Anchen Pharmaceuticals, Inc.
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Anchen Pharmaceuticals, Inc. Drugs
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![Bupropion Hydrochloride Tablet, Film Coated, Extended Release [Anchen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4c518892-8a67-493a-8251-7a6dac4345bc&name=4b84993f-figure-01.jpg)
Bupropion Hydrochloride
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, as this may lead to an increased risk of adverse effects including seizures. 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) are 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 Medication Guide at the end of the package insert. The goal of therapy with bupropion hydrochloride extended-release tablets (SR) are 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).
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![Levetiracetam Extended-release (Levetiracetam) Tablet, Film Coated, Extended Release [Anchen Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=64a585fa-d55a-4851-a4bf-1be55b3067d9&name=397470a1-figure-01.jpg)
Levetiracetam Extended-release
Treatment should be initiated with a dose of 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg.
2.1 Adult Patients With Impaired Renal Function
Extended-release levetiracetam tablets dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:
Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group CreatinineClearance(mL/min/1.73m2) Dosage(mg) Frequency Normal > 80 1000 to 3000 Every 24 h Mild 50 to 80 1000 to 2000 Every 24 h Moderate 30 to 50 500 to 1500 Every 24 h Severe < 30 500 to 1000 Every 24 h
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