Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
Anchen Pharmaceuticals, Inc.
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
Bupropion hydrochloride extended-release tablets (SR) are indicated as an aid to smoking cessation treatment. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients treated with WELLBUTRIN (bupropion hydrochloride), the immediate-release formulation; WELLBUTRIN SR (bupropion hydrochloride), the sustained-release formulation; WELLBUTRIN XL (bupropion hydrochloride), the extended-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent. Bupropion hydrochloride extended-release tablets (SR) 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 (SR) are contraindicated in patients undergoing
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg of bupropion hydrochloride, are purple, round-shaped, film-coated tablets engraved with “A204” in bottles of 60 (NDC 10370-204-06) tablets and in bottles of 1000 (NDC 10370-204-00) tablets. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) (see USP). Dispense in tight, light-resistant containers as defined in the USP. WELLBUTRIN® and WELLBUTRIN XL® are registered trademarks of GlaxoSmithKline. KALETRA® is a registered trademark of Abbott Laboratories.
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE Anchen Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Bupropion Hydrochloride Extended- Release Tablets USP (SR) Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (SR) 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 (SR), 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 changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; the second section is about the risk of suicidal thoughts and actions with antidepressant medicines; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)?” 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. Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion hydrochloride extended-release tablets (SR) to help them quit smoking. These symptoms can develop during treatment with bupropion hydrochloride extended-release tablets (SR) or after stopping treatment with bupropion hydrochloride extended-release tablets (SR). 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 hydrochloride extended-release tablets (SR) and call yo Aqra d-dokument sħiħ
BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ANCHEN PHARMACEUTICALS, INC. ---------- BUPROPION HYDROCHLORIDE EXTENDED RELEASE TABLETS USP (SR) “MEDICATION GUIDE” ENCLOSED WARNING Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion hydrochloride extended-release tablets (SR) for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion hydrochloride extended-release tablets (SR) who continued to smoke. All patients being treated with bupropion hydrochloride extended-release tablets (SR) should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of preexisting psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking bupropion hydrochloride extended-release tablets (SR) in the post-marketing experience. When symptoms were reported, most were during treatment with bupropion hydrochloride extended-release tablets (SR), but some were following discontinuation of treatment with bupropion hydrochloride extended-release tablets (SR). These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of bupropion hydrochloride extended-release Aqra d-dokument sħiħ