Medication info

DobiPri Tablet 1mg (Varenicline Salicylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
Light Pharmatech Co., Ltd.
Appearance
Light blue, convex, rectangular film-coated tablet on both sides.
Packaging
28 tablets/box [(14 tablets/Blister × 2)]
Approval status
Expired

MFDS item code 201904330 · Approved 2019.06.25

This product's status changed to Expired on 2024.06.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment for smoking cessation
Who takes it
Adults · Children
Adult dose
After setting a quit date, patients should start taking Smoex 1 week before that date. Alternatively, they may begin smoking cessation between day 8 and day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dosage of Smoex 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 of Smoex tablets, the dose may be reduced temporarily or permanently. Smoex should be administered for 12 weeks. For patients who have successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of Smoex 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 medicine should be considered. The amount smoked should be reduced by 50% from the pretreatment level within the first 4 weeks after starting treatment, and by a further 50% over the next 4 weeks. Smoking should then be reduced continuously, with complete cessation achieved by week 12. Continue this medicine for an additional 12 weeks, for a total treatment duration of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. For patients who fail to quit smoking during the initial 12 weeks of treatment or resume smoking after treatment, review the reasons for 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 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 Smoex 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. Since 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
Use in patients under 18 years of age is not recommended because the safety and efficacy of Smoex have not been established in children.

Ingredients

Manufacturer
Light Pharmatech Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

Adjunctive therapy for smoking cessation helps patients who are trying to quit smoking reduce withdrawal symptoms and increase their chances of success. This can prevent health issues caused by smoking and improve overall health. Adjunctive therapies include nicotine replacement therapy, pharmacological treatment, and counseling, effectively supporting the patient's will to quit. This medicine aids in alleviating various symptoms that may occur during the quitting process and helps prevent relapse. Therefore, it is used as an adjunctive therapy for smoking cessation.

How to take

Adult dose

After setting a quit date, patients should start taking Smoex 1 week before that date. Alternatively, they may begin smoking cessation between day 8 and day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dosage of Smoex 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 of Smoex tablets, the dose may be reduced temporarily or permanently. Smoex should be administered for 12 weeks. For patients who have successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of Smoex 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 medicine should be considered. The amount smoked should be reduced by 50% from the pretreatment level within the first 4 weeks after starting treatment, and by a further 50% over the next 4 weeks. Smoking should then be reduced continuously, with complete cessation achieved by week 12. Continue this medicine for an additional 12 weeks, for a total treatment duration of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. For patients who fail to quit smoking during the initial 12 weeks of treatment or resume smoking after treatment, review the reasons for 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 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 Smoex 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. Since 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

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

Precautions

This medication is used to assist with quitting smoking. Psychological changes such as depression, anxiety, and suicidal thoughts may occur during treatment, so mental status should be carefully monitored. If there is a history of psychiatric conditions, it must be reported to the physician, and if unusual symptoms appear, usage should be stopped immediately and consultation sought. This medication should not be administered to individuals with allergic reactions or hypersensitivity to its components. Women who are pregnant or breastfeeding should use it cautiously after consulting a doctor. Common side effects include nausea, headaches, insomnia, and unusual dreams. Rarely, there may be occurrences of angioedema, severe skin reactions, and cardiovascular issues, so any symptoms that arise should be reported to a physician immediately. Caution is advised while driving or operating machinery, as drowsiness and dizziness may occur. There is minimal interaction with other medications, but alcohol consumption should be minimized or avoided. Elderly patients with decreased kidney function may require dosage adjustment based on doctor's instructions. In case of overdose, immediate medical attention should be sought. Keep out of reach of children and store in the original container.

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 thoughts
  • hostility
  • restlessness
  • anxiety
  • panic
  • dysphoria
  • depressive mood
  • insomnia
  • irritability
  • frustration
  • anger
  • concentration difficulties
  • 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
  • dysphoria
  • mental relaxation
  • headache
  • drowsiness
  • dizziness
  • taste abnormalities
  • trembling
  • narcolepsy
  • sensory loss
  • speech disorders
  • motor coordination disorders
  • taste perception impairment
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • photophobia
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ECG segment depression
  • reduced ECG amplitude
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorder
  • 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 distension
  • abdominal pain
  • dental pain
  • dyspepsia
  • bloating
  • dry mouth
  • bloody 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 menstruation
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • asthenia
  • lethargy
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular extrasystole
  • myocardial infarction
  • cardiac flutter
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Meniere's disease
  • thyroid disorders
  • dry eyes
  • eye irritation
  • blurriness
  • visual disturbances
  • acquired night blindness
  • transient visual loss
  • cataracts
  • ocular vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity
  • drug hypersensitivity
  • abnormal ECG
  • increased muscle enzymes
  • abnormal urine test
  • diabetes
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disturbances
  • amnesia
  • migraines
  • odor disturbances
  • 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
  • hypersensitivity
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal thoughts
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute kidney failure
  • urinary retention
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleurisy
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reaction
  • hypotension
  • peripheral ischemia
  • thrombosis
  • erysipelas
  • sleep disorders
  • nightmares
  • excessive dreaming
  • sleep disorders
  • nightmares
  • excessive dreaming
  • sleep disorders
  • nightmares
  • excessive dreaming
  • excessive dreaming
  • neuritis
  • exacerbation of pneumonia
  • arterial stenosis
  • nipple pain
  • exacerbation of malignant neoplasm
  • feeling light-headed
  • unpleasant sensation
  • mental distress
  • hair loss
  • increased phlegm
  • memory disturbances
  • coldness
  • worsening of 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 must be stored in a tightly sealed container to protect it from air and moisture. For best results, store the medication at room temperature between 1°C and 30°C. Avoid places that are too cold or too hot.

Appearance and packaging

Appearance

Light blue, convex, rectangular film-coated tablet on both sides.

Package unit

28 tablets/box [(14 tablets/Blister × 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.