Generic Name and Formulations:
Varenicline (as tartrate) 0.5mg, 1mg; tabs.

Company:
Pfizer Inc.
Indications for CHANTIX:
Smoking cessation aid.

Adult:
Provide patients with counseling and educational support. Set a target "quit date". Begin therapy 1 week before target quit date. Alternatively, may begin therapy and then quit smoking between Days 8 and 35 of treatment. Take after eating with a glass of water. ≥18yrs: initially 0.5mg once daily for 3 days, then 0.5mg twice daily for 4 days, then 1mg twice daily. May reduce dose if intolerable nausea or other adverse effects occur. Treat for 12 weeks; may continue 12 more weeks if patient successfully stops smoking to further increase the likelihood of abstinence. Severe renal impairment: initially 0.5mg once daily; may titrate to max 0.5mg twice daily. End stage renal disease with hemodialysis: max 0.5mg once daily if tolerated. Reeva luate if abstinence is not achieved after 1st 12 weeks. If patient motivated to quit, encourage another attempt with Chantix once factors contributing to failed attempt have been addressed.

Children:
<18yrs: not established.

Pharmacological Class:
alpha4-beta2 nicotinic acetylcholine receptor partial agonist.

Warnings/Precautions:
Psychiatric disorders (monitor). Seizure disorder. Cardiovascular disease; monitor for new or worsening signs/symptoms. Renal impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
May affect alcohol tolerance; reduce alcohol consumption until effects are known. Smoking cessation may affect metabolism of other drugs (eg, warfarin, theophylline, insulin). Increased adverse effects with nicotine replacement therapy.

Adverse Reactions:
Nausea, other GI effects (eg, constipation, flatulence, vomiting), sleep disturbance (eg, abnormal dreams, insomnia); nicotine withdrawal symptoms (due to smoking cessation); serious neuropsychiatric symptoms (eg, behavioral changes, agitation, depression, suicidal ideation), cardiovascular events; angioedema, serious skin reactions, seizures (discontinue if occurs).

REMS:
YES

How Supplied:
Tabs—56; Starting Month PAK (0.5mg x 11 tabs + 1mg x 42 tabs)—1; Continuing Month PAK (1mg x 56 tabs)—1