DRUGS & SUPPLEMENTS
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Simvastatine is a hypolipidemic agent from a group of statins, an inhibitor of HMG-CoA reductase. This medication is a prodrug because it has in its structure the closed lactone ring which is hydrolyzed after intake.
Lipid-lowering effect of statins is associated with lower levels of total cholesterol by LDL-C. Reducing cholesterol is dose-dependent and is not linear but exponential. Statins do not affect the activity of lipoprotein and hepatic lipase, have no significant effect on the synthesis and catabolism of free fatty acids, thats why their effect on TG levels again and indirectly through their main effects on reducing LDL-C.
According to the controlled studies of Simvastatine increases HDL-C to 14%.
In addition to the hypolipidemic actions Simvastatine has beneficial effects in endothelial dysfunction, on the vascular wall, the state of atheroma, improves blood rheology, have antioxidant, antiproliferative properties. There is evidence that Simvastatine improves endothelial function within 30 days of therapy.
Simvastatine therapy was accompanied by a decrease in the incidence of cardiovascular disorders, regardless of baseline LDL-C.
After oral administration Simvastatine is well absorbed from the gastrointestinal tract (average 85%). Cmax is reached after 4 h. Taking Simvastatine just before eating with low fat does not affect its the pharmacokinetic parameters.
During a "first pass" through the liver Simvastatine biotransformed to form active beta-metabolites. The plasma protein binding is 95%.
The concentration of the active metabolite of Simvastatine in human systemic circulation is less than 5%.
Excreted in unchanged form and as metabolites, mainly in the bile - 60-85%, 10-15% - in the form of inactive metabolites are excreted by the kidneys.
Primary hypercholesterolemia with the ineffectiveness of diets, combined hypercholesterolemia and hypertriglyceridemia.
The dosing regimen of Simvastatine is individual. The initial dose is 5-20 mg. If necessary the dose is increased every 4 weeks. Simvastatine is taken 1 time / day in the evening. The maximum dose is 40 mg / day.
For patients receiving immunosuppressive drugs, the recommended starting dose is 5 mg; the maximum dose is 5 mg / day.
In severe renal insufficiency, the initial dose is 5-10 mg / day.
Digestive system: constipation, diarrhea, loss of appetite, flatulence, nausea, abdominal pain, pancreatitis, increased ALT, AST, GGT, ALP.
CNS and peripheral nervous system: headache, dizziness, muscle cramps, paresthesia, peripheral neuropathy.
Cardiovascular system: possible transient hypotension.
Musculoskeletal system: myalgia, myopathy, rhabdomyolysis, increased CPK.
Allergic reactions: seldom - angioedema, lupus like syndrome, vasculitis, thrombocytopenia, eosinophilia, ESR increase, arthritis, rash, fever, shortness of breath.
Dermatological reactions: photosensitivity, skin rash, itching, redness of skin, alopecia.
An active pathological process in the liver, persistent elevation of transaminases, pregnancy, lactation, hypersensitivity to Simvastatine.
Simvastatine is contraindicated in pregnancy and lactation.
Category effects on the fetus by FDA - X.
With careful use Simvastatine in patients with liver disease, with chronic alcoholism, with hypotension, reduced or increased tone of skeletal muscle of unknown etiology, epilepsy, severe renal insufficiency.
Before and during treatment it is necessary to monitor liver function.
Patients receiving anticoagulant coumarin derivatives, before and during treatment with Simvastatine should monitor the prothrombin time.
Simvastatine therapy should be discontinued if a significant increase in CK activity or suspected myopathy, the development of acute or severe illness when any risk factors predisposing to renal failure due to rhabdomyolysis.
It is not recommended to use Simvastatine concurrently with immunosuppressants, fibrates, nicotinic acid, antifungal azole derivatives drugs.
Safety and efficacy of Simvastatine in a pediatric practice are not established. It is not recommended to use this medication for children.
Simultaneous administration of Simvastatine with:
Depending on the reaction of the Simvastatine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Simvastatine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Simvastatine addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology