Chantix Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

Varenicline is used by adults to help stop smoking. To increase your chance of success, use this medication with a stop-smoking program that includes education, support, and counseling. Quitting smoking lowers your risk of heart and lung disease, as well as cancer. Varenicline works by blocking nicotine’s effects in the brain that make you want to smoke.Discuss the risks and benefits of this medication, as well as other ways to quit smoking (such as nicotine replacement treatment), with your doctor.

How to use Chantix

Read the Medication Guide provided by your pharmacist before you start taking varenicline and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

There are different ways to use varenicline. One way is to set a date to quit smoking before beginning treatment with this drug. Begin taking varenicline as directed by your doctor, 1 to 2 weeks before the quit date. Take one 0.5-milligram tablet once a day for 3 days, then increase to one 0.5-milligram tablet twice a day for 4 days. The dose is slowly increased to lessen the chance of side effects (such as nausea, unusual dreams). It is okay to smoke during this time. Stop smoking on the quit date. Take the dose prescribed by your doctor twice a day for the rest of the treatment period (usually 12 weeks).

Another way to use varenicline is to start taking the drug before you choose a date to quit smoking. Start with the 0.5-milligram tablets and increase the dose as directed by your doctor. Pick a date to quit smoking that is between days 8 and 35 of treatment. Stop smoking on the date you have chosen. Take the dose prescribed by your doctor for the rest of the treatment period.

If you are not able to pick a quit date, your doctor may direct you to start taking this medication and gradually reduce smoking with a goal to quit by the end of your treatment. Follow your doctor’s directions carefully and reduce smoking as directed.

If this medication comes in a dosing package, carefully follow the directions on the dosing package. There are two types of dosing packs: a starting pack and a continuing pack, each containing different strengths of this medication. If this medication comes in a bottle, carefully follow your doctor’s directions on the prescription label. If you have any questions about how to take this medication, talk to your doctor or pharmacist.

Take this medication by mouth after eating food and with a full glass of water.

The dosage is based on your medical condition and response to treatment.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Do not take more than 1 milligram twice a day.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if you continue to smoke after a few weeks of treatment. If you are not able to quit smoking after 12 weeks of treatment, talk to your doctor.

If you are successful and cigarette-free after 12 weeks of treatment, your doctor may recommend another 12 weeks of treatment with varenicline.

Side Effects

See also Precautions section.

Nausea, headache, vomiting, drowsiness, gas, constipation, trouble sleeping, unusual dreams, or changes in taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: burning feeling in feet/toes, unusual pain in the legs when walking.

Stop taking varenicline and get medical help right away if you have any very serious side effects, including: seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion), harmful behavior to self/others/property.

Rarely, varenicline may cause serious mental/mood changes, even after stopping the medication. Drinking alcohol while taking this medication may increase the risk for mental/mood changes. Quitting smoking itself may also cause mental/mood changes. Stop taking varenicline and tell your doctor or pharmacist right away if you have symptoms such as depression/suicidal thoughts, agitation, aggression, or other unusual thoughts or behavior.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking varenicline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood disorders (such as schizophrenia, bipolar disorder, depression), heart/blood vessel disease (such as coronary artery disease, peripheral vascular disease, stroke), seizure.

This drug may make you dizzy, drowsy, lose consciousness, or make it difficult to concentrate. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This drug may also make you more sensitive to alcohol (including increased drunkenness, unusual behavior, and limited or no memory of things that happened). Limit alcoholic beverages. Be aware of how alcohol affects you while taking this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Smoking can affect the way your body removes certain drugs such as insulin, theophylline, warfarin, among others. When you stop smoking, your doses of these drugs may need to be adjusted by your doctor. Tell all your doctors and pharmacists that you are quitting smoking and of all the products you take.

Does Chantix interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Chantix 1 mg tablet

Color: light blueShape: oblongImprint: Pfizer CHX 1.0

This medicine is a light blue, oblong, film-coated, tablet imprinted with “Pfizer” and “CHX 1.0”.

Chantix 0.5 mg tablet

Color: whiteShape: oblongImprint: Pfizer CHX 0.5

This medicine is a light blue, oblong, film-coated, tablet imprinted with “Pfizer” and “CHX 1.0”.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued 3-9-2015.

