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

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Bupropion Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNING
Suicidality and Antidepressant Drugs
WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric DisordersPRECAUTIONS: Information for PatientsPRECAUTIONS: Pediatric Use





BUPROPION HYDROCHLORIDE DESCRIPTION


Bupropion Hydrochloride





CLINICAL PHARMACOLOGY









PRECAUTIONS: Drug Interactions





WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION
PRECAUTIONS: Renal Impairment
PRECAUTIONS: Geriatric Use


CLINICAL TRIALS




INDICATIONS & USAGE


CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY

BUPROPION HYDROCHLORIDE CONTRAINDICATIONS







WARNINGS

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders:















  • ●Dose: At doses of sustained-release bupropion up to a dose of 300 mg/day, the incidence of seizure is approximately 0.1% (1/1,000) and increases to approximately 0.4% (4/1,000) at the maximum recommended dose of 400 mg/day.






  • ●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.
  • ●Recommendations for Reducing the Risk of Seizure: Retrospective analysis of clinical experience gained during the development of bupropion suggests that the risk of seizure may be minimized if

  • ●the daily dose is administered twice daily, and
  • ●the rate of incrementation of dose is gradual.
  • ●No single dose should exceed 200 mg to avoid high peak concentrations of bupropion and/or its metabolites.
  • ●Bupropion hydrochloride extended-release tablets (SR) should be administered with extreme caution to patients with a history of seizure, cranial trauma, or other predisposition(s) toward seizure, or patients treated with other agents (e.g., antipsychotics, other antidepressants, theophylline, systemic steroids, etc.) that lower seizure threshold.
CLINICAL PHARMACOLOGYPRECAUTIONSDOSAGE AND ADMINISTRATION


PRECAUTIONS

General:












Cardiovascular Effects:




CLINICAL PHARMACOLOGYWARNINGSDOSAGE AND ADMINISTRATION

Renal Impairment:


INFORMATION FOR PATIENTS














LABORATORY TESTS

Laboratory Tests:


DRUG INTERACTIONS









CONTRAINDICATIONS

WARNINGS
PRECAUTIONS: Cardiovascular Effects
CONTRAINDICATIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY




LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE

CLINICAL PHARMACOLOGY
PRECAUTIONS: Renal ImpairmentDOSAGE AND ADMINISTRATION

BUPROPION HYDROCHLORIDE ADVERSE REACTIONS

WARNINGSPRECAUTIONS




















PRECAUTIONS
PRECAUTIONS











DRUG ABUSE AND DEPENDENCE







OVERDOSAGE








DOSAGE & ADMINISTRATION

WARNINGS


CLINICAL TRIALSCLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGYWARNINGSPRECAUTIONS
CLINICAL PHARMACOLOGYPRECAUTIONS

HOW SUPPLIED













SPL MEDGUIDE

MEDICATION GUIDE




  • ●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?




  • ●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:

  • ●attempts to commit suicide
  • ●new or worse depression
  • ●new or worse anxiety
  • ●feeling very agitated or restless
  • ●panic attacks
  • ●trouble sleeping (insomnia)
  • ●new or worse irritability
  • ●acting aggressive, being angry, or violent
  • ●acting on dangerous impulses
  • ●an extreme increase in activity and talking (mania)
  • ●other unusual changes in behavior or mood
  • ●What else do I need to know about antidepressant medicines?

  • ●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.
  • ●Bupropion hydrochloride extended-release tablets (SR) have not been studied in children under the age of 18 and are not approved for use in children and teenagers.






  • ●attempts to commit suicide
  • ●new or worse depression
  • ●new or worse anxiety
  • ●panic attacks
  • ●feeling very agitated or restless
  • ●acting aggressive, being angry, or violent
  • ●acting on dangerous impulses
  • ●an extreme increase in activity and talking (mania)
  • ●abnormal thoughts or sensations
  • ●seeing or hearing things that are not there (hallucinations)
  • ●feeling people are against you (paranoia)
  • ●feeling confused
  • ●other unusual changes in behavior or mood
  • ●When you try to quit smoking, with or without bupropion, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.




  • ●who take certain medicines.
  • ●The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (SR). For more information, see the sectionsWho should not take bupropion hydrochloride extended-release tablets (SR)?andWhat should I tell my doctor before using bupropion hydrochloride extended-release tablets (SR)?Tell your doctor about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are using bupropion hydrochloride extended-release tablets (SR) unless your doctor has said it is okay to take them.


  • ●Severe allergic reactions. Some people have severe allergic reaction to bupropion hydrochloride extended-release tablets (SR). Stop taking bupropion hydrochloride extended-release tablets (SR) 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 (SR), 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 (SR)?




  • ●are taking Zyban(used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WellbutrinTablets or Wellbutrin XLExtended-Release Tablets. Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (SR).
  • ●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 (SR), 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 (SR).
  • ●What should I tell my doctor before using bupropion hydrochloride extended-release tablets (SR)?


  • ●are pregnant or plan to become pregnant. It is not known if bupropion hydrochloride extended-release tablets (SR) can harm your unborn baby.
  • ●are breastfeeding. Bupropion passes through your milk. It is not known if bupropion 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 (SR).
  • ●How should I take bupropion hydrochloride extended-release tablets (SR)?

  • ●Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (SR). 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 (SR) at the same time each day.
  • ●Take your doses of bupropion hydrochloride extended-release tablets (SR) at least 8 hours apart.
  • ●You may take bupropion hydrochloride extended-release tablets (SR) 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 (SR) can increase your chance of having a seizure.
  • ●If you take too many bupropion hydrochloride extended-release tablets (SR), or overdose, call your local emergency room or poison control center right away.
  • ●Do not take any other medicines while using bupropion hydrochloride extended-release tablets (SR) unless your doctor has told you it is okay.
  • ●It may take several weeks for you to feel that bupropion hydrochloride extended-release tablets (SR) are working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets (SR) exactly as directed by your doctor. Call your doctor if you do not feel bupropion hydrochloride extended-release tablets (SR) are working for you.
  • ●Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (SR) without talking with your doctor first.
  • ●What should I avoid while taking bupropion hydrochloride extended-release tablets (SR)?

  • ●Do not drive a car or use heavy machinery until you know how bupropion hydrochloride extended-release tablets (SR) affect you. Bupropion hydrochloride extended-release tablets (SR) can impair your ability to perform these tasks.
  • ●What are possible side effects of bupropion hydrochloride extended-release tablets (SR)?






  • ●Bupropion hydrochloride extended-release tablets (SR) may have an odor.
  • ●General Information about bupropion hydrochloride extended-release tablets (SR).

  • ●This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (SR). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (SR) that is written for health professionals.












INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
HYDROXYPROPYL CELLULOSE

CELLULOSE, MICROCRYSTALLINE
COLLOIDAL SILICON DIOXIDE
STEARIC ACID
MAGNESIUM STEARATE
HYDROCHLORIC ACID
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Bupropion Hydrochloride





Bupropion Hydrochloride



Bupropion Hydrochloride

Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-270(NDC:0591-3541)
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
hydroxypropyl cellulose
cellulose, microcrystalline
SILICON DIOXIDE
STEARIC ACID
MAGNESIUM STEARATE
HYDROCHLORIC ACID
lactose monohydrate
titanium dioxide
polyethylene glycol

Product Characteristics

Color Size Imprint Code Shape
white 11 mm WPI;839 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-270-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079095 2011-05-12


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