Varenicline

Pharmacologic Category

Partial Nicotine Agonist; Smoking Cessation Aid

Dosing: Adult

Smoking cessation: Oral:

Initial:

Days 1 to 3: 0.5 mg once daily.

Days 4 to 7: 0.5 mg twice daily.

Maintenance (day 8 and later): 1 mg twice daily; may consider a temporary or permanent dose reduction if usual dose is not tolerated (Tonstad 2006; manufacturer's labeling).

Duration: Continue maintenance dose for 11 weeks (for a total of 12 weeks of treatment); if the patient successfully quits smoking at the end of 12 weeks, an additional 12-week course may increase likelihood of success (Tonstad 2006).

Approaches to selecting a tobacco quit date: May either choose a fixed quit date (ie, start varenicline, then quit on day 8) or a flexible quit date (ie, start varenicline, then quit between days 8 to 35). Alternatively, a gradual quit date (ie, start varenicline and reduce smoking 50% by week 4, reduce an additional 50% by week 8, and continue reducing with a goal of complete abstinence by week 12) is acceptable (Hajek 2011; Rigotti 2019; manufacturer's labeling).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Initial: 0.5 mg once daily; maximum maintenance dose: 0.5 mg twice daily

ESRD (receiving hemodialysis): Maximum dose: 0.5 mg once daily

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Adjustment for Toxicity: Adult

Patients who cannot tolerate adverse events may require temporary (or permanent) reduction in dose.

Dosing: Pediatric

Smoking cessation: Adolescents ≥17 years: Note: Efficacy has not been established in patients <17 years of age; a randomized, double-blind, placebo-controlled trial including 216 pediatric patients 12 to 16 years of age showed that varenicline did not improve continuous abstinence rates; use is not recommended in pediatric patients ≤16 years of age. In another double-blind, placebo-controlled trial of 157 adolescents and young adults 14 to 19 years of age (mean age: 19.1 ± 1.5 years), the primary efficacy endpoint of end of treatment (week 12) abstinence was the same in both treatment and placebo groups at 8.9%; significant findings in secondary endpoints were observed, including higher weekly self-reported abstinence rates, and patients who achieved 7-day abstinence reported shorter time to achieve 7 days abstinence (39 days compared to 59 days with placebo) (Gray 2019).

Initial: See "Approaches to selecting a tobacco quit date" for additional information.

Days 1 to 3: Oral: 0.5 mg once daily.

Days 4 to 7: Oral: 0.5 mg twice daily.

Maintenance (≥ Day 8): Oral: 1 mg twice daily for 11 weeks; may consider a temporary or permanent dose reduction if usual dose is not tolerated. If patient successfully quits smoking at the end of the 12 weeks, may continue for another 12 weeks to help maintain success. Patients who are motivated to quit and do not succeed in stopping smoking during prior therapy, or who relapse after treatment, should be encouraged to make another attempt with varenicline once factors contributing to the failed attempt have been identified and addressed.

Dosing adjustment for toxicity: Adolescents ≥17 years: Patients who cannot tolerate adverse events may require temporary (or permanent) reduction in dose.

Dosing: Renal Impairment: Pediatric

Adolescents ≥17 years:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Initial: 0.5 mg once daily; maximum maintenance dose: 0.5 mg twice daily.

End-stage renal disease (ESRD) (receiving hemodialysis): Maximum maintenance dose: 0.5 mg once daily.

Dosing: Hepatic Impairment: Pediatric

Adolescents ≥17 years: No dosage adjustment necessary.

Calculations

Use: Labeled Indications

Smoking cessation: As an aid to smoking cessation treatment.

* See Uses in AHFS Essentials for additional information.

Comparative Efficacy

VARENICLINE

Clinical Practice Guidelines

COPD:

Canadian Thoracic Society Recommendations for Management of Chronic Obstructive Pulmonary Disease, 2007 Update

GOLD, "Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease," 2019

CVD Prevention:

American College of Cardiology/American Heart Association (ACC/AHA), “2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease,” March 2019

Nicotine Dependence:

Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline, U.S. Department of Health and Human Services. May 2008

Administration: Oral

Administer after eating and with a full glass of water.

Administration: Pediatric

Oral: Administer after eating and with a full glass of water.

Dietary Considerations

Take after eating and with a full glass of water to decrease gastric upset.

