Ezentia Tablet (10 Tab)

EZENTIA TABLET (10 TAB) by SUN PHARMA LABORATORIES LTD.

Name

• Brand Name: EZENTIA TABLET
• Common Name: Ezetimibe

Composition

Each EZENTIA 10 tablet contains 10 mg of ezetimibe as the active ingredient. It also contains excipients such as lactose monohydrate.

Uses

EZENTIA TABLET is prescribed to treat high cholesterol by lowering "bad" cholesterol (LDL) levels in the blood. It can be used alone or in combination with statins or fenofibrate.

Key indications include:

• Primary Hypercholesterolaemia: As adjunctive therapy to diet for the reduction of elevated total cholesterol and low-density lipoprotein cholesterol (LDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.
• Homozygous Familial Hypercholesterolaemia (HoFH): Administered with a statin, it reduces elevated total-C and LDL-C levels.
• Sitosterolemia: Also used for the management of sitosterolemia.
• Cardiovascular Risk Reduction: Helps reduce the risk of heart disease, chest pain (angina), strokes, and heart attacks by managing cholesterol effectively.

Dosage and Administration

The recommended dose of EZENTIA TABLET is one tablet once a day. It can be taken at any time of the day, with or without food. Patients should maintain an appropriate lipid-lowering diet during treatment.

• Elderly and Children (≥ 10 years): No dosage adjustment is required.
• Concomitant use with Bile Acid Sequestrants: EZENTIA TABLET should be taken at least 2 hours before or 4 hours after administration of a bile acid sequestrant.

Side Effects

Common side effects include:

• Abdominal pain
• Diarrhea
• Flatulence
• Tiredness/fatigue
• Joint pain
• Headache
• Sore throat, runny nose, sneezing, cough

Serious side effects, though rare, can include:

• Muscle pain or weakness (myopathy), which can rarely lead to rhabdomyolysis and kidney damage, especially when used with statins. Patients should report unexplained muscle pain promptly.
• Increased liver enzymes.
• Allergic reactions such as swelling of the face, lips, tongue, and/or throat, and difficulty in breathing or swallowing.
• Cholelithiasis (gallbladder stones) when co-administered with fibrates, particularly fenofibrate.

Precautions

• Hypersensitivity: Contraindicated in patients with hypersensitivity to ezetimibe or any excipients.
• Hepatic Impairment: Contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7). No dosage adjustment is needed for mild hepatic impairment. Caution is advised in patients with liver disease, and liver function should be monitored.
• Pregnancy and Lactation: Contraindicated during pregnancy and lactation.
• Children: Contraindicated in children under 10 years of age due to lack of clinical data on safety and efficacy.
• Concomitant Medications:
  • Statins: Refer to the professional information for the specific statin when co-administering, as it is contraindicated with active liver disease or unexplained persistent elevations in serum transaminases.
  • Fibrates: Caution is advised due to the possible risk of cholelithiasis and gallbladder disease, especially with fenofibrate.
  • Ciclosporin: Caution is needed, and ciclosporin concentrations should be monitored.
  • Anticoagulants (e.g., Warfarin): International Normalised Ratio (INR) should be appropriately monitored if EZENTIA is added to coumarin anticoagulants.
• Lactose Intolerance: Contains lactose monohydrate; patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take EZENTIA TABLET.

Storage

Store EZENTIA TABLET at or below 25°C, or below 30°C. Keep in a cool and dry place, away from moisture and direct sunlight, and out of sight and reach of children.

EZENTIA TABLET, containing the active ingredient Ezetimibe, is a medication primarily used to manage high cholesterol levels. It works by limiting the absorption of cholesterol in the intestines. Below are some frequently asked questions about EZENTIA TABLET.

What is EZENTIA TABLET used for?

EZENTIA TABLET is used to treat high blood cholesterol, including primary hyperlipidemia, mixed hyperlipidemia, homozygous familial hypercholesterolemia (an inherited form of high cholesterol), and homozygous sitosterolemia. It helps reduce "bad" cholesterol (LDL) and total cholesterol, thereby lowering the risk of heart disease and stroke. It can be used alone or in combination with other cholesterol-lowering medicines, such as statins.

How does EZENTIA TABLET work?

EZENTIA TABLET works by selectively inhibiting the absorption of cholesterol and phytosterols from the small intestine. It targets a specific protein called Niemann-Pick C1-Like 1 (NPC1L1) on the intestinal cells, which is crucial for cholesterol uptake. By blocking this protein, EZENTIA TABLET reduces the amount of cholesterol that enters the bloodstream and decreases the cholesterol available to liver cells, leading to increased clearance of cholesterol from the blood.

What is the usual dosage of EZENTIA TABLET?

The recommended dose of EZENTIA TABLET is one 10 mg tablet once a day. It can be taken at any time of the day, with or without food. Patients should continue on an appropriate lipid-lowering diet and, if indicated, a weight loss program during treatment.

What are the possible side effects of EZENTIA TABLET?

Common side effects may include upper respiratory tract infections, joint pain, diarrhea, tiredness or fatigue, stomach pain, headache, and nausea. More serious, but less common, side effects can include muscle pain, tenderness, or weakness (myopathy, rhabdomyolysis), liver problems (indicated by elevated liver enzymes), and allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.

Is EZENTIA TABLET safe during pregnancy or breastfeeding?

EZENTIA TABLET is generally not recommended during pregnancy due to limited data on its safety and potential harmful effects observed in animal studies. It should only be used if a doctor determines that the potential benefits outweigh the risks to the unborn baby. It is contraindicated during breastfeeding as the active ingredient, ezetimibe, has been shown to be secreted into breast milk in animal studies, and it is not known if it passes into human breast milk. It may have undesirable effects on the newborn.

Can EZENTIA TABLET be taken with other medications?

EZENTIA TABLET can be taken with statins, often for enhanced cholesterol-lowering effects, but this combination can increase the risk of muscle problems and elevated liver enzymes. It may also be used with fenofibrate, though there's an increased risk of gallstones. If taken with bile acid sequestrants (like cholestyramine), EZENTIA should be taken at least 2 hours before or 4 hours after to avoid reduced effectiveness. Concomitant use with cyclosporine can increase levels of both drugs, requiring close monitoring. If taken with warfarin or other coumarin anticoagulants, INR should be monitored due to a possible increased risk of bleeding.

What precautions should be taken while taking EZENTIA TABLET?

Inform your doctor if you have liver disease, as EZENTIA TABLET is contraindicated in patients with moderate to severe hepatic impairment. Monitor for any unexplained muscle pain, tenderness, or weakness, especially if you are also taking a statin, and report it immediately to your doctor. Liver function tests may be conducted before and during treatment, particularly when used with statins. It is advisable to avoid alcohol consumption, as it can worsen high cholesterol and potentially increase the risk of liver problems. The medication should not be used in children under 10 years of age.

What happens if a dose of EZENTIA TABLET is missed?

If you miss a dose of EZENTIA 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 EZENTIA TABLET be stored?

EZENTIA TABLET should be stored in a cool, dry place, away from moisture and direct sunlight, at a temperature below 30°C. Keep it out of sight and reach of children and pets. It should not be stored in the bathroom.