Ezetimibe: Package Insert and Label Information (Page 4 of 4)

14.2 Homozygous Familial Hypercholesterolemia (HoFH)

A study was conducted to assess the efficacy of ezetimibe in the treatment of HoFH. This double-blind, randomized, 12-week study enrolled 50 patients with a clinical and/or genotypic diagnosis of HoFH, with or without concomitant LDL apheresis, already receiving atorvastatin or simvastatin (40 mg). Patients were randomized to one of three treatment groups, atorvastatin or simvastatin (80 mg), ezetimibe administered with atorvastatin or simvastatin (40 mg), or ezetimibe administered with atorvastatin or simvastatin (80 mg). Due to decreased bioavailability of ezetimibe in patients concomitantly receiving cholestyramine [see Drug Interactions (7.4)] , ezetimibe was dosed at least 4 hours before or after administration of resins. Mean baseline LDL-C was 341 mg/dL in those patients randomized to atorvastatin 80 mg or simvastatin 80 mg alone and 316 mg/dL in the group randomized to ezetimibe plus atorvastatin 40 or 80 mg or simvastatin 40 or 80 mg. ezetimibe, administered with atorvastatin or simvastatin (40 and 80 mg statin groups, pooled), significantly reduced LDL-C (21%) compared with increasing the dose of simvastatin or atorvastatin monotherapy from 40 to 80 mg (7%). In those treated with ezetimibe plus 80 mg atorvastatin or with ezetimibe plus 80 mg simvastatin, LDL-C was reduced by 27%.

14.3 Homozygous Sitosterolemia (Phytosterolemia)

A study was conducted to assess the efficacy of ezetimibe in the treatment of homozygous sitosterolemia. In this multicenter, double-blind, placebo-controlled, 8-week trial, 37 patients with homozygous sitosterolemia with elevated plasma sitosterol levels (>5 mg/dL) on their current therapeutic regimen (diet, bile-acid-binding resins, statins, ileal bypass surgery and/or LDL apheresis), were randomized to receive ezetimibe (n=30) or placebo (n=7). Due to decreased bioavailability of ezetimibe in patients concomitantly receiving cholestyramine [see Drug Interactions (7.4)] , ezetimibe was dosed at least 2 hours before or 4 hours after resins were administered. Excluding the one subject receiving LDL apheresis, ezetimibe significantly lowered plasma sitosterol and campesterol, by 21% and 24% from baseline, respectively. In contrast, patients who received placebo had increases in sitosterol and campesterol of 4% and 3% from baseline, respectively. For patients treated with ezetimibe, mean plasma levels of plant sterols were reduced progressively over the course of the study. The effects of reducing plasma sitosterol and campesterol on reducing the risks of cardiovascular morbidity and mortality have not been established.

Reductions in sitosterol and campesterol were consistent between patients taking ezetimibe concomitantly with bile acid sequestrants (n=8) and patients not on concomitant bile acid sequestrant therapy (n=21).

Limitations of Use

The effect of ezetimibe on cardiovascular morbidity and mortality has not been determined.

16 HOW SUPPLIED/STORAGE AND HANDLING

Ezetimibe Tablets, USP 10 mg are white to off‑white, capsule‑shaped, flat, beveled edged tablets engraved with ‘G80’ on one side and plain on the other side. They are supplied as follows:

Bottles of 30, NDC 68462-226-30
Bottles of 90, NDC 68462-226-90
Bottles of 500, NDC 68462-226-05
Bottles of 1000, NDC 68462-226-10
Unit-dose packages of 100, NDC 68462-226-11

Storage

Store at 20o C to 25o C (68o F to 77o F); excursions permitted to 15ºC to 30o C (59ºF to 86o F) [see USP Controlled Room Temperature]. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information).

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

17.1 Muscle Pain

All patients starting therapy with ezetimibe should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. The risk of this occurring is increased when taking certain types of medication. Patients should discuss all medication, both prescription and over-the-counter, with their physician.

17.2 Liver Enzymes

Liver tests should be performed when ezetimibe is added to statin therapy and according to statin recommendations.

17.3 Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using ezetimibe added to statin therapy. Discuss future pregnancy plans with your patients, and discuss when to stop combination ezetimibe and statin therapy if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking combination ezetimibe and statin therapy and call their healthcare professional.

17.4 Breastfeeding

Women who are breastfeeding should be advised to not use ezetimibe added to statin therapy. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professionals.

Manufactured by:

Glenmark Pharmaceuticals Limited
India

Manufactured for:

glenmarklogo

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

January 2022

Ezetimibe Tablets, USP
(e zet’ i mibe)
Patient Information about Ezetimibe Tablets, USP

Read this information carefully before you start taking ezetimibe tablets and each time you get more ezetimibe tablets. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about ezetimibe tablets, ask your doctor. Only your doctor can determine if ezetimibe tablets is right for you.

What are ezetimibe tablets?

