GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Rosuvastatin Calcium Tablets 5mg
B. Rosuvastatin Calcium Tablets 10mg
C. Rosuvastatin Calcium Tablets 20mg
D. Rosuvastatin Calcium Tablets 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Rosuvastatin Calcium Tablets 5mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin …….……….5mg
Excipients…………………………………...q. s
Colours: Indigo Blue

B. Rosuvastatin Calcium Tablets USP 10mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin …….………...10mg
Excipients………………………………….…. q. s
Colours: Titanium Dioxide USP


C. Rosuvastatin Calcium Tablets USP 20mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin ……………….20mg
Excipients………………………………….…. q. s
Colours: Iron oxide Red

D. Rosuvastatin Calcium Tablets USP 40mg
Each film-coated tablet contains:
Rosuvastatin calcium
Equivalent to Rosuvastatin ……………...40mg
Excipients……………………………………q. s
Colours: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Rosuvastatin 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: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Lipid metabolism regulator.
Take Rosuvastatin by mouth with or without food.
Read enclosed leaflet before use.
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

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 country.

Rosuvastatin Calcium Tablets 10mg Technical Specification:

Product Name:
Rosuvastatin Calcium Tablets 10mg
Brand Name:Generic
Strength:5mg, 10mg, 20mg, 40mg
Dosage Form:Tablet (Film coated)
Route of Administration:Via oral Route
Packing:100s, 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, Cardiology, Cardiovascular System
Indication: Rosuvastatin is used in adult’s adolescents and children 6 years or older to treat high cholesterol.
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:

  • Rosuvastatin Calcium Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rosuvastatin Calcium Tablets 10mg
    Each film-coated tablet contains:
    Rosuvastatin calcium
    Equivalent to Rosuvastatin …….……….10mg
    Excipients……………………………………q. s
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Rosuvastatin 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:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Lipid metabolism regulator.

Take Rosuvastatin by mouth with or without food.

Read enclosed leaflet before use.

Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

Keep medicine out of reach of children.

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 country.

Why Taj Pharmaceuticals?

Taj Pharma is your trusted choice for Rosuvastatin Calcium Tablets. Our commitment to improving heart health goes beyond medication – it’s a commitment to you. With a legacy of pharmaceutical excellence, Taj Pharma offers unparalleled quality, affordability, and accessibility in cholesterol management. Our Rosuvastatin Calcium Tablets are meticulously manufactured, ensuring the highest standards of effectiveness and safety. We understand the importance of affordable healthcare, which is why our medication is priced competitively, making it accessible to a broader population. Choose Taj Pharma for your heart health needs and experience the difference in healthcare quality and affordability that sets us apart from the rest. Your well-being is our priority.

What is Rosuvastatin Calcium Tablets and its use?

Rosuvastatin Calcium Tablets are a medication primarily prescribed to manage high levels of cholesterol in the blood. Rosuvastatin is the active ingredient, and it belongs to a class of drugs known as statins. These tablets are available in various doses and are taken orally.

Uses of Rosuvastatin Calcium Tablets:

  • Lowering Cholesterol: Rosuvastatin works by inhibiting an enzyme in the liver involved in the production of cholesterol. By reducing the liver’s ability to produce cholesterol, it helps lower the levels of low-density lipoprotein (LDL) cholesterol, often referred to as “bad” cholesterol, in the bloodstream.
  • Increasing High-Density Lipoprotein (HDL) Cholesterol: Rosuvastatin can also increase the levels of high-density lipoprotein (HDL) cholesterol, often called “good” cholesterol. HDL cholesterol helps remove excess LDL cholesterol from the bloodstream.
  • Reducing Triglycerides: It can lower triglyceride levels, which are another type of fat in the blood. Elevated triglyceride levels are associated with an increased risk of heart disease.
  • Cardiovascular Risk Reduction: Beyond cholesterol management, Rosuvastatin is often prescribed to reduce the risk of cardiovascular events, such as heart attacks, strokes, and the need for medical procedures to open blocked arteries (angioplasty or stent placement). It is particularly recommended for individuals with known heart disease or those at high risk of developing it.
  • Preventing Atherosclerosis: By lowering cholesterol levels, Rosuvastatin helps slow down or prevent the buildup of fatty deposits (atherosclerosis) in the arteries, reducing the risk of artery blockages and related complications.
  • Management of Familial Hypercholesterolemia: It is used in individuals with a genetic condition called familial hypercholesterolemia, which causes abnormally high cholesterol levels.

It’s important to note that Rosuvastatin Calcium Tablets are typically prescribed as part of a comprehensive approach to managing cardiovascular risk factors. This includes lifestyle modifications such as a heart-healthy diet, regular exercise, and smoking cessation.

How Does Rosuvastatin Calcium Tablets work?

Rosuvastatin Calcium Tablets work by inhibiting an enzyme in the liver called HMG-CoA reductase. This enzyme plays a central role in the production of cholesterol in the body. Here’s how Rosuvastatin works:

  • Inhibition of HMG-CoA Reductase: Rosuvastatin contains the active ingredient rosuvastatin calcium, which is a type of medication known as a statin. When you take Rosuvastatin Calcium Tablets orally, the medication is absorbed into your bloodstream and eventually reaches the liver.
  • Blocking Cholesterol Production: Once in the liver, Rosuvastatin inhibits HMG-CoA reductase. This enzyme is responsible for converting HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) into mevalonate, a precursor of cholesterol. By blocking this enzyme, Rosuvastatin reduces the liver’s ability to produce cholesterol.
  • Lowering LDL Cholesterol: The primary effect of Rosuvastatin is a significant reduction in the levels of low-density lipoprotein (LDL) cholesterol, often referred to as “bad” cholesterol. LDL cholesterol is a major contributor to the buildup of fatty deposits (atherosclerosis) in the arteries, which can lead to blockages and increase the risk of heart disease.
  • Increasing HDL Cholesterol: Rosuvastatin can also modestly increase the levels of high-density lipoprotein (HDL) cholesterol, often called “good” cholesterol. HDL cholesterol helps remove excess LDL cholesterol from the bloodstream, further contributing to heart health.
  • Lowering Triglycerides: Additionally, Rosuvastatin has the benefit of lowering triglyceride levels, which are another type of fat in the blood. Elevated triglycerides are associated with an increased risk of heart disease.

