Medication info

Terachams Tablet 0.5 mg (Varenicline Salicylate)

Prescription medicationExpired
Ingredient · strength
Varenicline Salicylate›Strength being verified
Manufacturer / importer
Teragen Etex Co., Ltd.
Appearance
White or grayish-white, bilaterally convex, rectangular film-coated tablets
Packaging
11 tablets (11 tablets/BlisterX1)
Approval status
Expired

MFDS item code 201803701 · Approved 2018.09.12

This product's status changed to Expired on 2023.09.12. 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
1. Usual dosage in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting 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 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 – end of treatment 1 mg twice daily Patients who cannot tolerate the adverse reactions of this medicine may temporarily or permanently reduce the dose. This medicine is administered for 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. Within the first 4 weeks after starting this medicine, reduce smoking by 50% compared with before treatment; reduce it by a further 50% within the following 4 weeks, and continue to reduce smoking so that complete abstinence is achieved by week 12. Administer this medicine for an additional 12 weeks for a total treatment duration of 24 weeks. Patients who fail to quit smoking with the first 12 weeks of treatment, or who resume smoking after treatment, should review the reasons for failure and try again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit smoking during the first 12 weeks of treatment or resume smoking after treatment. 2. 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, a maximum dose of 0.5 mg once daily may be administered if well tolerated. 3. Elderly patients and patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, use caution when selecting the dose; monitoring renal function may be useful.
Children's dosage
Use in patients under 18 years of age is not recommended.

Ingredients

Manufacturer
Teragen Etex Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

Adjunct therapies for smoking cessation include nicotine replacement therapy or medication therapy. These methods help relieve withdrawal symptoms and enhance smoking cessation success rates. It is important for patients to consult with a specialist to choose an appropriate treatment method. This can help maintain healthy lifestyle habits and escape the risks of smoking. Smoking cessation adjunct therapies effectively assist in quitting smoking.

Dosage and Administration

Adult dosage

1. Usual dosage in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting 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 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 – end of treatment 1 mg twice daily Patients who cannot tolerate the adverse reactions of this medicine may temporarily or permanently reduce the dose. This medicine is administered for 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. Within the first 4 weeks after starting this medicine, reduce smoking by 50% compared with before treatment; reduce it by a further 50% within the following 4 weeks, and continue to reduce smoking so that complete abstinence is achieved by week 12. Administer this medicine for an additional 12 weeks for a total treatment duration of 24 weeks. Patients who fail to quit smoking with the first 12 weeks of treatment, or who resume smoking after treatment, should review the reasons for failure and try again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit smoking during the first 12 weeks of treatment or resume smoking after treatment. 2. 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, a maximum dose of 0.5 mg once daily may be administered if well tolerated. 3. Elderly patients and patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, use caution when selecting the dose; monitoring renal function may be useful.

Children's dosage

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

Precautions

This medication is used to assist in smoking cessation. During treatment, serious mental health issues such as depression, anxiety, aggression, hallucinations, and suicidal thoughts may occur, so caution is required. Patients with a history of psychiatric disorders must consult their doctor before use, and they should carefully monitor any changes in mental state during treatment. Pregnant or breastfeeding women should use this medication cautiously and consult with a doctor when necessary. While taking this medication, side effects such as nausea, headaches, insomnia, and abnormal dreams are common, and if these symptoms are severe or persistent, patients should consult a doctor. Patients with a history of seizures or those at risk for seizures should be adequately assessed for risks before taking this medication, and should immediately stop use and inform medical personnel if a seizure occurs. Activities requiring concentration, such as driving or operating machinery, should be approached with caution until the body's response to this medication is confirmed. Interactions with other drugs are minimal, but alcohol consumption may exacerbate side effects, so it is advisable to avoid or minimize alcohol while taking this medication. No specific antidote exists in cases of overdose, so appropriate treatment should be received according to symptoms, and dose adjustments may be necessary for patients with decreased kidney function. Store this medication out of the reach of children, and keep it in its original container to maintain quality.

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 state
  • discomfort
  • depressed 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 fatigue
  • headache
  • drowsiness
  • dizziness
  • taste abnormalities
  • tremors
  • hypersomnia
  • sensory impairment
  • speech disorders
  • motor coordination disorders
  • taste disorders
  • circadian rhythm sleep disorders
  • conjunctivitis
  • eye pain
  • scotomas
  • photophobia
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • electrocardiogram segment depression
  • electrocardiogram amplitude reduction
  • increased blood pressure
  • flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • vocal cord disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper airway cough syndrome
  • runny nose
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • dyspepsia
  • bloating
  • dry mouth
  • blood in stool
  • gastritis
  • belching
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • hyperhidrosis
  • arthralgia
  • myalgia
  • back pain
  • muscle spasms
  • joint stiffness
  • increased 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
  • thrombocytopenia
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular ectopy
  • myocardial infarction
  • cardiac 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 disturbances
  • acquired night blindness
  • transient visual loss
  • cataracts
  • ocular vascular diseases
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reaction
  • drug hypersensitivity
  • electrocardiogram 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
  • abnormal smell perception
  • psychomotor hyperactivity
  • 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
  • irritability
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal thoughts
  • 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 thought processes
  • hallucinations
  • headache
  • drowsiness
  • dizziness
  • brain fog
  • taste abnormalities
  • syncope
  • fatigue
  • malaise
  • asthenia
  • itching
  • dyspnea
  • increased sputum production
  • myalgia
  • gum swelling
  • nipple pain
  • insomnia
  • anxiety
  • abnormal thought processes
  • neuritis
  • syncope
  • worsening pneumonia
  • arterial stenosis
  • lack of efficacy
  • unpleasant feeling
  • mental distress
  • hair loss
  • increased sputum production
  • memory abnormalities
  • coldness
  • worsening condition
  • irritation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure
  • excessive muscle tension
  • gastric ulcer

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius room temperature.

Appearance and packaging

Appearance

White or grayish-white, bilaterally convex, rectangular film-coated tablets

Package unit

11 tablets (11 tablets/BlisterX1)

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.