Varenicline

DEA Class; Rx

Common Brand Names; Chantix

Nicotinic acetylcholine receptor agonist
Oral formulation used to promote smoking cessation; intranasal formulation used for dry eye disease
Monitor closely for emerging or worsening suicidal thoughts/behavior, depression, or other changes in mood or behavior

Indicated for use as an adjunct to psychosocial interventions for tobacco cessation (smoking cessation).

Documented hypersensitivity or skin reactions to drug or components of formulation

Nonsmokers

• Nausea (15-40%; dose related)
• Abnormal dreams
• Headache
• Insomnia
• Appetite changes
• Chest pain
• Constipation
• Dry mouth
• Dyspepsia
• Dyspnea
• Flatulence
• Gastroesophageal reflux disease (GERD)
• Fatigue or lethargy
• Pruritus
• Rash
• Somnolence
• Rhinorrhea
• Vomiting
• Upper respiratory tract disorder
• Abnormal liver function tests
• Anemia
• Anxiety
• Arrhythmia
• Arthralgia
• Depression
• Diarrhea
• Dizziness
• Epistaxis
• Hypertension
• Myocardial infarction (MI)
• Polyuria
• Respiratory disorder

May cause nausea; reduce dose if nausea occurs

Somnambulism reported, including cases describing harmful behavior to self, others, or property; instruct patients to discontinue varenicline and notify their healthcare professional

Seizures reported; some patients had no history of seizures, whereas others had a history of seizure disorder that was remote or well-controlled; in most cases, the seizure occurred within the first month of therapy; use with caution in patients with history of seizures or with other factors that might lower seizure threshold

May cause CNS depression; use caution when performing tasks requiring mental alertness, such as, operating heavy machinery or driving

Hypersensitivity reactions reported, including angioedema

Rare but serious skin reactions reported, including Stevens-Johnson Syndrome and erythema multiforme

Available data have not suggested increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke

Because there are no data on presence of varenicline in human milk and effects on breastfed infant, breastfeeding women should monitor their infant for seizures and excessive vomiting, which are adverse reactions that have occurred in adults that may be clinically relevant in breastfeeding infants