157 27 Generic drug products are required to have the same labeling as the brand-name drug to which they were compared at the time of approval (reference listed drug [RLD]).The Code of Federal Regulations, Title 21, mandates that PIs be included with packages of prescription drugs and biologic products. <<28F03E3A88BD854D90869A7477E18AE1>]>> 2 Lake and FD&C Red No. x�b```�6V�) cc`a�X� R�Kr����j�a�>�������svs��,z l�٦�}��f�4��E��'�^6.�fC���Q̏��2k1p0T_5�� ��|�WO�"_������3Rp�w�>'s{xCA�Ȥ�6��Nl�4H�ʽ>���ç�*;�*�e�XT\�QjV=6��KLA/�IW���߁�E�*�$y��02���E���X�sl��0=�1�E'�-��� �}� !~�]:A]@-^�eT��F�m�i���(��i��W���Ң���vF�ТlA�z ݣ�|B`����q`��@�&����VL�~ In rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavior response, and increase rates of responding in several schedule‑controlled behavior paradigms. 0000001857 00000 n 0000002008 00000 n Considering this, when pharmacists receive a drug information inquiry or encounter a clinical dilemma, it may be wise to initiate the search for information with the PI. Postmarketing reports have described seizures in breastfed infants. The molecular formula is CWELLBUTRIN SR is supplied for oral administration as 100‑mg (blue), 150‑mg (purple), and 200‑mg (light pink), film‑coated, sustained‑release tablets. Dosing with WELLBUTRIN SR Tablets should begin at 150 mg/day given as a single daily dose in the morning. Last reviewed by: Kristi Monson, PharmD. +��e���qO��tl�G�ӈK�y�Ў��g{8=�w]�RI�Pւ�C��wE8�Nu��O,��� ��D�c��S�ׅN�W>7N��o9~��k=ͣ��}S��ف� �̐Iʾ��Če���;c�k�9AM�*䟢l� �|RN��S��'�}'�����#X�a�#֘�mg�A��/�}H�.����]�Zw4�Qpā�86���x:�/��;sf�V������se�3)����la���S�:����CKy��ȗu�=�m�]��8�M˙\�b��Fy,�qR@=Fn@ �Ll�.E��_߱���j��8��9 ���@(��I�f;Z�ةP�Z)�����-c�.3�ݻw�X��Z�f.u�(�BT�c���=��[A�~��R���ג���4^d�Se�VJ��'�����(\c ?>q���6����_v�^37X��h�Ys *�߮ 0000004235 00000 n Research Triangle Park, NC: GlaxoSmithKline;2013 March. 5 0 obj As with other drug information resources, the key for effective and efficient use of the resources is user familiarity with it. However, higher doses (which could not be tested because of the risk of seizure) might be modestly attractive to those who abuse CNS stimulant drugs.WELLBUTRIN SR is intended for oral use only. Food and Drug Administration, Center for Drug Evaluation and Research. There are no known antidotes for bupropion. Wellbutrin SR [package insert]. Bupropion and its metabolites are cleared renally and may accumulate in such patients to a greater extent than usual. FDA. Copyright © 2000 - 2020 Jobson Medical Information LLC unless otherwise noted. Read More On: Wellbutrin SR and Weight Loss.
0 WELLBUTRIN SR may be taken with or without food. FDA Web site. 4 The latest requirements for “Content and Format of Labeling for Human Prescription Drug and Biological Products” went into effect on June 30, 2006, and are outlined in Title 21 of … In eight week controlled trials mean weight loss for trial completers was 0.1 kg for placebo, 0.8 kg for WELLBUTRIN® SR 100 mg/day, 1.4 kg at 150 mg/ day, and 2.3 kg at 300 mg/day. f·X�S��=Ѩ9ˋv���́�>�����F���Ek�����Xv�ۃ�a��&D˾\�'�����Yl�0h����ql�fkۜ�y�qxs(E�D濌��s�K�YX�c���f�9�{�ɜ�+� <> WELLBUTRIN SR tablets should be swallowed whole and not crushed, divided, or chewed. 0000012167 00000 n
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0000000836 00000 n SR TABLETAS * WELLBUTRIN SR TABLETY * WELLBUTRIN SR * NDC NO 0173-0947-55 * NDC NO 0173-0135-55 * NDC NO 0173-0722-00 * BUPROPION HYDROCHLORIDE, FORMULATED PRODUCT Recommended use Medicinal Product This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace.
In primate models assessing the positive reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. Educate patients that Wellbutrin XL contains the same active ingredient (bupropion) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that Wellbutrin XL should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride (such as Wellbutrin SR, the sustained-release formulation, Wellbutrin, the … Induction of emesis is not recommended.WELLBUTRIN SR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re‑uptake inhibitor, or other known antidepressant agents. 1. ingredient as the antidepressant medications WELLBUTRIN®, WELLBUTRIN® SR, and WELLBUTRIN XL ®. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials.