Product Description

Rosuvastatin 10 mg & Fenofibrate 160 mg Tablets IP is a fixed-dose combination medication used to manage elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG). This combination helps reduce the risk of cardiovascular events such as heart attack, stroke, and angina by lowering “bad” cholesterol and triglycerides and increasing “good” cholesterol (HDL). Rosuvastatin is a statin that inhibits HMG-CoA reductase, reducing cholesterol synthesis in the liver. Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPARα), enhancing lipid metabolism and triglyceride breakdown.

Uses

• Treatment of hypercholesterolemia (high cholesterol)

• Treatment of hypertriglyceridemia (high triglycerides)

• Management of mixed dyslipidemia (elevated LDL, TG, and low HDL)

• Reduction of cardiovascular risk in patients with dyslipidemia, including diabetic dyslipidemia

How it works

• Rosuvastatin: Inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis, leading to decreased cholesterol production and increased LDL receptor expression in the liver, which enhances clearance of LDL cholesterol from the blood. It also reduces very low-density lipoprotein (VLDL) production, lowering triglycerides.

• Fenofibrate: Activates PPARα, increasing the synthesis of lipoprotein lipase and other enzymes that promote the breakdown and elimination of triglyceride-rich lipoproteins. It also increases HDL cholesterol by enhancing apolipoprotein A-I and A-II production. Fenofibrate additionally promotes uric acid excretion, helping reduce hyperuricemia.

Benefits

• Effectively lowers LDL cholesterol and triglycerides while increasing HDL cholesterol.

• Reduces the risk of cardiovascular events such as myocardial infarction and stroke.

• The fenofibrate component helps reduce elevated uric acid levels, beneficial in patients with hyperuricemia or gout.

• Useful in diabetic patients with dyslipidemia to minimize cardiovascular risk.

• Combination therapy targets multiple lipid abnormalities simultaneously for better lipid control.

How to use

• Swallow the tablet whole with water; do not crush, break, or chew.

• Take at the same time each day, with or without food, preferably with meals to reduce gastrointestinal discomfort.

• Follow your doctor’s instructions regarding dosage and duration.

• Regular monitoring of lipid profile, liver function tests, and renal function is recommended during therapy.

Side Effects

Common side effects:

• Nausea

• Headache

• Abdominal pain or discomfort

• Muscle pain or weakness (myalgia)

• General weakness or fatigue

• Dizziness or daytime drowsiness

Serious but rare side effects:

• Rhabdomyolysis (severe muscle breakdown)

• Liver enzyme elevations or liver damage

• Pancreatitis

• Gallstones (due to fenofibrate)

• Allergic reactions (rash, itching, swelling)

Safety Advice

• Avoid alcohol consumption during treatment to reduce the risk of liver damage and side effects like dizziness or drowsiness.

• Rosuvastatin is pregnancy category X and contraindicated in pregnancy and breastfeeding. Consult your doctor before use.

• Use with caution in patients with liver or kidney disease; dose adjustments may be necessary.

• Inform your doctor if you experience unexplained muscle pain, tenderness, or weakness, especially with fever or malaise.

• Avoid concomitant use with fusidic acid or other drugs that increase the risk of muscle toxicity without medical supervision.

• Inform your doctor about all medications you are taking, including immunosuppressants, anticoagulants, anti-HIV drugs, and anti-inflammatory drugs, to avoid interactions.

Storage Conditions

Store at a temperature below 30°C (86°F) in a cool, dry place.

FAQs

Can I take Rosuvastatin 10mg Fenofibrate 160mg Tablets IP along with fusidic acid (an antibiotic)?

Usually, it is not safe to take Rosuvastatin 10mg Fenofibrate 160mg Tablets IP with fusidic acid as it may lead to muscle weakness, tenderness, or pain. Please consult your doctor before taking Rosuvastatin 10mg Fenofibrate 160mg Tablets IP along with fusidic acid.

Can Rosuvastatin 10mg Fenofibrate 160mg Tablets IP cause muscle pain?

Yes, taking Rosuvastatin 10mg Fenofibrate 160mg Tablets IP can cause muscle pain (myalgia) and long-term complications like rhabdomyolysis and myopathy. Also, please tell your doctor if you have constant muscle weakness.

Can Rosuvastatin 10mg Fenofibrate 160mg Tablets IP be taken at night?

Yes, Rosuvastatin 10mg Fenofibrate 160mg Tablets IP can be taken at night or any other time with or without food. It is better to take it at a fixed time.

Can Rosuvastatin 10mg Fenofibrate 160mg Tablets IP make you feel tired?

Yes, Rosuvastatin 10mg Fenofibrate 160mg Tablets IP can make you feel tired as it reduces the energy supply to the muscles in the body. People suffering from heart or liver diseases feel more tired while taking Rosuvastatin 10mg Fenofibrate 160mg Tablets IP. 

Can people affected with diabetes take Rosuvastatin 10mg Fenofibrate 160mg Tablets IP?

Yes. Rosuvastatin 10mg Fenofibrate 160mg Tablets IP is also prescribed for the treatment of diabetic dyslipidemia (high cholesterol and lipid in diabetes). However, you should consult a doctor before using Rosuvastatin 10mg Fenofibrate 160mg Tablets IP.

Are Rosuvastatin 10mg Fenofibrate 160mg Tablets IP a blood thinner?

No, Rosuvastatin 10mg Fenofibrate 160mg Tablets IP is not a blood thinner. It is a cholesterol-lowering medicine.

How do you take Rosuvastatin 10mg Fenofibrate 160mg Tablets IP?

Rosuvastatin 10mg Fenofibrate 160mg Tablets IP should be swallowed as a whole with water; do not crush or chew them.

Can the use of Rosuvastatin 10mg Fenofibrate 160mg Tablets IP cause liver damage?

Liver damage is a very rare side effect of Rosuvastatin 10mg Fenofibrate 160mg Tablets IP. Let the doctor know if you have liver problems.

What lifestyle changes should I adopt while taking Rosuvastatin 10mg Fenofibrate 160mg Tablets IP?

Follow a low-fat diet, avoid fried foods, exercise regularly, and do not drink alcohol.

Who should not take Rosuvastatin 10mg Fenofibrate 160mg Tablets IP?

Rosuvastatin 10mg Fenofibrate 160mg Tablets IP should not be taken by people who are allergic to any of its components or pregnant women.

What precautions should I take when using Rosuvastatin 10mg Fenofibrate 160mg Tablets IP?

You are recommended not to consume alcohol along with Rosuvastatin 10mg Fenofibrate 160mg Tablets IP to avoid unpleasant side effects like drowsiness, dizziness, or sleepiness.