Simvastatin Tablets USP 40mg Technical specifications:

Product Name:Simvastatin Tablets USP
Brand Name:Generics
Strength:5mg, 10mg, 20mg, 40mg, 80mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral route
Packing:30s, 90s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antihyperlipidemic, Anti-hypertensive, Cardiology, Cardiovascular.
Indication: Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.
Storage:Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Simvastatin Tablets USP  40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Simvastatin Tablets USP 40mg
    Each film-coated tablets contains:
    Simvastatin USP …………………. 40mg
    Excipients……………………………. Q.S.
    Colours: Iron Oxide Black

THERAPEUTIC INDICATIONS:

  • Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    Using this medicine while you are pregnant can harm your unborn baby.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
    Any unused product or waste material should be disposed of in accordance with local requirements.

STORAGE & DOSAGE:

  • Storage:  Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
  • Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Why Taj Pharmaceuticals?

Explore the compelling reasons why Taj Pharma should be your top choice for Simvastatin Tablets USP. For decades, Taj Pharma has been synonymous with exceptional quality and affordability in the pharmaceutical industry. Our Simvastatin Tablets USP uphold our commitment to improving cardiovascular health with proven effectiveness. At Taj Pharma, we prioritize your well-being and work tirelessly to provide you with safe and reliable medications. Simvastatin is a widely trusted medication for managing cholesterol levels, and our tablets adhere to the highest standards of pharmaceutical quality. We rigorously test and ensure that each tablet contains the precise amount of Simvastatin necessary for optimal therapeutic results.

Beyond quality, Taj Pharma also stands out for its dedication to innovation. We continuously invest in research and development to bring you the latest advancements in cardiovascular care. Our Simvastatin Tablets USP are a testament to our unwavering pursuit of excellence and our commitment to making a positive impact on your health. Trust Taj Pharma for Simvastatin Tablets USP, and experience the difference that quality, affordability, and innovation can make in your cardiovascular health journey. Your well-being is our priority, and we are here to support you every step of the way. Choose Taj Pharma for a healthier tomorrow.

What is Simvastatin Tablets and its use?

Simvastatin Tablets are a medication used to treat high cholesterol levels in the blood. They belong to a class of drugs known as statins or HMG-CoA reductase inhibitors. Simvastatin works by reducing the production of cholesterol in the liver, thereby lowering total cholesterol and low-density lipoprotein (LDL) cholesterol levels, often referred to as “bad” cholesterol. It also has a modest effect in increasing high-density lipoprotein (HDL) cholesterol, often called “good” cholesterol.

The primary uses of Simvastatin Tablets include:

  • Lowering High Cholesterol: Simvastatin is prescribed to individuals with high levels of LDL cholesterol, which is a risk factor for cardiovascular diseases such as heart attacks and strokes. By lowering LDL cholesterol levels, it helps reduce the risk of these serious health conditions.
  • Preventing Cardiovascular Events: In addition to lowering cholesterol, Simvastatin has been shown to reduce the risk of heart attacks, strokes, and other cardiovascular events in people who have a history of heart disease or are at high risk due to factors like diabetes, smoking, or hypertension.
  • Managing Atherosclerosis: Simvastatin can slow down or even reverse the process of atherosclerosis (the buildup of plaque in the arteries), which is a major contributor to heart disease.

It’s important to note that Simvastatin should be taken as part of a comprehensive treatment plan that includes a heart-healthy diet, regular exercise, and lifestyle modifications. The dosage and duration of treatment with Simvastatin should be determined by a healthcare professional based on an individual’s cholesterol levels, overall health, and specific risk factors.

As with any medication, Simvastatin may have potential side effects and interactions with other drugs, so it should be used under the guidance and supervision of a healthcare provider. It’s also crucial for individuals taking Simvastatin to have regular check-ups to monitor cholesterol levels and assess the effectiveness and safety of the medication.

How does Simvastatin Tablets work?

