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 varenicline is 0.5 mg once daily. If necessary, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, the maximum dose of 0.5 mg once daily may be administered. No dose adjustment is necessary in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.

Child dose

The safety and efficacy of this medicine in children have not been established; therefore, use in patients younger than 18 years is not recommended.

Precautions

This medication is used to assist with quitting smoking. During treatment, it may affect mental health, so if symptoms such as depression, anxiety, suicidal thoughts, or behaviors occur, immediate consultation with a doctor is required. Careful observation is warranted for individuals with a history of psychiatric disorders, and symptoms may worsen, so consultation with a doctor is advisable. Patients who have allergic reactions or hypersensitivity to any component of this drug should not take it. Women who are pregnant or breastfeeding must consult a doctor before using this medication and carefully consider its potential effects on the fetus or infant. Side effects such as nausea, headache, insomnia, abnormal dreams, anxiety, and depression may occur while taking this medication. Nausea is particularly common, and if symptoms are severe, dosage adjustments may be necessary. Caution should be exercised when engaging in activities requiring alertness, such as driving or operating machinery, as drowsiness or decreased concentration may occur. Patients with cardiovascular diseases may experience worsening symptoms after taking this medication and should receive regular medical attention. This medication is excreted through the kidneys; thus, dosage adjustments may be needed for patients with decreased kidney function. In cases of overdose, contact a medical institution immediately for appropriate treatment. Keep out of reach of children and store in the original container to prevent misuse and degradation of quality. There is a low potential for drug interactions, but it is advisable to avoid or minimize alcohol consumption. Always inform the physician of any psychiatric history and current health status before taking this medication, and if any unusual symptoms arise during treatment, consult medical staff immediately.

Side effects

suicidal thoughts, suicidal behavior, suicide, changes in behavior or thoughts, depression, mania, mood changes, psychosis, aggressive behavior, hallucinations, paranoia, delusions, thoughts of murder, hostility, agitation, anxiety, panic state, discomfort, depressive mood, insomnia, irritability, frustration, anger, difficulty concentrating, restlessness, decreased heart rate, increased appetite, weight gain, decreased platelet count, weight gain, decreased appetite, increased appetite, abnormal dreams, insomnia, abnormal thoughts, restlessness, mood changes, decreased libido, discomfort, mental gloss, headache, drowsiness, dizziness, altered taste, tremors, somnolence, sensory impairment, speech disorder, movement coordination disorder, taste hypesthesia, circadian rhythm sleep disorder, conjunctivitis, eye pain, scotoma, glare, tinnitus, angina, tachycardia, palpitations, increased heart rate, atrial fibrillation, decreased electrocardiogram segment height, reduced electrocardiogram amplitude, increased blood pressure, facial flushing, upper respiratory tract disorders, dyspnea, cough, upper respiratory tract inflammation, airway congestion, voice dysfunction, allergic rhinitis, throat irritation, sinus congestion, upper respiratory cough syndrome, runny nose, snoring, nausea, gastroesophageal reflux disease, vomiting, constipation, diarrhea, abdominal distension, abdominal pain, toothache, dyspepsia, bloating, dry mouth, passage of blood in stool, gastritis, belching, aphthous stomatitis, gum pain, hematemesis, rash, itching, erythema, acne, hyperhidrosis, arthralgia, myalgia, back pain, muscle spasms, joint stiffness, frequent urination, nocturia, diabetes, polyuria, heavy menstrual bleeding, sexual dysfunction, chest pain, fatigue, chest discomfort, influenza-like illness, fever, weakness, lethargy, abnormal liver function tests, anemia, lymphadenopathy, leukocytosis, splenomegaly, arrhythmia, bradycardia, premature ventricular contractions, myocardial infarction, cardiac arrhythmia, coronary artery disease, cor pulmonale, acute coronary syndrome, dizziness, hearing loss, Ménière's disease, thyroid disease, dry eyes, eye irritation, blurred vision, visual impairment, acquired night blindness, transient visual loss, cataracts, ocular vascular disease, vitreous floaters, gingivitis, dysphagia, enterocolitis, gastrointestinal bleeding, oral ulcers, esophagitis, peptic ulcer, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disease, hypersensitivity reactions, drug hypersensitivity, electrocardiogram abnormalities, increased muscle enzymes, urine test abnormalities, diabetes mellitus, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory disorders, amnesia, migraine, abnormal olfaction, psychomotor agitation, restless legs syndrome, syncope, balance disorders, cerebrovascular events, convulsions, facial nerve paralysis, mental disorders, multiple sclerosis, eye twitching, psychomotor dysfunction, transient ischemic attack, visual field defects, anxiety, depression, emotional disorders, irritability, aggressiveness, restlessness, disorientation, dissociation, euphoria, hallucinations, suicidal thoughts, nephrolithiasis, abnormal urine, urethral syndrome, acute renal failure, urinary retention, menstrual disorders, erectile dysfunction, epistaxis, respiratory diseases, asthma, pleuritis, pulmonary embolism, dermatitis, dry skin, eczema, psoriasis, urticaria, photosensitivity reactions, hypotension, peripheral ischemia, thrombosis, insomnia, sleep disorders, nightmares, excessive dreaming, sleep disorders, nightmares, excessive dreaming, sleep disorders, nightmares, excessive dreaming, insomnia, anxiety, abnormal thinking, hallucinations, suicidal thoughts, headache, drowsiness, dizziness, mental fog, altered taste, syncope, fatigue, lethargy, weakness, chest discomfort, chest pain, decreased appetite, anorexia, itching, rash, dyspnea, increased sputum, myalgia, gum swelling, nipple pain, seizures, traffic accidents, drowsiness, dizziness, loss of consciousness, decreased concentration, relief, sleep disorders, increased irritability, relief, nausea, vomiting, irritability, smoking urges, depression, insomnia, vascular edema, vascular edema, Stevens-Johnson syndrome, erythema multiforme, ischemic and hemorrhagic cerebrovascular events, myocardial infarction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius (room temperature). This way, the efficacy of the medication can be safely maintained.

Appearance and packaging

Appearance

Light blue, biconvex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/Alu-AluX2)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.