High concentrations of LDL cholesterol can lead to artery damage, potentially leading to cardiac complications and stroke
The safety profiles were similar between the two treatment groups except that the incidence of myopathy was approximately 1
Only a few cases of rhabdomyolysis occur per million people taking statins
Information regarding rosuvastatin interactions added in line with the manufacturer's updated SPC
The MHRA advises that simvastatin 80 mg should be considered only in people with severe hypercholesterolaemia and high risk of cardiovascular complications who Summary Aims: Cardiovascular disease (CVD) is the most common cause of death worldwide
5 Similarly, interactions with clinically significant consequences are dose- dependent, and this is highly pertinent, with NICE guidance recommending use of high-intensity The incidence of myopathy/rhabdomyolysis in the 5-year HPS (Heart Protection Study) RCT, which compared simvastatin 40 mg/d and placebo in 20 536 participants, was <0
High concentrations of LDL cholesterol can lead to artery damage, potentially leading to cardiac complications and stroke
People with a history of alcohol abuse or liver disease should discuss the risks of Most recently, the United States (US) Food and Drug Administration (FDA) issued a warning about increased incidence of myopathy and rhabdomyolysis with simvastatin 80 mg compared with the 20-mg dose
Conclusions The MHRA Drug Safety Update (August 2012) highlights changes to the simvastatin SmPC regarding interactions that can increase the risk of myopathy and/or rhabdomyolysis
The safety prof iles were similar between the two treatment groups except that the incidence of myopathy was approximately 1
Other calcium channel blockers do not interact with simvastatin; Reference: 1) MHRA Drug Safety Update (August 2012)
If as dose is missed, take the missed dose as soon as possible
MHRA is an executive agency, sponsored by the Major changes in simvastatin labeling took place in June 2011 when the US FDA recommended limiting the maximum dosage of simvastatin to 80 mg in new patients and at certain doses when concomitantly used with other drugs, and revised the contraindication lists of drugs interacting with simvastatin
Suositeltu annos on yksi 10 mg:n, 20 mg:n, 40 mg:n tai 80 mg:n Simvastatin Orion ‑tabletti suun kautta, kerran vuorokaudessa
Simvastatin contains the active substance simvastatin
This can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue
DOI: 10
This medicine may help prevent medical problems (eg, heart or blood vessel problems, heart attacks, or strokes) caused by clogged blood vessels
02 % for patients on 20 mg
The safety profiles were similar between the two treatment groups except that the incidence of myopathy was approximately 1
there is an increased risk of myopathy associated with high-dose (80 mg) simvastatin MHRA Drug Safety Update (August 2012)
For more information and a discussion on the limitations of the evidence regarding benefits for intensive statin therapy over normal statin dosing, please refer to MeReC Rapid Review No
It happens rarely, but less than 1 in 1,000 people taking simvastatin may have a serious side effect
Safety and effectiveness of simvastatin in patients 10-17 years of age with heterozygous familial hypercholesterolemia have been evaluated in a The August 2012 edition of the MHRA's Drug Safety Update (vol 6, issue 1)1 highlights updated contraindications and dose recommendations for simvastatin when used with a number of other medicines
Your doctor may increase your dose as needed
, for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions (5
Approximately half of these myopathy cases occurred during the first year of treatment
Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication
Istin ® (amlodipine) • Co-administration of multiple doses of
Simvastatin is an oral HMG-CoA reductase inhibitor indicated as an adjunct to diet, exercise, weight loss, and possibly other medications as part of an
The incidence of confirmed myopathy was substantially higher in patients randomized to simvastatin 80 mg (1%) compared to 20 mg (~0
It is estimated to account for 10% to 20% of patients with
Patients on high dose simvastatin and those taking certain other medicines have an increased risk of developing myopathy Jun 5, 2023 · Simvastatin is an oral HMG-CoA reductase inhibitor indicated as an adjunct to diet
Avoid prescribing 80-mg simvastatin because of the high risk for myopathy
Pharmaceutical risk reduction with high-intensity statin therapy is advisable for high-risk patients
Sep 27, 2017 · Given Health Canada’s warning regarding the potential risks of high-dose simvastatin, our primary aim was to test changes in the proportion of beneficiaries per month receiving simvastatin doses greater than or equal to 80 mg simvastatin before and after the Health Canada regulatory warning on 7 November 2012
, for 12 months or more) without evidence of muscle toxicity; If a patient on simvastatin 80 mg/day needs to initiate an interacting drug (one that will increase simvastatin concentrations); simvastatin should be switched to an alternative statin 4 days ago · Muscle effects The risk of myopathy, myositis, and rhabdomyolysis associated with statin use is rare
Hypercholesterolemia (high cholesterol in the blood), familial homozygous—Dosage may be adjusted in this condition
Apr 19, 2023 · Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2022 issue of Drug Safety Update, up to 23 January 2022
UK
Results of clinical trials have shown that simultaneous administration of simvastatin and amlodipine can Simvastatin Brand names: Zocor, Simvador
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Simvastatin: increased risk of myopathy at high dose (80 mg) Simvastatin er en prodrug, som hydrolyseres til den aktive substans β-hydroxycarboxylsyre (simvastatinsyre)
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