Novastat Tg 20 Tablet (10 Tab)

NOVASTAT TG 20 TABLET (10 TAB) by LUPIN LTD

Name

• Brand Name: Novastat-TG 20 Tablet

Composition

• Novastat-TG 20 Tablet contains two active ingredients:
  • Fenofibrate (160 mg)
  • Rosuvastatin (20 mg)

Uses

Novastat-TG 20 Tablet is a combination medicine used to manage high levels of cholesterol and triglycerides in the blood, especially when lifestyle changes alone are insufficient. It is prescribed for:

• Management of mixed dyslipidemia.
• Lowering high total cholesterol levels and hypercholesterolemia.
• Reduction of harmful low-density lipoprotein (LDL) cholesterol.
• Lowering elevated triglycerides levels (hypertriglyceridemia).
• Raising beneficial high-density lipoprotein (HDL) cholesterol levels.
• Reducing the risk of heart attack, stroke, and other cardiovascular complications in patients with coronary heart disease or type 2 diabetes.

Dosage and Administration

• Novastat-TG 20 Tablet should be taken as directed by your doctor. It can be taken with a meal or on an empty stomach.
• Swallow the tablet whole with a glass of water; do not crush, break, or chew it.
• It is generally taken once daily, preferably at the same time each day to help remember the dose.
• The dosage and duration are determined by the physician based on individual medical conditions, lipid levels, and response to treatment.
• It is important to adhere to the prescribed dosage and schedule for optimal therapeutic outcomes.

Side Effects

Common side effects may include:

• Headache.
• Dizziness.
• Abdominal pain.
• Nausea and sometimes vomiting.
• Diarrhea or constipation.
• Flatulence (excessive gas).
• Joint pain (arthralgia) and back pain.
• Muscle pain (myalgia) and muscle spasms.
• Nasopharyngitis, pharyngolaryngeal pain.
• Abnormal liver function tests.

Serious but rare side effects:

• Liver dysfunction or damage (indicated by fever, rash, loss of appetite, dark urine, yellow skin/eyes).
• Severe muscle weakness or cramps (myopathy, rhabdomyolysis).
• Allergic reactions (rash, swelling).

Precautions

• Pregnancy and Breastfeeding: Novastat-TG 20 Tablet is contraindicated during pregnancy and is probably unsafe for breastfeeding women. Consult a doctor.
• Liver Disease: Use with caution in patients with mild to moderate liver impairment; contraindicated in severe liver impairment or active liver disease. Regular monitoring of liver function is advised.
• Kidney Disease: Use with caution in patients with kidney problems; contraindicated in severe renal impairment. Dose adjustment may be necessary.
• Gallbladder Disease: Avoid use if you have pre-existing gallbladder disease.
• Alcohol: Caution is advised as alcohol consumption may increase the risk of liver dysfunction.
• Muscle Problems: Inform your doctor if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever.
• Drug Interactions:
  • Increased risk of bleeding with blood thinners like warfarin.
  • Concomitant use with medicines that reduce immune system activity (e.g., ciclosporin) may lead to kidney damage.
  • Antacids may decrease the concentration of rosuvastatin.
  • Avoid concomitant use with fusidic acid due to increased risk of muscle disorders.
  • Oral contraceptives containing estrogen may interfere with fenofibrate.
• Elderly Patients: Use with caution as they may be at a greater risk of muscle problems.
• Hypersensitivity: Do not use if allergic to fenofibrate, rosuvastatin, or any component of the formulation.

Storage

• Store Novastat-TG 20 Tablet at room temperature, ideally between 15°C to 30°C (or below 30°C).
• Keep the medicine in a tightly closed container, protected from light and moisture.
• Ensure it is kept out of the reach and sight of children and pets.
• Always use this medicine before its expiry date.

What is NOVASTAT TG 20 TABLET used for?

