Simvastatin Tablets

Active Ingredients: Simvastatin

Simvastatin Tablets are a drug used to lower cholesterol levels. It is also used to reduce the risk of heart complications in people with diabetes, coronary heart disease, and other cardiovascular risk factors. Simvastatin is used as adjunctive therapy with a low-fat/low-cholesterol diet and other lifestyle changes.

This medication is indicated for primary hyperlipidemia, mixed dyslipidemia, hypertriglyceridemia, hyperlipidemia, and primary dysbetalipoproteinemia. It is also used in the treatment of homozygous familial hypercholesterolemia (HoFH), and it may be prescribed for adolescents and children with heterozygous familial hypercholesterolemia (HeFH) when dietary changes alone are not effective.

Simvastatin belongs to the class of drugs known as HMG-CoA reductase inhibitors or statins. It works by blocking enzymes that are needed to produce cholesterol in the liver.

Statins are widely prescribed and are considered to have very minimal adverse effects. The usage of this class of drugs has been steadily increasing due to rising rates of cardiovascular disease (CVD), which is a major cause of death throughout the world. Treatment with statins is considered a cost-effective option, and they have been clinically shown to reduce mortality from fatal and non-fatal cardiovascular disease. Simvastatin is the recommended statin on the World Health Organization's List of Essential Medicines.

This medication is produced and exported by AdvaCare Pharma. These Simvastatin Tablets are manufactured in our facilities in China, India, and the USA. Our manufacturing facilities are GMP certified and are regularly inspected to ensure they meet health, safety, and environmental standards.

AdvaCare Pharma is a trusted Simvastatin manufacturer committed to providing quality-assured, cost-effective pharmaceuticals for an ever-changing global market. Manufacturing a wide range of 200+ pharmaceutical products in tablet form, we ensure that all of our oral solid dosage forms adhere to stringent GMP standards.

We operate according to a unique "vested supplier-distributor relationship" business model, in which we tie our success in a market to that of our distributor. Such a model facilitates a closer relationship by working together to achieve pre-defined goals for market entry and expansion. As a Simvastatin manufacturer and global supplier, we implement unique strategies to ensure successful distribution.

What is Simvastatin used for?

It is used to lower total cholesterol, including low-density lipoprotein (LDL) and triglycerides in the body, which helps increase high-density lipoprotein (HDL).

It is also used to prevent cardiovascular events like heart attacks and strokes and slow the development of cardiovascular complications.

How are Simvastatin Tablets used?

This medication is intended to be taken orally. Simvastatin Tablets are more effective when taken in the evening.

Why is Simvastatin Tablets recommended to be taken in the evening?

Simvastatin is advised to be taken in the evening for optimal effectiveness. This timing aligns with the body's peak nighttime cholesterol production, enhances the inhibition of the targeted enzyme (HMG-CoA reductase), ensures consistency in administration, optimizes medication absorption when taken with an evening meal, and promotes patient convenience. Following healthcare professionals' specific instructions is essential for personalized guidance.

What happens if a dose is missed?

The tablets should be taken as soon as possible unless it is nearly time for the next dose. Two doses should not be taken at the same time.

What dose should be taken?

Recommended dosage may vary based on different medical conditions.

Patients with renal insufficiency should follow an adjusted dose. Patients whose estimated CrCL (creatinine clearance) is 15-19ml/min should use a starting dose of 5mg, once in the evening. The dosing for CrCl < 15ml/min has not been formally defined.

Pediatric Dosing For heterozygous familial hypercholesterolemia in children older than 10 years old, the usual dose is 10-40mg, taken every evening. The maximum dosage is 40mg per day. The dose may be adjusted as needed every 4 weeks.

Pediatric patients with renal insufficiency with an estimated CrCL (creatinine clearance) of 15-19ml/min should use a starting dose of 5mg, once in the evening. The dosing for CrCl < 15ml/min has not been formally defined.

The dosage is based on medical condition, response to treatment, age, and weight. Refer to a doctor or pharmacist for guidelines on dosage. Do not exceed what they advise.

Who can use Simvastatin?

Simvastatin Tablets can be taken by adults and children over 10 years old, but caution is advised for specific groups of patients.

Pregnant The safety has not been established for pregnant women, so simvastatin should be avoided during pregnancy in patients without high risk. In high-risk patients, this drug should only be prescribed if the benefits outweigh the risks.

Based on conflicting human data available, there is a possible risk of teratogenicity. Delayed fetal development may also occur, due to the drug's mechanism of action.

