Bilypsa 4 Mg Tablet (10 Tab)

Bilypsa 4 mg Tablet is a medication manufactured by Zydus Healthcare Limited (also referred to as Zydus Cadila or Zydus Lifesciences Limited).

• Composition Each tablet contains 4 mg of Saroglitazar, which acts as a dual Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist.

• Uses Bilypsa 4 mg Tablet is prescribed for the management of:

  • Noncirrhotic Non-Alcoholic Steatohepatitis (NASH), a condition involving liver inflammation and damage due to fat accumulation.
  • Non-alcoholic Fatty Liver Disease (NAFLD) in patients with comorbidities such as obesity, Type 2 Diabetes Mellitus, Dyslipidemia, or Metabolic Syndrome.
  • Diabetic dyslipidemia and hypertriglyceridemia in individuals with Type 2 Diabetes Mellitus, particularly when not adequately controlled by statin therapy alone. It helps to lower triglycerides, LDL cholesterol, and improve HDL cholesterol, while also aiding in blood sugar control and enhancing insulin sensitivity.

• Dosage and Administration The typical dosage is 4 mg once daily, taken orally. It can be consumed with or without food, preferably at the same time each day for optimal benefit. Tablets should be swallowed whole and not chewed, crushed, or broken. Patients should adhere to their doctor's prescribed dose and duration, and not discontinue the medication without medical advice. Adherence to a recommended diet and exercise program is also crucial.

• Side Effects Common side effects may include flatulence, indigestion, abdominal distension, weakness, nausea, headache, mild gastrointestinal discomfort, asthenia, chest discomfort, dizziness, fever, and gastritis. These are generally not severe, but a doctor should be consulted if they persist or cause concern.

• Precautions Caution is advised for patients with existing kidney, heart, or pancreas problems, or a history of significant alcohol consumption. Regular monitoring of liver function, kidney function, and blood glucose levels may be required. Pregnant or breastfeeding women should consult their doctor, as the safety in these populations is not fully established, and it's uncertain if Saroglitazar passes into breast milk. Bilypsa is not recommended for children under 18 years of age. Patients should inform their doctor about all other medications to avoid potential drug interactions. Alcohol intake should be limited or avoided due to its potential to worsen liver health. Watch for symptoms like sudden weight gain, swelling, or signs of heart failure. Dizziness may occur, so caution is advised when driving. Do not use if allergic to Saroglitazar or any other component.

• Storage Store Bilypsa 4 mg Tablets in a cool, dry place below 25°C or 30°C, protected from light and moisture. Keep out of the reach of children and pets. Always check the expiration date on the packaging.

Here are frequently asked questions about BILYPSA 4 MG TABLET (Saroglitazar):

What is BILYPSA 4 MG TABLET used for?

BILYPSA 4 MG TABLET, containing Saroglitazar, is primarily used for managing diabetic dyslipidemia and hypertriglyceridemia in patients with type 2 diabetes mellitus, especially when these conditions are not adequately controlled by statin therapy alone. It is also indicated for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Noncirrhotic Non-Alcoholic Steatohepatitis (NASH) in individuals with comorbidities like diabetes, obesity, metabolic syndrome, or dyslipidemia. Additionally, it helps in controlling high blood sugar levels in type 2 diabetes.

How does BILYPSA 4 MG TABLET work?

BILYPSA (Saroglitazar) is a dual peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist. It works by activating both PPAR-alpha and PPAR-gamma receptors. Activation of PPAR-alpha helps to lower high blood triglycerides, VLDL (very low-density lipoprotein), and LDL (bad) cholesterol, while increasing HDL (good) cholesterol. Activation of PPAR-gamma improves insulin sensitivity, which helps the body use insulin more effectively, thereby reducing blood sugar levels. This dual action helps manage both abnormal lipid levels and blood glucose levels.

What is the usual dosage of BILYPSA 4 MG TABLET?

The usual recommended dosage is one 4 mg tablet once daily. It is typically taken orally, preferably before the first meal of the day, or as advised by your doctor. It is important to adhere to the prescribed dosage and not to chew, crush, or break the tablet.

What are the possible side effects of BILYPSA 4 MG TABLET?

Common side effects may include stomach inflammation (gastritis), nausea, vomiting, weakness (asthenia), chest discomfort or pain, dizziness, headache, and fever (pyrexia). In some cases, a mild but significant increase in serum creatinine has been noted. More serious, though less common, concerns include liver function abnormalities and, rarely, edema (swelling) or severe muscle pain. Inform your doctor if any side effects persist or worsen, or if you notice rapid weight gain.

Is BILYPSA 4 MG TABLET safe during pregnancy or breastfeeding?

BILYPSA (Saroglitazar) is generally not recommended during pregnancy (Pregnancy Category C) as it may pose a risk to the fetus. It should only be used if the potential benefit justifies the potential risk, and under strict medical supervision. It is also not known whether Saroglitazar is excreted into breast milk; therefore, nursing mothers should avoid taking this medicine or consult their doctor to discuss the risks and benefits.

Can BILYPSA 4 MG TABLET be taken with other medications?

BILYPSA may interact with other medications. Caution is advised when taken with other anti-diabetic drugs (like metformin or sulfonylureas) as it may increase the risk of low blood sugar (hypoglycemia). It may also enhance the effects of other cholesterol-lowering medications (like statins or fibrates), potentially increasing the risk of muscle-related side effects or liver toxicity. Combining it with blood thinners (anticoagulants such as warfarin) may increase the risk of bleeding. Always inform your doctor about all prescription medications, over-the-counter drugs, herbal products, and dietary supplements you are taking to avoid potential interactions.

What precautions should be taken while taking BILYPSA 4 MG TABLET?

Inform your doctor if you have any allergies to Saroglitazar or its components. Use this medicine with caution if you have a history of liver or kidney impairment, or cardiovascular disease, especially with episodic congestive heart failure; regular monitoring of liver function and signs of heart failure is advised. It is not recommended for use in children under 18 years of age. Avoid alcohol consumption as it may cause unpleasant side effects. Since BILYPSA may cause dizziness, exercise caution while driving or operating heavy machinery until you know how the medicine affects you.

What happens if a dose of BILYPSA 4 MG TABLET is missed?

If you miss a dose of BILYPSA, 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 two doses at once to make up for a missed dose.

How should BILYPSA 4 MG TABLET be stored?

Store BILYPSA tablets in a cool, dry place, away from direct sunlight and moisture. Keep them in their original packaging and out of the reach of children. The recommended storage temperature is typically at room temperature, ideally between 20°C to 25°C (68°F to 77°F).