The dose of CRESTOR should not exceed 10 mg once daily Medical. 0000015149 00000 n FDA issued a Public Health Advisory notifying healthcare professionals of a revised package insert for use in the 22 member states of the European Union (EU). 1. xڴULu^�e(���4Rf��l�p�!��m$MAL����lk�A�u� p��nq�2%$#�� �u�(��d����K�w�����{���������{�� @�>�� D�10�����B�.��5q}6隁iK��0�{�0��B7Q{���D��Z���Uu�6j�Le� sA�:�Q�ӱ�i͞�e����TubbM�,� 20 mg: Pink, round, biconvex, coated tablets. 0000028380 00000 n 0000023327 00000 n 10 mg: Pink, round, biconvex, coated tablets. CRESTOR is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL‑C, and triglycerides and to increase HDL‑C in adult patients with primary hyperlipidemia or mixed dyslipidemia. 0000029704 00000 n
Debossed “CRESTOR” and “10” on one side of the tablet.20 mg: Pink, round, biconvex, coated tablets.
Audience: Physicians, pharmacists, and other healthcare professionals. Debossed “CRESTOR” and “10” on one side of the tablet. 3 0 obj CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003 -----RECENT MAJOR … 4 0 obj 0000039358 00000 n See full prescribing information for CRESTOR. 0000009901 00000 n %PDF-1.6 %���� 0000008460 00000 n 2047 0 obj <>stream endobj %����
AstraZeneca today revised the package insert … 0000010410 00000 n Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate. Debossed “CRESTOR” and “5” on one side of the tablet.10 mg: Pink, round, biconvex, coated tablets. 1 0 obj
Yet, the all-important “Dosage and Administration” section, which most doctors do read, makes no mention of … endobj stream Debossed “CRESTOR” and “5” on one side of the tablet.10 mg: Pink, round, biconvex, coated tablets.
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Debossed “CRESTOR” on one side and “40” on the other side of the tablet.All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. �PA��^�< ���4�T��H�/ғ��y�#����4N3��4�`'# 3�H�a{5��k��2���"�W$ WE]'# �XG" 3X0i�fhi��NFf��H��j���:H#�M�D�'��KsIzH]Q��j�R� ,nj���sL�0�������& d4��6���³N�s�!�8#���E�*�W���D|�p5�q��!� �\~;>���v҈Ed+3iH����i8��}�N| xref %%EOF 0000009203 00000 n 0000005635 00000 n 0000005277 00000 n
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Crestor (rosuvastatin) - Jun 9, 2004. Debossed “CRESTOR” on one side and “40” on the other side of the tablet. If you are in the US and would like additional information regarding AstraZeneca drugs, please contact the Information Center at AstraZeneca at 1-877-893-1510 1-877-893-1510. 0000004263 00000 n CRESTOR has not been studied in Fredrickson Type I and V dyslipidemias. • You have been advised to take a statin, because changing your diet and doing more exercise were not enough to correct your cholesterol levels. Crestor's manufacturer is also reminding doctors that they should consider using lower starting doses of Crestor in some individuals. 0000008028 00000 n CRESTOR is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL‑C, and triglycerides and to increase HDL‑C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Package leaflet: information for the patient Crestor® 5 mg film-coated tablets Crestor® 10 mg film-coated tablets Crestor® 20 mg film-coated tablets Crestor® 40 mg film-coated tablets rosuvastatin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 0000011609 00000 n The usual starting dose is 10 to 20 mg once daily. Derived from respective Product Package Insert / Drug Class Review: HMG CoA Reductase Inhibitors (Statins) VHA Pharmacy Benefit Management Strategic Healthcare Group and the Medical Advisory Panel White Zone- Available Generically
CRESTOR, as well as other HMG-CoA reductase inhibitors should be used with caution Toggle navigation. x��\mo���n��a>�E�!�|=.��5WM{�C��^,��#)��S��ݙ%%�ܵei(_>�6E�ݝyfvf����{����O?���=|��#�q~� View head-to-head data 3 1.
The maximum CRESTOR … The tablet should be swallowed whole. 2 0 obj The usual starting dose is 10 to 20 mg once daily. Offer good for 12 …
0000007742 00000 n The dose of CRESTOR should not exceed 10 mg once daily Initiate CRESTOR therapy with 5 mg once daily. 0000012037 00000 n �C�� ����}���g.�����χ������3�Eq?�˕���b�n�c��J��~9?�6��x�$�:��ƹ���z�~�¹P���l�\D�b�:���K�Х�V����6��2l�C��í�Q�[�?p�����J���;J�B��ä�u���`��� ;s�1͵�H()"W/���Z�4��8�D���X;�d�V�E/?�Oi\�0���w��@�y�� =2��� G��Om`+Ǔ�km�y�ֻb�W�[�z� ��$��!�UY�CE#��h�ͮ 10 mg: Pink, round, biconvex, coated tablets. Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, darolutamide, regorafenib, certain anti-viral medicines or their combinations. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. <> The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.The maximum CRESTOR dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose CRESTOR can be administered as a single dose at any time of day, with or without food.
CRESTOR is an HMG Co-A reductase inhibitor indicated for: TG levels and to increase HDL-C (1.1) _____ 10 OVERDOSAGE 1.1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CRESTOR safely and effectively. 0000016406 00000 n 0000000016 00000 n %PDF-1.7 0000100799 00000 n The tablet should be swallowed whole.When initiating CRESTOR therapy or switching from another HMG‑CoA reductase inhibitor therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy. 0000039624 00000 n 0000014208 00000 n Debossed “CRESTOR” and “20” on one side of the tablet. 0000012294 00000 n 0000026938 00000 n 0000026168 00000 n