Champix

Varenicline tartrate

Smoking cessation.

1 mg bid after 1-wk titration: Day 1-3: 0.5 mg once daily; day 4-7: 0.5 mg bid; day 8 to end of treatment: 1 mg bid. Duration: 12 wk. Start dosing 1 wk before the quit date. Alternatively, patient can begin dosing & then quit smoking between days 8 & 35 of treatment. Patient who has successfully stopped smoking at the end of 12 wk Additional 12-wk treatment course w/ 1 mg bid as maintenance of abstinence. Patient who is not able or willing to quit abruptly Reduce smoking during 1st 12-wk treatment & quit by the end of treatment. Continue for additional 12 wk for total of 24 wk of treatment. Severe renal impairment (estimated CrCl <30 mL/min) Initially 0.5 mg once daily for the 1st 3 days then increased to 1 mg once daily.

May be taken with or without food: Swallow whole.

Hypersensitivity.

Discontinue treatment at 1st sign of rash or skin reaction; if hypersensitivity reactions including angioedema, swelling of face, mouth (tongue, lips & gums), neck (throat & larynx) & extremities occur. Severe cutaneous reactions including SJS & erythema multiforme. Increased irritability, urge to smoke, depression, &/or insomnia after discontinuation of treatment. Neuropsychiatric symptoms including changes in behavior or thinking, anxiety, psychosis, mood swings, aggressive behavior, agitation, depressed mood, suicidal ideation & behavior in patients attempting to quit smoking. History of seizures or other conditions that potentially lower seizure threshold. Patients w/ CV disease, new or worsening CV symptoms & those experiencing signs & symptoms of MI or stroke. May impair ability to drive or operate machinery. ESRD patients. Avoid use during pregnancy. Lactation. Not recommended for use in ped patients. Elderly (decreased renal function).

Nasopharyngitis; abnormal dreams, insomnia; headache; nausea. Bronchitis, sinusitis; increased wt, increased/decreased appetite; somnolence, dizziness, dysgeusia; dyspnoea, cough; GERD, vomiting, constipation, diarrhoea, abdominal distension & pain, toothache, dyspepsia, flatulence, dry mouth; rash, pruritus; arthralgia, myalgia, back pain; chest pain, fatigue; abnormal LFT.

Increased systemic exposure w/ cimetidine. Increased intoxicating effects of alcohol. Decreased ave systolic BP w/ nicotine replacement therapy.

Drugs Used in Substance Dependence

N07BA03 - varenicline ; Belongs to the class of drugs used in the management of nicotine dependence.

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