Bupropion Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

Bupropion Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNING
Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders:WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric DisordersPRECAUTIONS: Information for PatientsPRECAUTIONS: Pediatric Use


Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior
WARNINGS: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation TreatmentPRECAUTIONS: Information for Patients

DESCRIPTION


DESCRIPTION




CLINICAL PHARMACOLOGY


Pharmacodynamics


Absorption:

Metabolism:


PRECAUTIONS: Drug Interactions
PRECAUTIONS: Drug Interactions


Elimination:
Population Subgroups:
Hepatic:
WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION
Renal:PRECAUTIONS: Renal Impairment
Left Ventricular Dysfunction:
Age:PRECAUTIONS: Geriatric Use
Gender:
Smokers:
CLINICAL TRIALS
Major Depressive Disorder:



Seasonal Affective Disorder:


INDICATIONS & USAGE

Major Depressive Disorder:
CLINICAL TRIALS

CLINICAL TRIALS
Seasonal Affective Disorder:
CLINICAL TRIALS


CONTRAINDICATIONS








WARNINGS

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders:





All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.


Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment:
BOXED WARNINGADVERSE REACTIONSThese have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide


Advise patients and caregivers that the patient using bupropion for smoking cessation should 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. In many post-marketing cases, resolution of symptoms after discontinuation of ZYBANwas reported, although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

Screening Patients for Bipolar Disorder:


Bupropion-Containing Products:
Patients should be made aware that bupropion hydrochloride extended-release tablets (XL) contain the same active ingredient found in ZYBANused as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (XL) should not be used in combination with ZYBANor any other medications that contain bupropion, such as WELLBUTRIN SR(bupropion hydrochloride), the sustained-release formulation or WELLBUTRIN(bupropion hydrochloride), the immediate-release formulation.


Seizures:
Bupropion is associated with a dose-related risk of seizures. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications, which must be considered in selection of patients for therapy with bupropion hydrochloride extended-release tablets (XL). Bupropion hydrochloride extended-release tablets USP (XL) should be discontinued and not restarted in patients who experience a seizure while on treatment.
As bupropion hydrochloride extended-release tablets (XL) bioequivalent to both the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion, the seizure incidence with bupropion hydrochloride extended-release tablets (XL), while not formally evaluated in clinical trials, may be similar to that presented below for the immediate-release and sustained-release formulations of bupropion.
  • ●     Dose: At doses up to 300 mg/day of the sustained-release formulation of bupropion (WELLBUTRIN SRthe incidence of seizure is approximately 0.1% (1/1,000).


  • ●     Patient factors: Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system (CNS) tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold.
  • ●     Clinical situations: Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.
  • ●     Concomitant medications: Many medications (e.g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.



  • ●     the total daily dose of bupropion hydrochloride extended-release tablets (XL) does not exceed 450 mg,
  • ●     the rate of incrementation of dose is gradual.





Potential for Hepatotoxicity:


PRECAUTIONS

General

Agitation and Insomnia:







Psychosis, Confusion, and Other Neuropsychiatric Phenomena:


Activation of Psychosis and/or Mania:


Altered Appetite and Weight:






Allergic Reactions:



Cardiovascular Effects:




Hepatic Impairment:

CLINICAL PHARMACOLOGYWARNINGSDOSAGE AND ADMINISTRATION

Renal Impairment:


INFORMATION FOR PATIENTS

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions,Quitting Smoking, Quit-Smoking Medication, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions, andWhat other important information should I know about bupropion hydrochloride extended-release tablets (XL) ?

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders:

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment:

Bupropion-Containing Products:








LABORATORY TESTS



DRUG INTERACTIONS



CLINICAL PHARMACOLOGY: Metabolism



Drugs Metabolized By Cytochrome P450IID6 (CYP2D6):

MAO Inhibitors:CONTRAINDICATIONS
Levodopa and Amantadine:
Drugs That Lower Seizure Threshold:WARNINGS
Nicotine Transdermal System:PRECAUTIONS: Cardiovascular Effects
Alcohol:CONTRAINDICATIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects




LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE

BOX WARNINGWARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders

GERIATRIC USE


CLINICAL PHARMACOLOGY
PRECAUTIONS: Renal ImpairmenDOSAGE AND ADMINISTRATION

ADVERSE REACTIONS

WARNINGSPRECAUTIONS
Major Depressive Disorder:CLINICAL PHARMACOLOGY
Adverse Events Leading to Discontinuation of Treatment With WELLBUTRINor WELLBUTRIN SR


Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With WELLBUTRIN

WARNINGSPRECAUTIONS


Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials:
300 mg/day of WELLBUTRIN SR
400 mg/day of WELLBUTRIN SR
Seasonal Affective Disorder: Adverse Events Leading to Discontinuation of Treatment With Bupropion Hydrochloride Extended-Release Tablets (XL):
Adverse Events Occurring at an Incidence of 2% or More Among Patients Treated With Bupropion Hydrochloride Extended-Release Tablets (XL) :



Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials:
Adverse Events During Taper or Following Discontinuation of Bupropion Hydrochloride Extended-Release Tablets (XL):

Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion:
WARNINGSPRECAUTIONS


Body (General):PRECAUTIONS
Cardiovascular:PRECAUTIONS
Digestive:
Endocrine:
Hemic and Lymphatic:
Metabolic and Nutritional:
Musculoskeletal:
Nervous System:
Respiratory:
Skin:
Special Senses:
Urogenital:

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class:
Humans:


Animals:

OVERDOSAGE

Human Overdose Experience:

Overdosage Management:



DOSAGE & ADMINISTRATION

General Dosing Considerations:WARNINGS
Major Depressive Disorder:Initial Treatment:
Increasing the Dosage Above 300 mg/day:
Maintenance Treatment:
Seasonal Affective Disorder:



Switching Patients from WELLBUTRINTablets or from WELLBUTRIN SRSustained-Release Tablets:
Dosage Adjustment for Patients with Impaired Hepatic Function:CLINICAL PHARMACOLOGYWARNINGSPRECAUTIONS
Dosage Adjustment for Patients with Impaired Renal Function:CLINICAL PHARMACOLOGYPRECAUTIONS

HOW SUPPLIED




STORAGE AND HANDLING




SPL MEDGUIDE

buPROPion Hydrochloride Extended-Release Tablets (XL)
Rx Only


What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (XL) ?
Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions
Talk to your doctor, or your family member's, healthcare provider about:
  • ●     all risks and benefits of treatment with antidepressant medicines
  • ●     all treatment choices for depression or other serious mental illness
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
     1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
     2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • ●               Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • ●               Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • ●               Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
What else do I need to know about antidepressant medicines?
  •      Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
  •      Antidepressants are medicines used to treat depression and other illnesses.It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  •      Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  •      Antidepressant medicines can interact with other medicines.Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  •      Not all antidepressant medicines prescribed for children are FDA approved for use in children.Talk to your child's healthcare provider for more information.

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions






What Other Important Information Should I Know About bupropion hydrochloride extended-release tablets (XL)?
  •      Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets (XL) , especially in people:
  • ●     with certain medical problems.
  • ●     who take certain medicines.
Do not take any other medicines while you are using bupropion hydrochloride extended-release tablets (XL) unless your doctor has said it is okay to take them.
     If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your doctor right away.
  •      High blood pressure (hypertension): Some people get high blood pressure, that can be severe, while taking bupropion hydrochloride extended-release tablets (XL).The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking.
  •      Severe allergic reactions. Some people have severe allergic reactions to bupropion hydrochloride extended-release tablets (XL):Stop taking bupropion hydrochloride extended-release tablets (XL) and call your doctor right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
  •      Unusual thoughts or behaviors:Some patients have unusual thoughts or behaviors while taking bupropion hydrochloride extended-release tablets (XL), including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your doctor.
     What are bupropion hydrochloride extended-release tablets (XL)?

     Who should not take bupropion hydrochloride extended-release tablets (XL)?
     Do not take bupropion hydrochloride extended-release tablets (XL) if you:

