Medication info

Bicotin 0.5 mg (Varenicline Salicylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Varenicline Salicylate›0.825mg / 1 tablet
Manufacturer / importer
Ahn-Guk Pharmaceutical Co., Ltd.
Appearance
White or grayish-white, bilaterally convex, elongated film-coated tablets
Packaging
11 tablets (11 tablets/Blister X 1)
Approval status
Expired

MFDS item code 201804168 · 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
Smoking cessation aid
Who takes it
Adults · Children
Adult dose
Usual adult dosage: Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may begin quitting smoking 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 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 adverse reactions to this medication, 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 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 pretreatment level within the first 4 weeks after starting treatment and by an additional 50% within the next 4 weeks, with continued reductions so that complete smoking cessation is achieved by week 12. Continue this medication 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 do not quit smoking during the initial 12 weeks of treatment, or who resume smoking after treatment, should review the factors contributing to failure before trying 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 of treatment or resumed smoking after treatment. Patients with renal impairment: No dosage adjustment is required 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 the medication is well tolerated, a maximum dose of 0.5 mg once daily may be administered. Elderly patients and patients with hepatic impairment: No dosage adjustment is required in patients with hepatic impairment. Since renal function is more likely to be reduced in elderly patients, use caution when selecting the dose; monitoring renal function may be useful.
Child dose
Under 18 years of age: Use is not recommended.

Ingredients

Manufacturer
Ahn-Guk Pharmaceutical Co., Ltd.

Efficacy & effects

Smoking cessation aid

View approved original text

Adjunct therapies for smoking cessation serve to relieve withdrawal symptoms and increase the success rate of quitting smoking. Typical methods include nicotine replacement therapy, behavioral therapy, and medication. These adjunct therapies help reduce physical and psychological difficulties during the smoking cessation process. Thus, adjunct therapies for smoking cessation are used to support the will to quit smoking and assist in successful cessation.

How to take

Adult dose

Usual adult dosage: Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may begin quitting smoking 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 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 adverse reactions to this medication, 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 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 pretreatment level within the first 4 weeks after starting treatment and by an additional 50% within the next 4 weeks, with continued reductions so that complete smoking cessation is achieved by week 12. Continue this medication 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 do not quit smoking during the initial 12 weeks of treatment, or who resume smoking after treatment, should review the factors contributing to failure before trying 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 of treatment or resumed smoking after treatment. Patients with renal impairment: No dosage adjustment is required 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 the medication is well tolerated, a maximum dose of 0.5 mg once daily may be administered. Elderly patients and patients with hepatic impairment: No dosage adjustment is required in patients with hepatic impairment. Since renal function is more likely to be reduced in elderly patients, use caution when selecting the dose; monitoring renal function may be useful.

Child dose

Under 18 years of age: Use is not recommended.

Precautions

This medication is used to assist in quitting smoking, and caution is necessary as neuropsychiatric symptoms or suicidal tendencies may occur during treatment. Patients should discontinue use and consult a doctor immediately if they experience any mental changes such as depression, anxiety, hallucinations, or aggressive behavior. Patients with hypersensitivity to this medication or a history of allergies should avoid it. Women who are pregnant or breastfeeding should make careful decisions regarding the use of this medication and consult a doctor during pregnancy or breastfeeding. Initial use may commonly cause symptoms such as nausea, headache, insomnia, and abnormal dreams, but most are mild and transient. Some cardiovascular-related adverse reactions have been reported in patients with cardiovascular diseases; patients should inform a doctor immediately if symptoms worsen. Caution is advised when engaging in hazardous activities such as driving or operating machinery, as this medication may cause drowsiness or dizziness. Alcohol consumption may exacerbate the side effects of this medication, so it is advisable to avoid or minimize alcohol while taking it. Dosing may need adjustment depending on renal function, so patients with kidney disease should consult a doctor. In case of overdose, seek medical attention immediately for appropriate treatment. This medication is not recommended for children, and caution is required for the elderly based on kidney function. Storage should be in a place out of reach of children, in its original container to maintain quality.

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
  • thoughts of murder
  • hostility
  • restlessness
  • anxiety
  • panic state
  • discomfort
  • depressive mood
  • insomnia
  • irritability
  • frustration
  • anger
  • difficulty concentrating
  • impatience
  • decreased heart rate
  • increased appetite
  • weight gain
  • decreased platelet count
  • weight gain
  • decreased appetite
  • increased appetite
  • abnormal dreams
  • insomnia
  • abnormal thoughts
  • impatience
  • mood changes
  • decreased libido
  • discomfort
  • mental restlessness
  • headache
  • drowsiness
  • dizziness
  • taste disturbances
  • tremors
  • sleepiness
  • sensory reduction
  • speech disorder
  • motor coordination disorder
  • taste hypesthesia
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • floaters
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ST segment depression in ECG
  • decreased amplitude in ECG
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract infection
  • 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 distension
  • abdominal pain
  • toothache
  • dyspepsia
  • bloating
  • 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
  • increased urinary frequency
  • nocturia
  • diabetes
  • polyuria
  • excessive menstruation
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • weakness
  • lethargy
  • liver function test abnormalities
  • anemia
  • lymphadenopathy
  • leukocytosis
  • splenomegaly
  • arrhythmia
  • bradycardia
  • premature ventricular contractions
  • myocardial infarction
  • heart flutter
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Meniere's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurred vision
  • visual disturbances
  • acquired night blindness
  • transient vision loss
  • cataract
  • ocular vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • small intestine and colon inflammation
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcer
  • intestinal obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reactions
  • drug hypersensitivity reactions
  • abnormal ECG
  • muscle enzyme elevation
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disorders
  • amnesia
  • migraine
  • abnormal olfactory perception
  • psychomotor hyperactivity
  • restless legs syndrome
  • fainting
  • balance disorders
  • cerebrovascular events
  • seizures
  • facial nerve paralysis
  • mental disorders
  • multiple sclerosis
  • eye tremors
  • psychomotor dysfunction
  • transient ischemic attacks
  • visual field defects
  • anxiety
  • depression
  • emotional disorders
  • irritability
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal ideation
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • menstrual disorders
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleurisy
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reactions
  • hypotension
  • peripheral ischemia
  • thrombosis
  • nausea
  • headache
  • insomnia
  • abnormal dreams
  • dyspepsia
  • abdominal pain
  • constipation
  • vomiting
  • xerostomia
  • bloating
  • oral ulceration
  • gastroesophageal reflux disease
  • insomnia
  • abnormal dreams
  • sleep disorders
  • depression
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • suicidal ideation
  • hallucinations
  • headache
  • drowsiness
  • dizziness
  • mental fog
  • taste disturbances
  • fainting
  • fatigue
  • lethargy
  • weakness
  • chest discomfort
  • chest pain
  • decreased appetite
  • anorexia
  • increased appetite
  • itching
  • rash
  • dyspnea
  • increased phlegm
  • myalgia
  • gum swelling
  • nipple pain
  • seizures
  • relief
  • sleep disorders
  • increased irritability
  • traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • unpleasant subjective reactions
  • abnormal and aggressive behavior
  • amnesia
  • vascular edema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • ischemic and hemorrhagic reactions
  • cerebrovascular events
  • myocardial infarction
  • unstable angina

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

Storage

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

Appearance and packaging

Appearance

White or grayish-white, bilaterally convex, elongated film-coated tablets

Package unit

11 tablets (11 tablets/Blister 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.