BUPROPION HYDROCHLORIDE tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)

Tilgjengelig fra:

Proficient Rx LP

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Major Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of 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

Produkt oppsummering:

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 63187-124-30 Bottles of 90 NDC 63187-124-90 Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *The following are registered trademarks of their respective manufacturers: WELLBUTRIN® and WELLBUTRIN XL® /GlaxoSmithKline; ZYBAN® /GlaxoSmithKline; PARNATE® /GlaxoSmithKline; NARDIL® /Warner Lambert Company; MARPLAN® /Validus Pharmaceuticals LLC; KALETRA® /Abbott Laboratories. PHARMACIST-DETACH HERE AND GIVE MEDICATION GUIDE TO PATIENT-------------------------------------------------------------------------- MEDICATION GUIDE Bupropion Hydrochloride Extended-Release Tablets USP (XL) Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (XL) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about bupropion hydrochloride extended-release tablets (XL), ask your doctor or pharmacist. IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “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 This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your doctor, or your family member’s, healthcare provider about: Bupropion hydrochloride extended-release tablets (XL) have not been studied in children under the age of 18 and is not approved for use in children and teenagers. Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking. Although bupropion hydrochloride extended-release tablets (XL) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN® which is used to help patients quit smoking. Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion. If you, your family member, or your caregiver notice agitation, hostility, depression, or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms, stop taking bupropion and call your healthcare provider right away: 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. Before taking bupropion, tell your healthcare provider if you have ever had depression or other mental illnesses. You should also tell your doctor about any symptoms you had during other times you tried to quit smoking, with or without bupropion. What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (XL)? If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your doctor right away. Do not take bupropion hydrochloride extended-release tablets (XL) again if you have a seizure. What are bupropion hydrochloride extended-release tablets (XL)? Bupropion hydrochloride extended-release tablets (XL) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder and for prevention of autumn-winter seasonal depression (seasonal affective disorder). Who should not take bupropion hydrochloride extended-release tablets (XL)? Do not take bupropion hydrochloride extended-release tablets (XL) if you: What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)? How should I take bupropion hydrochloride extended-release tablets (XL)? What should I avoid while taking bupropion hydrochloride extended-release tablets (XL)? What are possible side effects of bupropion hydrochloride extended-release tablets (XL)? Bupropion hydrochloride extended-release tablets (XL) can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects. Common side effects reported in studies of major depressive disorder include weight loss, loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often. In studies of seasonal affective disorder, common side effects included weight loss, constipation, and gas. If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime. These are not all the side effects of bupropion hydrochloride extended-release tablets (XL). For a complete list, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Anchen Pharmaceuticals Inc. at 1-888-493-0857 or FDA at 1-800-FDA-1088. How should I store bupropion hydrochloride extended-release tablets (XL)? General Information about bupropion hydrochloride extended-release tablets (XL). This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (XL). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (XL) that is written for health professionals. What are the ingredients in bupropion hydrochloride extended-release tablets (XL)? Active ingredient: bupropion hydrochloride. Inactive ingredients: dehydrated alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, hydrogenated vegetable oil and ethyl alcohol. The tablets are printed with edible black ink. *The following are registered trademarks of their respective manufacturers: WELLBUTRIN® and WELLBUTRIN XL® /GlaxoSmithKline; ZYBAN® /GlaxoSmithKline; PARNATE® /GlaxoSmithKline; NARDIL® /Warner Lambert Company; MARPLAN® /Validus Pharmaceuticals LLC; KALETRA® /Abbott Laboratories. This Medication Guide has been approved by the U.S. Food and Drug Administration. Rx only Manufactured by: Anchen Pharmaceuticals, Inc. Irvine, CA 92618 08/11 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
Proficient Rx LP
----------
MEDICATION GUIDE
BuPROPion Hydrochloride (bue proe' pee on hye'' droe klor' ide)
Extended-Release Tablets USP (XL)
IMPORTANT: Be sure to read the three sections of this Medication
Guide. The first section is about the
risk of suicidal thoughts and actions with antidepressant medicines;
the second section is about the risk of
changes in thinking and behavior, depression and suicidal thoughts or
actions with medicines used to quit
smoking; and the third section is entitled “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
This section of the Medication Guide is only about the risk of
suicidal thoughts and actions with
antidepressant medicines.
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 the risk of suicidal thoughts or
actions in some children,
teenagers, or young adults within the first few months of treatment.
2.
Depression or 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. These
include people who have (or have a family history of) bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
3.
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 your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Ke

Preparatomtale

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
PROFICIENT RX LP
----------
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP (XL)
“MEDICATION GUIDE” ENCLOSED.
WARNING
Suicidality and Antidepressant Drugs
_USE IN TREATING PSYCHIATRIC DISORDERS:_ Antidepressants increased the
risk compared to placebo of
suicidal thinking and behavior (suicidality) in children, adolescents,
and young adults in short-term
studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering
the use of bupropion hydrochloride extended-release tablets (XL) or
any other antidepressant in a
child, adolescent, or young adult must balance this risk with the
clinical need. Short-term studies
did not show an increase in the risk of suicidality with
antidepressants compared to placebo in
adults beyond age 24; there was a reduction in risk with
antidepressants compared to placebo in
adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves
associated with increases in the risk of suicide. Patients of all ages
who are started on
antidepressant therapy should be monitored appropriately and observed
closely for clinical
worsening, suicidality, or unusual changes in behavior. Families and
caregivers should be
advised of the need for close observation and communication with the
prescriber. Bupropion
hydrochloride extended-release tablets (XL) are not approved for use
in pediatric patients. (See
WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric
Disorders,
PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric
Use.)
_USE IN SMOKING CESSATION TREATMENT_: WELLBUTRIN (bupropion
hydrochloride tablets),
WELLBUTRIN SR
(bupropion hydrochloride extended-release tablets (SR)), and bupropion
hydrochloride extended-release tablets (XL) are not approved for
smoking cessation treatment,
but bupropion under the name ZYBAN is approved for this use. Serious
neuropsychiatric
events, including but not limited to depression, suicidal