  • ●     have or had a seizure disorder or epilepsy.
  •      are taking ZYBAN(used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRINTablets, or WELLBUTRIN SRSustained-Release Tablets.Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (XL).
  • ●     drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden.
  • ●     have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL(phenelzine sulfate), PARNATE(tranylcypromine sulfate), or MARPLAN(isocarboxazid).
  • ●     have or had an eating disorder such as anorexia nervosa or bulimia.
  • ●     are allergic to the active ingredient in bupropion hydrochloride extended-release tablets (XL), bupropion, or to any of the inactive ingredients. See the end of this leaflet for a complete list of ingredients in bupropion hydrochloride extended-release tablets (XL).
     What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)?
  • ●     Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems. SeeAntidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.
  •      Tell your doctor about your other medical conditions including if you:
  •      are pregnant or plan to become pregnant.It is not known if bupropion hydrochloride extended-release tablets (XL) can harm your unborn baby.
  •      are breastfeeding.Bupropion hydrochloride extended-release tablets (XL) passes through your milk. It is not known if bupropion hydrochloride extended-release tablets (XL) can harm your baby.
  •      have liver problems,especially cirrhosis of the liver.
  • ●     have kidney problems.
  • ●     have an eating disorder such as anorexia nervosa or bulimia.
  • ●     have had a head injury.
  • ●     have had a seizure (convulsion, fit).
  • ●     have a tumor in your nervous system (brain or spine).
  • ●     have had a heart attack, heart problems, or high blood pressure.
  • ●     are a diabetic taking insulin or other medicines to control your blood sugar.
  • ●     drink a lot of alcohol.
  • ●     abuse prescription medicines or street drugs.
  •      Tell your doctor about all the medicines you take,including prescription and non-prescription medicines, vitamins and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are using bupropion hydrochloride extended-release tablets (XL).
How should I take bupropion hydrochloride extended-release tablets (XL)?
  • ●     Take bupropion hydrochloride extended-release tablets (XL) exactly as prescribed by your doctor.
  •      Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (XL).If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures. You must swallow the tablets whole.Tell your doctor if you cannot swallow medicine tablets.
  • ●     Take bupropion hydrochloride extended-release tablets (XL) at the same time each day.
  • ●     Take your doses of bupropion hydrochloride extended-release tablets (XL) at least 24 hours apart.
  • ●     You may take bupropion hydrochloride extended-release tablets (XL) with or without food.
  • ●     If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time.This is very important.Too many bupropion hydrochloride extended-release tablets (XL) can increase your chance of having a seizure.
  • ●     If you take too many bupropion hydrochloride extended-release tablets (XL), or overdose, call your local emergency room or poison control center right away.
  • ●     The bupropion hydrochloride extended-release tablets (XL) tablet is covered by a shell that slowly releases the medicine inside your body. You may notice something in your stool that looks like a tablet. This is normal. This is the empty shell passing from your body.
  •      Do not take any other medicines while using bupropion hydrochloride extended-release tablets (XL) unless your doctor has told you it is okay.
  • ●     If you are taking bupropion hydrochloride extended-release tablets (XL) for the treatment of major depressive disorder, it may take several weeks for you to feel that bupropion hydrochloride extended-release tablets (XL) are working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets (XL) exactly as directed by your doctor. Call your doctor if you do not feel bupropion hydrochloride extended-release tablets (XL) are working for you.
  • ●     If you are taking bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes associated with seasonal affective disorder, it is important to keep taking bupropion hydrochloride extended-release tablets (XL) through the autumn-winter season, or as directed by your doctor.
  • ●     Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (XL) without talking with your doctor first.
What should I avoid while taking bupropion hydrochloride extended-release tablets (XL)?
  • ●     Do not drink a lot of alcohol while taking bupropion hydrochloride extended-release tablets (XL). If you usually drink a lot of alcohol, talk with your doctor before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
  • ●     Do not drive a car or use heavy machinery until you know how bupropion hydrochloride extended-release tablets (XL) affects you. Bupropion hydrochloride extended-release tablets (XL) can impair your ability to perform these tasks.
What are possible side effects of bupropion hydrochloride extended-release tablets (XL)?






How should I store bupropion hydrochloride extended-release tablets (XL)?
  • ●     Store bupropion hydrochloride extended-release tablets (XL) at room temperature. Store out of direct sunlight. Keep bupropion hydrochloride extended-release tablets (XL) in its tightly closed bottle.
  • ●     Bupropion hydrochloride extended-release tablets (XL) may have an odor.
General Information about bupropion hydrochloride extended-release tablets (XL).
  • ●     Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (XL) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (XL) to other people, even if they have the same symptoms you have. It may harm them. Keep bupropion hydrochloride extended-release tablets (XL) out of the reach of children.

What are the ingredients in bupropion hydrochloride extended-release tablets (XL)?






PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Bupropion Hydrochloride

Bupropion Hydrochloride TABLET, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-894(NDC:67767-141)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE BUPROPION 150 mg

Inactive Ingredients

Ingredient Name Strength
COPOVIDONE
hydroxypropyl cellulose
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
titanium dioxide
polyethylene glycol
talc
METHACRYLIC ACID
TRIETHYL CITRATE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
povidone
water
HYDROCHLORIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 9 mm 141 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-894-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077285 2012-03-05


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