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BUDEPRION

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Overview

What is BUDEPRION?

Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, are 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 designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.  The molecular weight is 276.2. The molecular formula is CHClNO•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 (XL) are supplied for oral administration as 150-mg and 300-mg, round white to off-white extended-release tablets.  Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethyl alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide and hydrogenated vegetable oil. The tablets are printed with edible black ink.  The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.  USP drug release testing is pending



What does BUDEPRION look like?



What are the available doses of BUDEPRION?

Sorry No records found.

What should I talk to my health care provider before I take BUDEPRION?

Sorry No records found

How should I use BUDEPRION?

Major Depressive Disorder:

The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS).

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.

The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

General Dosing Considerations:

Major Depressive Disorder: Initial Treatment:

Increasing the Dosage Above 300 mg/day:

Maintenance Treatment:

Switching Patients from Wellbutrin

(bupropion hydrochloride tablets) or from Wellbutrin

SR (bupropion hydrochloride extended-release tablets (SR), revise subsection as follows:

When switching patients from Wellbutrin (bupropion hydrochloride tablets) to bupropion hydrochloride extended-release tablets (XL) or from Wellbutrin SR (bupropion hydrochloride extended-release tablets (SR)) to bupropion hydrochloride extended-release tablets (XL), give the same total daily dose when possible.  Patients who are currently being treated with Wellbutrin (bupropion hydrochloride tablets) at 300 mg/day (for example, 100 mg 3 times a day) may be switched to bupropion hydrochloride extended-release tablets (XL) 300 mg once daily.  Patients who are currently being treated with Wellbutrin SR (bupropion hydrochloride extended-release tablets (SR)) at 300 mg/day (for example, 150 mg twice daily) may be switched to bupropion hydrochloride extended-release tablets (XL) 300 mg once daily.

Dosage Adjustment for Patients With Impaired Hepatic Function:

Dosage Adjustment for Patients With Impaired Renal Function:


What interacts with BUDEPRION?

Sorry No Records found


What are the warnings of BUDEPRION?

Sorry No Records found


What are the precautions of BUDEPRION?

Sorry No Records found


What are the side effects of BUDEPRION?

Sorry No records found


What should I look out for while using BUDEPRION?

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a seizure disorder.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients treated with ZYBAN (bupropion hydrochloride extended-release tablets (SR), Wellbutrin (bupropion hydrochloride tablets), the immediate-release formulation, Wellbutrin SR (bupropion hydrochloride extended-release tablets (SR)), the sustained-release formulation, or any other medications that contain bupropion because the incidence of seizure is dose dependent.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

The concurrent administration of bupropion hydrochloride extended-release tablets (XL) and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride extended-release tablets (XL).

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up bupropion hydrochloride extended-release tablets (XL).


What might happen if I take too much BUDEPRION?

Human Overdose Experience:

Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.

Overdosage Management:

Activated charcoal should be administered. There is no experience with the use of forced diuresis, dialysis, hemoperfusion, or exchange transfusion in the management of bupropion overdoses. No specific antidotes for bupropion are known.

Due to the dose-related risk of seizures with bupropion hydrochloride extended-release tablets (XL), hospitalization following suspected overdose should be considered. Based on studies in animals, it is recommended that seizures be treated with intravenous benzodiazepine administration and other supportive measures, as appropriate.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the (PDR).


How should I store and handle BUDEPRION?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07Bupropion hydrochloride extended-release tablets USP (XL) 150 mg, are white to off-white, round, tablets printed with “A101”.  They are supplied as follow:Bottles of 30 NDC # 10370-101-03Bottles of 60 NDC # 10370-101-06Bottles of 90 NDC # 10370-101-09Bottles of 500 NDC # 10370-101-50Bottles of 1000 NDC # 10370-101-00Bupropion hydrochloride extended-release tablets USP (XL) 300 mg, are white to off-white, round, tablets printed with “A102”.  They are supplied as follow:Bottles of 30 NDC # 10370-102-03Bottles of 60 NDC # 10370-102-06Bottles of 90 NDC # 10370-102-09Bottles of 500 NDC # 10370-102-50Bottles of 1000 NDC # 10370-102-00Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]*The following are registered trademarks of their respective manufacturers: ZYBANWELLBUTRIN, and WELLBUTRIN SR /GlaxoSmithKlineRx OnlyManufactured by:Anchen Pharmaceuticals, Inc.Irvine, CA 92618 08/07


