Simvastatin (Page 11 of 11)
17.2 Liver Enzymes
It is recommended that liver function tests be performed before the initiation of simvastatin tablets, and thereafter when clinically indicated. All patients treated with simvastatin tablets should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
17.3 Pregnancy
Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using simvastatin tablets. Discuss future pregnancy plans with your patients, and discuss when to stop taking simvastatin tablets if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking simvastatin tablets and call their healthcare professional.
17.4 Breastfeeding
Women who are breastfeeding should not use simvastatin tablets. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.
Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA
Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad -380 054, India.
10 2959 3 605000
Issued November 2020
PRINCIPAL DISPLAY PANEL
SIMVASTATIN simvastatin tablet, film coated | ||||||||||||||||||||||||||||||||
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Labeler — PD-Rx Pharmaceuticals, Inc. (156893695) |
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695) |
Establishment | |||
Name | Address | ID/FEI | Operations |
PD-Rx Pharmaceuticals, Inc. | 156893695 | repack (43063-726) |
Revised: 05/2022 PD-Rx Pharmaceuticals, Inc.
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