Bilypsa Tablet (45 Tab)

BILYPSA TABLET

Bilypsa Tablet is a medication manufactured by Cadila Healthcare Ltd. (also referred to as Zydus Cadila or Zydus Lifesciences Limited) used in the management of various metabolic conditions.

Composition

The active ingredient in Bilypsa Tablet is Saroglitazar (4mg). It functions as a dual peroxisome proliferator-activated receptor (PPAR) α/γ agonist.

Uses

Bilypsa Tablet is prescribed for several medical conditions, particularly in individuals with type 2 diabetes mellitus:

• Diabetic Dyslipidemia and Hypertriglyceridemia: It helps manage abnormal lipid levels, including reducing high triglycerides and "bad" cholesterol (LDL, VLDL, non-HDL) while increasing "good" cholesterol (HDL). It is often used when statin therapy alone is insufficient.
• Noncirrhotic Non-Alcoholic Steatohepatitis (NASH): This involves liver inflammation and damage due to excess fat.
• Non-Alcoholic Fatty Liver Disease (NAFLD): Especially in patients with comorbidities such as obesity, type 2 diabetes mellitus, high blood cholesterol levels, or metabolic syndrome.
• It also aids in lowering blood glucose levels and improving insulin sensitivity.

Dosage and Administration

Bilypsa Tablet should be taken as directed by a doctor. It can be taken with or without food, ideally at the same time each day for consistent effect. The tablet should be swallowed whole with water and not broken, crushed, or chewed. The typical dosage for diabetic dyslipidemia is 4 mg once daily.

Side Effects

Common side effects may include:

• Headache
• Nausea, vomiting
• Diarrhoea
• Stomach inflammation (gastritis), indigestion, flatulence, abdominal distension, abdominal discomfort/pain
• Weakness, asthenia
• Chest discomfort
• Dizziness
• Fever, increased body temperature

Consult a doctor if side effects persist or worsen.

Precautions

• Liver and Kidney Impairment: Use with caution in patients with liver or kidney problems, as dosage adjustments or close monitoring may be required.
• Heart Failure: Use with caution in individuals with heart failure.
• Pregnancy and Breastfeeding: Limited information is available regarding safety during pregnancy, and it may be unsafe. It should be used with caution, or avoided during breastfeeding as it is unknown if it passes into breast milk. Always consult a doctor.
• Alcohol: Avoid alcohol consumption as it may worsen liver problems.
• Children: Not recommended for use in children below 18 years of age due to a lack of safety and efficacy data.
• Drug Interactions: Inform your doctor about all other medicines being taken, as interactions may occur.
• Do not discontinue Bilypsa Tablet without consulting your doctor.

Storage

Store Bilypsa Tablet in a cool and dry place, below 25°C. Keep it away from direct sunlight and moisture, and out of the reach of children and pets. Always check the expiration date before use.

What is Bilypsa Tablet used for?

Bilypsa Tablet is primarily used to manage 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 prescribed for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) with associated comorbidities like obesity, type 2 diabetes, dyslipidemia, or metabolic syndrome, and for Noncirrhotic Non-Alcoholic Steatohepatitis (NASH).

How does Bilypsa Tablet work?

Bilypsa Tablet contains Saroglitazar, which acts as a dual Peroxisome Proliferator-Activated Receptor (PPAR)-α/γ agonist. The PPAR-alpha effect helps reduce the synthesis and secretion of triglycerides, promotes the breakdown of fats (lipolysis), and enhances the liver's oxidation of fatty acids, which can increase levels of good cholesterol (HDL). The PPAR-gamma effect works by reducing the metabolic burden on the liver and muscles, improving glucose utilization, and reducing insulin resistance. This dual action helps in lowering bad cholesterol (LDL, VLDL), triglycerides, and blood sugar levels while improving insulin sensitivity.

What is the usual dosage of Bilypsa Tablet?

The typical recommended dosage for Bilypsa Tablet is 4 mg once daily. It should be taken exactly as prescribed by your doctor. While it can be taken with or without food, it is often recommended to take it after a meal or with a snack to help avoid stomach upset. Swallow the tablet whole with water, and do not break, crush, or chew it. Your doctor will determine the correct dose, frequency, and duration of treatment based on your specific condition and response to the medication.

What are the possible side effects of Bilypsa Tablet?

Common side effects of Bilypsa Tablet may include stomach inflammation (gastritis), nausea, vomiting, weakness (asthenia), chest discomfort, dizziness, fever, headache, diarrhea, flatulence, indigestion, and abdominal distension. Most of these side effects are usually temporary and resolve on their own. However, if any side effects persist or worsen, it is advisable to consult your doctor.

Is Bilypsa Tablet safe during pregnancy or breastfeeding?

During Pregnancy: Limited information is available regarding the safe use of Bilypsa Tablet during pregnancy, and it is generally not recommended as animal studies have shown potential harm to the developing baby. You should consult your doctor if you are pregnant or planning to conceive, and take this medicine only if the potential benefits are considered to outweigh the risks.

During Breastfeeding: It is not known whether Bilypsa Tablet is excreted into breast milk. Therefore, nursing mothers should avoid its use or consult their doctor to discuss the potential risks and benefits before taking this medicine.

Can Bilypsa Tablet be taken with other medications?

It is important to inform your doctor about all other medicines, supplements, or herbal products you are currently taking, as Bilypsa Tablet can interact with some of them. Potential interactions include:

• Statins (e.g., atorvastatin, simvastatin): Concomitant use may enhance their lipid-lowering effects.
• Fibrates (e.g., gemfibrozil, fenofibrate): Combining Bilypsa with fibrates may increase the risk of liver toxicity and muscle damage; it's generally advised to avoid this combination unless absolutely necessary and with close monitoring.
• Oral Anticoagulants (e.g., warfarin): Bilypsa Tablet may enhance the blood-thinning effect, increasing the risk of bleeding. Close monitoring of INR levels is recommended.
• Antidiabetic Medications (e.g., metformin, insulin): Bilypsa Tablet may increase the effects of other antidiabetic drugs, potentially leading to low blood sugar (hypoglycemia).
• Pioglitazone (another PPAR-γ Agonist): Combining with Bilypsa Tablet may increase the risk of water retention, swelling (edema), and weight gain; generally avoided unless prescribed by a doctor with careful monitoring.

What precautions should be taken while using Bilypsa Tablet?

Exercise caution if you have pre-existing liver or kidney disease, as dosage adjustments or close monitoring may be required. Patients with heart conditions, especially those with a history of congestive heart failure, should use this medicine with caution and monitor for signs of fluid retention, swelling, or rapid weight gain. Alcohol consumption should be avoided while taking Bilypsa Tablet as it may worsen liver problems and can interfere with the medication's effects. This medicine is not recommended for children under 18 years of age. Regular monitoring of liver function, kidney function, and blood glucose levels may be necessary during treatment. Also, adhere to a low-fat, low-sugar diet and engage in regular exercise as recommended by your doctor for better results. Do not discontinue the medication without consulting your doctor.

What happens if a dose of Bilypsa Tablet is missed?

If you forget to take a dose of Bilypsa Tablet, 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 double the dose to make up for a missed one.

How should Bilypsa Tablet be stored?

Bilypsa Tablet should be stored in a cool and dry place, at a temperature below 25°C (or below 30°C), away from direct sunlight and moisture. Always keep the medication out of the reach and sight of children and pets. It is also important to check the expiration date on the packaging before use.