Product Description

Atorvastatin 10 mg & Fenofibrate 160 mg Tablets IP belong to the class of antilipemic (lipid-lowering) agents, primarily used to treat mixed dyslipidemia (high levels of cholesterol and triglycerides) and prevent cardiovascular diseases such as heart attacks and strokes. Hyperlipidemia involves elevated low-density lipoprotein (LDL or "bad" cholesterol), triglycerides (TG), and often reduced high-density lipoprotein (HDL or "good" cholesterol), increasing the risk of atherosclerosis (plaque buildup in arteries), especially in patients with existing heart disease, diabetes, or risk factors like smoking.

This combination tablet contains two active ingredients:

• Atorvastatin (a statin or HMG-CoA reductase inhibitor) blocks the liver enzyme responsible for cholesterol production, thereby lowering LDL cholesterol and TG while increasing HDL.

• Fenofibrate (a fibrate), which activates peroxisome proliferator-activated receptor alpha (PPAR-α) to enhance lipoprotein lipase activity, breaking down fats in the blood for better utilization and excretion. It primarily lowers TG and LDL while raising HDL.

Together, they provide synergistic effects for better lipid control when diet and exercise alone are insufficient. Take as prescribed by your doctor, typically once daily. Common side effects include muscle pain, headache, nausea, constipation, and abdominal pain, which usually resolve spontaneously. However, monitor for serious issues like muscle weakness (rhabdomyolysis) or liver dysfunction.

Inform your doctor before use if you have allergies to any components, active liver disease, unexplained muscle pain, hypothyroidism, heavy alcohol use (>2 drinks/day), kidney impairment, or a history of gallstones. Contraindicated in pregnancy (FDA category X for atorvastatin; potential fetal harm) and breastfeeding (excreted in milk). Not recommended for children under 10-12 years without specialist advice. Regular blood tests for liver enzymes, lipids, and muscle function (CK levels) are essential. Seek immediate medical help for symptoms like severe muscle pain, dark urine, jaundice, or allergic reactions.

Uses

• Treatment of mixed hyperlipidemia (high LDL cholesterol and triglycerides)

• Prevention of cardiovascular events (e.g., heart attack, stroke) in high-risk patients

• Management of hypertriglyceridemia to reduce pancreatitis risk
  

How it works

Atorvastatin 10 mg & Fenofibrate 160 mg Tablets IP combine a statin (atorvastatin) and a fibrate (fenofibrate). Atorvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis in the liver, reducing LDL and TG production while increasing LDL receptor activity to clear bad cholesterol from the blood. Fenofibrate stimulates PPAR-α receptors, boosting lipoprotein lipase to accelerate the breakdown and removal of TG-rich lipoproteins, decreasing TG and LDL levels while elevating HDL. This dual action improves overall lipid profile, reduces arterial plaque, and lowers cardiovascular risk.

Benefits

• Lowers LDL ("bad") cholesterol and triglycerides while raising HDL ("good") cholesterol for comprehensive lipid management

• Reduces the buildup of fatty plaques in arteries (atherosclerosis), preventing heart attacks, strokes, and peripheral artery disease

• Especially beneficial for patients with mixed dyslipidemia or those not responding to single-agent therapy, when combined with lifestyle changes (diet, exercise)

• Helps manage cardiovascular risk in patients with diabetes, obesity, or a family history of heart disease

• The fenofibrate component may also improve insulin sensitivity and reduce inflammation in blood vessels

How to use

Swallow the tablet whole with a glass of water; do not break, chew, or crush it.

• Take once daily, preferably in the evening (for atorvastatin, as cholesterol synthesis peaks at night), with or without food. However, taking with a meal may improve fenofibrate absorption.

• Follow a low-fat, low-cholesterol diet and regular exercise as advised by your doctor.

• Do not exceed the prescribed dose; regular lipid monitoring is required to adjust therapy.

Side Effects

• Muscle pain or weakness (myalgia)

• Headache

• Nausea or abdominal pain

• Constipation or diarrhea

• Joint pain or back pain

• Blurred vision

• Increased blood sugar (hyperglycemia)

• Elevated liver enzymes (monitor with tests)

• Allergic reactions (rash, itching)

• Rare but serious: Rhabdomyolysis (muscle breakdown), liver damage, or gallstones

Safety Advice

• Avoid alcohol while taking Atorvastatin 10 mg & Fenofibrate 160 mg Tablets IP, as it can elevate triglycerides, worsen liver function, and increase myopathy risk.

• Strictly contraindicated in pregnancy due to potential fetal harm (e.g., birth defects from statins); discontinue immediately if pregnancy occurs and use effective contraception. Not recommended during breastfeeding, as both drugs pass into breast milk.

• Use with caution in patients with kidney or liver impairment (dose adjustment or avoidance may be needed); regular monitoring of liver function tests (LFTs) and creatine kinase (CK) is essential.

• Inform your doctor of all medications to avoid interactions (e.g., increased myopathy risk with fibrates + statins, or with antibiotics like erythromycin/clarithromycin, antifungals, or cyclosporine).

• Lifestyle: Adopt a heart-healthy diet (low in saturated fats), exercise regularly (30 minutes/day), quit smoking, and manage weight/stress. Report unexplained muscle pain, dark urine, or yellowing of skin/eyes immediately.

Storage Conditions

• Store at temperatures below 30°C (86°F).

FAQs

What is the use of Atorvastatin 10mg & Fenofibrate 160mg Tablet?

They are used to treat high lipid levels (cholesterol and triglycerides) and reduce the risk of heart disease by lowering LDL/TG and raising HDL.

Can I continue eating fatty junk foods alongside taking Atorvastatin 10mg & Fenofibrate 160mg Tablet?

Strictly no, a patient is advised to take a proper healthy diet free of oily and fatty products, as recommended by the doctor, for the best results of this medication.

Is this drug safe with contraceptives?

As such, no harmful interaction has been reported, yet a doctor consultation is advised.

Can Atorvastatin 10mg & Fenofibrate 160mg Tablet help in weight loss?

This drug is primarily used to lower high levels of fatty acids in blood & and using it for weight loss is only done on a doctor's recommendation after he/she thoroughly checks the state of the patient.

Can Atorvastatin 10mg & Fenofibrate 160mg Tablet be used with antibiotics in an infected patient?

Certain antibiotics like erythromycin and clarithromycin interact with Atorvastatin 10mg & Fenofibrate 160mg Tablet and hence should not be used simultaneously with Atorvastatin 10mg & Fenofibrate 160mg Tablet unless consulted & recommended by a doctor.

What are the side effects of Atorvastatin 10mg & Fenofibrate 160mg Tablet?

Atorvastatin 10mg & Fenofibrate 160mg Tablet may cause side effects like hyperglycemia (high blood sugar), headache, blurred vision, stomach pain, constipation, headaches, joint swelling (oedema), joint pain, muscle pain, back pain, slow heart rate, and nausea. If the side effects are persistent, reach out to your doctor.

Can Atorvastatin 10mg & Fenofibrate 160mg Tablet cause liver damage?

Liver damage is a very rare side effect of Atorvastatin 10mg & Fenofibrate 160mg Tablet. Consult the doctor if you notice signs of liver problems, like yellowing of skin and eyes, itchy skin, or dark urine.

Can Atorvastatin 10mg & Fenofibrate 160mg Tablet cause muscle pain?

Atorvastatin 10mg & Fenofibrate 160mg Tablet can cause muscle pain as a side effect. Consult the doctor if you have muscle pain, muscle spasms/cramps, or muscle weakness.

What lifestyle changes should be adopted while taking Atorvastatin 10mg & Fenofibrate 160mg Tablet?

Follow a healthy diet and exercise regularly. Avoid smoking and alcohol consumption. Manage stress by doing meditation.