Women in Reproductive Years During treatment, effective contraception should be utilized to avoid pregnancy. Stop treatment with this medicine if a patient becomes pregnant during treatment.

Breastfeeding Simvastatin should be avoided in high-risk patients unless the benefits outweigh the risks. There is a possible risk of drug excretion into the milk, but there is no human data to assess the risk of infant harm or the effects on milk production.

Children Simvastatin should only be prescribed for severe forms of hypercholesterolemia. The safety of higher doses (greater than 40mg) has not been reported or clinically studied, nor have the long-term effects on patients under the age of 18.

Elderly (age ≥ 65) Older patients may be more susceptible to rhabdomyolysis than other groups of patients.

Can Simvastatin Tablets be abruptly stopped?

Abruptly stopping Simvastatin Tablets is generally not recommended. Discontinuation should be discussed with a healthcare provider, as abrupt cessation may lead to a rebound effect and an increase in cholesterol levels. Healthcare professionals can provide guidance on gradual dosage adjustments or alternative treatments.

Other warnings or considerations

As simvastatin is metabolized by the liver and excreted by the kidney, creatinine (Cr) and liver function tests (LFTs) should be performed before starting this medication and then done as needed during treatment.

Patients with hepatic impairment may need dosage adjustments to prevent the accumulation of the drug in the body. Those with renal impairment may be at a higher risk of side effects.

Creatine kinase (CK) levels should be measured before beginning treatment for patients at risk of developing myopathy.

This includes patients who are elderly or female or those who have renal impairment, uncontrolled hypothyroidism, a history of hereditary muscular disorders, a history of muscular toxicity due to a statin or fibrate, current alcohol abuse, or who are currently taking certain medications. Alternative treatments should be used for patients with significantly elevated CK levels at baseline (> 5 x ULN). During treatment, if muscle issues occur, patients should have their CK levels evaluated. Discontinue treatment if CK levels are significantly elevated; consider discontinuation under medical discretion if symptoms are severe and ongoing.

Blood glucose levels should be monitored in patients at risk of developing diabetes, including those with a fasting glucose of 5.6-6.9 mmol/L, high levels of triglycerides, or hypertension.

As with all pharmaceuticals, some unwanted effects can occur from the use of Simvastatin Tablets.

For a comprehensive understanding of all potential side effects, consult a medical professional.

If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor immediately.

Due to possible drug interactions, consult with your doctor about any medications you are taking before your treatment with simvastatin. Treatment with this medication is contraindicated with certain medications, including protease inhibitors (HIV medications such as darunavir, nelfinavir, and ritonavir), cobicistat, cyclosporine (immunosuppressant), antifungals (including itraconazole, ketoconazole, levoketoconazole, posaconazole, and voriconazole), erythromycin (antibiotic), idelalisib, lonafarnib, tucatinib, danazol, mifepristone, gemfibrozil, and ribociclib.

This medication may not be suitable for people with certain conditions, so it is important to consult with a doctor if you have any health conditions. Some conditions, such as liver disease, kidney disease, diabetes, or thyroid disorders, may require adjusted dosages or need ongoing monitoring.

Treatment with simvastatin is contraindicated in patients with myopathy, acute hepatic failure, or decompensated cirrhosis.

Grapefruit may increase the risk of severe side effects, so grapefruit products should be avoided during treatment.

Statins, including simvastatin, may reduce levels of coenzyme Q10 in the body, which has been associated with muscle-related symptoms. Some individuals may choose to supplement with coenzyme Q10, but this should be done under the guidance of a healthcare provider.

Cost Effectiveness of Simvastatin Treatment to Lower Cholesterol Levels in Patients with Coronary Heart Disease

This is an analysis to estimate the cost per year of life gained with simvastatin therapy, considering factors such as age, sex, and pre-treatment cholesterol levels in patients with coronary heart disease.

This analysis provided separate estimates for men and women across various age groups (from 35 to 70 years) and pre-treatment total cholesterol levels (ranging from 213 to 309mg per deciliter).

The results revealed that in the analysis limited to direct costs, the cost per year of life gained varied widely, ranging from $3,800 for 70-year-old men with cholesterol levels of 309mg/dL to $27,400 for 35-year-old women with cholesterol levels of 213mg/dL. When indirect costs were included, the results ranged from cost savings in younger patients to a cost of $13,300 per year of life gained in 70-year-old women with cholesterol levels of 213mg/dL.

The conclusion of this study is that simvastatin therapy is cost-effective among both men and women across the ages and cholesterol levels studied in patients with coronary heart disease.