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
References

Safety Announcement

[10-24-2011] The U.S. Food and Drug Administration (FDA) has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline).

Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT; e.g., NicoDerm patches). However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events (see Data Summary below for more information). Although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix.

Healthcare professionals and patients should continue to follow the recommendations in the physician label and the patient Medication Guide, and to monitor for neuropsychiatric symptoms when prescribing or using Chantix. Based on FDA’s assessment of currently available data, the Agency continues to believe that the drug’s benefits outweigh the risks and the current warnings in the Chantix drug label are appropriate.

The risk of serious neuropsychiatric events with Chantix is currently highlighted in the Boxed Warning and Warnings and Precautions section of the physician label and in the patient Medication Guide. Such events can include changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. These warnings were based on postmarketing reports describing changes in mood and behavior during and after Chantix use (see 2008 Public Health Advisory and 2009 Public Health Advisory).

FDA is continuing to evaluate the risk of neuropsychiatric events with Chantix. The drug manufacturer is conducting a large safety clinical trial of Chantix to assess neuropsychiatric adverse events, and results from this study are expected in 2017.

Additional Information for Patients

• Some patients have experienced changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions while using Chantix to help them quit smoking. Some patients had these symptoms soon after they began taking Chantix, and others developed them after several weeks of treatment, or after stopping Chantix.
• Before taking Chantix, patients should inform their healthcare professional if they have ever had depression or other mental health problems.
• If a patient develops agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for them, or if a patient develops suicidal ideation or behavior, they should immediately discontinue Chantix and report these symptoms to their healthcare professional.
• Patients should read the Medication Guide that they get along with their Chantix prescription. It explains the risks associated with the use of Chantix.
• Patients should report serious side effects from the use of Chantix to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of this page.

Additional Information for Healthcare Professionals 

• Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Chantix.
• Serious neuropsychiatric adverse events, including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide, have been reported in patients taking Chantix.
• Healthcare professionals should ask patients about any history of psychiatric illness, especially depression, prior to initiating treatment with Chantix.
• Healthcare professionals should advise patients and caregivers that the patient should immediately stop taking Chantix and contact a healthcare professional if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior while taking or shortly after discontinuing Chantix.
• Healthcare professionals should encourage patients to read the Medication Guide they receive along with their Chantix prescription.
• Healthcare professionals should report adverse events involving Chantix to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of this page

Data Summary

FDA sponsored two observational studies of neuropsychiatric adverse events with Chantix. One was conducted by the Department of Veterans Affairs’ (VA) Center for Medication Safety (VAMedSAFE), and the other by the Department of Defense’s (DoD) U.S. Army Medical Command’s Pharmacovigilance Center (PVC; hereafter referred to as the “DoD study”).

The VA study was a retrospective cohort study to evaluate the incidence of mental health hospitalizations among veterans using Chantix or nicotine replacement therapy (NRT). Patients starting Chantix or NRT between May 1, 2006 and September 30, 2007, but with no Chantix or NRT use in the previous year, were selected and matched in a 1:1 ratio by use of propensity scores (reflecting demographic characteristics, comorbidities, and psychiatric history). Propensity score matching is a method of balancing patient characteristics between the treatment groups being compared. The study’s main outcome was psychiatric hospitalization, with a coded primary discharge diagnosis for one of a number of psychiatric conditions, including drug-induced mental disorders, schizophrenic disorders, other psychotic disorders, depression, suicide attempts, and other mood disorders. Because the spontaneous adverse event reports for Chantix suggested a relatively short time to onset for psychiatric reactions, psychiatric hospitalizations for selected psychiatric diagnoses were assessed for 30 days after a prescription fill for Chantix or NRT.

The VA study population included 14,131 Chantix users and an equal number of NRT users. Among these patients, there were 16 psychiatric hospitalizations in Chantix-treated patients, and 21 in NRT patients. A Cox proportional hazards analysis showed no statistically significant difference in the risk of psychiatric hospitalization for Chantix users compared to NRT users (hazard ratio [HR] for Chantix/NRT = 0.76; 95% confidence interval [CI] 0.40-1.46). A complementary analysis in a prevalent user cohort of patients who had used NRT in the past before initiating Chantix or refilling an NRT prescription also showed no statistically significant difference in psychiatric hospitalizations between the two treatment groups. Also, the results using time periods longer than 30 days after a prescription fill were similar.