Storage/Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to help you stop smoking.

Frequently reported side effects of this drug

• Passing gas

• Trouble sleeping

• Headache

• Nightmares

• Constipation

• Dry mouth

• Abdominal pain

• Change in taste

• Common cold symptoms

• Loss of strength and energy

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Depression like thoughts of suicide, anxiety, emotional instability, or confusion.

• Sensing things that seem real but are not

• Psychosis

• Anxiety

• Agitation

• Mood changes

• Behavioral changes

• Swelling in your throat

• Severe cerebrovascular disease like change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes.

• Heart attack like chest pain; pain in arms, back, neck, jaw, or abdomen; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting.

• Shortness of breath

• Severe nausea

• Vomiting

• Seizures

• Confusion

• Sleepwalking

• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes.

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf#page=22, must be dispensed with this medication.

Contraindications

Serious hypersensitivity reactions or skin reactions to varenicline or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). There have been postmarketing reports of traffic accidents, near-miss incidents in traffic, or other accidental injuries in patients taking varenicline.

• Hypersensitivity reactions: Postmarketing reports of hypersensitivity reactions (including angioedema) and rare cases of serious skin reactions (including Stevens-Johnson syndrome and erythema multiforme) have been reported. Patients should be instructed to discontinue use and contact healthcare provider if signs/symptoms occur.

• Nausea: Dose-dependent nausea may occur; both transient and persistent nausea has been reported. Dosage reduction may be considered for intolerable nausea.

• Neuropsychiatric effects: Postmarketing cases of serious neuropsychiatric events (including depression, suicidal thoughts, and suicide) have been reported in patients with or without preexisting psychiatric disease; some cases may have been complicated by symptoms of nicotine withdrawal following smoking cessation. Subsequent controlled trials in patients with or without psychiatric disorders; however, have not identified significant differences in neuropsychiatric effects for patients taking varenicline, bupropion, nicotine patches, or placebo (Anthenelli 2013; Anthenelli 2016; Gibbons 2013; Thomas 2015). Monitor all patients for behavioral changes and psychiatric symptoms (eg, agitation, depression, suicidal behavior, suicidal ideation); inform patients to discontinue treatment and contact their health care provider immediately if they experience any behavioral and/or mood changes. Of postmarketing cases, many resolved following therapy discontinuation.

• Somnambulism: Cases of somnambulism, involving harmful behavior to self, others or property, have been reported. Discontinue treatment if somnambulism occurs.

Disease-related concerns:

• Cardiovascular events: Treatment may increase risk of cardiovascular events. A meta-analysis of 15 clinical trials, including a placebo-controlled trial in patients with stable cardiovascular disease, showed an increased incidence of major cardiovascular events (combined outcome of cardiovascular-related death, nonfatal MI, nonfatal stroke) in patients using varenicline compared with placebo. Cardiovascular events were uncommon in both the varenicline and placebo groups. These findings did not reach statistical significance, although data was consistent. Events occurred primarily in patients with known cardiovascular disease. The meta-analysis also showed a lower incidence of all-cause and cardiovascular mortality in varenicline-treated patients, although this was not statistically significant either. Patients should be instructed to contact their health care provider if cardiovascular symptoms occur.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required with severe impairment.

• Seizures: Seizures have been reported in patients with or without a history of seizures. Seizures generally occurred within the first month of therapy. Consider the risks against the benefits before initiating in patients with a history of seizures or other factors that can lower the seizure threshold; discontinue use if seizures occur during therapy.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Dosage adjustment for renal function may be necessary. Although studies to date do not demonstrate any significant pharmacokinetic differences between elderly (65-75 years of age) and younger adults.

Warnings: Additional Pediatric Considerations

Varenicline has not demonstrated efficacy in patients ≤16 years; the manufacturer conducted a randomized, double-blind, placebo-controlled trial including 216 pediatric patients 12 to 16 years of age as part of the Pediatric Research Equity Act which showed that varenicline did not increase smoking abstinence rates compared to placebo in this age group (FDA 2019).

Pregnancy Considerations

Information related to the use of varenicline in pregnancy is limited (Harrison-Woolrych 2013; Kaplan 2014; Richardson 2017).