NOVASTAT TG 20 TABLET is a combination medicine primarily used in adults to manage mixed dyslipidemia and hypercholesterolemia. It helps lower high levels of "bad" cholesterol (LDL), total cholesterol, and triglycerides, while also increasing "good" cholesterol (HDL) in the blood. This action helps reduce the risk of heart disease, heart attack, stroke, and other cardiovascular complications, especially when lifestyle changes alone are not sufficient.

How does NOVASTAT TG 20 TABLET work?

NOVASTAT TG 20 TABLET contains two active ingredients: Fenofibrate (160 mg) and Rosuvastatin (20 mg). Fenofibrate works by activating a receptor called PPAR-α, which is crucial for lipid metabolism. This leads to the breakdown of triglyceride-rich particles and promotes the synthesis of HDL cholesterol. Rosuvastatin is a statin that inhibits the enzyme HMG-CoA reductase, an enzyme essential for cholesterol production in the liver. By blocking this enzyme, Rosuvastatin reduces the production of cholesterol and increases the liver's ability to remove LDL from the blood.

What is the usual dosage for NOVASTAT TG 20 TABLET?

The recommended dosage of NOVASTAT TG 20 TABLET is typically one tablet daily, or as prescribed by your physician. It can be taken with or without food, but it is often advised to take it at the same time each day to help remember. Your doctor will determine the appropriate dose based on your lipid levels and how you respond to the treatment.

What are the possible side effects of NOVASTAT TG 20 TABLET?

Common side effects may include headache, dizziness, abdominal pain, nausea, diarrhea, flatulence, joint pain, back pain, muscle spasms, nasopharyngitis, pharyngolaryngeal pain, constipation, and abnormal liver function tests. More serious, though rare, side effects can include liver damage or muscle breakdown (rhabdomyolysis). If you experience severe muscle pain or weakness, dark urine, yellowing of the skin or eyes, or signs of an allergic reaction, seek immediate medical attention.

Is NOVASTAT TG 20 TABLET safe during pregnancy or breastfeeding?

No, NOVASTAT TG 20 TABLET is considered highly unsafe during pregnancy and is contraindicated. Studies have shown significant harmful effects to the developing baby. It is also probably unsafe during breastfeeding, as limited human data suggests the drug may pass into breast milk and potentially harm the baby. Women of childbearing potential should use appropriate contraceptive measures.

Can NOVASTAT TG 20 TABLET be taken with other medications?

NOVASTAT TG 20 TABLET can interact with several medications. It may increase the risk of bleeding if taken with anticoagulants like warfarin. Concomitant use with immunosuppressants such as cyclosporine can increase the risk of kidney damage. Other medications that may interact include gout medication (colchicine), oral contraceptives (which may have decreased efficacy), gemfibrozil, antacids (which can decrease absorption), and fusidic acid (increased risk of muscle disorders). Always inform your doctor about all prescription, over-the-counter medications, and supplements you are taking.

What precautions should be taken while using NOVASTAT TG 20 TABLET?

Caution is advised if you have pre-existing liver disease, kidney disease, or gallbladder disease, as the medication could exacerbate these conditions. Dose adjustments may be necessary in patients with kidney or liver impairment. Alcohol consumption should be limited or avoided while taking this medication. Inform your doctor immediately if you experience muscle symptoms (pain or weakness), particularly if accompanied by fever, or if you notice stomach pain, loss of appetite, dark urine, or yellow skin/eyes. Do not stop taking the medicine without consulting your doctor, even if you feel better.

What happens if a dose of NOVASTAT TG 20 TABLET is missed?

If you miss a dose of NOVASTAT TG 20 TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should NOVASTAT TG 20 TABLET be stored?

NOVASTAT TG 20 TABLET should be stored at room temperature, typically between 15°C to 30°C. Keep the medicine in its original, tightly closed container, protected from light and moisture. Ensure it is kept out of the reach and sight of children and pets. Always check the expiry date on the packaging and do not use the medicine past this date.