Simvastatin
Tablet, Film Coated · Oral
Uses
Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: ( 1 ) To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Dosage and administration
Important Dosage and Administration Information: ( 2.1 ) Take simvastatin tablets orally once daily in the evening. Maximum recommended dosage is simvastatin tablets 40 mg once daily. An 80 mg daily dosage of simvastatin tablets are restricted to patients who have been taking simvastatin tablets 80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving simvastatin tablets 40 mg daily, prescribe alternative LDL-C lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating, and adjust the dosage if necessary. Adults : Recommended dosage is 20 mg to 40 mg once daily. ( 2.2 ) Pediatric Patients Aged 10 Years and Older with HeFH : Recommended dosage is 10 mg to 40 mg once daily. ( 2.3 ) Patients with Severe Renal Impairment : Recommended starting dosage is simvastatin 5 mg once daily. ( 2.4 , 8.6 ) See full prescribing information for simvastatin tablets dosage modifications due to drug interactions. ( 2.5 ) 2.1 Important Dosage and Administration Information Take simvastatin tablets orally once daily in the evening. The maximum recommended dosage is simvastatin tablets 40 mg once daily [see Dosage and Administration (2.2 , 2.3) ] . An 80 mg daily dosage of simvastatin tablets are restricted to patients who have been taking simvastatin 80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions (5.1) ] . If as dose is missed, take the missed dose as soon as possible. Do not double the next dose. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving simvastatin tablets 40 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating simvastatin tablets, and adjust the dosage if necessary. 2.2 Recommended Dosage in Adult Patients The recommended dosage range of simvastatin tablets are 20 mg to 40 mg once daily. 2.3 Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended dosage range of simvastatin tablets are 10 mg to 40 mg daily. 2.4 Recommended Dosage in Patients with Renal Impairment For patients with severe renal impairment [creatinine clearance (CLcr) 15 to 29 mL/min], the recommended starting dosage of simvastatin is 5 mg once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6) ]. There are no dosage adjustment recommendations for patients with mild or moderate renal impairment. 2.5 Dosage Modifications Due to Drug Interactions Concomitant use of simvastatin tablets with the following drugs requires dosage modification of simvastatin tablets [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] . Patients taking Lomitapide Reduce the dosage of simvastatin tablets by 50%. Do not exceed simvastatin tablets 20 mg once daily (or 40 mg once daily for patients who have previously taken an 80 mg daily dosage of simvastatin tablets chronically while taking lomitapide) [see Dosage and Administration (2.1) ]. Patients taking Verapamil, Diltiazem, or Dronedarone Do not exceed simvastatin tablets 10 mg once daily. Patients taking Amiodarone, Amlodipine, or Ranolazine Do not exceed simvastatin tablets 20 mg once daily.
Dosage forms and strengths
Simvastatin tablets: 5 mg: yellow colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘15’ on the other side. 10 mg: light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘01’ on the other side. 20 mg: light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘02’ on the other side. 40 mg: pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘03’ on the other side. 80 mg: pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘04’ on the other side. Tablets : 5 mg; 10 mg; 20 mg; 40 mg; 80 mg (3)
Contraindications
Simvastatin tablets are contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see Drug Interactions (7.1) ]. Concomitant use of cyclosporine, danazol or gemfibrozil [see Drug Interactions (7.1) ]. Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . Hypersensitivity to simvastatin or any excipients in simvastatin tablets. Hypersensitivity reactions, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported [see Adverse Reactions (6.2) ]. Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any excipient in simvastatin tablets ( 4 , 6.2 )
