Medication info

Cripix Tablet 0.5 mg (Varenicline Salicylate)

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

MFDS item code 201803352 · Approved 2018.08.16

This product's status changed to Expired on 2023.08.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Smoking cessation adjunctive therapy
Who uses it
Adults · Children
Adult dosage
Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may start quitting between days 8 and 35 after starting this medication. This medication should be taken after meals with plenty of water. The recommended dosage is as follows: after dose titration over 1 week, 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 the adverse reactions to this medication, the dose may be reduced temporarily or on an ongoing basis. The treatment period is 12 weeks. For patients who successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medication is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medication should be considered. Smoking should be reduced by 50% from the level before treatment within the first 4 weeks after starting this medication, and by an additional 50% within the following 4 weeks. Smoking should continue to be reduced so that complete cessation is achieved by week 12. Continue this medication for an additional 12 weeks, for a total treatment period of 24 weeks. Patients who fail to quit smoking after the initial 12 weeks of treatment or 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 during the initial 12 weeks of treatment or resume smoking after treatment. 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. Because renal function is more likely to be reduced in elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.
Children's dosage
Patients under 18 years of age: Use is not recommended.

Ingredients

Manufacturer
Huons Life Science Co., Ltd.

Efficacy & effects

Smoking cessation adjunctive therapy

View approved original text

Adjunct therapy for smoking cessation helps individuals who wish to quit smoking alleviate withdrawal symptoms and increase the success rate of quitting. Such adjunct therapies may include nicotine replacement therapy, medication, and behavioral therapy, each selected appropriately through consultation with a physician or pharmacist. The adjunct therapy helps mitigate symptoms like anxiety, decreased concentration, and overeating that may occur during the quitting process, aiding in maintaining a consistent cessation effort. Thus, adjunct therapy is crucial for sustaining smoking cessation and contributes to the establishment of healthy lifestyle habits. Therefore, adjunct therapy for smoking cessation is effective in quitting smoking.

Dosage and Administration

Adult dosage

Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may start quitting between days 8 and 35 after starting this medication. This medication should be taken after meals with plenty of water. The recommended dosage is as follows: after dose titration over 1 week, 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 the adverse reactions to this medication, the dose may be reduced temporarily or on an ongoing basis. The treatment period is 12 weeks. For patients who successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medication is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medication should be considered. Smoking should be reduced by 50% from the level before treatment within the first 4 weeks after starting this medication, and by an additional 50% within the following 4 weeks. Smoking should continue to be reduced so that complete cessation is achieved by week 12. Continue this medication for an additional 12 weeks, for a total treatment period of 24 weeks. Patients who fail to quit smoking after the initial 12 weeks of treatment or 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 during the initial 12 weeks of treatment or resume smoking after treatment. 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. Because renal function is more likely to be reduced in elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.

Children's dosage

Patients under 18 years of age: Use is not recommended.

Precautions

This medication is used to assist in smoking cessation. However, during the use of this medication, serious mental health issues such as depression, suicidal thoughts, or suicidal behaviors may arise. All patients taking this medication should closely monitor their mental health status and must inform their doctor if they have a history of psychiatric disorders. If there are any symptoms of anxiety, restlessness, depression, unusual behavior, or changes in thinking, the patient should stop taking the medication immediately and consult a physician. Women who are pregnant or breastfeeding should use this medication cautiously and decide on its use based on necessity. Common side effects such as nausea, headache, insomnia, and abnormal dreams may occur, so caution is needed. This medication may require dose adjustments in patients with renal impairment or the elderly. Caution should also be exercised when performing potentially dangerous activities such as driving or operating machinery, as this medication might cause drowsiness or decreased concentration. Additionally, alcohol intake may lead to unusual and aggressive behaviors; thus, it is advised to avoid or minimize alcohol consumption. If any severe allergic reactions occur, such as hypersensitivity, severe skin rashes, or angioedema, the medication should be discontinued immediately, and the healthcare provider should be informed. Patients with cardiovascular diseases may experience heart-related issues due to this medication, so they should consult their physician immediately if symptoms appear. Finally, this medication is not recommended for pediatric patients under 18 years old.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
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  • paranoia
  • delusions
  • homicidal ideation
  • hostility
  • agitation
  • anxiety
  • panic attacks
  • discomfort
  • depressive mood
  • insomnia
  • irritability
  • frustration
  • anger
  • concentration difficulties
  • 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
  • somnolence
  • sensory reduction
  • speech disorders
  • motor coordination disorders
  • taste reduction
  • circadian rhythm sleep disorders
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • decreased ECG segment amplitude
  • reduced ECG waveform amplitude
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • voice disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper respiratory cough syndrome
  • rhinorrhea
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • dyspepsia
  • bloating
  • dry mouth
  • passing blood in stool
  • gastritis
  • belching
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • hyperhidrosis
  • arthralgia
  • myalgia
  • back pain
  • muscle cramps
  • joint stiffness
  • increased urination
  • nocturia
  • diabetes
  • polyuria
  • heavy menstrual bleeding
  • 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 ectopy
  • myocardial infarction
  • heart palpitations
  • 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 nyctalopia
  • transient visual loss
  • nuclear cataract
  • ocular vascular disease
  • 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
  • abnormal ECG
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disturbances
  • amnesia
  • migraine
  • olfactory hallucinations
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • seizures
  • traffic accidents
  • near traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • sleep disorders
  • smoking urge
  • increased depression
  • increased insomnia
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • ischemic and hemorrhagic reactions
  • cerebrovascular events
  • myocardial ischemia
  • angioedema
  • facial swelling
  • lip swelling
  • tongue swelling
  • gingival swelling
  • neck swelling
  • laryngeal swelling
  • limb swelling
  • Stevens-Johnson syndrome
  • erythema multiforme
  • unstable angina
  • nausea
  • dizziness
  • abdominal pain
  • insomnia
  • anxiety
  • fatigue
  • lethargy
  • asthenia
  • inadequate effect
  • feeling spacey
  • unpleasant feeling
  • mental distress
  • hair loss
  • increased sputum
  • memory disturbances
  • coldness
  • worsening condition
  • irritation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure
  • excessive muscle tension
  • gastric ulcer
  • headache
  • abnormal dreams
  • excitement
  • waking up at dawn
  • sleep disorders
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • suicidal ideation
  • hallucinations
  • halitosis
  • thirst
  • chapped lips
  • nipple pain
  • pneumonia exacerbation
  • arterial stenosis
  • malignant neoplasm exacerbation

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve the efficacy of the medication.

Appearance and packaging

Appearance

White or grayish-white, biconvex, rectangular film-coated tablet

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.