Medication info

Chantix 0.5 mg (Varenicline Salicylate)

Prescription medicationApproval withdrawn
Ingredient · strength
Varenicline Salicylate›Strength being verified
Manufacturer / importer
(Co., Ltd.) Daewoong Pharmaceutical
Appearance
White or grayish-white, double-sided convex film-coated tablet
Packaging
11 tablets (11 tablets/PTP X 1)
Approval status
Approval withdrawn

MFDS item code 201803323 · 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This product's status changed to Approval withdrawn on 2023.03.29.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
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. Administer this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 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
Patients under 18 years of age: Use is not recommended because the safety and efficacy of this medicine have not been established in children.

Ingredients

Manufacturer
(Co., Ltd.) Daewoong Pharmaceutical

Efficacy & effects

Smoking cessation aid

View approved original text

This medication is used as an adjunct therapy for smoking cessation. It helps reduce nicotine dependence that may occur during quitting smoking and alleviates withdrawal symptoms. It supports patients in successfully quitting smoking and has positive effects on maintaining cessation. It is recommended for those planning to quit smoking or who have started.

Dosage and Administration

Adult dosage

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. Administer this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 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

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

Precautions

This medication aids in quitting smoking and works on nicotine receptors in the brain to alleviate withdrawal symptoms that may arise during cessation. While taking this medication, significant mental health issues such as depression, anxiety, hallucinations, and suicidal thoughts or behaviors may occur. If such symptoms arise, discontinue use immediately and consult a doctor. Patients with hypersensitivity or allergy to this medication's components should not use it. Women who are pregnant or breastfeeding should use this medication cautiously and consult with a doctor regarding the potential effects on the fetus or baby. Common side effects that may occur while taking this medication include nausea, headache, insomnia, and abnormal dreams, which may persist for some patients. Be cautious when engaging in activities requiring attention, such as driving or operating machinery, as this medication may cause drowsiness or impair concentration. The risk of side effects may be higher in elderly patients with impaired kidney function, so dose adjustment and monitoring of kidney function are necessary. In case of overdose, there is no specific antidote, and appropriate treatment should be administered based on symptoms. Kidney dialysis may be beneficial. This medication has relatively few interactions with other drugs, but alcohol consumption may worsen side effects, so it is advisable to avoid it. While taking this medication and attempting to quit smoking, carefully monitor any physical or mental changes, and immediately consult medical personnel if abnormal symptoms appear.

Side effects

  • Suicidal thoughts
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • psychosis
  • aggressive behavior
  • hallucinations
  • paranoia
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  • 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 slowness
  • headache
  • drowsiness
  • dizziness
  • taste disturbances
  • tremors
  • hypersomnia
  • sensory loss
  • speech disorders
  • coordination disorders
  • taste hypesthesia
  • circadian rhythm sleep disorders
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ECG ST segment depression
  • ECG T wave amplitude reduction
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • voice disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper respiratory cough syndrome
  • runny nose
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distention
  • abdominal pain
  • toothache
  • dyspepsia
  • flatulence
  • dry mouth
  • 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
  • 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 fluttering
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • hearing loss
  • Ménière's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurriness
  • acquired night blindness
  • transient visual loss
  • cataract
  • vascular eye 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
  • ECG abnormalities
  • increased muscle enzymes
  • urinalysis abnormalities
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention disorders
  • sensory disorders
  • amnesia
  • migraine
  • dysosmia
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • seizures
  • facial nerve paralysis
  • mental disorders
  • multiple sclerosis
  • eye twitching
  • psychomotor dysfunction
  • transient ischemic attacks
  • 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
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reactions
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disorders
  • nightmares
  • excessive dreaming
  • hallucinations
  • sleep disorders
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • suicidal thoughts
  • hallucinations
  • headache
  • drowsiness
  • dizziness
  • brain fog
  • taste disturbances
  • syncope
  • fatigue
  • lethargy
  • asthenia
  • chest discomfort
  • chest pain
  • decreased appetite
  • anorexia
  • increased appetite
  • itching
  • rash
  • dyspnea
  • increased sputum
  • myalgia
  • gum swelling
  • nipple pain
  • seizures
  • traffic accidents
  • near traffic accidents
  • accidental injuries
  • relief
  • relief
  • nausea
  • vomiting
  • increased irritability
  • smoking urge
  • depression
  • insomnia
  • abnormal sensations
  • hostility
  • aggression
  • delusions
  • mania
  • panic
  • irritability
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • ischemic and hemorrhagic reactions
  • cerebrovascular events
  • myocardial infarction

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius. This helps maintain the medication's efficacy and safety over time.

Appearance and packaging

Appearance

White or grayish-white, double-sided convex film-coated tablet

Package unit

11 tablets (11 tablets/PTP X 1)

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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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.