Medication info

Yuyu Varenicline Salicylate Tablet 1 mg

Prescription medicationExpired
Ingredient · strength
Varenicline Salicylate›Strength being verified
Manufacturer / importer
Yuyu Pharmaceutical Co., Ltd.
Appearance
Light blue, biphasic, convex, rectangular film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Expired

MFDS item code 201802493 · Approved 2018.06.15

This product's status changed to Expired on 2023.06.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment for smoking cessation
Who uses it
Adults · Children
Adult dosage
Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting smoking 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 this medicine is as follows: after 1 week of dose titration, 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 adverse reactions to this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, an additional 12 weeks of 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 reducing smoking while taking this medicine. Reduce the amount smoked by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by an additional 50% within the next 4 weeks. Continue reducing the amount smoked to achieve complete smoking cessation by Week 12. Take 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 receiving 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 is more likely to be reduced, so use caution when selecting the dose; monitoring renal function may be useful.
Children's dosage
Patients under 18 years of age: The safety and efficacy of this medicine have not been established in children; therefore, use is not recommended in patients under 18 years of age.

Ingredients

Manufacturer
Yuyu Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

This medication is used as an adjunct therapy to aid in smoking cessation. Quitting smoking is very important for health, and this drug helps alleviate withdrawal symptoms and increases the chances of successful quitting. Therefore, it effectively supports those attempting to quit smoking and improves various discomforts that may arise during the quitting process.

Dosage and Administration

Adult dosage

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting smoking 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 this medicine is as follows: after 1 week of dose titration, 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 adverse reactions to this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, an additional 12 weeks of 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 reducing smoking while taking this medicine. Reduce the amount smoked by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by an additional 50% within the next 4 weeks. Continue reducing the amount smoked to achieve complete smoking cessation by Week 12. Take 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 receiving 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 is more likely to be reduced, so use caution when selecting the dose; monitoring renal function may be useful.

Children's dosage

Patients under 18 years of age: The safety and efficacy of this medicine have not been established in children; therefore, use is not recommended in patients under 18 years of age.

Precautions

This drug is a medication to assist with smoking cessation, and care must be taken as it may cause neuropsychiatric symptoms or suicidal tendencies. During treatment, psychic symptoms such as anxiety, depression, aggression, and hallucinations may occur, so if unusual symptoms arise, the treatment should be stopped immediately, and medical advice should be sought. If there is a history of psychiatric disorders, it is essential to inform the physician, and mental status should be carefully monitored before and after treatment. This medication should not be administered to patients with hypersensitivity, and cautious use is required for pregnant or breastfeeding women. Common side effects include nausea, headache, insomnia, and abnormal dreams, so this should be noted. Caution is needed when engaging in dangerous activities such as driving or operating machinery after taking this medication, as drowsiness or dizziness may occur. This medication should also be used cautiously in patients with cardiovascular disease, and if heart-related symptoms arise, the physician should be informed immediately. Alcohol consumption may worsen the side effects of this medication, so it is best to avoid it during treatment. There are few drug interactions, but it is safe to consult a physician when taking other medications. It is not recommended for pediatric patients or adolescents under 18 years of age, and the dosage may need to be adjusted for the elderly according to kidney function. In case of overdose, medical attention should be sought immediately. This medication should be stored out of reach of children and kept in its original container to maintain quality.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • suicide
  • changes in behavior or thought
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
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  • paranoia
  • delusions
  • thoughts of murder
  • hostility
  • restlessness
  • anxiety
  • panic state
  • displeasure
  • depressive mood
  • insomnia
  • irritability
  • frustration
  • anger
  • difficulty concentrating
  • fidgeting
  • decreased heart rate
  • increased appetite
  • weight gain
  • reduced platelet count
  • weight gain
  • decreased appetite
  • increased appetite
  • abnormal dreams
  • insomnia
  • abnormal thoughts
  • fidgeting
  • mood changes
  • decreased libido
  • discomfort
  • mental exhaustion
  • headaches
  • drowsiness
  • dizziness
  • taste disturbances
  • trembling
  • somnolence
  • sensory impairment
  • speech disorders
  • motor coordination disorder
  • taste hypesthesia
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • reduced ST segment on ECG
  • decreased amplitude on ECG
  • increased blood pressure
  • facial flushing
  • upper respiratory disorder
  • dyspnea
  • cough
  • upper respiratory inflammation
  • airway congestion
  • voice disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper airway cough syndrome
  • rhinorrhea
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • dental pain
  • dyspepsia
  • bloating
  • dry mouth
  • passage of blood in stool
  • gastritis
  • burping
  • 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
  • weakness
  • lethargy
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • thrombocytopenia
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular ectopy
  • myocardial infarction
  • cardiac arrest
  • coronary artery disease
  • cor pulmonale
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Ménière'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 ulcers
  • esophagitis
  • peptic ulcer
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity
  • drug hypersensitivity
  • abnormal ECG
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disorder
  • amnesia
  • migraine
  • dysosmia
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorder
  • cerebrovascular incident
  • convulsions
  • facial nerve paralysis
  • mental disorders
  • multiple sclerosis
  • eye twitching
  • psychomotor dysfunction
  • transient ischemic attack
  • visual field defect
  • anxiety
  • depression
  • emotional disturbance
  • hypersensitivity
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal ideation
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute kidney injury
  • urinary retention
  • menstrual disorders
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • skin dryness
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • abnormal dreams
  • sleep disorders
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thinking
  • suicidal ideation
  • hallucinations
  • headaches
  • drowsiness
  • dizziness
  • feeling foggy
  • taste disturbances
  • syncope
  • fatigue
  • lethargy
  • weakness
  • chest discomfort
  • chest pain
  • decreased appetite
  • poor appetite
  • increased appetite
  • itching
  • dyspnea
  • increased sputum
  • myalgia
  • gum swelling
  • nipple pain
  • seizures
  • traffic accidents
  • near traffic accidents
  • accidental injury
  • relief
  • sleep disorders
  • smoking urges

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius to safely preserve its efficacy.

Appearance and packaging

Appearance

Light blue, biphasic, convex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTP 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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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.