Warnings and precautions
Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher simvastatin dosage. Chinese patients may be at higher risk for myopathy. Discontinue simvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing simvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.1 , 7.1 , 8.5 , 8.6 , 8.8 ) Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported. Discontinue simvastatin if IMNM is suspected. ( 5.2 ) Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzyme before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue simvastatin. ( 4 , 5.3 , 8.7 ) 5.1 Myopathy and Rhabdomyolysis Simvastatin may cause myopathy and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including simvastatin. In clinical studies of 24,747 simvastatin-treated patients with a median follow-up of 4 years, the incidence of myopathy, defined as unexplained muscle weakness, pain, or tenderness accompanied by creatinine kinase (CK) increases greater than ten times the upper limit of normal (10xULN), were approximately 0.03%, 0.08%, and 0.61% in patients treated with simvastatin 20 mg, 40 mg, and 80 mg daily, respectively. In another clinical study of 12,064 simvastatin-treated patients (with a history of myocardial infarction) with a mean follow-up of 6.7 years, the incidences of myopathy in patients taking simvastatin 20 mg and 80 mg daily were approximately 0.02% and 0.9%, respectively. The incidences of rhabdomyolysis (defined as myopathy with a CK >40xULN) in patients taking simvastatin 20 mg and 80 mg daily were approximately 0% and 0.4%, respectively [see Adverse Reactions (6.1) ]. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher simvastatin dosage; Chinese patients on simvastatin may be at higher risk for myopathy [see Contraindications (4) , Drug Interactions (7.1) , and Use in Specific Populations (8.8) ] . The risk of myopathy is increased by elevated plasma levels of simvastatin and simvastatin acid. The risk is also greater in patients taking an 80 mg daily dosage of simvastatin compared with patients taking lower simvastatin dosages and compared with patients using other statins with similar or greater LDL-C-lowering efficacy [see Adverse Reactions (6.1) ]. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of strong CYP3A4 inhibitors with simvastatin is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is required, temporarily suspend simvastatin during the duration of strong CYP3A4 inhibitor treatment. The concomitant use of simvastatin with gemfibrozil, cyclosporine, or danazol is also contraindicated [see Contraindications (4) and Drug Interactions (7.1) ]. Simvastatin dosage modifications are recommended for patients taking lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine or ranolazine [see Dosage and Administration (2.5) ]. Simvastatin use should be temporarily suspended in patients taking daptomycin. Lipid modifying doses ( > 1 gram/day) of niacin, fibrates, colchicine, and grapefruit juice may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1) ] . Use the 80 mg daily dosage of simvastatin only in patients who have been taking simvastatin 80 mg daily chronically without evidence of muscle toxicity [see Dosage and Administration (2.1) ]. If patients treated with an 80 mg daily dosage of simvastatin are prescribed an interacting drug that increases the risk for myopathy and rhabdomyolysis, switch to an alternate statin [see Drug Interactions (7.1) ]. Discontinue simvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK increases may resolve if simvastatin is discontinued. Temporarily discontinue simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis, e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the simvastatin dosage and advise patients receiving an 80 mg daily dosage of simvastatin of the increased risk of myopathy and rhabdomyolysis. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. 5.2 Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered.
