Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
ScieGen Pharmaceuticals, Inc.
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
Bupropion hydrochloride extended-release tablets, USP (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 with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see Warnings and Precautions ( 5.3)] . - Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3), Drug Interactions ( 7.3)]
Bupropion hydrochloride extended-release tablets, USP (SR) 150 mg of bupropion hydrochloride, are purple, blackberry flavored, round, biconvex, film coated tablets debossed with ‘SG, 338’ on one side and plain on other side and supplied in bottles of 30 tablets (NDC 50228-338-31), 60 tablets (NDC 50228-338-61) and 1,000 tablets (NDC 50228-338-11). Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
Abbreviated New Drug Application
BUPROPION HYDROCHLORIDE (SR)- bupropion hydrochloride tablet, film coated, extended release ScieGen Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Bupropion (bue-PROE-pee-on) Hydrochloride Extended-Release Tablets, USP (SR) 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. Talk to your healthcare provider or your family member’s healthcare provider about: • all risks and benefits of quit-smoking medicines. • all treatment choices for quitting smoking. When you try to quit smoking, with or without bupropion hydrochloride extended-release tablets, (SR), you may have symptoms that may be due to nicotine withdrawal, including: • urge to smoke • frustration • restlessness • depressed mood • anger • decreased heart rate • trouble sleeping • feeling anxious • increased appetite • irritability • difficulty concentrating • 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. Some people have had serious side effects while taking bupropion hydrochloride extended-release tablets, (SR), to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggressio Прочитайте повний документ
BUPROPION HYDROCHLORIDE (SR)- BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE SCIEGEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR), FOR ORAL USE INITIAL U.S. APPROVAL: 1985 WARNING: NEUROPSYCHIATRIC REACTIONS; AND SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS ( 5.1) MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. ( 5.1) INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets, USP (SR) are an aminoketone agent indicated as an aid to smoking cessation treatment. ( 1) DOSAGE AND ADMINISTRATION Starting dose: 150 mg per day for first 3 days. ( 2.1) General: Increase dose gradually to reduce seizure risk. ( 2.1, 5.3) Begin dosing one week before quit day. ( 2.1) After 3 days, increase the dose to 300 mg per day, given as 150 mg twice daily at an interval of at least 8 hours. ( 2.1) May be used with a nicotine transdermal system. ( 2.5) Moderate to severe hepatic impairment: 150 mg every other day. ( 2.6, 8.7) Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.6, 8.7) Renal impairment: Consider reducing the dose and/or frequency. ( 2.7, 8.6) DOSAGE FORMS AND STRENGTHS Tablets: 150 mg. ( 3) CONTRAINDICATIONS Seizure disorder. ( 4, 5.3) Current or prior diagnosis of bulimia or anorexia nervosa. ( 4, 5.3) Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. ( 4, 5.3) Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrochloride extended-release tablets (SR) or within 14 da Прочитайте повний документ