"Jan. 23, 2013 -- Women who smoke are now just as likely to die of lung cancer and other smoking-related diseases as men -- and smokers of both sexes die, on average, about a decade earlier than non-smokers.
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DOSAGE AND ADMINISTRATION
Usual Dosage for Adults
The recommended and maximum dose of ZYBAN is 300 mg/day, given as 150 mg twice daily. Dosing should begin at 150 mg/day given every day for the first 3 days, followed by a dose increase for most patients to the recommended usual dose of 300 mg/day. There should be an interval of at least 8 hours between successive doses. Doses above 300 mg/day should not be used (see WARNINGS). ZYBAN should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures. Treatment with ZYBAN should be initiated while the patient is still smoking, since approximately 1 week of treatment is required to achieve steady-state blood levels of bupropion. Patients should set a "target quit date" within the first 2 weeks of treatment with ZYBAN, generally in the second week. Treatment with ZYBAN should be continued for 7 to 12 weeks; longer treatment should be guided by the relative benefits and risks for individual patients. If a patient has not made significant progress towards abstinence by the seventh week of therapy with ZYBAN, it is unlikely that he or she will quit during that attempt, and treatment should probably be discontinued. Conversely, a patient who successfully quits after 7 to 12 weeks of treatment should be considered for ongoing therapy with ZYBAN. Dose tapering of ZYBAN is not required when discontinuing treatment. It is important that patients continue to receive counseling and support throughout treatment with ZYBAN, and for a period of time thereafter.
Individualization of Therapy
Patients are more likely to quit smoking and remain abstinent if they are seen frequently and receive support from their physicians or other healthcare professionals. It is important to ensure that patients read the instructions provided to them and have their questions answered. Physicians should review the patient's overall smoking cessation program that includes treatment with ZYBAN. Patients should be advised of the importance of participating in the behavioral interventions, counseling, and/or support services to be used in conjunction with ZYBAN. See Medication Guide at the end of the prescribing information.
The goal of therapy with ZYBAN is complete abstinence. If a patient has not made significant progress towards abstinence by the seventh week of therapy with ZYBAN, it is unlikely that he or she will quit during that attempt, and treatment should probably be discontinued.
Patients who fail to quit smoking during an attempt may benefit from interventions to improve their chances for success on subsequent attempts. Patients who are unsuccessful should be evaluated to determine why they failed. A new quit attempt should be encouraged when factors that contributed to failure can be eliminated or reduced, and conditions are more favorable.
Maintenance: Nicotine dependence is a chronic condition. Some patients may need continuous treatment. Systematic evaluation of ZYBAN 300 mg/day for maintenance therapy demonstrated that treatment for up to 6 months was efficacious. Whether to continue treatment with ZYBAN for periods longer than 12 weeks for smoking cessation must be determined for individual patients.
Combination Treatment With ZYBAN and a Nicotine Transdermal System (NTS)
Combination treatment with ZYBAN and NTS may be prescribed for smoking cessation. The prescriber should review the complete prescribing information for both ZYBAN and NTS before using combination treatment. See also Clinical Trials for methods and dosing used in the ZYBAN and NTS combination trial. Monitoring for treatment-emergent hypertension in patients treated with the combination of ZYBAN and NTS is recommended.
Dosage Adjustment for Patients with Impaired Hepatic Function
ZYBAN should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 150 mg every other day in these patients. ZYBAN should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency of dosing should be considered in patients with mild-to-moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).
Dosage Adjustment for Patients with Impaired Renal Function
ZYBAN Sustained-Release Tablets, 150 mg of bupropion hydrochloride, are purple, round, biconvex, film-coated tablets printed with "ZYBAN 150" in bottles of 60 (NDC 0173-0556-02) tablets and the ZYBAN Advantage Pack® containing 1 bottle of 60 (NDC 0173-0556-01) tablets.
Store at controlled room temperature, 20° to 25°C (68° to 77°F) (see USP). Dispense in tight, light-resistant containers as defined in the USP.
Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709, Manufactured by: GlaxoSmithKline Research Triangle Park or DSM Pharmaceuticals, Inc. Greenville, NC 27834. Revised: August 2011
Last reviewed on RxList: 7/2/2012
This monograph has been modified to include the generic and brand name in many instances.
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