Medication info

Yuyu Varenicline Salicylate Tablet 0.5 mg

Prescription medicationExpired
Ingredient · strength
Varenicline Salicylate›Strength being verified
Manufacturer / importer
Yuyu Pharmaceutical Co., Ltd.
Appearance
White or grayish-white, double-convex, rectangular film-coated tablet
Packaging
11 tablets (11 tablets/Blister X 1)
Approval status
Expired

MFDS item code 201802494 · 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
Usual dosage for adults 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. 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. Take this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 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. Elderly patients and patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment.
Children's dosage
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. It helps reduce withdrawal symptoms and cravings for smokers, thus aiding in increasing the success rate of quitting smoking. Therefore, it is effectively used for patients who have decided to quit smoking.

Dosage and Administration

Adult dosage

Usual dosage for adults 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. 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. Take this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 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. Elderly patients and patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment.

Children's dosage

Use is not recommended in patients under 18 years of age.

Precautions

This drug helps with smoking cessation and during usage, serious mental health issues may arise such as depression, suicidal thoughts, aggressive behavior, and hallucinations. Caution is necessary. If these symptoms occur, discontinue use immediately and consult a doctor. Those allergic to this medication should not use it, and women who are pregnant or breastfeeding should use it cautiously. During the initial treatment phase, side effects such as nausea, headache, insomnia, and abnormal dreams may commonly occur, and these symptoms are generally mild or temporary. Patients with cardiovascular disease should consult with a physician before use, as cardiac issues may worsen. Seizures may occur during treatment; therefore, individuals with a history of seizures or those at risk for seizures should consult their doctor before use. The side effects may be exacerbated when taken with alcohol, so alcohol consumption should be avoided or minimized during treatment. Caution is advised when engaging in hazardous activities such as driving or operating machinery until physical responses are assessed after dosing. It is advisable not to use this medication for children, as safety has not been established. Elderly or patients with reduced kidney function may require dosage adjustments, following the physician's instructions. In the case of overdose, seek appropriate medical attention immediately. This medication should be stored in its original container, out of the reach of children.

Side effects

  • suicidal ideation
  • suicidal behavior
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
  • paranoia
  • delusions
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  • homicidal ideation
  • hostility
  • restlessness
  • anxiety
  • panic state
  • discomfort
  • insomnia
  • irritability
  • frustration
  • anger
  • difficulty concentrating
  • agitation
  • decreased heart rate
  • increased appetite
  • weight gain
  • decreased platelet count
  • weight gain
  • decreased appetite
  • increased appetite
  • abnormal dreams
  • insomnia
  • abnormal thoughts
  • agitation
  • mood changes
  • decreased libido
  • discomfort
  • mental calmness
  • headache
  • drowsiness
  • dizziness
  • taste disturbance
  • tremor
  • hypersomnia
  • sensory loss
  • speech disorder
  • motor coordination disorder
  • taste loss
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • reduced electrocardiogram segments
  • decreased electrocardiogram 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 airway cough syndrome
  • rhinorrhea
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • indigestion
  • bloating
  • dry mouth
  • passage of blood in 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 menstrual bleeding
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • asthenia
  • malaise
  • 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
  • Ménière's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurriness
  • vision impairment
  • acquired night blindness
  • transient visual loss
  • subcapsular cataract
  • eye vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • ileocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcer
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reaction
  • drug hypersensitivity
  • abnormal electrocardiogram
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit
  • sensory disturbances
  • amnesia
  • migraine
  • altered olfactory sense
  • psychomotor hyperactivity
  • restless legs syndrome
  • syncope
  • balance disorder
  • cerebrovascular events
  • seizures
  • facial nerve palsy
  • mental disorders
  • multiple sclerosis
  • eye tremors
  • psychomotor dysfunction
  • transient ischemic attacks
  • visual field defects
  • anxiety
  • depression
  • mood disorders
  • irritability
  • aggression
  • agitation
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal ideation
  • nephrolithiasis
  • abnormal urination
  • urethral syndrome
  • acute kidney failure
  • urinary retention
  • erectile dysfunction
  • epistaxis
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reactions
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disorders
  • nightmares
  • excessive dreaming
  • hallucinations
  • suicidal ideation
  • hallucinations
  • insomnia
  • depression
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thinking
  • suicidal ideation
  • hallucinations
  • headache
  • drowsiness
  • dizziness
  • mental confusion
  • taste disturbances
  • syncope
  • fatigue
  • malaise
  • asthenia
  • itching
  • rash
  • dyspnea
  • increased sputum
  • myalgia
  • gingival swelling
  • nipple pain
  • seizures
  • hypersensitivity
  • smoking urges
  • depression
  • insomnia
  • motor vehicle accident
  • near-miss traffic accident
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • vascular edema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • cerebrovascular events
  • myocardial infarction

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 and moisture, and it is best to store it at room temperature between 1 to 30 degrees Celsius. This will help maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

White or grayish-white, double-convex, rectangular film-coated tablet

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.