Champix

Varenicline is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking.

Product dosage: 1mg
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Synonyms Chantix

Champix (varenicline) is a prescription medication specifically designed to assist adults in quitting smoking. It functions as a partial agonist selective for the α4β2 nicotinic acetylcholine receptor, reducing both the severity of nicotine withdrawal symptoms and the rewarding effects of smoking. By targeting the underlying neurobiological mechanisms of nicotine dependence, it provides a structured pharmacological approach to support behavioral change and long-term abstinence. Its efficacy is well-established in numerous large-scale, randomized controlled trials, making it a cornerstone of modern smoking cessation therapy.

Features

• Active pharmaceutical ingredient: Varenicline (as varenicline tartrate)
• Presentation: Film-coated tablets in strengths of 0.5 mg and 1 mg
• Mechanism of Action: Partial agonist at the α4β2 nicotinic acetylcholine receptor
• Dosing Regimen: A titrated 12-week course with a specific quit date
• Packaging: Available in calendar blister packs to support adherence to the dosing schedule

Benefits

• Significantly reduces the urge to smoke and alleviates nicotine withdrawal symptoms, such as irritability, restlessness, and depressed mood.
• Diminishes the satisfaction derived from smoking if a lapse occurs, thereby reducing the likelihood of a full relapse.
• Provides a structured, evidence-based treatment timeline to guide patients through the most challenging initial phases of quitting.
• Offers a non-nicotine therapeutic option, which can be preferable for patients wishing to avoid nicotine replacement therapy (NRT).
• Demonstrated superior efficacy in achieving long-term abstinence compared to placebo and bupropion in head-to-head clinical studies.
• Can be used in conjunction with behavioral support programs for a comprehensive, multi-modal treatment approach.

Common use

Champix is indicated as an aid to smoking cessation in adults. It is prescribed for patients who are motivated to quit smoking and is most effective when used as part of a comprehensive cessation program that includes educational materials and counseling support. The treatment is initiated while the patient is still smoking, with a designated “quit date” set for between day 8 and day 14 of treatment. This allows the drug to achieve steady-state plasma concentrations, preparing the patient physiologically for abstinence.

Dosage and direction

The dosage of Champix must be individualized and administered under the direction of a healthcare professional. The standard course of treatment is 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional 12-week course may be considered to further increase the likelihood of long-term abstinence.

• Days 1 to 3: 0.5 mg once daily.
• Days 4 to 7: 0.5 mg twice daily.
• Day 8 to end of treatment: 1 mg twice daily. The tablets should be taken orally after eating and with a full glass of water to minimize potential nausea. Dose titration is essential for tolerability. For patients with severe renal impairment (estimated creatinine clearance <30 mL/min), the target dose is reduced to 1 mg once daily following the same initial titration. Champix is not recommended for patients with end-stage renal disease.

Precautions

Patients should be advised of the following precautions:

• Neuropsychiatric Symptoms: Patients, their caregivers, and families should be alert to and monitor for the emergence or worsening of depression, suicidal ideation, suicidal behavior, or changes in behavior or thinking. These symptoms, along with agitation, hostility, and anxiety, have been reported in patients attempting to quit smoking with Champix. Immediate medical attention should be sought if such symptoms occur.
• Nausea: Nausea is a common side effect. Taking the dose with food and a full glass of water can help manage it. Dose reduction is also an option.
• Cardiovascular Events: Patients with underlying cardiovascular (CV) disease should be monitored. While a definitive causal relationship has not been established, physicians should weigh the benefits against potential risks in patients with known CV disease.
• Seizures: Although rare, seizures have been reported. Champix should be used with caution in patients with a history of seizures or other factors that can lower the seizure threshold.
• Somnanbulism: Reports of sleepwalking have been described. Patients should be advised to discontinue Champix and notify their physician if they experience such episodes.
• Pregnancy and Lactation: The risks and benefits must be carefully considered, as the safety of varenicline in pregnant women has not been established. It is not recommended during breastfeeding.

