Medication info

Bicotin Tablets 1 mg (Varenicline Salicylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
Ahn-Guk Pharmaceutical Co., Ltd.
Appearance
Light blue, biconvex, rectangular film-coated tablet
Packaging
28 tablets (14 tablets/Blister X 2)
Approval status
Expired

MFDS item code 201804167 · Approved 2018.10.23

This product's status changed to Expired on 2023.10.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Aids to smoking cessation
Who takes it
Adults · Children
Adult dose
Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dose 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 For patients who cannot 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 with the initial 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 who cannot or do not wish to stop smoking abruptly, consider gradually stopping smoking while taking this medicine. Within the first 4 weeks after starting this medicine, patients should reduce their smoking by 50% compared with before starting treatment, and reduce it by an additional 50% over the next 4 weeks. Continue to reduce smoking so that complete abstinence is achieved by 12 weeks. Continue treatment with 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. In elderly patients, renal function may be more likely to be reduced, so use caution 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
Ahn-Guk Pharmaceutical Co., Ltd.

Efficacy & effects

Aids to smoking cessation

View approved original text

This medication is used as an adjunct therapy to assist in smoking cessation. It helps individuals who wish to quit smoking to relieve withdrawal symptoms and reduce cravings, thereby contributing to a higher success rate in quitting smoking and improving health.

How to take

Adult dose

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dose 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 For patients who cannot 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 with the initial 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 who cannot or do not wish to stop smoking abruptly, consider gradually stopping smoking while taking this medicine. Within the first 4 weeks after starting this medicine, patients should reduce their smoking by 50% compared with before starting treatment, and reduce it by an additional 50% over the next 4 weeks. Continue to reduce smoking so that complete abstinence is achieved by 12 weeks. Continue treatment with 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. In elderly patients, renal function may be more likely to be reduced, so use caution 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 used to assist in smoking cessation. During treatment with this medication, special attention should be given to mental health. Serious psychiatric symptoms such as depression, anxiety, agitation, aggression, hallucinations, and suicidal thoughts may occur in some patients. If such symptoms occur, the medication should be discontinued immediately and a physician should be consulted. This medication should not be given to patients with hypersensitivity, and women who are pregnant or breastfeeding should use it cautiously. The most common side effect during the initial dose is nausea, which usually improves from mild to moderate over time. However, some patients may experience prolonged nausea. Symptoms of discomfort, insomnia, anxiety, and concentration difficulties may also be experienced while quitting smoking, and this medication and the quitting process may both affect mental health, so caution is needed. Caution is required when performing hazardous activities such as driving or operating machinery due to the risk of accidents caused by drowsiness or dizziness. This medication has been associated with some cardiovascular abnormalities in patients with cardiovascular diseases; therefore, those with heart conditions or new symptoms should inform their physician immediately. There is little potential for interaction with other medications, but alcohol consumption may enhance effects or result in unusual behavior; thus, alcohol should be avoided or minimized. The risks to the fetus during pregnancy have not been fully established; hence, it should only be used when absolutely necessary and with physician consultation. While breastfeeding, this medication could be passed into breast milk; thus, a discussion with a physician should determine whether to continue breastfeeding or discontinue the medication. Use in patients under 18 is not recommended. Elderly patients may have decreased kidney function, requiring dosage adjustments and regular monitoring of kidney function. In the case of overdose, no specific antidote is available, and appropriate treatment should be conducted based on symptoms; dialysis may be helpful in severe kidney disease. This medication should be stored out of reach of children and kept in its original container to prevent deterioration or misuse.

Side effects

  • Suicidal ideation
  • 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
  • concentration difficulties
  • restlessness
  • decrease in heart rate
  • increased appetite
  • weight gain
  • nausea
  • headache
  • abnormal dreams
  • abnormal thoughts
  • mental exhaustion
  • drowsiness
  • dizziness
  • taste distortion
  • tremors
  • hypersomnia
  • sensory impairment
  • speech disorders
  • motor coordination disorders
  • taste deficiency syndrome
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • blind spots
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • electrocardiogram segment depression
  • decreased electrocardiogram amplitude
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • shortness of breath
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • voice disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper respiratory cough syndrome
  • runny nose
  • snoring
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • indigestion
  • bloating
  • dry mouth
  • passage of bloody stools
  • gastritis
  • belching
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • hyperhidrosis
  • 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
  • lethargy
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • thrombocytopenia
  • splenomegaly
  • arrhythmia
  • bradycardia
  • premature ventricular contractions
  • myocardial infarction
  • cardiac flutter
  • coronary artery disease
  • cor pulmonale
  • acute coronary syndrome
  • hearing loss
  • Meniere's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurriness
  • 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 reactions
  • drug hypersensitivity
  • electrocardiogram abnormalities
  • muscle enzyme elevation
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • myositis
  • attention disorder
  • amnesia
  • migraine
  • olfactory disturbances
  • psychomotor hyperactivity
  • 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 deficits
  • anxiety
  • mood disorders
  • hypersensitivity
  • aggression
  • disorientation
  • dissociation
  • euphoria
  • suicidal ideation
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • skin dryness
  • eczema
  • psoriasis
  • hives
  • photosensitivity reactions
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disorders
  • nightmares
  • excessive dreaming
  • sleep disorders
  • nightmares
  • excessive dreaming
  • hallucinations
  • mental disorders
  • suicidal ideation
  • insomnia
  • anxiety
  • abnormal thoughts
  • hallucinations
  • suicidal ideation
  • headache
  • drowsiness
  • dizziness
  • feeling foggy
  • taste distortion
  • syncope
  • fatigue
  • lethargy
  • asthenia
  • itching
  • rash
  • shortness of breath
  • increased sputum
  • myalgia
  • gum swelling
  • nipple pain
  • seizures
  • traffic accidents
  • near traffic accidents
  • accidental injury
  • relief
  • hypersensitivity
  • smoking urges
  • sleep disorders
  • increased hypersensitivity
  • death due to overdose of illicit drugs
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • cerebrovascular events
  • myocardial infarction
  • unstable angina
  • insomnia
  • anxiety
  • abnormal thoughts
  • neuritis
  • syncope
  • pneumonia exacerbation
  • arterial stenosis
  • feeling foggy
  • discomfort
  • psychological distress
  • hair loss
  • increased sputum
  • memory abnormalities
  • coldness
  • worsening condition
  • irritation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure
  • generalized 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 sealed container to protect it from air or moisture. Additionally, it should be stored at room temperature between 1 degrees Celsius and 30 degrees Celsius, away from extremes of heat or cold, to maintain its efficacy for a long time.

Appearance and packaging

Appearance

Light blue, biconvex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/Blister 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.

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.