Simvastatin Tablets work by inhibiting an enzyme called HMG-CoA reductase, which plays a crucial role in the production of cholesterol in the liver. Here’s how Simvastatin works to lower cholesterol levels:

  • Inhibition of HMG-CoA Reductase: The liver is responsible for producing cholesterol, a waxy substance that is essential for various bodily functions. HMG-CoA reductase is an enzyme involved in the early stages of cholesterol synthesis. Simvastatin is a type of medication known as a statin, or HMG-CoA reductase inhibitor. It works by blocking the activity of this enzyme.
  • Reduction in Cholesterol Production: When you take Simvastatin, it effectively reduces the liver’s ability to produce cholesterol. This reduction in cholesterol production results in lower levels of total cholesterol and LDL (low-density lipoprotein) cholesterol in the bloodstream. LDL cholesterol is often referred to as “bad” cholesterol because elevated levels are associated with an increased risk of cardiovascular diseases.
  • Increase in LDL Receptors: Simvastatin not only decreases the production of LDL cholesterol but also increases the number of LDL receptors on the surface of liver cells. These receptors are responsible for removing LDL cholesterol from the blood. By increasing the number of LDL receptors, Simvastatin helps the liver remove more LDL cholesterol from circulation, further lowering LDL cholesterol levels.
  • Modest Increase in HDL Cholesterol: Simvastatin may also have a modest effect on increasing levels of HDL (high-density lipoprotein) cholesterol, often referred to as “good” cholesterol. HDL cholesterol helps remove LDL cholesterol from the blood vessels, reducing the risk of atherosclerosis (hardening and narrowing of the arteries).

Overall, Simvastatin’s primary mechanism of action is to lower LDL cholesterol levels, which in turn helps reduce the risk of cardiovascular events such as heart attacks and strokes. It is typically prescribed as part of a comprehensive approach to managing high cholesterol, including lifestyle changes such as a heart-healthy diet and regular exercise. The specific dosage and treatment plan should be determined by a healthcare provider based on an individual’s cholesterol levels and overall cardiovascular risk. Regular monitoring is essential to assess the effectiveness and safety of Simvastatin therapy.

Benefits of Simvastatin Tablets:

  • Lowering Cholesterol: The primary benefit of Simvastatin is its ability to significantly lower cholesterol levels, particularly LDL cholesterol. This can help reduce the risk of cardiovascular diseases, including heart attacks and strokes, especially in individuals with high cholesterol levels.
  • Cardiovascular Risk Reduction: Simvastatin has been shown to reduce the risk of heart attacks, strokes, and other cardiovascular events, particularly in people with a history of heart disease or those at high risk due to risk factors like diabetes, smoking, or hypertension.
  • Atherosclerosis Management: Simvastatin can slow down or even reverse the progression of atherosclerosis (the buildup of plaque in the arteries), which is a major contributor to heart disease. This can improve blood flow and reduce the risk of complications.
  • Improved Lipid Profile: Simvastatin can increase HDL (good) cholesterol levels to some extent, further improving the overall lipid profile.
  • Well-Tolerated: In many cases, Simvastatin is well-tolerated with few side effects, allowing individuals to continue long-term treatment.

Side Effects of Simvastatin Tablets:

While Simvastatin is generally considered safe and effective, it can cause some side effects in certain individuals. Common side effects may include:

  • Muscle Pain: Muscle pain or weakness, known as myalgia, is one of the most commonly reported side effects of Simvastatin. In rare cases, it can lead to a more serious condition called rhabdomyolysis, characterized by severe muscle breakdown.
  • Digestive Issues: Some people may experience gastrointestinal symptoms such as nausea, diarrhea, or constipation.
  • Liver Abnormalities: Simvastatin can cause liver enzyme levels to rise, which is usually reversible and not associated with liver damage. Regular monitoring of liver function is typically recommended.
  • Headache: Headaches are another possible side effect, though they are usually mild.
  • Insomnia: Some individuals may experience sleep disturbances or insomnia while taking Simvastatin.
  • Memory and Cognitive Issues: Although rare, there have been reports of cognitive issues such as memory loss or confusion associated with statin use. These cases are generally reversible upon discontinuation of the medication.
  • Rare Allergic Reactions: While extremely rare, some individuals may experience allergic reactions that can cause symptoms like hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. If such reactions occur, seek immediate medical attention.

