the package insert of the medicine Sinvatrox.
Reduction of the elevated levels of total cholesterol and LDL-cholesterol in patients with hypercholesterolemia primary, when the response to diet and other medications non-pharmacological alone has been inadequate. Reduction of high cholesterol levels in patients with hypercholesterolemia combined or hypertriglyceridemia, when the hypercholesterolemia is the abnormality more important. Reduction of the progression of coronary atherosclerosis, including reducing the development of new lesions or new occlusions in patients with coronary heart disease.
When should I not use?
The use of simvastatin is contra-indicated in patients with liver disease active or persistent elevations and unexplained of serum transaminases. During pregnancy. In patients with a history of hypersensitivity to the drug.
How to use?
The patient should be placed on a diet of cholesterol before receiving simvastatin and should continue on this diet during treatment. Hypercholesterolemia: initial dose usual is 10 mg/day as a single dose in the evening. Patients with hypercholesterolemia mild to moderate can be treated with initial dosing of 5 mg. Adjustments posológicos, if necessary, should be made at intervals of not less than 4 weeks, up to a maximum of 40 mg/day as a single dose in the evening. If the level of LDL-cholesterol is reduced to less than 75 mg/dl (1,94 mmol), or if the total cholesterol plasma level less than 140 mg/dl (3,6 mmol), consider reducing the dose of simvastatin. Coronary atherosclerosis: 20 mg as a single dose in the evening. The dosage should be reduced if the levels of cholesterol plasma total reach values lower than 110 mg/dl (2,85 mmol). Concomitant therapy: simvastatin is effective alone or in combination with the seqüestrantes of bile acids. In patients receiving immunosuppressive therapy concomitantly with simvastatin, the maximum recommended dose is 10 mg/day. Dosage in renal impairment: in patients with severe renal insufficiency (debug creanina < 30 ml/min), you should carefully consider the use of doses above 10 mg/ml and, when necessary, should be implemented with caution. – Overdose have been reported few cases of overdosage; none of the patients presented specific symptoms, and all recovered without sequelae. The maximum dose taken was 450 mg. Measures should be taken common.
What are the evils that can cause me?
abdominal Pain, constipation and flatulence. Other side effects reported in smaller proportions were asthenia and headache, nausea, diarrhea, rash, dyspepsia, alopecia, dizziness, cramp in muscle, myalgia, pancreatitis, neuropathy peripheral, vomiting, pruritus, and anemia. Myopathy has been reported rarely. A syndrome of apparent hypersensitivity which includes some of the following findings: angioedema, syndrome, lupus-like, polimialgia rheumatic, vasculitis, thrombocytopenia, eosinophilia, increased ESR, arthritis, arthralgia, urticaria, photosensitivity, fever, redness, dyspnea, and malaise have been reported rarely. There was rarely rhabdomyolysis and hepatitis/jaundice. Persistent elevations and sharp increase in transaminases have been reported rarely. Elevations in alkaline phosphatase and y-glutamyl transpeptidase, serum creatine phosphokinase (CPK) derived from skeletal muscle have been reported. Changes in liver function tests were usually mild and transient. – Drug interactions: coumarin derivatives appear to slightly increase the prothrombin time when used concomitantly with simvastatin. In patients taking an anticoagulant the prothrombin time should be determined before the start of therapy with simvastatin and then, in the intervals usually recommended for patients under therapy cumarínica. Fibrates: increased risk of myopathy. Immunosuppressive agents, itraconazole and niacin: see precautions. Interference in laboratory tests: may occur elevations in levels of transaminases, alkaline phosphatase, y-glutamyl-transpeptidase, and serum creatine phosphokinase (see adverse Reactions).
Warnings and Precautions
what should I know before using?
it is Recommended to perform liver function tests before initiation of therapy and periodically thereafter in all patients. You should give special attention to those patients who developed elevated levels of serum transaminases and, in these patients, measurements should be repeated promptly and carried out more frequently. Aminotransferase levels show evidence of progression, particularly if rises above three times the upper limit of normality, and so persistent, the drug should be discontinued. Simvastatin should be used with caution in patients who consume substantial quantities of alcohol and (or) have a history of liver disease. As with other lipid-lowering, moderate elevations (less than three times the upper value of the normal) transaminases have been reported during therapy with simvastatin. These changes appear soon after the start of therapy, were usually transient and not accompanied by any symptom; treatment discontinuation was not required. Elevations of discrete and transient levels of CPK (skeletal muscle) have been commonly observed in patients receiving simvastatin, but generally without any clinical significance. Therapy with HMG-COA reductase inhibitors have been rarely associated with myopathy. This diagnosis should be considered in any patient with diffuse myalgias, hypersensitivity muscle and/or elevations of important levels of creatinine-fosfoquinase (CPK), that is, above 10 times the upper limit of normality. The use of simvastatin should be suspended if you are experiencing high levels of CPK, or if there is a suspicion or diagnosis of myopathy. It is known that the risk of myopathy with inhibitors of HMG-COA reductase inhibitors increases substantially with immunosuppressive therapy concomitant, including ciclosporinas, or with the simultaneous use of a derivative fíbrico or doses lipid-lowering of niacin. There have been rare reports of rhabdomyolysis serious with acute renal failure secondary. In this way, the benefits and the risks of the concomitant use of simvastatin with immunosuppressive drugs, fibrates, or with doses of lipid-lowering of niacin (nicotinic acid) should be carefully considered. Inhibitors of HMG-COA reductase inhibitors and the agents for the therapy antifungal derivatives of azol inhibit the synthesis of cholesterol at different points. In patients receiving cyclosporine should be discontinued temporarily to simvastatin, if it is required therapy antifungal derivatives of azol; patients who are not receiving cyclosporine should be carefully monitored if it is required therapy antifungal derivatives of azol. Therapy with simvastatin should be temporarily suspended or discontinued in any patient with an acute condition, serious, suggestive of myopathy or risk factor that predisponha renal failure secondary to rhabdomyolysis. Simvastatin may cause fetal harm when administered to pregnant women. Therefore, it should be administered to women of childbearing age only when such patients have very low probability of getting pregnant. If the patient becomes pregnant during use of simvastatin, the drug should be discontinued and the patient advised of possible risks to the fetus. It is not known whether simvastatin or its metabolites are excreted in human milk and because of the potential for severe reactions in nursing infants, women in tratramento with the drug should not breastfeed their children. Not yet proven the safety and efficacy of simvastatin in children. Therefore, it is not recommended for paediatric use. The effectiveness and frequency of adverse findings in clinical or laboratory in patients over the age of 65 years, was similar to that observed in the population as a whole. In patients with the homozygous form of familial hypercholesterolaemia, in which there is complete absence of receptors for LDL, it is unlikely that therapy with simvastatin results in clinical benefit. Simvastatin takes effect only moderately reducer of triglycerides, and is not indicated when hypertriglyceridemia is the abnormality more important (hyperlipidemias types I, IV, and V).