What is ezetimibe?

Ezetimibe reduces the amount of cholesterol absorbed by the body.

Ezetimibe is used to treat high cholesterol.
Ezetimibe is sometimes given with other cholesterol-lowering medications.

Important information
Ezetimibe is only part of a complete program of treatment that also includes
diet, exercise, and weight control. Follow your diet, medication, and exercise
routines very closely.
Some cholesterol medications should not be taken at the same time. If you
take ezetimibe with another cholesterol medicine, follow your doctor's
dosing instructions very carefully.

SLIDESHOW

Looking Ahead: Pharma Projections for 2016 - And Beyond

You should not use ezetimibe if you have moderate to severe liver
disease. You should not use ezetimibe with a "statin" cholesterol
medicine if you have active liver disease, or if you are pregnant or
breast-feeding a baby.
Call your doctor right away if you have unexplained muscle pain, tenderness,
or weakness especially if you also have fever, unusual tiredness, and dark
colored urine.

Before taking this medicine

You should not use ezetimibe if you are allergic to it, or if you have:

moderate to severe liver disease.

You should not use ezetimibe with a "statin" cholesterol medicine (Zocor,
Lipitor, Crestor, and others) if:

you have active liver disease;

you are pregnant; or

you are breast-feeding a baby.

To make sure this medicine is safe for you, tell your doctor if you have:

kidney disease; or

a thyroid disorder.

Before you start taking this medicine, tell your doctor if you already take a
statin cholesterol medicine.
Some cholesterol medications can cause a condition that results in the
breakdown of skeletal muscle tissue, leading to kidney failure. This condition
may be more likely to occur in older adults and in people who have kidney
disease or poorly controlled hypothyroidism (underactive thyroid).
You should not take ezetimibe with a statin medication if you are
pregnant or breast-feeding.
It is not known whether ezetimibe alone will harm an unborn baby. Tell your
doctor if you are pregnant or plan to become pregnant. Use effective birth
control to prevent pregnancy while you are using ezetimibe with a statin
medication.
It is not known whether ezetimibe alone passes into breast milk or if it could
harm a nursing baby. Tell your doctor if you are breast-feeding a baby. You
should not breast-feed if you take this medicine with a statin medication.

How should I take ezetimibe?

Take ezetimibe exactly as it was prescribed for you. Follow all directions on
your prescription label. Do not take this medicine in larger or smaller amounts
or for longer than recommended.
Ezetimibe is usually taken once daily. Take the medicine at the same time
each day.
You may take this medicine with or without food.
Ezetimibe may be taken at the same time with fenofibrate, or with a statin
medication such as atorvastatin, lovastatin, simvastatin, pravastatin, or
fluvastatin.
Some cholesterol medications should not be taken at the same time.

If you also take cholestyramine, colestipol, or colesevelam: You may

take ezetimibe 2 hours before taking any of these medicines or wait at least
4 hours after taking any of these other medicines.
You should not take ezetimibe with gemfibrozil.

You may need frequent blood tests to check your liver function if you take
ezetimibe with a statin medicine.
It may take up to 2 weeks before your cholesterol levels improve. Keep using
your medication as directed. You will need frequent blood tests to measure
your cholesterol levels.
Ezetimibe is only part of a complete program of treatment that also includes
diet, exercise, and weight control. Follow your diet, medication, and exercise
routines very closely.
Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is
almost time for your next scheduled dose. Do not take extra medicine to make
up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-2221222.

What should I avoid while taking ezetimibe?

Avoid eating foods that are high in fat or cholesterol. This medicine will not be
as effective in lowering your cholesterol if you do not follow a cholesterollowering diet plan.

Ezetimibe side effects

Get emergency medical help if you have signs of an allergic reaction to
ezetimibe: hives; difficult breathing; swelling of your face, lips, tongue, or
throat.
Some cholesterol medications can cause a condition that results in the
breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor
right away if you have unexplained muscle pain, tenderness, or weakness
especially if you also have fever, unusual tiredness, and dark colored urine.
Side effects may be more likely in older adults.
Common ezetimibe side effects may include:

muscle or joint pain;

stuffy nose, sinus pain, sore throat;

diarrhea; or

pain in an arm or leg.

This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to
FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)

Ezetimibe dosing information

Usual Adult Dose for Hyperlipidemia:

10 mg once a day with or without food.
Usual Adult Dose for Sitosterolemia:
10 mg once a day with or without food.

What other drugs will affect ezetimibe?

Tell your doctor about all your current medicines and any you start or stop
using, especially:

cyclosporine; or

a blood thinner (warfarin, Coumadin, Jantoven).

This list is not complete. Other drugs may interact with ezetimibe, including
prescription and over-the-counter medicines, vitamins, and herbal products.
Not all possible interactions are listed in this medication guide.

