Medication info
Zerocotin 1mg (Varenicline Salicylate)

Zerocotin 1mg (Varenicline Salicylate)

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

MFDS item code 201803335 · Approved 2018.08.14

Summary

Main use
Smoking cessation aid
Who takes it
Adults · Children
Adult dose
1. Usual dose in adults Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may start quitting between days 8 and 35 after starting this medication. This medication should be taken after meals with plenty of water. The recommended dosage 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 until the end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions to this medication, the dose may be reduced temporarily or on an ongoing basis. The treatment period is 12 weeks. For patients who successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medication is recommended 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 medication should be considered. Smoking should be reduced by 50% from the level before treatment within the first 4 weeks after starting this medication, and by an additional 50% within the following 4 weeks. Smoking should continue to be reduced so that complete cessation is achieved by week 12. Continue this medication for an additional 12 weeks, for a total treatment period of 24 weeks. Patients who fail to quit smoking after the initial 12 weeks of treatment or 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 fail to quit during the initial 12 weeks of treatment or resume 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. 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
Patients under 18 years of age: Use is not recommended because the safety and efficacy of this medication have not been established in children.

Ingredients

Manufacturer
Vivozon Pharmaceutical Co., Ltd.

Efficacy & effects

Smoking cessation aid

View approved original text

Supportive therapies for smoking cessation include nicotine replacement therapy, pharmacotherapy, and behavioral therapy. These methods help alleviate withdrawal symptoms and reduce cravings during the quitting process. Patients can increase their chances of quitting successfully through these supportive therapies. It is essential to consult with a healthcare professional to select the appropriate supportive therapy. These treatments effectively support cessation and contribute to health improvement.

How to take

Adult dose

1. Usual dose in adults Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may start quitting between days 8 and 35 after starting this medication. This medication should be taken after meals with plenty of water. The recommended dosage 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 until the end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions to this medication, the dose may be reduced temporarily or on an ongoing basis. The treatment period is 12 weeks. For patients who successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medication is recommended 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 medication should be considered. Smoking should be reduced by 50% from the level before treatment within the first 4 weeks after starting this medication, and by an additional 50% within the following 4 weeks. Smoking should continue to be reduced so that complete cessation is achieved by week 12. Continue this medication for an additional 12 weeks, for a total treatment period of 24 weeks. Patients who fail to quit smoking after the initial 12 weeks of treatment or 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 fail to quit during the initial 12 weeks of treatment or resume 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. 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

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

Precautions

This medication is used to aid smoking cessation, and caution is needed regarding neuropsychiatric symptoms and suicidal tendencies. Symptoms affecting mental health, such as depression, anxiety, restlessness, aggressive behavior, hallucinations, and delusions may arise during treatment; if such symptoms occur, discontinue use immediately and consult a physician. This medication should not be administered to patients with hypersensitivity, and pregnant or breastfeeding women should use it cautiously. Common side effects during use include nausea, headache, insomnia, and unusual dreams, most of which are mild to moderate. Caution is needed when engaging in hazardous activities like driving or operating machinery, as drowsiness or dizziness may occur. Patients with cardiovascular disease should consult their physician thoroughly, as the use of this medication may worsen heart-related symptoms. Drug interactions are relatively low; however, abnormal and aggressive behavior has been reported with alcohol consumption, so it is advisable to avoid or limit alcohol intake. This medication is eliminated through the kidneys; therefore, dosage adjustment may be necessary for patients with impaired kidney function or the elderly. Overdose should be managed with standard treatment, and it is not recommended for children. Store this medication out of reach of children and keep it in its original container to prevent quality degradation.

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
  • murderous 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 lethargy
  • headache
  • drowsiness
  • dizziness
  • taste disturbance
  • trembling
  • hypersomnia
  • sensory impairment
  • dysarthria
  • motor coordination disorder
  • hypogeusia
  • 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
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorder
  • difficulty breathing
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • vocal cord disorder
  • 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
  • indigestion
  • bloating
  • dry mouth
  • blood in stool
  • gastritis
  • belching
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • sweating
  • arthralgia
  • myalgia
  • back pain
  • muscle cramps
  • joint stiffness
  • frequent urination
  • nocturia
  • diabetes
  • polyuria
  • menorrhagia
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • asthenia
  • malaise
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • thrombocytopenia
  • splenomegaly
  • arrhythmia
  • bradycardia
  • PVCs
  • myocardial infarction
  • cardiac arrhythmia
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Ménière's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurriness
  • vision impairment
  • acquired night blindness
  • transient visual loss
  • cataract
  • ocular vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • small intestine colitis
  • gastrointestinal bleeding
  • oral ulcer
  • esophagitis
  • peptic ulcer
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reaction
  • drug hypersensitivity reaction
  • abnormal ECG
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle spasms
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disturbances
  • 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
  • hyperirritability
  • 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 reaction
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disorders
  • nightmares
  • excessive dreaming
  • sleep disorders
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • suicidal thoughts
  • hallucinations
  • headache
  • drowsiness
  • dizziness
  • brain fog
  • taste disturbance
  • syncope
  • fatigue
  • malaise
  • asthenia
  • chest discomfort
  • chest pain
  • decreased appetite
  • poor appetite
  • increased appetite
  • itching
  • vascular edema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • vascular edema
  • facial
  • oral
  • neck
  • limb edema due to vascular edema
  • difficulty breathing
  • seizures
  • relief
  • sleep disorders
  • increased irritability
  • traffic accident
  • near traffic accident
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • unpleasant feelings
  • mental anguish
  • hair loss
  • memory disturbances
  • coldness
  • worsening condition
  • irritation
  • 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 sealed container to prevent exposure to air or moisture, keeping the storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage helps maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Light blue, bilaterally convex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTP × 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.

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.