Medication info
Gunfix Tablet 1 mg (Varenicline Salicylate)

Gunfix Tablet 1 mg (Varenicline Salicylate)

Prescription medicationTabletOral
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
Daewoong Bio Co., Ltd.
Appearance
Light blue, biconvex, rectangular film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201803354 · Approved 2018.08.16

Summary

Main use
Smoking cessation adjunctive therapy
Who takes it
Adults · Children
Adult dose
1. Usual dose in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may quit smoking between days 8 and 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dose is 1 mg twice daily after titration over 1 week, as follows: Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8 until the end of treatment 1 mg twice daily For patients unable to 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 during 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 unable or unwilling to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Patients should reduce the amount they smoke by 50% from baseline within the first 4 weeks after starting treatment, reduce it by a further 50% within the next 4 weeks, and continue reducing smoking so that they can achieve complete abstinence 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 used. 3. Elderly patients 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 elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.
Child dose
Under 18 years of age: The safety and efficacy of this medicine have not been established in children; therefore, use in patients under 18 years of age is not recommended.

Ingredients

Manufacturer
Daewoong Bio Co., Ltd.

Efficacy & effects

Smoking cessation adjunctive therapy

View approved original text

This medication is used as an assistive therapy for smoking cessation. It helps individuals attempting to quit smoking by alleviating withdrawal symptoms and reducing nicotine cravings. This contributes to a higher success rate in quitting smoking and improving health in the long term. As it plays an effective supportive role in the smoking cessation process, it is recommended for those who are determined to quit smoking.

How to take

Adult dose

1. Usual dose in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may quit smoking between days 8 and 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dose is 1 mg twice daily after titration over 1 week, as follows: Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8 until the end of treatment 1 mg twice daily For patients unable to 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 during 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 unable or unwilling to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Patients should reduce the amount they smoke by 50% from baseline within the first 4 weeks after starting treatment, reduce it by a further 50% within the next 4 weeks, and continue reducing smoking so that they can achieve complete abstinence 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 used. 3. Elderly patients 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 elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.

Child dose

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

Precautions

This medication is used to aid smoking cessation. During use, neuropsychiatric symptoms such as depression, anxiety, and suicidal thoughts may occur, so caution is needed. Patients with a history of psychiatric disorders or worsening symptoms should consult their physician. Patients with allergic reactions or hypersensitivity to this medication should not use it. In cases of pregnancy or breastfeeding, the use of this medication should be carefully considered in light of its effects on the fetus or infant. Safety and efficacy in pediatric patients have not been established, so it is not recommended for patients under 18 years of age. Elderly patients may require dose adjustments based on renal function and should follow the physician's instructions. Common side effects during the use of this medication may include nausea, headache, insomnia, and abnormal dreams. Patients with cardiovascular diseases may experience worsening heart symptoms and should immediately inform their physician if symptoms arise. Caution should be exercised as drowsiness or dizziness may occur when driving or operating machinery. Alcohol consumption may exacerbate the side effects of this medication, so it is advisable to avoid or minimize intake. If suicidal thoughts or behavior, mood changes, or abnormal behaviors are observed during treatment with this medication, it should be discontinued immediately and healthcare professionals should be consulted. If major allergic reactions such as angioedema or severe skin rashes occur, medication should be stopped immediately and emergency treatment sought. In cases of overdose, immediate medical attention should be obtained. This medication should be stored out of reach of children, and it is safe to keep it in its original container.

Side effects

Suicidal thoughts, suicidal behavior, suicide, changes in behavior or thoughts, depression, mania, mood changes, psychosis, aggressive behavior, hallucinations, paranoia, delusions, homicidal thoughts, hostility, agitation, anxiety, panic state, discomfort, depressed 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 lethargy, headache, drowsiness, dizziness, taste disturbance, tremor, hypersomnia, sensory impairment, speech disorder, motor coordination disorder, taste loss, circadian rhythm sleep disorder, conjunctivitis, eye pain, scotoma, photophobia, tinnitus, angina, tachycardia, palpitations, increased heart rate, atrial fibrillation, decreased ST segment on electrocardiogram, decreased amplitude of electrocardiogram, increased blood pressure, facial flushing, upper respiratory disorders, dyspnea, cough, upper respiratory tract inflammation, airway congestion, vocal cord disorders, allergic rhinitis, throat irritation, sinus congestion, upper airway cough syndrome, runny nose, snoring, nausea, gastroesophageal reflux disease, vomiting, constipation, diarrhea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth, passage of blood in stool, gastritis, belching, aphthous stomatitis, gum pain, hematemesis, rash, itching, erythema, acne, hyperhidrosis, arthralgia, myalgia, back pain, muscle spasm, joint stiffness, frequent urination, nocturia, diabetes, polyuria, menorrhagia, sexual dysfunction, chest pain, fatigue, chest discomfort, influenza-like illness, fever, asthenia, lethargy, abnormal liver function tests, anemia, lymphadenopathy, leukocytosis, thrombocytopenia, splenomegaly, arrhythmia, bradycardia, ventricular extrasystole, myocardial infarction, cardiac arrest, coronary artery disease, cor pulmonale, acute coronary syndrome, dizziness, hearing impairment, Meniere's disease, thyroid disorders, dry eye, eye irritation, blurred vision, visual disturbances, acquired night blindness, transient visual loss, cataract, ocular vascular disorders, vitreous floaters, gingivitis, dysphagia, small bowel colitis, 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, abnormal urinalysis, diabetes mellitus, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory impairments, amnesia, migraine, abnormal sense of smell, 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 loss, anxiety, depression, emotional disturbances, irritability, aggressiveness, agitation, disorientation, dissociation, euphoria, hallucinations, suicidal thoughts, nephrolithiasis, abnormal urine, urethral syndrome, acute kidney failure, urinary retention, erectile dysfunction, nasal bleeding, respiratory diseases, asthma, pleuritis, pulmonary embolism, dermatitis, skin dryness, eczema, psoriasis, urticaria, phototoxic reactions, hypotension, peripheral ischemia, thrombosis, insomnia, abnormal dreams, sleep disorders, nightmares, excessive dreaming, anxiety, abnormal thoughts, suicidal thoughts, hallucinations, headache, drowsiness, dizziness, mental cloudiness, taste disturbances, syncope, fatigue, lethargy, asthenia, chest discomfort, chest pain, decreased appetite, anorexia, increased appetite, itching, dyspnea, increased sputum, myalgia, gum swelling, nipple pain, seizures, traffic accidents, near traffic accidents, drowsiness, dizziness, loss of consciousness, decreased concentration, mild relief, mild relief, sleep disorders, increased irritability, mild relief, unpleasant feelings, mental distress, hair loss, increased sputum, memory disturbances, coldness, worsening condition, stimulation, burning sensation, decreased blood pressure, increased blood pressure

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Light blue, biconvex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTP X 2)

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.

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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.