Side effects
The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥5%) are upper respiratory infection, headache, abdominal pain, constipation, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical studies, 2,423 adult patients were exposed to simvastatin with a median duration of follow-up of approximately 18 months. The most commonly reported adverse reactions (incidence ≥5%) in these simvastatin clinical studies were: upper respiratory infections (9%), headache (7%), abdominal pain (7%), constipation (7%), and nausea (5%). Overall, 1.4% of patients discontinued simvastatin due to adverse reactions. The most common adverse reactions that led to discontinuation were: gastrointestinal disorders (0.5%), myalgia (0.1%), and arthralgia (0.1%). In a Cardiovascular Outcomes Study (the Scandinavian Simvastatin Survival Study [Study 4S]), adult patients (age range 35 to 71 years, 19% women, 100% Caucasians) were treated with 20 to 40 mg per day of simvastatin or placebo over a median of 5.4 years [see Clinical Studies (14) ] ; adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 1. Table 1: Adverse Reactions Reported ≥2% of Patients Treated with Simvastatin and Greater than Placebo in Study 4S % Placebo (N = 2,223) % Simvastatin (N = 2,221) Bronchitis 6.3 6.6 Abdominal pain 5.8 5.9 Atrial fibrillation 5.1 5.7 Gastritis 3.9 4.9 Eczema 3.0 4.5 Vertigo 4.2 4.5 Diabetes mellitus 3.6 4.2 Insomnia 3.8 4.0 Myalgia 3.2 3.7 Urinary tract infection 3.1 3.2 Edema/swelling 2.3 2.7 Headache 2.1 2.5 Sinusitis 1.8 2.3 Constipation 1.6 2.2 Myopathy/Rhabdomyolysis In clinical studies with a median follow-up of at least 4 years, in which 24,747 patients received simvastatin, the incidence of myopathy (defined as unexplained muscle weakness, pain, or tenderness accompanied by CK increases greater than 10xULN) was approximately 0.03%, 0.08%, and 0.61% for the simvastatin 20 mg, 40 mg, and 80 mg daily groups, respectively. In a clinical outcomes study in which 12,064 adult patients with a history of myocardial infarction were treated with simvastatin (mean follow-up 6.7 years), the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum CK >10x [1200 U/L] ULN) in patients taking simvastatin 20 mg and 80 mg daily was approximately 0.02% and 0.9%, respectively. The incidence of rhabdomyolysis (defined as myopathy with a CK >40xULN) in patients on simvastatin 20 mg and 80 mg daily was approximately 0% and 0.4%, respectively. The incidence of myopathy and rhabdomyolysis were highest during the first year and then decreased during the subsequent years of treatment. In another clinical outcomes study in which 10,269 adult patients were treated with simvastatin 40 mg per day (mean follow-up of 5 years), the incidence of myopathy/rhabdomyolysis was <0.1% in patients treated with simvastatin. Elevations in Liver Enzyme Tests Moderate (less than 3xULN) elevations of serum transaminases have been reported with use of simvastatin. Persistent increases to more than 3xULN in serum transaminases have occurred in approximately 1% of patients receiving simvastatin in clinical studies. Marked persistent increases of hepatic transaminases have occurred with simvastatin. Elevated alkaline phosphatase and γ-glutamyl transpeptidase have also been reported. In Study 4S, with a median follow-up of 5.4 years, 1,986 adult patients were treated with simvastatin 20 mg once daily, of whom 37% titrated to 40 mg once daily. The percentage of patients with one or more occurrences of transaminase elevations to >3xULN was 0.7% in patients taking simvastatin compared with 0.6% in patients taking placebo. Elevated transaminases leading to discontinuation of study treatment occurred in 0.4% of patients taking simvastatin and 0.2% of patients taking placebo. The majority of elevated transaminases leading to treatment discontinuation occurred within in the first year. Adverse Reactions in Pediatric Patients with Heterozygous Familial Hypercholesterolemia In a 48-week clinical study in pediatric patients 10 years of age and older (43% female, 97.7% Caucasians, 1.7% Hispanics, 0.6% Multiracial) with HeFH (n=175), treated with placebo or simvastatin (10 to 40 mg daily), the most common adverse reactions were upper respiratory infection, headache, abdominal pain, and nausea [see Use in Specific Populations (8.4) and Clinical Studies (14) ]. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of simvastatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug interactions
See full prescribing information for details regarding concomitant use of simvastatin with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis. ( 2.5 , 7.1 ) Coumarin Anticoagulants : Obtain INR before simvastatin initiation and monitor INR during simvastatin dosage initiation or adjustment. ( 7.2 ) Digoxin : During simvastatin initiation, monitor digoxin levels. ( 7.2 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Simvastatin Simvastatin is a substrate of CYP3A4 and of the transport protein OATP1B1. Simvastatin exposure can be significantly increased with concomitant administration of inhibitors of CYP3A4 and OATP1B1. Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with simvastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Simvastatin Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with simvastatin increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher simvastatin dosages. Intervention: Concomitant use of strong CYP3A4 inhibitors with simvastatin is contraindicated [see Contraindications (4) ]. If treatment with a CYP3A4 inhibitor is unavoidable, suspend simvastatin during the course of strong CYP3A4 inhibitor treatment. Examples: Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing products, and nefazodone. Cyclosporine, Danazol, or Gemfibrozil Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine, danazol, or gemfibrozil with simvastatin. Gemfibrozil may cause myopathy when given alone. Intervention: Concomitant use of cyclosporine, danazol, or gemfibrozil with simvastatin is contraindicated [see Contraindications (4) ]. Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with simvastatin. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed simvastatin 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed simvastatin 20 mg daily [see Dosage and Administration (2.5) ]. Lomitapide Clinical Impact: Simvastatin exposure is approximately doubled with concomitant use of lomitapide and the risk of myopathy and rhabdomyolysis is increased. Intervention: Reduce the dose of simvastatin by 50% if initiating lomitapide. Do not exceed simvastatin 20 mg daily (or simvastatin 40 mg daily for patients who have previously taken an 80 mg daily dosage of simvastatin chronically) while taking lomitapide [see Dosage and Administration (2.1 , 2.5) ]. Daptomycin Clinical Impact: Cases of rhabdomyolysis have been reported with simvastatin administered with daptomycin. Both simvastatin and daptomycin can cause myopathy and rhabdomyolysis when given alone and the risk of myopathy and rhabdomyolysis may be increased by coadministration. Intervention: If treatment with daptomycin is required, consider temporarily suspending simvastatin during the course of daptomycin treatment. Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with simvastatin. The risk of myopathy is greater in Chinese patients. In a clinical study (median follow-up 3.9 years) of patients at high risk of CVD and with well-controlled LDL-C levels on simvastatin 40 mg/day with or without ezetimibe 10 mg/day, there was no incremental benefit on cardiovascular outcomes with the addition of lipid-modifying doses of niacin. Intervention: Concomitant use of simvastatin with lipid-modifying dosages of niacin is not recommended in Chinese patients [see Use in Specific Populations (8.8) ]. For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin concomitantly with simvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Fibrates (other than Gemfibrozil) Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with simvastatin. Intervention: Consider if the benefit of using fibrates concomitantly with simvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with simvastatin. Intervention: Consider if the benefit of using colchicine concomitantly with simvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Grapefruit Juice Clinical Impact: Grapefruit juice can raise the plasma levels of simvastatin and may increase the risk of myopathy and rhabdomyolysis. Intervention: Avoid grapefruit juice when taking simvastatin.
Use in specific populations
Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Breastfeeding not recommended during treatment with simvastatin. ( 8.2 ) 8.1 Pregnancy Risk Summary Discontinue simvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Simvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, simvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with simvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data ) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered simvastatin during the period of organogenesis at doses that resulted in 2.5 and 2 times, respectively, the human exposure at the maximum recommended human dosage of 80 mg/day, based on body surface area (mg/m 2 ) (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data Simvastatin was given to pregnant rats at doses of 6.25, 12.5 and 25 mg/kg/day (0.6 times, 1.3 times, and 2.5 times, respectively, the maximum recommended dosage of 80 mg/day when normalized to body surface area) from gestation days 6 to 17 and to pregnant rabbits from gestation days 6 to 18 at doses of 2.5, 5, and 10 mg/kg/day (0.5 times, 1 times, and 2 times, respectively, the maximum recommended dosage of 80 mg/day when normalized to body surface area). For both species, there was no evidence of maternal toxicity or embryolethality. In rats, mean fetal body weights in the 25 mg/kg/day group were decreased 5.4%. Similar fetal body weight effects were not observed in rabbits. Simvastatin doses of 6.25, 12.5 and 25 mg/kg/day (0.6 times, 1.3 times, and 2.5 times, respectively, the maximum recommended dosage of 80 mg/day when normalized to body surface area) were given to pregnant rats from gestation day 15 to lactation day 21. Slight decreases in maternal body weight gain and pup postnatal day 0 weight were observed in the 25 mg/kg/day dose group. Mean body weight gain of pups during lactation was slightly decreased at doses ≥12.5 mg/kg/day. Post weaning weight, behavior, reproductive performance and fertility of the offspring were not affected at any dose tested. Placental transfer of simvastatin was not evaluated in rats or rabbits. However, it has been shown that other drugs in this class cross the placenta. 8.2 Lactation Risk Summary There is no information about the presence of simvastatin in human or animal milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, it has been shown that another drug in this class passes into human milk. Statins, including simvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with simvastatin [see Use in Specific Populations (8.1) , Clinical Pharmacology (12.1) ]. 8.4 Pediatric Use The safety and effectiveness of simvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH. Use of simvastatin for this indication is based on a double-blind, placebo-controlled clinical study in 175 pediatric patients (99 boys and 76 girls at least 1 year post-menarche) 10 years of age and older with HeFH. In this limited controlled study, there was no significant effect on growth or sexual maturation in the boys or girls, or on menstrual cycle length in girls.