The DoD study was also a retrospective cohort study comparing the acute (30-day) rates of hospitalizations for neuropsychiatric adverse events among new users of Chantix (n=19,933) and NRT patch (n=15,867) who started therapy from August 1, 2006 to August 31, 2007 in the Military Health System. Patients were drawn from active duty military personnel, military retirees, and the dependents of either. Chantix users were matched using propensity scores to NRT users, with subgrouping by concomitant use of the prescription smoking cessation drug bupropion. After propensity score matching, there were 11,978 Chantix users and an equal number of NRT users in the study sample. The main outcome was a primary hospital discharge diagnosis for a neuropsychiatric condition. The following neuropsychiatric diagnoses were identified using ICD-9 codes: drug-induced mental disorders, transient mental disorders, schizophrenia, episodic and mood disorders, delusional disorders, other nonorganic psychoses, anxiety disorders, personality disorders, posttraumatic stress disorder (PTSD), depressive disorders, and suicide attempt.

In the DoD study’s propensity score matched samples, there were 18 psychiatric hospitalizations among Chantix users and 16 among NRT users. A Cox proportional hazard analysis did not show a statistically significant difference (HR for Chantix/NRT = 1.13; 95% CI 0.57-2.21). There was also no significant difference in psychiatric hospitalizations for Chantix users compared to NRT users when patients with concomitant bupropion use were excluded (HR = 0.91; 95% CI 0.39-2.14). Most (43) of the 55 neuropsychiatric hospitalizations (18 of the 23 Chantix events and 25 of the 32 NRT events) occurred in patients with a neuropsychiatric diagnosis in the year preceding the Chantix/NRT prescription fill, although such patients were a minority of the cohorts. Among patients with a neuropsychiatric diagnosis in the preceding year, 0.7% of Chantix users and 1.4% of NRT users were hospitalized for psychiatric care.

A strength of both studies was the inclusion of patients with pre-existing psychiatric disorders, since these patients were typically excluded from the clinical trials conducted with Chantix before it was approved (i. e., in premarketing trials).

Although neither study found a measurable increase in psychiatric hospitalizations with Chantix versus NRT, these results should be interpreted with the limitations of both studies in mind. The sample sizes in both studies were too small to assess rare, idiosyncratic events. Focusing on psychiatric hospitalizations is a useful approach for  assessing the risk of serious neuropsychiatric adverse events, but it does not allow an assessment of less severe neuropsychiatric events that did not result in a psychiatric hospitalization (in the periods studied). Although the studies did not find a difference in psychiatric hospitalization risk between Chantix and NRT, they do not exclude the possibility that both treatments carry a similar risk. In addition, the VA study did not include PTSD as a reason for psychiatric hospitalization; one published report suggested that patients with PTSD may be more susceptible to the neuropsychiatric adverse effects of Chantix. ³ Also, the DoD study only assessed a 30-day risk period following the fill date of the first qualifying prescription for Chantix or NRT and did not evaluate the rate of neuropsychiatric hospitalizations occurring over a longer duration following a Chantix prescription fill.

Overall, FDA has determined that the current warnings in the Chantix drug label, based on postmarketing surveillance reports, remain appropriate.

FDA is continuing to evaluate the risk of neuropsychiatric adverse events with Chantix. The manufacturer of Chantix, Pfizer, is conducting a large safety clinical trial of Chantix to assess neuropsychiatric adverse events as outcomes. Results from this trial are expected in 2017.

References

1. MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US). Drug & Supplements Monograph: Varenicline. Available from: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a606024.html. Accessed September 6, 2011.
2. SDI, Vector One®: National (VONA) and Total Patient Tracker (TPT). May 2006-July 2011. Data extracted September 2011.

3. Campbell AR, Anderson KD. Mental health stability in veterans with posttraumatic stress disorder receiving varenicline. Am J Health Syst Pharm. 2010;67:1832-7.

• Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban
• Public Health Advisory: Important Information on Chantix (varenicline)
• Varenicline (marketed as Chantix) Information
• Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la revisiÃn de seguridad de Chantix (vareniclina) y el riesgo de efectos neuropsiquiÃtricos adversos

Wellbutrin vs Chantix: Differences and Side Effects

Wellbutrin

• Are Chantix and Wellbutrin the same thing?
• What are the possible side effects of Wellbutrin?
• What are the possible side effects of Chantix?
• What is Wellbutrin?
• What is Chantix?
• What drugs interact with wellbutrin?
• What drugs interact with Chantix?
• How should Wellbutrin be taken?
• How should I take shantyx?

Are Wellbutrin and Shantix the same thing?

Wellbutrin (bupropion) is an antidepressant used to treat major depression and seasonal affective disorder and Chantix (varenicline) is used for smoking cessation. The Zyban brand name Bupropion is used in the same way as Chantix to help people quit smoking by reducing cravings and other withdrawal effects.

What are the possible side effects of Wellbutrin?

Common side effects of Wellbutrin include:

convulsions (especially at higher doses).

What are the possible side effects of Chantix?

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Common side effects of Chantix include:

• nausea (may persist for several months),
• abdominal pain,
• upset stomach,
• constipation,
• gas
• vomiting a,
• headaches,
• weakness ,
• fatigue,
• unusual dreams,
• trouble sleeping (insomnia),
• headache, dry mouth, or
• bad taste in the mouth.

What is Wellbutrin?

Wellbutrin is a prescription medicine used to treat adults with a specific type of depression called major depressive disorder.

What is Chantix?

Chantix is ​​a prescription drug to help people stop smoking.

Quitting smoking can reduce your chances of getting lung disease, heart disease, or certain smoking-related cancers.

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CHANTIX is not known to be safe and effective in children.

It is not known if CHANTIX is safe and effective when used with other smoking cessation medicines.

What drugs interact with wellbutrin?

Wellbutrin may interact with insulin, anticoagulants and asthma medications. Wellbutrin may also interact with many medications, including heart or blood pressure medications, HIV or AIDS medications, anticonvulsants, other antidepressants, medications to treat psychiatric disorders, antibiotics, antihistamines that cause drowsiness, bronchodilators, birth control pills, or hormone replacement estrogens bladder or urinary tract medications, diet pills, stimulants, ADHD medications, oral diabetes medications, nausea/vomiting/motion sickness medications, medications to treat or prevent malaria, medications to treat Parkinson’s disease, medications for restless leg syndrome, pituitary tumor medicines, medicines used to prevent transplant rejection, narcotics, medicines that cause numbness, steroids, theophylline, or medicines for an ulcer or irritable bowel.

What drugs interact with Chantix?

Chantix may interact with insulin, anticoagulants and asthma medications.

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How should I take Wellbutrin?

• Take Wellbutrin exactly as directed by your doctor. Do not change your dose or stop taking Wellbutrin without first talking to your doctor.
• Swallow Wellbutrin tablets whole. Do not chew, cut or crush Wellbutrin tablets.
• Take Wellbutrin at the same time each day.
• Take doses of Wellbutrin at least 6 hours apart.
• You can take Wellbutrin with or without food.
• If you miss a dose, do not take an extra dose to make up for the missed dose. Wait and take your next dose at the usual time. It is very important. Too much Wellbutrin can increase the chance of an attack.
• If you take too much Wellbutrin or overdose, call your local emergency room or poison control center right away.
• Do not take any other medicines while taking Wellbutrin unless your doctor has told you that this is normal.
• If you are taking Wellbutrin for major depressive disorder, it may take you a few weeks to feel that Wellbutrin is working. Once you feel better, it is important to continue taking Wellbutrin as directed by your healthcare provider. Call your doctor if you don’t feel Wellbutrin is right for you.

How should I take shantyx?

There are 3 ways to use CHANTIX to stop smoking. Talk to your doctor about the following 3 ways to use CHANTIX:

• Pick a quit date. Start taking CHANTIX 1 week (7 days) prior to your quit date. Take CHANTIX for 12 weeks.
• OR
• Start CHANTIX before your quit date. Choose a date to quit smoking between 8 and 35 days of treatment. Take CHANTIX for 12 weeks.
• OR
• If you are sure you cannot or do not want to stop smoking right away, start taking CHANTIX and reduce smoking during the first 12 weeks of treatment as follows:

Days 1-3:	0, 5 mg once a day
Days 4-7:	0. 5 mg twice a day
Day 8 – end of treatment:	1 mg twice a day

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