Nicotine exposure is associated with adverse events to both the mother and fetus. All pregnant females should be encouraged to stop smoking. However, data is insufficient to recommend varenicline for smoking cessation during pregnancy (ACOG 721 2017).

Breast-Feeding Considerations

It is not known if varenicline is present in breast milk.

There is insufficient information related to the use of varenicline to recommend use for smoking cessation in breastfeeding women (ACOG 721 2017). Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother. Infants exposed via breast milk should be monitored for seizures or excessive vomiting.

Briggs' Drugs in Pregnancy & Lactation

Varenicline

Adverse Reactions

>10%:

Central nervous system: Headache (12% to 19%), insomnia (9% to 19%), abnormal dreams (8% to 13%), irritability (11%), suicidal ideation (11%), depression (4% to 11%)

Gastrointestinal: Nausea (16% to 40%), vomiting (5% to 11%)

1% to 10%:

Cardiovascular: Angina pectoris (4%), chest pain (3%), peripheral edema (2%), myocardial infarction (≤1%)

Central nervous system: Anxiety (8%), malaise (7%), agitation (5% to 7%), sleep disorder (3% to 5%), tension (4%), drowsiness (3%), hostility (2% to 3%), lethargy (1% to 2%), nightmares (1% to 2%)

Dermatologic: Skin rash (3%)

Gastrointestinal: Flatulence (6% to 9%), constipation (5% to 8%), dysgeusia (5% to 8%), abdominal pain (7%), diarrhea (6%), xerostomia (6%), dyspepsia (5%), increased appetite (3% to 4%), anorexia (≤2%), decreased appetite (≤2%), gastroesophageal reflux disease (1%)

Respiratory: Upper respiratory tract infection (5% to 7%), dyspnea (2%), rhinorrhea (≤1%)

<1%, postmarketing, and/or case reports: Abnormal hepatic function tests, abnormality in thinking, abnormal urinalysis, accidental injury, acne vulgaris, acute coronary syndrome, acute renal failure, aggressive behavior, allergic rhinitis, altered sense of smell, amnesia, anemia, angioedema, arthralgia, asthma, atrial fibrillation, back pain, behavioral changes, Bell palsy, blurred vision, bradycardia, cardiac arrhythmia, cardiac flutter, cataract (subcapsular), cerebrovascular accident, chills, conjunctivitis, cor pulmonale, coronary artery disease, deafness, decreased libido, decreased mental acuity, decreased visual acuity, delusions, diabetes mellitus, difficulty thinking, disorientation, dissociative disorder, dizziness, dysarthria, dysphagia, ECG abnormality, eczema, edema, elevation in serum levels of skeletal-muscle enzymes, emotional disturbance, emotional lability, enterocolitis, epistaxis, equilibrium disturbance, erectile dysfunction, eructation, erythema, erythema multiforme, esophagitis, euphoria, eye irritation, eye pain, fever, flu-like symptoms, flushing, gallbladder disease, gastric ulcer, gastritis, gastrointestinal hemorrhage, hallucination, homicidal ideation, hyperglycemia, hyperhidrosis, hyperlipidemia, hypersensitivity reaction, hypoglycemia, hypokalemia, intestinal obstruction, lack of concentration, leukocytosis, loss of consciousness, lymphadenopathy, mania, Meniere disease, menstrual disease, migraine, multiple sclerosis, muscle cramps, musculoskeletal pain, myalgia, myositis, nephrolithiasis, nocturia, nocturnal amblyopia, nystagmus, ophthalmic vascular disease, oral mucosa ulcer, osteoporosis, palpitations, pancreatitis, panic, paranoia, photophobia, pleurisy, pollakiuria, polyuria, psoriasis, psychomotor agitation, psychomotor retardation, psychosis, pulmonary embolism, respiratory tract disease, restless leg syndrome, seizure, sensory disturbance, sexual difficulty, skin photosensitivity, somnambulism, splenomegaly, Stevens-Johnson syndrome, syncope, tachycardia, thrombocytopenia, thrombosis, thyroid disease, tinnitus, toothache, transient blindness, transient ischemic attacks, tremor, upper respiratory tract inflammation, urethral disease, urinary retention, urine abnormality, urticaria, ventricular premature contractions, vertigo, visual field defect, vitreous opacity, weight gain, xeroderma, xerophthalmia

* See Cautions in AHFS Essentials for additional information.