Pregnancy
8.1 Pregnancy Risk Summary Discontinue simvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Simvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, simvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with simvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data ) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered simvastatin during the period of organogenesis at doses that resulted in 2.5 and 2 times, respectively, the human exposure at the maximum recommended human dosage of 80 mg/day, based on body surface area (mg/m 2 ) (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data Simvastatin was given to pregnant rats at doses of 6.25, 12.5 and 25 mg/kg/day (0.6 times, 1.3 times, and 2.5 times, respectively, the maximum recommended dosage of 80 mg/day when normalized to body surface area) from gestation days 6 to 17 and to pregnant rabbits from gestation days 6 to 18 at doses of 2.5, 5, and 10 mg/kg/day (0.5 times, 1 times, and 2 times, respectively, the maximum recommended dosage of 80 mg/day when normalized to body surface area). For both species, there was no evidence of maternal toxicity or embryolethality. In rats, mean fetal body weights in the 25 mg/kg/day group were decreased 5.4%. Similar fetal body weight effects were not observed in rabbits. Simvastatin doses of 6.25, 12.5 and 25 mg/kg/day (0.6 times, 1.3 times, and 2.5 times, respectively, the maximum recommended dosage of 80 mg/day when normalized to body surface area) were given to pregnant rats from gestation day 15 to lactation day 21. Slight decreases in maternal body weight gain and pup postnatal day 0 weight were observed in the 25 mg/kg/day dose group. Mean body weight gain of pups during lactation was slightly decreased at doses ≥12.5 mg/kg/day. Post weaning weight, behavior, reproductive performance and fertility of the offspring were not affected at any dose tested. Placental transfer of simvastatin was not evaluated in rats or rabbits. However, it has been shown that other drugs in this class cross the placenta.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of simvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH. Use of simvastatin for this indication is based on a double-blind, placebo-controlled clinical study in 175 pediatric patients (99 boys and 76 girls at least 1 year post-menarche) 10 years of age and older with HeFH. In this limited controlled study, there was no significant effect on growth or sexual maturation in the boys or girls, or on menstrual cycle length in girls. The safety and effectiveness of simvastatin have not been established in pediatric patients younger than 10 years of age with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH).
Geriatric use
8.5 Geriatric Use Of the total number of simvastatin-treated patients in clinical studies 1,021 (23%) patients, 5,366 (52%) patients, and 363 (15%) patients were ≥65 years old, respectively. In Study HPS, 615 (6%) patients were ≥75 years old [see Clinical Studies (14) ]. In a clinical study of patients treated with simvastatin 80 mg daily, patients ≥65 years of age had an increased risk of myopathy, including rhabdomyolysis, compared to patients <65 years of age. A pharmacokinetic study with simvastatin use showed the mean plasma level of total inhibitors to be approximately 45% higher in geriatric patients between 70 to 78 years of age compared with patients between 18 to 30 years of age [see Clinical Pharmacology (12.3) ] . Advanced age (≥65 years) is a risk factor for simvastatin-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving simvastatin for the increased risk of myopathy [see Warnings and Precautions (5.1) ].
