Statpure F 20

Name

• Brand Name: Statpure F 20 Tablet

Composition

• Active Ingredients: Each tablet contains Fenofibrate (145 mg) and Rosuvastatin (20 mg).

Uses Statpure F 20 Tablet is a combination medicine primarily used to manage high levels of cholesterol and triglycerides (a type of fat) in the blood. It is indicated for:

• Primary hypercholesterolemia.
• Mixed dyslipidemia (low good cholesterol and high bad cholesterol and triglycerides).
• Reducing the risk of heart attacks and strokes in patients with multiple risk factors for cardiovascular problems.
• It serves as an adjunct to diet and lifestyle modifications when lifestyle changes alone are insufficient.

Dosage and Administration This medicine should be taken as directed by your doctor. It can be taken with or without food. Regular intake, along with appropriate lifestyle changes and a low-fat diet, is recommended to maximize effectiveness. Do not take more than the prescribed dose and do not stop taking the medicine without consulting your doctor.

Side Effects

• Common Side Effects: Headache, abdominal pain, nausea, constipation, muscle pain (myalgia), weakness (asthenia), vomiting, flatulence, joint pain, and elevated creatine kinase.
• Serious Side Effects (Rare): Liver damage (fever, rash, loss of appetite, dark urine, yellow skin or eyes), unusual bleeding or bruising, and severe, unexplained muscle pains.

Precautions

• Contraindications: Statpure F 20 Tablet is contraindicated during pregnancy and breastfeeding. It should not be used in individuals with severe liver disease, severe kidney diseases, repeated or unexplained muscle aches, gallbladder disease, inflammation of the pancreas, or those taking cyclosporine.
• Warnings: Alcohol consumption is unsafe as it may increase the risk of liver problems. Caution is advised for patients with mild to moderate liver impairment, kidney problems, hypothyroidism, or pancreatitis. It is not recommended for children below 18 years of age. Patients may experience cognitive impairment (forgetfulness, memory loss, confusion).
• Drug Interactions: Inform your doctor about all other medications you are taking, especially immunosuppressants (like cyclosporine), anticoagulants (like warfarin), HIV protease inhibitors (such as ritonavir, lopinavir), other cholesterol-lowering medicines (like gemfibrozil, niacin), fusidic acid, antacids, and antiviral medicines, as interactions may occur.

Storage Store Statpure F 20 Tablet below 30°C. Keep it in a cool and dry place, away from direct sunlight, and out of the sight and reach of children.

What is STATPURE F 20 used for?

STATPURE F 20 is a combination medicine primarily used to manage high levels of cholesterol and triglycerides (a type of fat) in the blood. It is prescribed when lifestyle changes alone have not been effective. This medication helps in treating conditions like primary hypercholesterolaemia, mixed dyslipidaemia, and hypertriglyceridemia, thereby reducing the risk of cardiovascular events such as heart attacks and strokes.

How does STATPURE F 20 work?

STATPURE F 20 contains two active ingredients: Rosuvastatin (20mg) and Fenofibrate (145mg). Rosuvastatin is a statin that works by inhibiting an enzyme called HMG-CoA-reductase, which is essential for the body to produce cholesterol. This action lowers "bad" cholesterol (LDL) and triglycerides. Fenofibrate is a fibric acid derivative that reduces the levels of triglycerides and "bad" cholesterol while increasing "good" cholesterol (HDL). Together, they work to lower unhealthy fat levels and improve the overall lipid profile.

What is the usual dosage of STATPURE F 20?

STATPURE F 20 should be taken orally in the dose and duration advised by your doctor. It can be taken with or without food, but it is recommended to take it at the same time each day to maintain consistency. The tablet should be swallowed whole and not chewed, cut, or crushed.

What are the possible side effects of STATPURE F 20?

Common side effects of STATPURE F 20 include headache, nausea, stomach pain, constipation, diarrhea, flatulence, and muscle pain. Some individuals may also experience itching, fever, weakness, joint pain, or photosensitivity. More serious, though rare, side effects can include liver damage (indicated by symptoms like yellowing of eyes, dark urine, loss of appetite), severe muscle pain, or unexplained muscle weakness, particularly if accompanied by fever. If you experience persistent or severe side effects, or any signs of liver damage or severe muscle issues, consult your doctor immediately.

Is STATPURE F 20 safe during pregnancy or breastfeeding?

STATPURE F 20 is considered unsafe and is not recommended during pregnancy as it may cause harm to the developing fetus. Similarly, it is contraindicated for breastfeeding women because the medicine may pass into breast milk and potentially harm the infant. Women of childbearing age should use appropriate contraceptive measures while taking this medication.

Can STATPURE F 20 be taken with other medications?

STATPURE F 20 can interact with several medications, potentially leading to increased risks or reduced effectiveness. It is important to inform your doctor about all medicines you are taking, including over-the-counter drugs and herbal supplements. Key interactions include:

• Immunosuppressants (e.g., cyclosporine): May increase the risk of muscle damage (myopathy).
• Anticoagulants (e.g., warfarin): May enhance effects and require closer monitoring of blood clotting.
• HIV Protease Inhibitors (e.g., ritonavir, lopinavir): Can significantly increase rosuvastatin levels, raising the risk of side effects.
• Other cholesterol-lowering medications (e.g., gemfibrozil, other statins): May increase the chance of muscle disorders or have additive effects.
• Antacids: May decrease the concentration of rosuvastatin in the blood, affecting efficacy.
• Fusidic acid: Concomitant use should be avoided due to an increased risk of muscle disorders.

What precautions should be taken while using STATPURE F 20?

• Liver Disease: Not recommended for patients with severe liver disease or active liver conditions. Regular monitoring of liver function tests may be advised.
• Kidney Problems: Should be used with caution in patients with kidney disease. It is not recommended for severe kidney impairment.
• Alcohol Consumption: Avoid or limit alcohol consumption as it may increase the risk of liver problems.
• Diabetes: Diabetic patients should monitor their blood sugar levels, as the medicine may alter them.
• Grapefruit Juice: Avoid consuming grapefruit or grapefruit juice, as it may increase the levels of the medication in your blood.
• Elderly Patients: Use with caution in elderly patients, as they may be at increased risk of side effects.
• Muscle Symptoms: Inform your doctor if you experience unexplained muscle pain or weakness, especially with fever.
• Do not stop taking the medicine without consulting your doctor, even if you feel better.

What happens if a dose of STATPURE F 20 is missed?

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

How should STATPURE F 20 be stored?

STATPURE F 20 should be stored at room temperature, ideally between 10-30°C, and protected from moisture and light. Keep the medicine in its original packaging, tightly closed, and out of the reach of children and pets.