Medication info

Nicost 0.5 mg (Varenicline Salicylate)

Prescription medicationExpired
Ingredient · strength
Varenicline Salicylate›Strength being verified
Manufacturer / importer
JW Pharmaceutical Corporation
Appearance
Biconvex rectangular film-coated tablets that are white or grayish-white
Packaging
11 tablets (11 tablets/PTP X 1)
Approval status
Expired

MFDS item code 201803324 · Approved 2018.08.14

This product's status changed to Expired on 2023.08.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Smoking cessation aid
Who uses it
Adults · Children
Adult dosage
After dose titration over 1 week, administer 1 mg twice daily. Days 1–3: 0.5 mg once daily Days 4–7: 0.5 mg twice daily Day 8 until 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 with this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be administered for an additional 12 weeks. For patients who cannot or do not wish to stop smoking abruptly, consider gradually stopping 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 a further 50% within the next 4 weeks. Continue to reduce smoking so that complete abstinence can be achieved by week 12. Administer 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.
Children's dosage
Use is not recommended in patients under 18 years of age because the safety and efficacy of this medicine have not been established in children.

Ingredients

Manufacturer
JW Pharmaceutical Corporation

Efficacy & effects

Smoking cessation aid

View approved original text

Adjunct therapy for smoking cessation is used to reduce nicotine dependence due to smoking and increase the success rates of quitting. This therapy may include nicotine replacement therapy, pharmacotherapy, and counseling. Patients can strengthen their resolve to quit smoking and alleviate withdrawal symptoms through this adjunctive therapy. It plays an important role in effectively carrying out smoking cessation treatment, so proactive utilization is recommended. This can help in forming healthy lifestyle habits and preventing diseases.

Dosage and Administration

Adult dosage

After dose titration over 1 week, administer 1 mg twice daily. Days 1–3: 0.5 mg once daily Days 4–7: 0.5 mg twice daily Day 8 until 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 with this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be administered for an additional 12 weeks. For patients who cannot or do not wish to stop smoking abruptly, consider gradually stopping 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 a further 50% within the next 4 weeks. Continue to reduce smoking so that complete abstinence can be achieved by week 12. Administer 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.

Children's dosage

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

Precautions

This medication is used to aid in smoking cessation and requires caution regarding neuropsychiatric symptoms and suicidal tendencies. Serious mental symptoms such as depression, anxiety, aggression, hallucinations, and suicidal thoughts may occur during the course of taking this medication; therefore, if symptoms arise, the medication should be discontinued immediately and a doctor should be consulted. This medication should not be used in individuals with a history of hypersensitivity or allergic reactions. Pregnant or breastfeeding women should carefully consider the potential impact on the fetus or baby when taking this medication and consult a doctor if necessary. Common side effects during the course of taking this medication may include nausea, headache, insomnia, abnormal dreams, etc.; if these symptoms are severe or persistent, it is advisable to consult a doctor. Care should be taken since drowsiness or dizziness may occur during activities requiring alertness, such as driving or operating machinery. Older patients with impaired renal function may require dosage adjustments and should follow a doctor's instructions. This medication generally has low interactions with other medications, although alcohol consumption may increase the risk of side effects and should be avoided if possible. Physiological changes from smoking cessation may alter the effects of other medications, so inform your doctor of any other medications you are taking. Safety and effectiveness in children have not been established; therefore, it is not recommended for patients under the age of 18. If seizures occur while taking this medication, it should be discontinued immediately and the medical staff should be informed. If serious allergic reactions such as skin rashes or angioedema appear, discontinue the medication immediately and seek emergency care. Patients with cardiovascular disease should be carefully monitored as symptoms may worsen with the use of this medication, and any new symptoms should be reported to a doctor immediately. This medication should be stored out of reach of children and is safest when kept in its original container.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
Show 262 more
  • paranoia
  • delusions
  • homicidal ideation
  • hostility
  • restlessness
  • anxiety
  • panic state
  • discomfort
  • depressive mood
  • insomnia
  • irritability
  • frustration
  • anger
  • difficulty concentrating
  • 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
  • discomfort
  • mental slowness
  • headache
  • drowsiness
  • dizziness
  • taste disorders
  • tremors
  • hypersomnia
  • sensory impairment
  • speech impairment
  • motor coordination dysfunction
  • hypogeusia
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ECG ST segment depression
  • ECG T-wave amplitude reduction
  • 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 airway cough syndrome
  • nasal discharge
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • indigestion
  • bloating
  • dry mouth
  • passage of bloody stool
  • 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
  • heavy menstrual bleeding
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • weakness
  • lethargy
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • thrombocytopenia
  • 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 impairment
  • acquired night blindness
  • transient visual loss
  • subcapsular cataract
  • retinal vascular diseases
  • vitreous floaters
  • gingivitis
  • dysphagia
  • small bowel colitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • intestinal obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reactions
  • drug hypersensitivity
  • ECG abnormalities
  • muscle enzyme elevation
  • urine test abnormalities
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit
  • sensory dysfunction
  • amnesia
  • migraine
  • abnormal olfaction
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular accidents
  • convulsions
  • facial nerve paralysis
  • mental disorders
  • multiple sclerosis
  • eye twitching
  • psychomotor dysfunction
  • transient ischemic attacks
  • visual field loss
  • anxiety
  • depression
  • emotional disorders
  • irritability
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • 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
  • urticaria
  • photosensitivity reactions
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disorders
  • nightmares
  • excessive dreaming
  • sleep disturbances
  • nightmares
  • insomnia
  • anxiety
  • abnormal thoughts
  • hallucinations
  • suicidal ideation
  • fatigue
  • lethargy
  • weakness
  • chest discomfort
  • chest pain
  • decreased appetite
  • anorexia
  • itching
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • seizures
  • traffic accidents
  • near traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • sleep disorders
  • increased irritability
  • excessive dreaming
  • neuritis
  • exacerbation of pneumonia
  • arterial stenosis
  • nipple pain
  • exacerbation of malignant neoplasms
  • ineffective treatment
  • feeling dazed
  • unpleasant feeling
  • mental distress
  • hair loss
  • increased sputum
  • memory abnormalities
  • cold sensation
  • worsening 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 should be stored in a tightly closed container to protect it from air or moisture, and it is best to store it at room temperature between 1°C and 30°C. Storing it this way maintains the medication's efficacy and ensures safe use.

Appearance and packaging

Appearance

Biconvex rectangular film-coated tablets that are white or grayish-white

Package unit

11 tablets (11 tablets/PTP 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.