Overdosage
No specific antidotes for simvastatin are known. Contact Poison Control (1-800-222-1222) for latest recommendations.
Description
Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus . Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S -[1α,3α,7β,8β (2 S *,4 S *),-8aβ]]. The molecular formula of simvastatin is C 25 H 38 O 5 and its molecular weight is 418.57. Its structural formula is: Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP are available for oral administration in strength of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg. Each tablet contains following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin acid and its metabolites are inhibitors of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.
How supplied
Simvastatin Tablets USP, 5 mg are yellow colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘15’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-050-30 (Child Resistant Closure) Bottles of 45 NDC 65862-050-45 (Child Resistant Closure) Bottles of 90 NDC 65862-050-90 (Child Resistant Closure) Bottles of 100 NDC 65862-050-01 (Child Resistant Closure) Bottles of 100 NDC 65862-050-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-050-99 (Non-Child Resistant Closure) Bottles of 2,500 NDC 65862-050-26 (Non-Child Resistant Closure) Simvastatin Tablets USP, 10 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘01’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-051-30 (Child Resistant Closure) Bottles of 45 NDC 65862-051-45 (Child Resistant Closure) Bottles of 90 NDC 65862-051-90 (Child Resistant Closure) Bottles of 100 NDC 65862-051-01 (Child Resistant Closure) Bottles of 100 NDC 65862-051-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-051-99 (Non-Child Resistant Closure) Bottles of 2,500 NDC 65862-051-26 (Non-Child Resistant Closure) Simvastatin Tablets USP, 20 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘02’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-052-30 (Child Resistant Closure) Bottles of 45 NDC 65862-052-45 (Child Resistant Closure) Bottles of 90 NDC 65862-052-90 (Child Resistant Closure) Bottles of 100 NDC 65862-052-01 (Child Resistant Closure) Bottles of 100 NDC 65862-052-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-052-99 (Non-Child Resistant Closure) Bottles of 2,500 NDC 65862-052-26 (Non-Child Resistant Closure) Simvastatin Tablets USP, 40 mg are pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘03’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-053-30 (Child Resistant Closure) Bottles of 45 NDC 65862-053-45 (Child Resistant Closure) Bottles of 90 NDC 65862-053-90 (Child Resistant Closure) Bottles of 100 NDC 65862-053-01 (Child Resistant Closure) Bottles of 100 NDC 65862-053-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-053-99 (Non-Child Resistant Closure) Bottles of 2,000 NDC 65862-053-22 (Non-Child Resistant Closure) Simvastatin Tablets USP, 80 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘04’ on the other side. They are supplied as follows: Bottles of 30 NDC 65862-054-30 (Child Resistant Closure) Bottles of 45 NDC 65862-054-45 (Child Resistant Closure) Bottles of 90 NDC 65862-054-90 (Child Resistant Closure) Bottles of 100 NDC 65862-054-00 (Non-Child Resistant Closure) Bottles of 1,000 NDC 65862-054-99 (Non-Child Resistant Closure) Bottles of 3,000 NDC 65862-054-39 (Non-Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Myopathy and Rhabdomyolysis Advise patients that simvastatin may cause myopathy and rhabdomyolysis. Inform patients taking an 80 mg daily dose of simvastatin that they are at an increased risk. Inform patients that the risk is also increased when taking certain types of medication or consuming grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to inform other healthcare providers prescribing a new medication or increasing the dose of an existing medication that they are taking simvastatin. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Contraindications (4) , Warnings and Precautions (5.1) , and Drug Interactions (7.1) ] . Hepatic Dysfunction Inform patients that simvastatin may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3) ]. Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with simvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.4) ]. Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if simvastatin should be discontinued [see Use in Specific Populations (8.1) ]. Lactation Advise patients that breastfeeding is not recommended during treatment with simvastatin [see Use in Specific Populations (8.2) ] . Missed Dose Instruct patients to take simvastatin only as prescribed. If a dose is missed, it should be taken as soon as possible. Advise patients not to double their next dose. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 09/2023
Label text from the FDA structured product label by Aurobindo Pharma Limited (revised May 11, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Simvastatin in 156 products
Simvastatin NDC products (156)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6920 | Simvastatin 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6306 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6236 | Simvastatin 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5788 | Simvastatin 80 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5019 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4901 | Simvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4897 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4801 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4736 | Simvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6307 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6389 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6390 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6421 | Simvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6424 | Simvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6425 | Simvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6459 | Simvastatin 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6922 | Simvastatin 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7088 | Simvastatin 80 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7776 | Simvastatin 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7777 | Simvastatin 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7780 | Simvastatin 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7781 | Simvastatin 20 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7782 | Simvastatin 40 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7783 | Simvastatin 80 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 16729-156 | Simvastatin 5 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-007 | Simvastatin 80 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-006 | Simvastatin 40 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-005 | Simvastatin 20 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 16729-004 | Simvastatin 10 mg/1 Tablet, Film Coated | Accord Healthcare, Inc. | ANDA |
| 68084-511 | Simvastatin 10 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-210 | Simvastatin 40 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 68084-512 | Simvastatin 20 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 71610-611 | Simvastatin 80 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-615 | Simvastatin 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-622 | Simvastatin 20 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-623 | Simvastatin 40 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-966 | Simvastatin 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-610 | Simvastatin 40 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 53401-026 | Simvastatin 40 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 53401-018 | Simvastatin 80 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 53401-013 | Simvastatin 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-050 | Simvastatin 40 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-250 | Simvastatin 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-609 | Simvastatin 20 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 65862-051 | Simvastatin 10 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-050 | Simvastatin 5 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-052 | Simvastatin 20 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-054 | Simvastatin 80 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-053 | Simvastatin 40 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 70377-003 | Simvastatin 20 mg/1 Tablet, Film Coated | Biocon Pharma Inc, | ANDA |
| 70377-002 | Simvastatin 10 mg/1 Tablet, Film Coated | Biocon Pharma Inc, | ANDA |
| 70377-001 | Simvastatin 5 mg/1 Tablet, Film Coated | Biocon Pharma Inc, | ANDA |
| 70377-004 | Simvastatin 40 mg/1 Tablet, Film Coated | Biocon Pharma Inc, | ANDA |
| 70377-005 | Simvastatin 80 mg/1 Tablet, Film Coated | Biocon Pharma Inc, | ANDA |
| 71335-2262 | Simvastatin 5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-7421 | Simvastatin 5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-3408 | Simvastatin 80 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-3393 | Simvastatin 20 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-3392 | Simvastatin 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-3385 | Simvastatin 40 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1891 | Simvastatin 20 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1905 | Simvastatin 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1906 | Simvastatin 40 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-9630 | Simvastatin 40 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-9636 | Simvastatin 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-9642 | Simvastatin 20 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-9717 | Simvastatin 80 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 31722-513 | Simvastatin 40 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-512 | Simvastatin 20 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-511 | Simvastatin 10 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-510 | Simvastatin 5 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-514 | Simvastatin 80 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-4782 | Simvastatin 20 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 67046-0542 | Simvastatin 10 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0626 | Simvastatin 20 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0628 | Simvastatin 40 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 72189-452 | Simvastatin 10 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-427 | Simvastatin 40 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-421 | Simvastatin 20 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 84677-016 | Simvastatin 20 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 84677-015 | Simvastatin 10 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 84677-014 | Simvastatin 5 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 84677-017 | Simvastatin 40 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 84677-018 | Simvastatin 80 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 68180-482 | Simvastatin 5 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-479 | Simvastatin 20 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-478 | Simvastatin 10 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-465 | Simvastatin 80 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-464 | Simvastatin 40 mg/1 Tablet, Film Coated | Lupin Pharmaceuticals, Inc. | ANDA |