By effectively lowering LDL cholesterol and, to a lesser extent, increasing HDL cholesterol and lowering triglycerides, Rosuvastatin helps to reduce the overall risk of cardiovascular events such as heart attacks, strokes, and the need for medical procedures to open blocked arteries.

Benefits of Rosuvastatin Calcium Tablets:

  • Cholesterol Reduction: Rosuvastatin effectively lowers LDL (bad) cholesterol levels in the blood, reducing the risk of atherosclerosis and related cardiovascular events such as heart attacks and strokes.
  • Triglyceride Lowering: It can also lower triglyceride levels, further reducing the risk of heart disease, particularly in individuals with high triglycerides.
  • Increased HDL Cholesterol: Rosuvastatin can increase HDL (good) cholesterol levels, which is associated with better heart health.
  • Cardiovascular Risk Reduction: By addressing multiple lipid abnormalities, Rosuvastatin helps reduce the overall risk of cardiovascular events and the need for invasive medical procedures.
  • Prevention of Atherosclerosis: It slows down or prevents the buildup of fatty deposits in the arteries, reducing the risk of arterial blockages and their complications.
  • Management of Familial Hypercholesterolemia: Rosuvastatin is an important treatment option for individuals with familial hypercholesterolemia, a genetic condition that results in extremely high cholesterol levels.

Side Effects of Rosuvastatin Calcium Tablets:

It’s important to note that not everyone who takes Rosuvastatin will experience these side effects, and many people tolerate the medication well. However, some potential side effects may include:

  • Muscle Pain and Weakness: Statins, including Rosuvastatin, can cause muscle-related symptoms, such as muscle pain, tenderness, or weakness. In rare cases, this can lead to a more serious condition called rhabdomyolysis, which requires immediate medical attention.
  • Digestive Issues: Some individuals may experience gastrointestinal side effects like nausea, diarrhea, constipation, or abdominal pain.
  • Headache: Rosuvastatin can occasionally cause headaches.
  • Liver Enzyme Abnormalities: It may lead to elevated liver enzymes in some individuals, which is typically monitored through blood tests.
  • Increased Blood Sugar: In rare cases, Rosuvastatin can lead to elevated blood sugar levels, which may be a concern for individuals with diabetes or prediabetes.
  • Memory and Cognitive Effects: Some individuals have reported memory problems or cognitive changes while taking statins, although the evidence for this is mixed, and more research is needed.
  • Allergic Reactions: Although rare, some people may experience allergic reactions to Rosuvastatin, including skin rash, itching, and swelling of the face, lips, or tongue.

Frequently asked questions (FAQs) about Rosuvastatin Calcium Tablets:

  1. What is Rosuvastatin Calcium and how does it work?

Rosuvastatin Calcium is a medication that belongs to a class of drugs known as statins. It works by inhibiting an enzyme in the liver responsible for cholesterol production, leading to reduced levels of LDL (bad) cholesterol in the blood.

  1. What is the recommended dosage of Rosuvastatin Calcium Tablets?

The dosage of Rosuvastatin varies depending on individual factors such as age, existing health conditions, and cholesterol levels. It is important to follow the prescribed dosage provided by your healthcare provider.

  1. How should Rosuvastatin Calcium Tablets be taken?

Rosuvastatin is typically taken orally, with or without food, as directed by a healthcare professional. It’s important to take it consistently at the same time each day.

  1. Can Rosuvastatin Calcium Tablets be used alone, or are they usually prescribed alongside other medications?

Rosuvastatin can be used alone, but it is sometimes prescribed in combination with other medications to effectively manage cholesterol levels, particularly in individuals with very high cholesterol or complex medical conditions.

  1. Are there any dietary restrictions while taking Rosuvastatin Calcium Tablets?

While taking Rosuvastatin, it’s recommended to follow a heart healthy diet low in saturated fats and cholesterol. This can further help in managing cholesterol levels.

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

Yes, Rosuvastatin can interact with certain medications and supplements. It’s important to inform your healthcare provider about all the medications, supplements, and herbal products you are taking to prevent potential interactions.

  1. How long does it take for Rosuvastatin to show results in lowering cholesterol levels?

The effects of Rosuvastatin on cholesterol levels can vary among individuals. Some people may see improvements within a few weeks, while others may take longer. Regular follow-ups with a healthcare provider are crucial to monitor progress.

  1. What should I do if I miss a dose of Rosuvastatin Calcium Tablets?

If you miss a dose, take it as soon as you remember. However, if it is close to the time of your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses.

  1. Can Rosuvastatin Calcium Tablets be taken during pregnancy or while breastfeeding?

It is generally not recommended during pregnancy or while breastfeeding. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits with your healthcare provider.

  1. Are there any lifestyle changes recommended while taking Rosuvastatin Calcium Tablets?

Yes, lifestyle changes such as adopting a heart healthy diet, engaging in regular exercise, avoiding smoking, and limiting alcohol consumption can complement the effectiveness of Rosuvastatin in managing cholesterol levels.

As Rosuvastatin Calcium Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Rosuvastatin Calcium 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

Rosuvastatin Calcium 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 Rosuvastatin Calcium 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