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Pharmacodynamics:

Pharmacokinetics:

In a study comparing 14-day dosing with bupropion hydrochloride extended-release tablets  (XL) 300 mg once daily to the immediate-release formulation of bupropion at 100 mg 3 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion).  Additionally, in a study comparing 14-day dosing with bupropion hydrochloride extended-release tablets (XL) 300 mg once daily to the sustained-release formulation of bupropion at 150 mg 2 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites.

Absorption:

Distribution:

Metabolism:

tert

Because bupropion is extensively metabolized, there is the potential for drug-drug interactions, particularly with those agents that are metabolized by the cytochrome P450IIB6 (CYP2B6) isoenzyme. Although bupropion is not metabolized by cytochrome P450IID6 (CYP2D6), there is the potential for drug-drug interactions when bupropion is co-administered with drugs metabolized by this isoenzyme (see PRECAUTIONS: Drug Interactions).

In humans, peak plasma concentrations of hydroxybupropion occur approximately 7 hours after administration of bupropion hydrochloride extended-release tablets (XL). Following administration of bupropion hydrochloride extended-release tablets (XL), peak plasma concentrations of hydroxybupropion are approximately 7 times the peak level of the parent drug at steady state.  The elimination half-life of hydroxybupropion is approximately 20 (±5) hours, and its AUC at steady state is about 13 times that of bupropion. The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of the hydroxybupropion metabolite. However, their elimination half-lives are longer, approximately 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs are 1.4 and 7 times that of bupropion, respectively.

Bupropion and its metabolites exhibit linear kinetics following chronic administration of 300 to 450 mg/day.

Elimination:

Population Subgroups:

Hepatic:

The second study showed no statistically significant differences in the pharmacokinetics of bupropion and its active metabolites in 9 patients with mild to moderate hepatic cirrhosis compared to 8 healthy volunteers. However, more variability was observed in some of the pharmacokinetic parameters for bupropion (AUC, C, and T) and its active metabolites (t½) in patients with mild to moderate hepatic cirrhosis. In addition, in patients with severe hepatic cirrhosis, the bupropion C and AUC were substantially increased (mean difference: by approximately 70% and 3-fold, respectively) and more variable when compared to values in healthy volunteers; the mean bupropion half-life was also longer (29 hours in patients with severe hepatic cirrhosis vs 19 hours in healthy subjects). For the metabolite hydroxybupropion, the mean C was approximately 69% lower. For the combined amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, the mean C was approximately 31% lower.  The mean AUC increased by about 1½-fold for hydroxybupropion and about 2½-fold for threo/erythrohydrobupropion. The median T was observed 19 hours later for hydroxybupropion and 31 hours later for threo/erythrohydrobupropion. The mean half-lives for hydroxybupropion and threo/erythrohydrobupropion were increased 5- and 2-fold, respectively, in patients with severe hepatic cirrhosis compared to healthy volunteers (see WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).

Renal:

Left Ventricular Dysfunction:

Age:

Gender:

Smokers:

Non-Clinical Toxicology
Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a seizure disorder.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients treated with ZYBAN (bupropion hydrochloride extended-release tablets (SR), Wellbutrin (bupropion hydrochloride tablets), the immediate-release formulation, Wellbutrin SR (bupropion hydrochloride extended-release tablets (SR)), the sustained-release formulation, or any other medications that contain bupropion because the incidence of seizure is dose dependent.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

The concurrent administration of bupropion hydrochloride extended-release tablets (XL) and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride extended-release tablets (XL).

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up bupropion hydrochloride extended-release tablets (XL).

As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility (see under ).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).