Medication info

Nicobai Tablet 1 mg (Varenicline Salicylate)

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

MFDS item code 201802490 · 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
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. 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.
Children's dosage
Under 18 years of age: Use is not recommended.

Ingredients

Manufacturer
Samjin Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

This medication is used as an adjunct therapy to assist with smoking cessation. It helps individuals attempting to quit smoking manage withdrawal symptoms and reduce cravings, supporting successful cessation. This treatment effectively facilitates the quitting process for patients and helps prevent relapse, thereby contributing to overall health improvement. It is utilized as an adjunct treatment for smoking cessation, aiding in maintaining a healthy lifestyle.

Dosage and Administration

Adult dosage

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. 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.

Children's dosage

Under 18 years of age: Use is not recommended.

Precautions

This drug is intended to aid smoking cessation; however, during use, psychiatric symptoms or suicidal tendencies may occur, requiring caution. If symptoms such as depression, anxiety, hallucinations, or aggressiveness manifest during treatment, the drug should be discontinued immediately and a doctor consulted. It should not be used in cases of hypersensitivity or known allergies to any of its components. Pregnant or breastfeeding women should use this medication cautiously and consult their doctor before use. Common gastrointestinal and psychiatric side effects may include nausea, headache, insomnia, and abnormal dreams. Nausea can be alleviated by adjusting the initial dosage; however, in severe cases, dosage reduction or discontinuation may be necessary. Caution should be exercised while performing hazardous activities such as driving or operating machinery, as symptoms like drowsiness or dizziness may occur. Although significant drug interactions with other medications have not been widely reported, it is advisable to avoid or minimize alcohol consumption. Elderly patients or patients with impaired renal function may require dosage adjustments, so follow a doctor's recommendations. In case of overdose, standard care should be taken; as there is no specific antidote, follow medical instructions accordingly. This medication should be stored out of reach of children and in its original container to maintain quality.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • psychosis
  • aggressive behavior
  • hallucinations
  • paranoia
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  • 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 relaxation
  • headache
  • drowsiness
  • dizziness
  • taste abnormalities
  • tremors
  • excessive sleepiness
  • sensory decrease
  • speech disorders
  • motor coordination disorders
  • decreased taste
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ST segment depression on ECG
  • decreased amplitude of ECG waves
  • increased blood pressure
  • flushing
  • upper respiratory disorders
  • dyspnea
  • cough
  • upper respiratory 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
  • toothache
  • dyspepsia
  • 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 cramps
  • joint stiffness
  • frequent urination
  • nocturia
  • diabetes
  • polyuria
  • menorrhagia
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • asthenia
  • lethargy
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • thrombocytopenia
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular extra beats
  • myocardial infarction
  • cardiac arrhythmia
  • coronary artery disease
  • cor pulmonale
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Ménière's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurred vision
  • visual impairment
  • acquired night blindness
  • transient visual loss
  • cataracts
  • ocular vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • intestinal obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reactions
  • drug hypersensitivity reactions
  • ECG abnormalities
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disorders
  • amnesia
  • migraine
  • parosmia
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • seizures
  • facial nerve palsy
  • 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 ideation
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • menstrual disorders
  • erectile dysfunction
  • epistaxis
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reactions
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • abnormal dreams
  • sleep disorders
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • suicidal ideation
  • hallucinations
  • agitation
  • waking up in the early morning
  • cough
  • pharyngolaryngeal headache
  • palpitations
  • weight gain
  • heat rash
  • seizures
  • traffic accident
  • near traffic accident
  • accidental injury
  • relief
  • sleep disorder
  • increased irritability
  • feeling dazed
  • excessive dreaming
  • neuritis
  • increased phlegm
  • pneumonia exacerbation
  • artery stenosis
  • nipple pain
  • exacerbation of malignant neoplasm
  • unpleasant feelings
  • mental distress
  • hair loss
  • memory abnormalities
  • coldness
  • deterioration of condition
  • stimulation
  • 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 prevent the ingress of air or moisture. It is recommended to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Light blue, double convex, oblong film-coated tablet

Package unit

28 tablets (14 tablets/PTP*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.