Frequently asked Questions about Simvastatin Tablets:

  1. What is Simvastatin?

Simvastatin is a medication that belongs to the class of drugs known as statins. It is used to lower cholesterol levels in the blood.

  1. Why is Simvastatin prescribed?

Simvastatin is prescribed to individuals with high cholesterol levels, especially those at risk of cardiovascular diseases. It can reduce LDL (low-density lipoprotein) cholesterol levels, often referred to as “bad” cholesterol.

  1. How does Simvastatin work?

Simvastatin works by inhibiting the enzyme HMGCoA reductase, which plays a key role in cholesterol production in the liver. By reducing cholesterol production and increasing LDL receptor activity, it lowers cholesterol levels in the blood.

  1. What are the benefits of taking Simvastatin?

The primary benefit of Simvastatin is the reduction of cholesterol levels, which can lower the risk of heart attacks, strokes, and other cardiovascular events. It can also slow down or reverse the progression of atherosclerosis (hardening of the arteries).

  1. What are the common side effects of Simvastatin?

Common side effects may include muscle pain, digestive issues (nausea, diarrhea), and headache. It can also affect liver enzyme levels and, in rare cases, cause serious muscle problems.

  1. How should I take Simvastatin?

Simvastatin is typically taken orally once daily, usually in the evening. It can be taken with or without food, but it’s essential to follow your healthcare provider’s instructions regarding dosage and timing.

  1. Can I drink alcohol while taking Simvastatin?

Moderate alcohol consumption is generally considered safe while taking Simvastatin. However, it’s advisable to limit alcohol intake and discuss it with your healthcare provider, as excessive alcohol can affect liver function.

  1. Are there any interactions with other medications or supplements?

Yes, Simvastatin can interact with certain medications and supplements. It’s crucial to inform your healthcare provider about all the medications and supplements you are taking to avoid potential interactions.

  1. Can I stop taking Simvastatin once my cholesterol levels are under control?

It’s essential to follow your healthcare provider’s guidance regarding the duration of treatment. In many cases, Simvastatin is taken long-term to maintain cholesterol levels within a healthy range.

  1. What lifestyle changes can complement Simvastatin therapy?

Adopting a heart healthy diet, engaging in regular exercise, quitting smoking, and maintaining a healthy weight are important lifestyle changes that can enhance the effectiveness of Simvastatin in managing cholesterol.

  1. Is Simvastatin safe during pregnancy or breastfeeding?

Simvastatin is not recommended during pregnancy or breastfeeding due to potential risks to the developing fetus and newborn. If you are pregnant or planning to become pregnant, consult your healthcare provider for alternative options.

  1. What should I do if I miss a dose of Simvastatin?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one.

As Simvastatin Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Simvastatin Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Simvastatin Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Simvastatin Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

Simvastatin Tablets USP 5mg
Simvastatin Tablets USP 10mg
Simvastatin Tablets USP 20mg
Simvastatin Tablets USP 40mg
Simvastatin Tablets USP 80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Simvastatin Tablets USP 5mg
Each film-coated tablets contains:
Simvastatin USP………………5mg
Excipients……………….………. Q.S.
Colours: Titanium Dioxide

b) Simvastatin Tablets USP 10mg
Each film-coated tablets contains:
Simvastatin USP……………….10mg
Excipients……………………………Q.S.
Colours: Iron Oxide Red

c) Simvastatin Tablets USP 20mg
Each film-coated tablets contains:
Simvastatin USP……………….20mg
Excipients: …………………………. Q.S.
Colours: Iron Oxide Yellow

d) Simvastatin Tablets USP 40mg
Each film-coated tablets contains:
Simvastatin USP …………………. 40mg
Excipients……………………………. Q.S.
Colours: Iron Oxide Black


e) Simvastatin Tablets USP 80mg
Each film-coated tablets contains:
Simvastatin USP……………….80mg
Excipients: …………………………. Q.S.
Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
USING THIS MEDICINE WHILE YOU ARE PREGNANT CAN HARM YOUR UNBORN BABY.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Any unused product or waste material should be disposed of in accordance with local requirements.

STORAGE & DOSAGE:

Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.