Medication info

Jungheon Varenicline Salicylate Tablet 1 Milligram

Prescription medicationTabletOralExpired
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
Jungheon Pharmaceutical Co., Ltd.
Appearance
Pale blue, biconvex, rectangular film-coated tablet
Packaging
28 tablets (14 tablets/BlisterX2)
Approval status
Expired

MFDS item code 201906255 · Approved 2019.09.03

This product's status changed to Expired on 2024.09.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment for smoking cessation
Who takes it
Adults · Children
Adult dose
1. Usual dosage in adults 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. 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. 2. Patients with renal impairment 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. 3. Elderly patients and patients with hepatic impairment 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
Administration is not recommended in patients under 18 years of age.

Ingredients

Manufacturer
Jungheon Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

Adjunct therapy for smoking cessation is used to assist patients who wish to quit smoking. It mainly includes nicotine replacement therapy or non-pharmacological support. This therapy is effective in alleviating withdrawal symptoms and reducing craving for tobacco. Additionally, it plays a vital role in increasing the success rate of quitting smoking. Patients can maintain healthier lifestyle habits through this adjunct therapy. Therefore, it is used as an adjunct therapy for smoking cessation.

How to take

Adult dose

1. Usual dosage in adults 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. 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. 2. Patients with renal impairment 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. 3. Elderly patients and patients with hepatic impairment 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

Administration is not recommended in patients under 18 years of age.

Precautions

This medication is a drug that helps with smoking cessation and may affect mental health during use, so caution is needed. Serious psychiatric symptoms such as depression, anxiety, aggression, hallucinations, and suicidal thoughts may occur during treatment with this drug. Therefore, patients with a history of psychiatric disorders must consult with a physician, and if symptoms occur, they should stop taking the medication immediately and consult healthcare professionals. In cases of pregnancy or breastfeeding, careful consideration should be given to the potential effects of this medication on the fetus or infant. Common side effects such as nausea, headaches, insomnia, and abnormal dreams may occur early in treatment, but they are mostly mild and improve over time. Patients with cardiovascular disease should follow their physician's instructions as heart-related symptoms may worsen with this medication. Caution is also required when engaging in hazardous activities such as driving or operating machinery, as this medication may cause drowsiness or decreased concentration. Additionally, taking this medication with alcohol may exacerbate side effects, so it is advisable to avoid alcohol consumption as much as possible. Its safety and efficacy have not been established for children and adolescents under 18 years of age, hence its use is not recommended. Elderly patients may require dose adjustments due to decreased renal function, and regular monitoring of renal function is necessary. In case of overdose, there is no specific antidote, thus appropriate treatment should be administered according to symptoms, and the medication should be kept out of reach of children.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
Show 253 more
  • paranoia
  • delusions
  • homicidal thoughts
  • hostility
  • restlessness
  • 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 relaxation
  • headache
  • drowsiness
  • dizziness
  • taste abnormalities
  • tremors
  • hypersomnia
  • sensory impairment
  • speech disorder
  • motor coordination disorder
  • taste loss
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ST segment depression
  • decreased amplitude of electrocardiogram
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorder
  • dyspnea
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • vocal cord disorder
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper respiratory cough syndrome
  • rhinorrhea
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distention
  • 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 cramps
  • joint stiffness
  • increased urination
  • nocturia
  • diabetes
  • polyuria
  • heavy menstruation
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • weakness
  • malaise
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • splenomegaly
  • arrhythmia
  • bradycardia
  • premature ventricular contractions
  • myocardial infarction
  • heart fluttering
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • dizziness
  • hearing impairment
  • Meniere's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurred vision
  • vision impairment
  • acquired night blindness
  • transient visual loss
  • subcapsular cataract
  • ocular vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcer
  • esophagitis
  • peptic ulcer
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reaction
  • drug hypersensitivity
  • abnormal electrocardiogram
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disorder
  • amnesia
  • migraine
  • olfactory disturbance
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorder
  • cerebrovascular event
  • convulsions
  • facial nerve paralysis
  • mental disorder
  • multiple sclerosis
  • eye twitching
  • psychomotor dysfunction
  • transient ischemic attack
  • visual field defect
  • anxiety
  • depression
  • emotional disorder
  • irritability
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal ideation
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • menstrual disorder
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reaction
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disorder
  • nightmares
  • excessive dreaming
  • sleep disorder
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • hallucinations
  • suicidal ideation
  • hallucinations
  • mental disorder
  • suicidal ideation
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • seizures
  • traffic accidents
  • near traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • sense of relief
  • sleep disorder
  • increased irritability
  • lack of effectiveness
  • feeling foggy
  • unpleasant feeling
  • mental pain
  • hair loss
  • increased sputum
  • memory abnormalities
  • feeling cold
  • worsening condition
  • irritation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure
  • excessive muscle tension
  • gastric ulcer

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pale blue, biconvex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/BlisterX2)

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.