Ezetimibe Tablets is indicated:

• In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
• In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH.
• In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.
• In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH).
• As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia.

When ezetimibe tablets is used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use.

• The recommended dose of ezetimibe tablets is 10 mg orally once daily, administered with or without food.
• If as dose is missed, take the missed dose as soon as possible. Do not double the next dose.
• Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe tablets.
•  Administer ezetimibe tablets at least 2 hours before or 4 hours after administration of a bile acid sequestrant [see Drug Interactions (7)]. 

10-mg tablets are white to off white capsule shaped, flat faced, beveled edge tablets, debossed with “A25ˮ on one side and plain on other side.

Ezetimibe tablets is contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe tablets. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see Adverse Reactions (6.2)].

When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ezetimibe tablets is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated. Refer to the Prescribing Information of these products for a list of their contraindications [see Warnings and Precautions (5.1)].

The following serious adverse reactions are discussed in greater detail in other sections of the label:

• Liver enzyme abnormalities [see Warnings and Precautions (5.2)]
•  Rhabdomyolysis and myopathy [see Warnings and Precautions (5.3)]

Table 3 includes a list of drugs with clinically important drug interactions when administered concomitantly with ezetimibe tablets and instructions for preventing or managing them.

Table 3: Clinically Important Drug Interactions with Ezetimibe Tablets

In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. 

Ezetimibe, USP is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is:

 Ezetimibe, USP is a white to off white, crystalline powder that is soluble in methanol. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablet, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, Hypromellose, sodium lauryl sulfate, crospovidone, microcrystaline cellulose, and magnesium stearate.

Primary Hyperlipidemia in Adults

Ezetimibe Tablet reduces total-C, LDL-C, Apo B, and non-HDL-C in patients with hyperlipidemia. Maximal to near maximal response is generally achieved within 2 weeks and maintained during chronic therapy.

Monotherapy

In two multicenter, double-blind, placebo-controlled, 12-week trials in 1719 patients (age range 18 to 86 years, 52% females; 91% White, 5% Black or African American, 1% Asian, 3% other races mostly identified as Hispanic or Latino ethnicity) with primary hyperlipidemia, ezetimibe tablet significantly lowered total-C, LDL-C, Apo B, and non-HDL-C compared to placebo (see Table 6). Reduction in LDL-C was consistent across age, sex, and baseline LDL-C.

TABLE 6: Response to Ezetimibe Tablet in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline*)

*Baseline -on no lipid-lowering drug.

†Ezetimibe Tablet significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to placebo.

Combination with Statins: Ezetimibe Tablet Added to On-going Statin Therapy

In a multicenter, double-blind, placebo-controlled, 8-week trial, 769 patients (age range 22 to 85 years, 42% females; 90% White, 6% Black or African American, 1% Asian, 3% other races; and 2% identified as Hispanic or Latino ethnicity) with primary hyperlipidemia, known coronary heart disease or multiple cardiovascular risk factors who were already receiving statin monotherapy but who had not met their NCEP ATP II target LDL-C goal, were randomized to receive either ezetimibe tablet or placebo in addition to their on-going statin.

Ezetimibe Tablet, added to on-going statin therapy, significantly lowered total-C, LDL-C, Apo B, and non-HDL-C compared with a statin administered alone (see Table 7). LDL-C reductions induced by Ezetimibe Tablet were generally consistent across all statins.

 TABLE 7: Response to Addition of Ezetimibe Tablet to On-Going Statin Therapy* in Patients with Hyperlipidemia (Mean % Change from Treated Baseline† ) 

*   Patients receiving each statin: 40% atorvastatin, 31% simvastatin, 29% others (pravastatin, fluvastatin, cerivastatin, lovastatin).

†  Baseline - on a statin alone.

‡   Ezetimibe Tablet + statin significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to statin alone.

 Combination with Statins: Ezetimibe Tablet Initiated Concurrently with a Statin

In four multicenter, double-blind, placebo-controlled, 12-week trials, in 2,382 patients (age range 18 to 87 years, 57% female; 88% White, 5% Black or African American, 2% Asian, 5% other races mostly identified as Hispanic or Latino) with hyperlipidemia, ezetimibe tablet or placebo was administered alone or with various doses of atorvastatin, simvastatin, pravastatin, or lovastatin.

When all patients receiving ezetimibe tablet with a statin were compared to all those receiving the corresponding statin alone, ezetimibe tablet significantly lowered total-C, LDL-C, Apo B, and non-HDL-C compared to the statin administered alone. LDL-C reductions induced by ezetimibe tablet were generally consistent across all statins. (See footnote †, Tables 8 to 11.)