Ezetimibe tablets are medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. Ezetimibe tablets are for patients who cannot control their cholesterol levels by diet and exercise alone. It can be used by itself or with other medicines to treat high cholesterol. You should stay on a cholesterol-lowering diet while taking this medicine.

Ezetimibe tablets work to reduce the amount of cholesterol your body absorbs. Ezetimibe tablets does not help you lose weight. Ezetimibe tablets has not been shown to prevent heart disease or heart attacks.

For more information about cholesterol, see the “What should I know about high cholesterol?” section that follows.

Who should not take ezetimibe tablets?

Do not take ezetimibe tablets if you are allergic to ezetimibe, the active ingredient in ezetimibe tablets, or to the inactive ingredients. For a list of inactive ingredients, see the “Inactive ingredients” section that follows.
If you have active liver disease, do not take ezetimibe tablets while taking cholesterol-lowering medicines called statins.
If you are pregnant or breastfeeding, do not take ezetimibe tablets while taking a statin.
If you are a woman of childbearing age, you should use an effective method of birth control to prevent pregnancy while using ezetimibe tablets added to statin therapy.


Ezetimibe tablets has not been studied in children under age 10.

What should I tell my doctor before and while taking ezetimibe tablets?

Tell your doctor about any prescription and non-prescription medicines you are taking or plan to take, including natural or herbal remedies.

Tell your doctor about all your medical conditions including allergies.

Tell your doctor if you:

ever had liver problems. Ezetimibe tablets may not be right for you.
are pregnant or plan to become pregnant. Your doctor will discuss with you whether ezetimibe tablets is right for you.
are breastfeeding. We do not know if ezetimibe tablets can pass to your baby through your milk. Your doctor will discuss with you whether ezetimibe tablets is right for you.
experience unexplained muscle pain, tenderness, or weakness.


How should I take ezetimibe tablets?

Take ezetimibe tablets once a day, with or without food. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. If you also take another medicine to reduce your cholesterol, ask your doctor if you can take them at the same time.
If you forget to take ezetimibe tablets, take it as soon as you remember. However, do not take more than one dose of ezetimibe tablets a day.
Continue to follow a cholesterol-lowering diet while taking ezetimibe tablets. Ask your doctor if you need diet information.
Keep taking ezetimibe tablets unless your doctor tells you to stop. It is important that you keep taking ezetimibe tablets even if you do not feel sick.


See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor may do blood tests to check your liver before you start taking ezetimibe tablets with a statin and during treatment.

What are the possible side effects of ezetimibe tablets?

In clinical studies patients reported few side effects while taking ezetimibe tablets. These included diarrhea, joint pains, and feeling tired.

Patients have experienced severe muscle problems while taking ezetimibe tablets, usually when ezetimibe tablets was added to a statin drug. If you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe tablets, contact your doctor immediately. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage.

Additionally, the following side effects have been reported in general use: allergic reactions (which may require treatment right away) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash, and hives; raised red rash, sometimes with target-shaped lesions; joint pain; muscle aches; alterations in some laboratory blood tests; liver problems; stomach pain; inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; headache; gallstones; inflammation of the gallbladder.

Tell your doctor if you are having these or any other medical problems while on ezetimibe tablets. For a complete list of side effects, ask your doctor or pharmacist.

What should I know about high cholesterol?

Cholesterol is a type of fat found in your blood. Your total cholesterol is made up of LDL and HDL cholesterol.

LDL cholesterol is called “bad” cholesterol because it can build up in the wall of your arteries and form plaque. Over time, plaque build-up can cause a narrowing of the arteries. This narrowing can slow or block blood flow to your heart, brain, and other organs. High LDL cholesterol is a major cause of heart disease and one of the causes for stroke.

HDL cholesterol is called “good” cholesterol because it keeps the bad cholesterol from building up in the arteries.

Triglycerides also are fats found in your blood.

General information about ezetimibe tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ezetimibe tablets for a condition for which it was not prescribed. Do not give ezetimibe tablets to other people, even if they have the same condition you have. It may harm them.

This summarizes the most important information about ezetimibe tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ezetimibe tablets that is written for health professionals.

Inactive ingredients:

Lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and Sodium starch glycolate.

Manufactured by:

Glenmark Pharmaceuticals Limited
India

Manufactured for:

logo

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115www.glenmarkpharma-us.com

January 2022

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

label30
(click image for full-size original)
EZETIMIBE ezetimibe tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-226
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (EZETIMIBE) EZETIMIBE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 8mm
Flavor Imprint Code G80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-226-30 30 TABLET in 1 BOTTLE None
2 NDC:68462-226-90 90 TABLET in 1 BOTTLE None
3 NDC:68462-226-05 500 TABLET in 1 BOTTLE None
4 NDC:68462-226-10 1000 TABLET in 1 BOTTLE None
5 NDC:68462-226-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68462-226-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078560 04/29/2022
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE (68462-226), ANALYSIS (68462-226)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE (68462-226), ANALYSIS (68462-226)

Revised: 01/2022 Glenmark Pharmaceuticals Inc., USA

Page 4 of 4 1 2 3 4

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.