Medication info

Champix 1 mg (Varenicline Salicylate)

Prescription medicationApproval withdrawn
Ingredient · strength
Varenicline Salicylate›Strength being verified
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
Light blue, double-convex, rectangular film-coated tablet
Packaging
28 tablets (14 tablets/PTPX2)
Approval status
Approval withdrawn

MFDS item code 201803325 · Approved 2018.08.14

This product's status changed to Approval withdrawn on 2023.03.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Smoking cessation aid
Who uses it
Adults · Children
Adult dosage
Usual dose for adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between days 8 and 35 after starting this medicine. Take this medicine after meals 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 until end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period with this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be administered 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, consider gradually stopping smoking while taking this medicine. Reduce the amount smoked by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by a further 50% within the next 4 weeks. Continue to reduce smoking so that complete abstinence can be achieved by week 12. Administer 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 smoking with 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 first 12 weeks of treatment or resumed 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 needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease undergoing hemodialysis, if well tolerated, a 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 decreased in elderly patients, caution should be exercised when selecting the dose, and monitoring renal function may be useful.
Children's dosage
Use is not recommended in patients under 18 years of age because the safety and efficacy of this medicine have not been established in children.

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Smoking cessation aid

View approved original text

This medicine is used as an adjunct therapy for smoking cessation. It helps individuals who want to quit smoking alleviate withdrawal symptoms and reduce the desire to smoke. Through this, it supports increased success rates for quitting smoking and maintaining a healthy lifestyle. It serves as an effective support measure for those determined to quit smoking.

Dosage and Administration

Adult dosage

Usual dose for adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between days 8 and 35 after starting this medicine. Take this medicine after meals 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 until end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period with this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be administered 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, consider gradually stopping smoking while taking this medicine. Reduce the amount smoked by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by a further 50% within the next 4 weeks. Continue to reduce smoking so that complete abstinence can be achieved by week 12. Administer 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 smoking with 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 first 12 weeks of treatment or resumed 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 needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease undergoing hemodialysis, if well tolerated, a 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 decreased in elderly patients, caution should be exercised when selecting the dose, and monitoring renal function may be useful.

Children's dosage

Use is not recommended in patients under 18 years of age because the safety and efficacy of this medicine have not been established in children.

Precautions

This medicine is used to assist with smoking cessation. During administration, serious mental health issues such as suicidal thoughts, suicidal behavior, depression, anxiety, hallucinations, and aggression may occur, so caution is necessary. Patients with a history of psychiatric disorders should be monitored particularly closely, and any symptoms that appear should be discussed with a physician immediately. Patients with hypersensitivity or allergies to this medication should not take it. If you are pregnant or breastfeeding, consult your doctor about the potential effects of this medication on the fetus or infant. Nausea, headache, insomnia, unusual dreams, dyspepsia, and various other side effects may occur during use, with nausea being particularly common. If these symptoms are severe or persistent, inform your physician. Caution should be exercised when performing tasks that require concentration, such as driving or operating machinery, as this medication may cause drowsiness or dizziness. This medication is excreted through the kidneys, so patients with decreased renal function or the elderly may require dosage adjustment. There is no specific antidote for overdose, and appropriate treatment should be received based on symptoms. This medication does not significantly interact with other drugs; however, alcohol consumption may exacerbate side effects, so it is advisable to avoid alcohol while taking this medication. During treatment, changes in mental state, feelings of depression, and suicidal thoughts may occur, so if these symptoms arise, the medication should be stopped immediately, and medical advice sought. Children and adolescents under 18 years of age are not recommended to use this medication as its safety and efficacy have not been established.

Side effects

  • Suicidal thoughts
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
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  • paranoia
  • delusions
  • homicidal ideation
  • 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 slackness
  • headache
  • drowsiness
  • dizziness
  • taste disturbances
  • tremors
  • daytime sleepiness
  • sensory loss
  • speech disorder
  • motor coordination disorders
  • taste disorder
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ECG ST segment depression
  • ECG T wave amplitude reduction
  • elevated blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • voice disorder
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper airway cough syndrome
  • rhinorrhea
  • 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 spasms
  • joint stiffness
  • frequent urination
  • nocturia
  • diabetes
  • polyuria
  • heavy menstrual bleeding
  • 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
  • heart palpitations
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • hearing loss
  • Meniere's disease
  • thyroid disorder
  • dry eyes
  • eye irritation
  • blurry vision
  • vision impairment
  • acquired night blindness
  • transient vision loss
  • subcapsular cataract
  • retinal vascular disorders
  • vitreous floaters
  • gingivitis
  • dysphagia
  • small intestine-colon inflammation
  • gastrointestinal bleeding
  • oral ulcer
  • esophagitis
  • peptic ulcer
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity
  • drug hypersensitivity
  • ECG abnormalities
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention disorders
  • sensory disorders
  • amnesia
  • migraine
  • olfactory disturbances
  • 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
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal thoughts
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • menstrual disorders
  • erectile dysfunction
  • nosebleeds
  • 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
  • headache
  • drowsiness
  • dizziness
  • mental fog
  • taste disturbances
  • syncope
  • fatigue
  • lethargy
  • asthenia
  • chest discomfort
  • chest pain
  • decreased appetite
  • anorexia
  • increased appetite
  • itching
  • rash
  • dyspnea
  • increased sputum
  • myalgia
  • gingival swelling
  • nipple pain
  • seizures
  • traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • sleep disorders
  • increased irritability
  • relief
  • sleep disorders
  • increased irritability
  • hypertonia
  • gastric ulcer
  • suicide attempt
  • suicidal act
  • vascular edema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • ischemia
  • hemorrhagic reaction
  • cerebrovascular event
  • myocardial infarction
  • unstable angina
  • insomnia
  • anxiety
  • abnormal thinking
  • neuropathy
  • syncope
  • pneumonia exacerbation
  • arterial stenosis
  • mental fog
  • excessive dreaming
  • increased sputum
  • malignant neoplasm exacerbation
  • discomfort
  • mental anguish
  • hair loss
  • memory disturbance
  • coldness
  • deterioration of condition
  • stimulation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure

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

Storage

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain the storage temperature between 1 degree to 30 degrees Celsius room temperature. Proper storage will help maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

Light blue, double-convex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTPX2)

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.

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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.