Adult Dosing

Smoking cessation

• 1 mg PO bid for 11 weeks
• Initially 0.5 mg PO daily x 3 days, then 0.5 mg PO bid x 4 days, followed by 1 mg PO bid from day 8 through the end of 12 weeks
• Stop smoking after 7 days of treatment
• Max: 2 mg/day
• May repeat an additional treatment course (12 wks) if patient has stopped smoking at the end of 12 weeks
• Start treatment one week prior to planned smoking cessation

Pediatric Dosing

• Safety and effectiveness in pediatric patients has not been established

• Smoking cessation

• Hypersensitivity to any of the ingredients of the product
• Patients less than 18 years

• Reports of serious neuropsychiatric events including depression, suicidal ideation, suicide attempt and completed suicide, in patients with or without preexisting psychiatric disease; some cases complicated by symptoms of nicotine withdrawal in patients who stopped smoking. Depression, suicidal ideation, has occurred in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking varenicline who continued to smoke; monitor carefully
• Advise patients and caregivers to contact healthcare provider if symptoms of suicidal ideation or suicidal behavior, agitation, hostility, depressed mood, or changes in behavior of the patient are observed. In many post-marketing cases, resolution of symptoms after discontinuation was reported, although in some cases the symptoms persisted; ongoing monitoring until symptom resolution is warranted
• Safety and efficacy in serious psychiatric illness have not been established
• Weigh risks against the benefits of smoking cessation
• Increase in likelihood of abstinence from smoking (for as long as one year) vs. placebo

Renal Dose Adjustment (Based on CrCl)

• 30-80 mL/min: No dose adjustments
• 30 mL/min: Start 0.5 mg PO daily, may be titrated to max 0.5 mg PO bid
• Hemodialysis: Max 0.5 mg PO daily. No supplement

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

See Supplemental Patient Information

• Approved for use only in adults (18 yrs)
• Serious neuropsychiatric symptoms in patients with or without preexisting psychiatric disease have occurred; discontinue if symptoms such as changes in behavior, suicidal ideation, agitation, depressed mood, or behavior occur [US Black Box Warning]
• Patients who discontinue treatment due to neuropsychiatric events should continue to be monitored until symptoms resolve
• Post-marketing reports of hypersensitivity reactions including angioedema
• Serious skin reactions, including Stevens-Johnson Syndrome and erythema multiforme may occur
• Cardiovascular events such as angina pectoris, nonfatal MI, nonfatal stroke has been reported when used in patients with stable cardiovascular disease
• Serious cardiovascular events such as nonfatal myocardial infarction, need for coronary revascularization, angina pectoris, transient ischemic attack, peripheral vascular disease have been reported during non-treatment follow up to 52 weeks. Varenicline has not been studied in patients with unstable cardiovascular disease
• May affect performance of skilled tasks
• Dose-dependent transient and persistent nausea may occur; reduce dosage
• Monitor for signs of suicidal ideation or behavior, or changes in behavior
• Monitor Cr at baseline

Cautions: Use cautiously in

• Renal impairment (refer dose adjustment section)
• Hx of psychiatric disorder
• Angioedema

Supplemental Patient Information

• Advise caregivers to monitor patients for symptoms of suicidal ideation or suicidal behavior, agitation, hostility, depressed mood, or changes in behavior
• Instruct patient to set a date to quit smoking and start varenicline 1 wk before the quit date or after starting varenicline set a date to quit smoking between days 8 and 35 of treatment. If patient has early lapses after quit day, encourage him/her to continue the attempt

Chantix interacts with :

	Clozapine
	Clozaril
	Fazaclo ODT
	Nicoderm
	Nicorette
	Nicotrol
	Olanzapine
	Versacloz
	Zyprexa
	Zyprexa Relprevv
	Zyprexa Zydis

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer recommends discontinuation of either the drug or of breastfeeding (taking into consideration the importance of drug to the mother).

• CNS: Headache, fatigue/malaise, anxiety, dysgeusia, somnolence, lethargy, syncope, seizures
• CV: Arrhythmias
• GI: Nausea, vomiting, abdominal pain, dyspepsia, flatulence, constipation, xerostomia, GERD, GI bleed, pancreatitis
• PSYCHIATRIC: Suicidality, behavior changes, mood swings, depression, thinking abnormal, insomnia, abnormal dreams, sleep disorders, nightmare, hallucinations
• RESP: Upper respiratory tract disorder, rhinorrhea, dyspnea
• DERM: Stevens-Johnson syndrome, erythema multiforme, rash, pruritis, photosensitivity
• METABOLIC: Appetite changes, anorexia
• EENT: Blurred vision, visual disturbances
• HEMA: Anemia, thrombocytopenia, hypokalemia, hyperkalemia
• GU: Nephrolithiasis, acute renal failure
• MISC: Hypersensitivity, angioedema, accidental injury, chills, fever

• Antagonizes and blocks alpha-4-beta-2 nicotinic acetylcholine receptors; prevents binding of nicotine to receptors
• Bioavailability ~90%
• Minimally metabolized by liver
• Renally excreted (92%) unchanged
• Half-life: 24 hrs

US Trade Name(s)

• Chantix

US Availability

Chantix

• TABS: 0.5, 1 mg
• Starter pack: 0.5 mg (11 tabs) and 1 mg (14 tabs)

Canadian Trade Name(s)

• Champix

Canadian Availability

Champix

• TABS: 0.5, 1 mg
• Starter pack: 0.5 mg (11 tabs) and 1 mg (14 tabs)

UK Trade Name(s)

• Champix

UK Availability

Champix

• TABS: 0.5, 1 mg
• Starter pack: 0.5 mg (11 tabs) and 1 mg (14 tabs)

Australian Trade Name(s)

• Champix

Australian Availability

Champix

• TABS: 0.5, 1 mg
• Combination pack: 0.5 mg (11 tabs) and 1 mg (42 tabs)

Psychiatric

Smoking Cessation Agents

Pulmonary

Smoking Cessation Agents

Pricing data from www.DrugStore.com in U.S.A.

• Chantix Continuing Month Pak 1 MG TABS [Box] (PFIZER U.S.)
  56 mg = $176.99
  168 mg = $483.97
• Chantix 1 MG TABS [Bottle] (PFIZER U.S.)
  56 mg = $179
  168 mg = $506.96
• Chantix 0.5 MG TABS [Bottle] (PFIZER U.S.)
  56 mg = $177.65
  168 mg = $499.17

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Chantix 0.5 MG Oral Tablet

Ingredient(s): Varenicline

Imprint: Pfizer;CHX;0;5

Color(s): White

Shape: Oval

Size (mm): 8.00

Score: 1

Inactive Ingredient(s): cellulose, microcrystalline / anhydrous dibasic calcium phosphate / croscarmellose sodium / silicon dioxide / magnesium stearate

Drug Label Author:
Pfizer Laboratories Div Pfizer Inc

DEA Schedule:
Non-Scheduled

Drug Name: Chantix Continuing Months Of Therapy Pack

Ingredient(s): Varenicline

Imprint: Pfizer;CHX;1;0

Color(s): Blue

Shape: Oval

Size (mm): 10.00

Score: 1

Inactive Ingredient(s): cellulose, microcrystalline / anhydrous dibasic calcium phosphate / croscarmellose sodium / silicon dioxide / magnesium stearate

Drug Label Author:
Pfizer Laboratories Div Pfizer Inc

DEA Schedule:
Non-Scheduled