| 0615-7992 | Simvastatin 10 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8056 | Simvastatin 40 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7993 | Simvastatin 20 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 16714-683 | Simvastatin 20 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-682 | Simvastatin 10 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-681 | Simvastatin 5 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-684 | Simvastatin 40 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-685 | Simvastatin 80 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 51655-113 | Simvastatin 40 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-387 | Simvastatin 40 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-448 | Simvastatin 20 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-459 | Simvastatin 20 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-598 | Simvastatin 10 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-643 | Simvastatin 40 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-841 | Simvastatin 40 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 68071-3530 | Simvastatin 20 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3426 | Simvastatin 40 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4331 | Simvastatin 10 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4996 | Simvastatin 20 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4998 | Simvastatin 40 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3391 | Simvastatin 20 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2560 | Simvastatin 20 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-1646 | Simvastatin 40 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2559 | Simvastatin 40 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-1711 | Simvastatin 10 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-727 | Simvastatin 10 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-320 | Simvastatin 10 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-316 | Simvastatin 20 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-304 | Simvastatin 40 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-726 | Simvastatin 40 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-733 | Simvastatin 80 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8342 | Simvastatin 20 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-8369 | Simvastatin 10 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-8406 | Simvastatin 80 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals, Inc. | ANDA |
| 63187-449 | Simvastatin 40 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-192 | Simvastatin 40 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-780 | Simvastatin 20 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-798 | Simvastatin 10 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-809 | Simvastatin 20 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-075 | Simvastatin 20 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-191 | Simvastatin 10 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 42708-169 | Simvastatin 20 mg/1 Tablet, Film Coated | QPharma, Inc | ANDA |
| 42708-168 | Simvastatin 40 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 42708-148 | Simvastatin 20 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 82009-016 | Simvastatin 80 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-015 | Simvastatin 40 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-014 | Simvastatin 20 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-013 | Simvastatin 10 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-012 | Simvastatin 5 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 70518-3349 | Simvastatin 40 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1426 | Simvastatin 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0954 | Simvastatin 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4102 | Simvastatin 5 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3630 | Simvastatin 20 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3648 | Simvastatin 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 60760-580 | Simvastatin 80 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-585 | Simvastatin 20 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-579 | Simvastatin 40 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 69367-374 | Simvastatin 10 mg/1 Tablet, Film Coated | Westminster Pharmaceuticals, LLC | ANDA |
| 69367-375 | Simvastatin 20 mg/1 Tablet, Film Coated | Westminster Pharmaceuticals, LLC | ANDA |
| 69367-376 | Simvastatin 40 mg/1 Tablet, Film Coated | Westminster Pharmaceuticals, LLC | ANDA |
| 69367-377 | Simvastatin 80 mg/1 Tablet, Film Coated | Westminster Pharmaceuticals, LLC | ANDA |
| 72865-306 | Simvastatin 10 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-307 | Simvastatin 20 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-308 | Simvastatin 40 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-309 | Simvastatin 80 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
| 72865-305 | Simvastatin 5 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals Inc. | ANDA |
Simvastatin recalls
- D-0408-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0409-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0410-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0411-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0412-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-1234-2020 Apr 22, 2020 · Class II · Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - D-1842-2019 Sep 4, 2019 · Class III · Terminated
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B - D-0223-2018 Jan 24, 2018 · Class III · Terminated
Presence of foreign substance: metallic razor blade was found in one bottle.
Frequently asked questions
What is Simvastatin used for?
Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart…
What are the side effects of Simvastatin?
The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Most common… See the full label for the complete list.
Who makes Simvastatin?
Simvastatin is listed by 27 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare, Inc., American Health Packaging, Aphena Pharma Solutions - Tennessee, LLC.
Has Simvastatin been recalled?
The FDA enforcement database lists 8 recalls for Simvastatin, most recently D-0408-2023 (class ii): CGMP Deviations: recalling drug products following an FDA inspection.