Zocor and/or Equivalent Simvastatin Prescription Information
Zocor contains the active ingredient, Simvastatin, which is classified as an Anti-Hyperlipidemic agent. Simvastatin is derived in the laboratory from the Aspergillus terreus and is used for the treatment of high levels of lipids in the blood stream such as Elevated Cholesterol and Triglycerides. Zocor also helps increase high density lipoprotein (good cholesterol) in the body. Zocor is a prescription drug, also available in generic form.
Zocor is primarily approved for the treatment of hypercholesterolemia (elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),) and hyper-triglyceridemia (Fredrickson type IV). It is also indicated for various conditions as follows:
Risk of coronary heart disease-associated mortality and cardiovascular events,
Risk of non-fatal MI and stroke,
Fredrickson type IIa (heterozygous familial and non-familial),
Fredrickson type IIb (mixed dyslipidemia),
Total-cholesterol and LDL-C in adults with homozygous familial hypercholesterolemia.
Zocor has not yet been studied in Fredrickson Types I and V dyslipidemias and is therefore not used in these conditions.
Dose, Administration and Dosage Forms:
Zocor is available in orally administered tablets in 5mg, 10mg, 20mg, 40mg, and 80mg strengths, and orally disintegrating tablets in 10mg, 20mg, 40mg, and 80mg strengths. Zocor is usually started with 10 to 20mg once per day administered in the evening. Daily dosages may vary from 5mg to 40 mg. Zocor should be started at 40mg per day in patients with a high risk of CHD. Adolescents (10-17 years of age) with HeFH should be started on 10 mg per day, not to exceed 40 mg per day. Zocor should be stored between 5 C to 30 C.
Mechanism of Action:
Zocor contains simvastatin as an active ingredient, which is actually an inactive lactone. Simvastatin is a prodrug which is hydrolyzed in the gastric system into its active metabolite beta-hydroxyacid , which is a simvastatin acid. Simvastatin acts on HMG-CoA to the mevalonate conversion pathway and suppresses cholesterol synthesis by the specific inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase enzyme. This enzyme is an early and rate-limiting step in the bio-synthesis of cholesterol. By this mechanism, simvastatin also reduces VLDL (bad cholesterol) and triglycerides and improves HDL-C (good cholesterol).
Side-effects and Safety Profile:
Various serious side-effects reported with Zocor usage include severe allergic reactions (severe rash, hives, dyspnea, chest tightness; swelling of mouth, face, lips, and tongue etc.); hepatic cirrhosis, cholestatic hepatitis, dark colored urine and pale stools, suppressed sexual ability, irregular heartbeats, joint pain, memory loss, memory impairment, abnormal bleeding and bruising, etc.
Moderately-severe side-effects associated with Zocor include rhabdomyolysis, myositis, upper respiratory infections, burning sensations, numbness, tingling, altered urine production, depression, skin blistering and peeling, persistent sore throat, loss of appetite, myalgia, arthralgia, tenderness, persistent nausea, back pain, trouble sleeping, muscle cramps, etc.
Non-serious side-effects associated with Zocor include headache, constipation, diarrhea, indigestion, vomiting, mild gastric pain, nausea, tiredness, weakness, etc.
Warnings and Contraindications:
Patients taking Zocor must be warned about the possible increased risk of myopathy, including rhabdomyolysis, at higher dosages. Patients must be advised to report proactively if they face any myopathy-associated symptoms.
Zocor usage is associated with liver enzyme abnormalities and persistent elevations in hepatic transaminases; therefore, liver enzyme testing is necessary before therapy initiation.
Zocor is classified as a pregnancy category X drug and is therefore contraindicated in pregnant women and women who may become pregnant. Women of childbearing age must use effective means of birth control while taking Zocor. Patients must discuss future pregnancy plans with prescribing healthcare professionals.
Zocor has not yet been studied in nursing women to determine whether or not simvastatin is excreted in human milk. Since other drugs of this class do excrete in human breast milk, Zocor should not be prescribed to nursing women to avoid potential harm to the infant.
Zocor is contraindicated as a concomitant therapy with strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, or danazol.
Zocor is contraindicated in patients who are allergic to simvastatin.
Zocor is contraindicated in patients with active hepatic disorder.
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