RVP

Drug Catalog - Product Detail

BUPROPION HCL SR REFILL TB 150MG 60

NDC Mfr Size Str Form
00591-3543-60 ACTAVIS PHARMA 60 150MG TABLET
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Bupropion hydrochloride extended-release tablets (SR) are a non-nicotine aid to smoking cessation. Bupropion hydrochloride extended-release tablets (SR) are chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (Wellbutrin ®* [bupropion hydrochloride] Tablets and Wellbutrin SR ®* [bupropion hydrochloride] Sustained-Release Tablets), bupropion hydrochloride extended-release tablets (SR) are also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 150 mg white to off-white, film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol. Bupropion hydrochloride structural formula
How Supplied
HOW SUPPLIED Bupropion hydrochloride extended-release tablets (SR), 150 mg of bupropion hydrochloride, are white to off-white, round, film-coated tablets imprinted with WPI over 867 on one side and supplied in bottles of 60 tablets (NDC 0591-3543-60) and the Starter Pack containing 1 bottle of 60 tablets (NDC 0591-3543-76). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP. *The following are registered trademarks of their respective manufacturers: Wellbutrin ® /GlaxoSmithKline, Wellbutrin XL ® /GlaxoSmithKline, Wellbutrin SR ® /GlaxoSmithKline. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: August 2009 0809B 172505-1
Indications & Usage
INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (SR) are indicated as an aid to smoking cessation treatment.
Dosage and Administration
DOSAGE AND ADMINISTRATION Usual Dosage for Adults: The recommended and maximum dose of bupropion hydrochloride extended-release tablets (SR) 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 ). Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed. Treatment with bupropion hydrochloride extended-release tablets (SR) 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 bupropion hydrochloride extended-release tablets (SR), generally in the second week. Treatment with bupropion hydrochloride extended-release tablets (SR) 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 bupropion hydrochloride extended-release tablets (SR), 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 bupropion hydrochloride extended-release tablets (SR). Dose tapering of bupropion hydrochloride extended-release tablets (SR) is not required when discontinuing treatment. It is important that patients continue to receive counseling and support throughout treatment with bupropion hydrochloride extended-release tablets (SR), 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 bupropion hydrochloride extended-release tablets (SR). Patients should be advised of the importance of participating in the behavioral interventions, counseling, and/or support services to be used in conjunction with bupropion hydrochloride extended-release tablets (SR). See information for patients at the end of the package insert. The goal of therapy with bupropion hydrochloride extended-release tablets (SR) is complete abstinence. If a patient has not made significant progress towards abstinence by the seventh week of therapy with bupropion hydrochloride extended-release tablets (SR), 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 bupropion hydrochloride extended-release tablets (SR) 300 mg/day for maintenance therapy demonstrated that treatment for up to 6 months was efficacious. Whether to continue treatment with bupropion hydrochloride extended-release tablets (SR) for periods longer than 12 weeks for smoking cessation must be determined for individual patients. Combination Treatment With Bupropion Hydrochloride Extended-Release Tablets (SR) and a Nicotine Transdermal System (NTS): Combination treatment with bupropion hydrochloride extended-release tablets (SR) and NTS may be prescribed for smoking cessation. The prescriber should review the complete prescribing information for both bupropion hydrochloride extended-release tablets (SR) and NTS before using combination treatment. See also CLINICAL TRIALS for methods and dosing used in the bupropion hydrochloride extended-release tablets (SR) and NTS combination trial. Monitoring for treatment-emergent hypertension in patients treated with the combination of bupropion hydrochloride extended-release tablets (SR) and NTS is recommended. Dosage Adjustment for Patients with Impaired Hepatic Function: Bupropion hydrochloride extended-release tablets (SR) 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. Bupropion hydrochloride extended-release tablets (SR) 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: Bupropion hydrochloride extended-release tablets (SR) should be used with caution in patients with renal impairment and a reduced frequency of dosing should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS ).