second dose with dinner rather than at bedtime may reduce insomnia and dream abnormalities. 72 Patient instructions Bupropion SR treatment should be initiated while the patient is still smoking, because approximately one week of treatment is required to achieve steady-state blood levels of bupropion. Patients should set a “target quit date” within the first two weeks of treatment, generally in the second week. The patient should begin taking 150 mg each day for the first three days. On the fourth day, the dose should be increased to one 150-mg tablet in the morning and one 150-mg tablet in the evening. This dosage should be continued through the end of treatment. There should be an interval of at least eight hours between doses. The tablet should be swallowed whole and not crushed, divided, or chewed. Treatment should be continued for 7 to 12 weeks. Drug therapy may be continued for an additional six months to help prevent relapse. Patients and support-givers should be advised to report any changes in neuro-psychiatric symptoms or worsening of preexisting psychiatric illness. 73 hostility, agitation, anxiety, and panic, as well as suicidal ideation, attempted suicide, and completed suicide. Depression has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking varenicline who continued to smoke. When symptoms were reported, most were during treatment, but some were following discontinuation of drug therapy. These events have occurred in patients with and without preexisting psychiatric disease. Some patients have experienced worsening of their psychiatric illnesses. All patients being treated with varenicline should be observed for neuropsychiatric symptoms or worsening of preexisting psychiatric illness. 72 The U.S. Food and Drug Administration (FDA) recently sponsored two observational studies of neuro-psychiatric adverse events with varenicline and determined that, based on post-marketing surveillance reports, the current warnings in the drug label remain appropriate. 77 On June 16, 2011, the FDA sent notification that varenicline may be associated with a small increased risk of certain adverse cardiovascular events in patients who have cardiovascular disease. This safety information was added to the medication’s warnings and precautions. Nevertheless, smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The clinician must weigh the known benefits of varenicline against its potential risks before recommending use of this drug by smokers with cardiovascular disease. Patients taking varenicline should contact their healthcare professional if they experience new or worsening symptoms of cardiovascular disease. 78 The FDA required the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo- controlled trials. The FDA updated the public following completion of the meta-analysis with the information that there was indeed a small increased cardiovascular risk, though it was not statistically significant. The clinician should advise patients and caregivers that the patient should stop taking varenicline and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. The risks of varenicline should be weighed against the benefits of its use. 79
bupropion SR should be observed for neuropsychiatric symptoms or worsening of preexisting psychiatric illness. The risks of bupropion SR should be weighed against the benefits of its use. The health benefits of quitting smoking are immediate and substantial. Bupropion SR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (pregnancy category C). Bupropion SR and its metabolites are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug. The safety and effectiveness of bupropion SR in the adolescent population has not been established. 72 Side effects Insomnia, dry mouth, dizziness, disturbed concentration, dream abnormality, rhinitis, rash, nervousness, nausea, diarrhea, anorexia, constipation, arthralgia, anxiety, and myalgia have been reported. The most common side effects reported are insomnia and dream abnormalities. Taking the Varenicline acts as a partial agonist, targeting the nicotine receptors in the brain. By binding to and partially stimulating the α 4 β 2 receptor, varenicline blocks nicotine while causing a reduced release of dopamine, decreasing the pleasurable effects of nicotine and reducing cravings. It has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with a placebo. In a 52-week trial comparing varenicline with a placebo, the continuous abstinence rate was significantly higher for the varenicline group than for the placebo group for weeks 13 to 24 (70.5% vs. 49.6%) as well as for weeks 13 to 52 (43.6% vs. 36.9%). 74 The abstinence rate of patients on varenicline therapy was superior to the patient group on bupropion SR in clinical trials. Continuous abstinence for varenicline at 52 weeks was 23% compared to 14.6% in the bupropion SR group. 75 Dosage The patient should set a date to stop smoking and begin varenicline one week before this date. Varenicline should be taken after eating and with a full glass of water. 76 The titration dosage schedule is as follows: Varenicline (Chantix) Mechanism of action Patients should be treated for a minimum of 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks is recommended to further increase the likelihood of long- term abstinence. If smoking cessation is not achieved after 12 weeks of therapy or if relapse has occurred, treatment should be discontinued until factors contributing to the failed attempt have been identified and resolved. Clinicians should consider a temporary or permanent dose reduction in patients who cannot tolerate the side effects. The safety and efficacy of the use of varenicline in combination with other smoking cessation therapies has not been established. 76 Warnings and precautions Caution should be exercised while driving or operating machinery until absence of side effects is established. Accidental injuries (e.g., traffic accidents) have been reported. Serious neuropsychiatric symptoms have been reported in patients being treated with varenicline, including changes in mood (e.g., depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, ● Days 1-3: 0.5 mg once daily. ● Days 4-7: 0.5 mg twice daily. ● Day 8-end of treatment: 1 mg twice daily.
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