Contraindications

Champix is contraindicated in the following populations:

• Patients with a known hypersensitivity to varenicline tartrate or any other components of the formulation.
• Its use is not recommended in patients with severe renal impairment (end-stage renal disease).

Possible side effect

The most common adverse reactions are dose-dependent and often transient. They include:

• Very common (≥1/10): Nausea, insomnia, abnormal dreams.
• Common (≥1/100 to <1/10): Headache, constipation, flatulence, vomiting, dyspepsia, dry mouth, dizziness, fatigue, sleep disorder, altered mood, irritability, agitation, anxiety, increased appetite.
• Uncommon (≥1/1,000 to <1/100): Depression, suicidal ideation, lethargy, hallucinations, disorientation, aggression, psychomotor hyperactivity, tachycardia, hypertension, flushing, rash, hyperhidrosis, arthralgia, muscle cramps, chest pain, tinnitus, dysgeusia (taste disturbance), polyuria.
• Rare (<1/1,000): Seizures, hypersensitivity reactions (including angioedema), somnambulism, retinopathy, ventricular arrhythmias, myocardial infarction.

Drug interaction

Formal drug-drug interaction studies have shown no clinically meaningful interactions with several common medications. However, considerations include:

• Cimetidine: Co-administration increased systemic exposure of varenicline by 29%. This is not considered clinically meaningful for most patients.
• Nicotine Replacement Therapy (NRT): Concurrent use may increase the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue. The efficacy of this combination has not been demonstrated.
• Drugs Primarily Cleared by Secretion via Organic Cation Transporter 2 (OCT2): Varenicline is a substrate of OCT2. Co-administration may theoretically alter the plasma levels of drugs that are substrates of this transporter (e.g., metformin, cimetidine). Dose adjustment of the co-administered drug may be required.
• Alcohol: There have been post-marketing reports of increased intoxicating effects of alcohol and, in some cases, aggressive or unusual behavior during treatment with Champix. Patients should be advised to reduce alcohol consumption until they know how Champix affects them.

Missed dose

If a dose is missed, it should be taken as soon as remembered. However, if it is close to the time for the next dose, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed one.

Overdose

Cases of overdose have been reported. Symptoms are generally an extension of its known adverse effect profile, including severe nausea, vomiting, drowsiness, and tachycardia. In the event of suspected overdose, standard supportive measures should be initiated as required. Due to the substantial renal elimination of varenicline, dialysis may be useful in severe cases. The maximum tolerated dose in clinical trials was 3 mg daily, and doses above this are not recommended.

Storage

Champix should be stored in its original blister package at room temperature (15°C to 30°C / 59°F to 86°F). It must be kept out of sight and reach of children and pets. The medication should not be used after the expiration date printed on the packaging.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The prescribing information provided by the manufacturer is the ultimate authority on the safe and effective use of this product.

Reviews

• Clinical Evidence: “A 2016 Cochrane review of 27 trials concluded that varenicline is more effective than placebo, bupropion, and single-form NRT for achieving long-term smoking abstinence. Pooled results from 15 trials with over 7,000 participants showed a risk ratio of 2.24 for abstinence versus placebo at 24 weeks.” - Cochrane Database of Systematic Reviews
• Real-World Effectiveness (EUREST-PLUS Study): “This prospective study confirmed the high effectiveness of varenicline in a real-world setting across eight European countries, with continuous abstinence rates at 52 weeks significantly higher than in unaided attempts.” - European Respiratory Journal
• Patient Testimonial (Compiled from various sources): “The first week was an adjustment with some nausea, but sticking with the dosing schedule was key. By my quit date, the smell of smoke was unappealing. The biggest benefit was that it quieted the ’noise’ of the craving, allowing me to focus on breaking the habit itself. Combined with support from my doctor, it was the tool I needed to succeed after 20 years of smoking.”