 TABLE 8: Response to Ezetimibe Tablet and Atorvastatin Initiated Concurrently in Patients with     Primary Hyperlipidemia (Mean % Change from Untreated Baseline*)

*Baseline - on no lipid-lowering drug.

†Ezetimibe Tablets + all doses of atorvastatin pooled (10-80 mg) significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to all doses of atorvastatin pooled (10-80 mg).

 TABLE 9: Response to Ezetimibe Tablet and Simvastatin Initiated Concurrently in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline*)

* Baseline - on no lipid-lowering drug.

† Ezetimibe Tablets + all doses of simvastatin pooled (10-80 mg) significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to all doses of simvastatin pooled (10-80 mg).

 TABLE 10: Response to Ezetimibe Tablet and Pravastatin Initiated Concurrently in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline*)

*Baseline - on no lipid-lowering drug.

† Ezetimibe Tablet + all doses of pravastatin pooled (10-40 mg) significantly reduced total-C, LDL-C, Apo B, and non-   HDL-C compared to all doses of pravastatin pooled (10-40 mg).

TABLE 11: Response to Ezetimibe Tablet and Lovastatin Initiated Concurrently in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline*)

*Baseline - on no lipid-lowering drug.

†Ezetimibe Tablet + all doses of lovastatin pooled (10-40 mg) significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to all doses of lovastatin pooled (10-40 mg).

Combination with Fenofibrate

In a multicenter, double-blind, placebo-controlled, clinical trial in patients with mixed hyperlipidemia, 625 patients (age range 20 to 76 years, 44% female; 79% White, 1% Black or African American, 20% other races; and 11% identified as Hispanic or Latino ethnicity) were treated for up to 12 weeks and 576 for up to an additional 48 weeks. Patients were randomized to receive placebo, ezetimibe tablet alone, 160 mg fenofibrate alone, or ezetimibe tablet and 160 mg fenofibrate in the 12-week trial. After completing the 12-week trial, eligible patients were assigned to ezetimibe tablet coadministered with fenofibrate or fenofibrate monotherapy for an additional 48 weeks.

Ezetimibe Tablet coadministered with fenofibrate significantly lowered total-C, LDL-C, Apo B,  and non-HDL-C compared to fenofibrate administered alone (see Table 12).

TABLE 12: Response to Ezetimibe Tablet and Fenofibrate Initiated Concurrently in Patients with Mixed Hyperlipidemia (Mean % Change from Untreated Baseline* at 12 weeks)

*Baseline - on no lipid-lowering drug.

The changes in lipid endpoints after an additional 48 weeks of treatment with ezetimibe tablet coadministered with fenofibrate or with fenofibrate alone were consistent with the 12-week data displayed above.

HeFH in Pediatric Patients

The effects of ezetimibe tablet coadministered with simvastatin (n=126) compared to simvastatin monotherapy (n=122) have been evaluated in males and females with HeFH. In a multicenter, double-blind, controlled trial followed by an open-label phase, 142 males and 106 postmenarchal females, 10 to 17 years of age (mean age 14.2 years, 43% females, 82% White, 4% Asian, 2% Black or African American, 13% multi- racial; 14% identified as Hispanic or Latino ethnicity) with HeFH were randomized to receive either ezetimibe tablet coadministered with simvastatin or simvastatin monotherapy. Inclusion in the trial required 1) a baseline LDL-C level between 160 and 400 mg/dL and 2) a medical history and clinical presentation consistent with HeFH. The mean baseline LDL-C value was 225 mg/dL (range: 161 to 351 mg/dL) in the ezetimibe tablet coadministered with simvastatin group compared to 219 mg/dL (range: 149 to 336 mg/dL) in the simvastatin monotherapy group. The patients received coadministered ezetimibe tablet and simvastatin (10 mg, 20 mg, or 40 mg) or simvastatin monotherapy (10 mg, 20 mg, or 40 mg) for 6 weeks, coadministered ezetimibe tablet and 40- mg simvastatin or 40-mg simvastatin monotherapy for the next 27 weeks, and open-label coadministered ezetimibe tablet and simvastatin (10 mg, 20 mg, or 40 mg) for 20 weeks thereafter.

The results of the trial at Week 6 are summarized in Table 13. Results at Week 33 were consistent with those at Week 6.

 TABLE 13: Mean Percent Difference at Week 6 Between the Pooled Ezetimibe Tablet Coadministered with Simvastatin Group and the Pooled Simvastatin Monotherapy Group in Adolescent Patients with HeFH

 HoFH in Adults and Pediatric Patients

A trial was conducted to assess the efficacy of ezetimibe tablet in the treatment of HoFH. This double-blind, randomized, 12-week trial enrolled 50 patients (age range 11 to 74 years, 58% female; 90% White, 2% Black or African American, 8% other races identified as Hispanic or Latino) 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 tablet administered with atorvastatin or simvastatin (40 mg), or ezetimibe tablet administered with atorvastatin or simvastatin (80 mg). Due to decreased bioavailability of ezetimibe in patients concomitantly receiving cholestyramine [see Drug Interactions (7)], 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 tablet plus atorvastatin 40 or 80 mg or simvastatin 40 or 80 mg. Ezetimibe tablet, 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 tablet plus 80-mg atorvastatin or with ezetimibe tablet plus 80-mg simvastatin, LDL-C was reduced by 27%.

Homozygous Sitosterolemia (Phytosterolemia) in Adults and Pediatric Patients

A trial was conducted to assess the efficacy of ezetimibe tablet in the treatment of homozygous sitosterolemia. In this multicenter, double-blind, placebo-controlled, 8-week trial, 37 patients (age range 9 to 72 years, 65% females; 89% White, 3% Asian, 8% other races identified as Hispanic or Latino) 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 tablet (n=30) or placebo (n=7). Due to decreased bioavailability of ezetimibe in patients concomitantly receiving cholestyramine [see Drug Interactions (7)], ezetimibe tablet was dosed at least 2 hours before or 4 hours after resins were administered. Excluding the one subject receiving LDL apheresis, ezetimibe tablet 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 tablet, mean plasma levels of plant sterols were reduced progressively over the course of the trial. Reductions in sitosterol and campesterol were consistent between patients taking ezetimibe tablet concomitantly with bile acid sequestrants (n=8) and patients not on concomitant bile acid sequestrant therapy (n=21).

Ezetimibe Tablets, USP 10 mg, are white to off white capsule shaped, flat faced, beveled edge

tablets, debossed with ‘A25’ on one side and plain on other side. They are supplied as follows:

NDC 67877-490-30 bottles of 30

NDC 67877-490-90 bottles of 90
NDC 67877-490-01 bottles of 100

NDC 67877-490-05 bottles of 500

NDC 67877-490-55 bottles of 5000

Storage  

Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).

Inform patients that ezetimibe tablet may cause liver enzyme elevations [see Warnings and Precautions (5.2)].

Muscle Pain

Advise patients that ezetimibe tablet may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.3), and Drug Interactions (7)].

Pregnancy

Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if ezetimibe tablet should be discontinued [see Use in Specific Populations (8.1)].

Breastfeeding

Advise patients who have a lipid disorder and are breastfeeding to discuss the options with their healthcare provider [see Use in Specific Populations (8.2)].

Missed Dose

Instruct patients to take ezetimibe tablet only as prescribed. If a dose is missed, it should be taken as soon as possible. Advise patients not to double their next dose.

For Patient Information, please visit:

http://www.ascendlaboratories.com/pti/ezetimibetablets.pdf

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: March, 2024

Ezetimibe (e zet' i mibe) Tablets, USP for oral use

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 is ezetimibe tablets?

Ezetimibe tablets is a medicine used with a cholesterol lowering diet:

• and with other cholesterol medicines called a statin, or alone (when additional cholesterol lowering treatments are not possible), to lower elevated low-density lipoprotein cholesterol (LDL-C) or bad cholesterol in adults with primary hyperlipidemia (too many fats in your blood), including heterozygous familial hypercholesterolemia (HeFH). HeFH is an inherited condition that causes high levels of bad cholesterol.
• and with a statin to lower LDL-C in adults and children 10 years of age and older with HeFH.
• and with a medicine called fenofibrate to lower elevated LDL-C in adults with mixed hyperlipidemia.
• to lower elevated sitosterol and campesterol levels in adults and in children 9 years of age and older with homozygous familial sitosterolemia (a rare inherited condition that prevents the body from getting rid of cholesterol from plants). Ezetimibe tablets is also used:
• with a statin and other cholesterol lowering treatments to lower elevated LDL-C levels in adults and patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). HoFH is an inherited condition that causes high levels of bad cholesterol. The safety and effectiveness of ezetimibe tablets has not been established in children:
• younger than 10 years of age with HeFH or HoFH.
• younger than 9 years of age with homozygous familial sitosterolemia.
•  with other types of hyperlipemia.

Do not take ezetimibe tablets:

• if you are allergic to ezetimibe or any of the ingredients in ezetimibe tablets. See the end of this Patient Information leaflet for a complete list of ingredients in ezetimibe tablets. Stop using ezetimibe tablets and get medical help right away if you have symptoms of a serious allergic reaction including:

• swelling of the face, tongue, or throat
• difficulty breathing or swallowing
• fainting or feeling dizzy
• very fast heartbeat
• severe skin rash, hives, and itching
• flu-like symptoms including fever, sore throat, cough, tiredness, and joint pain

•  with certain statins, fenofibrate, or other LDL-C lowering medicines if your healthcare provider has told you not to take them.

Before you take ezetimibe tablets, tell your healthcare provider about all your medical conditions, including if you:

• have liver problems. Ezetimibe tablets may not be right for you.
• are pregnant or plan to become pregnant. It is not known if ezetimibe tablets will harm your unborn baby. You and your healthcare provider should decide if you will take ezetimibe tablets while you are pregnant.
• are breastfeeding. It is not known if ezetimibe passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby if you take ezetimibe tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before you start taking any new medicines.

Taking ezetimibe tablets with certain other medicines may affect each other causing side effects. Ezetimibe tablets may affect the way other medicines work, and other medicines may affect how ezetimibe tablets works.

Especially tell your healthcare provider if you take:

• cyclosporine (a medicine for your immune system)
• fibrates (medicine for lowering cholesterol)
• bile acid sequestrants (medicine for lowering LDL-C)

 Ask your healthcare provider or pharmacist for a list of medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. 

How should I take ezetimibe tablets?

• Take ezetimibe tablets 1-time each 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 healthcare provider if you can take them at the same time.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses of ezetimibe tablets at the same time.
• While taking ezetimibe tablets, continue to follow your cholesterol-lowering diet and to exercise as your healthcare provider told you to.
• If you take a medicine called a bile acid sequestrant, take ezetimibe tablets at least 2 hours before or 4 hours after you take the bile acid sequestrant.
• Your healthcare provider may do blood tests to check your LDL-C levels as early as 4 weeks after starting treatment with ezetimibe tablets.
•  In case of an overdose, get medical help or contact a live Poison Center expert right away at 1- 800-222-1222. Advice is also available online at poisonhelp.org. 

What are the possible side effects of ezetimibe tablets?

Ezetimibe tablets may cause serious side effects including:

• increased liver enzymes. An increase in liver enzymes can happen in people taking ezetimibe tablets alone or with statins. Your healthcare provider may do blood tests to check your liver before and during treatment. Your healthcare provider may need to change or stop your treatment with ezetimibe tablets because of an increase in liver enzymes.
• muscle pain, tenderness, and weakness (myopathy). Muscle problems, including muscle breakdown (rhabdomyolysis) can happen. Tell your healthcare provider right away if:
  • you have unexplained muscle pain, tenderness, weakness, feel more tired than usual, or fever.
  • you have muscle problems that do not go away even after your healthcare provider has advised you to stop taking ezetimibe tablets. Your healthcare provider may do further tests to diagnose the cause of your muscle problems.
  Your chances of getting muscle problems are higher if you are also taking statins or fibrates. The most common side effects of ezetimibe tablets taken alone include:                                                
  

  upper respiratory tract infection	joint pain	pain in arms or legs	flu-like symptoms
  diarrhea	inflammation of the sinuses	feeling tired

   The most common side effects of ezetimibe tablets taken with a statin include:
  • runny nose, sore throat                               • joint pain                                                                                                          • flu-like symptoms
  • muscle aches and pains                              • diarrhea                                                                                                            • pain in arms or legs
  • upper respiratory tract infection                 • back pain                                                                                                         • feeling tired
  Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ezetimibe tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

 How should I store ezetimibe tablets?

• Store ezetimibe tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Protect from moisture.

Keep ezetimibe tablets and all medicines out of the reach of children.  

General information about safe and effective use of ezetimibe tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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 symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about ezetimibe tablets that is written for health professionals.

What are the ingredients in ezetimibe tablets?

Active ingredient: ezetimibe.

Inactive ingredients: Lactose monohydrate, croscarmellose sodium, Hypromellose, sodium lauryl sulfate, crospovidone, microcrystaline cellulose, and magnesium stearate.

For Patient Information, please visit:
http://www.ascendlaboratories.com/pti/ezetimibetablets.pdf

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: March, 2024 
PT 2508-05

NDC 67877-490-30
Ezetimibe Tablets, USP 10mg
Rx Only 30 Tablets
   
NDC 67877-490-90
Ezetimibe Tablets, USP 10mg
Rx Only 90 Tablets
 
NDC 67877-490-01
Ezetimibe Tablets, USP 10mg
Rx Only 100 Tablets
 
NDC 67877-490-05
Ezetimibe Tablets, USP 10mg
Rx Only 500 Tablets