In this trial, patients were carefully monitored and some interacting medicinal products were excluded. In particular, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because of the risk of adverse effects to the developing infant, Zocor should not be administered to breastfeeding mothers. Arora R, Liebo M, Maldonado F "Statin-induced myopathy: the two faces of Janus." Simvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants. Morales K, Wittink M, Datto C, et al. JAMA 283 (2000): 3205-10, 14. Drugs 50 (1995): 334-63, 5. Simvastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of CYP3A4. Elevated plasma levels of HMG-CoA reductase inhibitory activity increases the risk of myopathy and rhabdomyolysis, particularly with higher doses of simvastatin. Pedersen TR, Kjekshus J, Berg K, Haghfelt T, Faergeman O, Thorgeirsson G, Pyorala K, Miettinen T, Wilhelmsen L, Olsson AG, Wedel "Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S)." Newman TB, Hulley SB "Carcinogenicity of lipid-lowering drugs." Therefore, concomitant use of these drugs is contraindicated. Other adverse reactions reported in clinical trials were: diarrhea, rash, dyspepsia, flatulence, and asthenia. The incidence of myopathy with the 80 mg dose has been reported as disproportionately higher than that observed at lower doses and the risk of myopathy with simvastatin 80 mg/day is greater compared with other statins with similar or greater LDL-C lowering efficacy. Plosker GL, Mctavish D "Simvastatin - a reappraisal of its pharmacology and therapeutic efficacy in hypercholesterolaemia." With therapy discontinuation or interruption, transaminase levels generally returned to pretreatment levels. Bannwarth B, Miremont G, Papapietro PM "Lupuslike syndrome associated with simvastatin." What drugs interact with Zocor (simvastatin)? … Get emergency medical help if you have any of these signs of an allergic reaction to Zocor: hives; difficult breathing; swelling of your face, lips, tongue, or throat. The risk of myopathy, including rhabdomyolysis is increased by concomitant administration of cyclosporine or danazol. Other fibrates: Caution should be used when prescribing with simvastatin. Rhabdomyolysis causes the release of muscle protein (myoglobin) A new study tracked how they did. J Neurol Neurosurg Psychiatry 58 (1995): 625-8, 46. Clin Cardiol 16 (1993): 317-22, 9. Concomitant use of drugs labeled as having a strong inhibitory effect on CYP3A4 is contraindicated. Applies to simvastatin: oral suspension, oral tablet. The incidence of myopathy/rhabdomyolysis was <0.1% in patients treated with Zocor. The most serious potential side effects are liver damage and muscle inflammation or This was attributable to the noncardiac fraction of CK. These cognitive issues have been reported for all statins. In the pre-marketing controlled clinical studies and their open extensions (2,423 patients with median duration of follow-up of approximately 18 months), 1.4% of patients were discontinued due to adverse reactions. J Intern Med 240 (1996): 403-4. More frequent side effects include: eczema and increased creatine phosphokinase in blood specimen. Am J Med 87 (1989): s44-6, 30. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). Ann Pharmacother (2007): 58. Zetia, atorvastatin, Jardiance, simvastatin, Brilinta, fenofibrate, Lopid, Xarelto, rosuvastatin, Lipitor. Alvarez JM, Rawdanowiz TJ, Goldstein J "Rhadbdomyolysis after coronary artery bypass grafting in a patient receiving simvastatin." J Clin Endocrinol Metab 86 (2001): 4556-9, 34. O 0, 23. Omar MA, Wilson JP "FDA adverse event reports on statin-associated rhabdomyolysis." In a 48-week, controlled study in adolescent boys and girls who were at least 1 year post-menarche, 10-17 years of age (43.4% female, 97.7% Caucasians, 1.7% Hispanics, 0.6% Multiracial) with heterozygous familial hypercholesterolemia (n=175), treated with placebo or Zocor (10-40 mg daily), the most common adverse reactions observed in both groups were upper respiratory infection, headache, abdominal pain, and nausea. Molden E, Andersson KS "Simvastatin-associated rhabdomyolysis after coadministration of macrolide antibiotics in two patients." Are Statin Side Effects 'All in Your Head'? Galatti L, Polimeni G, Salvo F, Romani M, Sessa A, Spina E "Short-term memory loss associated with rosuvastatin."
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