Metabolism/Transport Effects

Substrate of OCT2

Drug Interactions Open Interactions

Alcohol (Ethyl): Varenicline may enhance the adverse/toxic effect of Alcohol (Ethyl). Specifically, alcohol tolerance may be decreased and the risk for neuropsychiatric adverse effects may be increased. Risk C: Monitor therapy

Erdafitinib: May increase the serum concentration of OCT2 Substrates. Risk C: Monitor therapy

Histamine H2 Receptor Antagonists: May increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concomitant use of cimetidine or other H2-antagonists, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Risk C: Monitor therapy

Nicotine: Varenicline may enhance the adverse/toxic effect of Nicotine. Risk C: Monitor therapy

Quinolones: May increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concurrent use of levofloxacin or other quinolone antibiotics, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Risk C: Monitor therapy

Tafenoquine: May increase the serum concentration of OCT2 Substrates. Management: Avoid use of OCT2 substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the OCT2 substrate and consider a reduced dose of the OCT2 substrate according to that substrate's labeling. Risk D: Consider therapy modification

Trimethoprim: May increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concomitant use of trimethoprim, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Risk C: Monitor therapy

Monitoring Parameters

Monitor for behavioral changes and psychiatric symptoms (eg, agitation, depression, suicidal behavior, suicidal ideation).

Advanced Practitioners Physical Assessment/Monitoring

Provide educational materials and counseling to support an attempt at quitting smoking. Carefully instruct patient in appropriate titration of doses. Monitor for behavioral and emotional changes, such as hostility, agitation, and suicide ideation. Monitor other medications patient is taking for potential need for dose adjustment after quitting smoking.

Nursing Physical Assessment/Monitoring

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Chantix: 0.5 mg

Chantix: 1 mg [contains fd&c blue #2 aluminum lake]

Chantix Continuing Month Pak: 1 mg [contains fd&c blue #2 aluminum lake]

Chantix Starting Month Pak: 0.5 mg x 11 & 1 mg x 42

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Miscellaneous, Oral:

Champix Starter Pack: 0.5 MG X 11 & 1 MG X 14 (25 ea)

Generic: 0.5 MG X 11 & 1 MG X 14 (25 ea)

Tablet, Oral:

Champix: 0.5 mg

Champix: 1 mg [contains fd&c blue #2 aluminum lake]

Generic: 0.5 mg, 1 mg

Anatomic Therapeutic Chemical (ATC) Classification

N07BA03

Generic Available (US)

Pricing: US

Tablets (Chantix Continuing Month Pak Oral)

1 mg (per each): $9.48

Tablets (Chantix Oral)

0.5 mg (per each): $9.48

1 mg (per each): $9.48

Tablets (Chantix Starting Month Pak Oral)

0.5 MG X 11 & 1 MG X 42 (per each): $10.02

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Partial neuronal α4 β2 nicotinic receptor agonist; prevents nicotine stimulation of mesolimbic dopamine system associated with nicotine addiction. Also binds to 5-HT3 receptor (significance not determined) with moderate affinity. Varenicline stimulates dopamine activity but to a much smaller degree than nicotine does, resulting in decreased craving and withdrawal symptoms.

Pharmacodynamics/Kinetics

Absorption: Well absorbed; unaffected by food

Protein binding: ≤20%

Metabolism: Minimal (<10% of clearance is through metabolism)

Bioavailability: ~90%

Half-life elimination: ~24 hours

Time to peak, plasma: ~3 to 4 hours

Excretion: Urine (92% as unchanged drug)

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment:

Moderate renal impairment (CrCl ≥30 to ≤50 mL/minute): Drug exposure increased 1.5-fold

Severe renal impairment (CrCl <30 mL/minute): Drug exposure increased 2.1-fold

ESRD requiring hemodialysis: Drug exposure increased 2.7-fold

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Infrequent occurrences of xerostomia (normal salivary flow resumes upon discontinuation) and dysgeusia have been reported. Rare occurrences of Bell palsy, erythema multiforme, oral mucosa ulcer, Stevens-Johnson syndrome, and toothache have also been reported.

Effects on Bleeding

No information available to require special precautions

Dental Usual Dosing

Smoking cessation: Oral:

Initial:

Days 1 to 3: 0.5 mg once daily

Days 4 to 7: 0.5 mg twice daily

Maintenance (≥ Day 8): 1 mg twice daily for 11 weeks

Note: Start 1 week before target quit date. Alternatively, patients may consider setting a quit date up to 35 days after initiation of varenicline (some data suggest that an extended pretreatment regimen may result in higher abstinence rates [Hajek, 2011]). If patient successfully quits smoking at the end of the 12 weeks, may continue for another 12 weeks to help maintain success. If not successful in first 12 weeks, then stop medication and reassess factors contributing to failure.

Related Information

First-Line Smoking Cessation Products

Pharmacotherapy Pearls

In all studies, patients received an educational booklet on smoking cessation and received up to 10 minutes of counseling at each weekly visit. Dosing started 1 week before target quit date. Successful cessation of smoking may alter pharmacokinetic properties of other medications (eg, theophylline, warfarin, insulin).

Index Terms

Varenicline Tartrate

FDA Approval Date

May 10, 2006

References

American College of Obstetricians and Gynecologists (ACOG) Committee on Underserved Women; Committee on Obstetric Practice. Committee opinion No. 721: smoking cessation during pregnancy. Obstet Gynecol. 2017;130(4):e200-e204. doi: 10.1097/AOG.0000000000002353.[PubMed 28937573]

Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016;387(10037):2507-2520. doi: 10.1016/S0140-6736(16)30272-0.[PubMed 27116918]

Anthenelli RM, Morris C, Ramey TS, et al. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005.[PubMed 24042367]

Chantix (varenicline) [prescribing information]. New York, NY: Pfizer Labs; February 2019.

Fiore M, Jaen CR, Baker TB, et al, “A Clinical Practice Guideline for Treating Tobacco Use and Dependence: 2008 Update. A U.S. Public Health Service Report,” Am J Prev Med, 2008, 35(2):158-76.[PubMed 18617085]

Food and Drug Administration (FDA). FDA in brief: FDA updates label for Chantix with data underscoring it's not effective in children 16 and younger. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-updates-label-chantix-data-underscoring-its-not-effective-children-16-and-younger. Published February 22, 2019. Accessed October 3, 2019.

Gibbons RD, Mann JJ. Varenicline, smoking cessation, and neuropsychiatric adverse events. Am J Psychiatry. 2013;170(12):1460-1467. doi: 10.1176/appi.ajp.2013.12121599.[PubMed 24030388]

Gray KM, Baker NL, McClure EA, et al. Efficacy and safety of varenicline for adolescent smoking cessation: a randomized clinical trial [published online October 14, 2019]. JAMA Pediatr. 2019.[PubMed 31609433]

Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji AR. Use of varenicline for 4 weeks before quitting smoking: decrease in ad lib smoking and increase in smoking cessation rates. Arch Intern Med. 2011;171(8):770-777.[PubMed 21518946]

Harrison-Woolrych M, Paterson H, Tan M. Exposure to the smoking cessation medicine varenicline during pregnancy: a prospective nationwide cohort study. Pharmacoepidemiol Drug Saf. 2013;22(10):1086-1092. doi: 10.1002/pds.3489.[PubMed 23926076]

Kaplan YC, Olgac Dündar N, Kasap B, Karadas B. Pregnancy outcome after varenicline exposure in the first trimester. Case Rep Obstet Gynecol. 2014;2014:263981. doi: 10.1155/2014/263981.[PubMed 24639907]

Richardson JL, Stephens S, Yates LM, et al. Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services. Reprod Toxicol. 2017;67:26-34. doi: 10.1016/j.reprotox.2016.11.010.[PubMed 27851994]

Rigotti NA. Pharmacotherapy for smoking cessation in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 25, 2019.

Thomas KH, Martin RM, Knipe DW, Higgins JP, Gunnell D. Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis. BMJ. 2015;350:h1109. doi: 10.1136/bmj.h1109.[PubMed 25767129]

Tonstad S, Tønneson P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):64-71.[PubMed 16820548]

Brand Names: International

Champix (AE, AR, AT, AU, BE, BG, BH, BR, BZ, CH, CL, CN, CO, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MT, MX, MY, NL, NO, NZ, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, UY, VE, VN, ZW); Varni (BD)

Last Updated 3/4/20

Google Sites

Report abuse