Ezetimibe Side Effects

Overview
Side Effects
Dosage

Interactions
Professional
More
o
o
o
o

More frequently reported side effects include upper respiratory tract infection.
See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ezetimibe: oral tablet
In addition to its needed effects, some unwanted effects may be caused by
ezetimibe. In the event that any of these side effects do occur, they may
require medical attention.
Frequency not determined

Abdominal fullness

black tarry stools

bleeding gums

bloating

blood in urine or stools

chills

constipation

darkened urine

fast heartbeat

fever

gaseous abdominal pain

general tiredness or weakness

indigestion

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands,

legs, feet, sex organs

loss of appetite

light-colored stools

muscle cramps or spasms

muscular tenderness, wasting or weakness

nausea

pains in stomach, side or abdomen, possibly radiating to the back

pinpoint red spots on skin

recurrent fever

severe nausea

skin rash

unusual bleeding or bruising

upper right abdominal pain

vomiting

yellow eyes or skin

Some of the side effects that can occur with ezetimibe may not need medical
attention. As your body adjusts to the medicine during treatment these side
effects may go away. Your health care professional may also be able to tell
you about ways to reduce or prevent some of these side effects. If any of the
following side effects continue, are bothersome or if you have any questions
about them, check with your health care professional:
More common

Fever

headache

muscle pain

runny nose

sore throat

Less common

Back pain

body aches or pain

chest pain

chills

cold or flu-like symptoms

congestion

coughing

diarrhea

difficulty in moving

dizziness

dryness or soreness of throat

hoarseness

muscle pain or stiffness

pain in joints

pain or tenderness around eyes and cheekbones

shortness of breath or troubled breathing

stomach pain

stuffy nose

tender, swollen glands in neck

tightness of chest or wheezing

trouble in swallowing

unusual tiredness or weakness

voice changes

For Healthcare Professionals

Applies to ezetimibe: oral tablet
General

General side effects including fatigue (2.2%) have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including diarrhea (3.7%) and abdominal pain

(3.0%) have been reported. Pancreatitis and nausea have also been reported
in postmarketing experience.[Ref]
A case of ezetimibe-induced acute pancreatitis occurred two weeks after
initiating therapy. Following discontinuation of ezetimibe the patient's
symptoms resolved and pancreatic enzyme levels normalized.[Ref]
Immunologic

Immunologic side effects including sinusitis (3.6%), pharyngitis (2.3%), and

viral infection (2.2%) have been reported.[Ref]
Musculoskeletal

Musculoskeletal side effects including back pain (4.1%) and arthralgia (3.8%)
have been reported. Other effects including myalgia, arthralgia, elevated
creatine phosphokinase, and rare reports of myopathy/rhabdomyolysis have
been reported in postmarketing experience.[Ref]
Respiratory

Respiratory side effects including coughing (2.3%) have been reported.[Ref]

Hypersensitivity

Hypersensitivity reactions including angioedema, anaphylaxis, rash, urticaria,

and erythema multiforme have been reported in postmarketing experience.[Ref]
Hepatic

Hepatic side effects including elevations in liver transaminases, hepatitis,

cholelithiasis, and cholecystitis have been reported in postmarketing
experience.[Ref]

Hematologic

Hematologic side effects including thrombocytopenia have been reported in

postmarketing experience.[Ref]
Nervous system

Nervous system side effects including dizziness, paresthesia, and headache

have been associated with ezetimibe in postmarketing experience.
Psychiatric

Psychiatric side effects including depression have been reported during the
postmarketing experience.
References
1. "Product Information. Zetia (ezetimibe)." Schering Corporation, Kenilworth, NJ.
2. Ahmad I, Ruby E, Usman H, Hotiana M, Hussain M, Rahman F "Ezetimibe-induced acute pancreatitis."
South Med J 100 (2007): 409-10
3. Havranek JM, Wolfsen AR, Warnke GA, Phillips PS "Monotherapy with ezetimibe causing myopathy." Am J
Med 119 (2006): 285-6
4. Pattis P, Wiedermann CJ "Ezetimibe-associated immune thrombocytopenia." Ann Pharmacother 42 (2008):
430-3

Not all side effects for ezetimibe may be reported. You should always consult
a doctor or healthcare professional for medical advice. Side effects can be
reported to the FDA

Ezetimibe Dosage
Overview

Side Effects
Dosage

 Interactions
Professional
More
o
o
o
o

Applies to the following strength(s): 10 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or
pharmacist.

Usual Adult Dose for:

Hyperlipidemia

Sitosterolemia

Additional dosage information:

Renal Dose Adjustments

Liver Dose Adjustments

Dose Adjustments

Precautions

Dialysis

Other Comments

Usual Adult Dose for Hyperlipidemia

10 mg once a day with or without food.

Usual Adult Dose for Sitosterolemia

10 mg once a day with or without food.

Renal Dose Adjustments

No adjustment necessary

Liver Dose Adjustments

If a patient has a Child-Pugh score of 7 or greater, then use of this drug is not
recommended.

Dose Adjustments
Ezetimibe is usually dosed daily, but its 22-hour elimination half life permits
significant cholesterol reduction with less frequent dosing. A study examined
lipid changes in 33 patients treated with three times weekly ezetimibe for
greater than or equal to one month, who had pre- and post-ezetimibe lipid
levels and no other concurrent changes in their lipid treatment. Ninety-four
percent of the patients in the study were treated with ezetimibe because they
experienced myalgias, elevated transaminase levels, or gastrointestinal
intolerance with higher doses of other lipid-lowering agents. Total cholesterol
decreased by 15% and low-density lipoprotein cholesterol by 20% during 58
plus or minus 50 days of treatment. Most patients (85%) tolerated the
treatment, and many (48%) achieved their low-density lipoprotein cholesterol
goals. The study concluded that ezetimibe given three times weekly
decreases total and low-density lipoprotein cholesterol and is well tolerated. It
is a viable treatment for patients intolerant of other lipid-lowering medications.

Precautions
Because of the unknown effects of the increased exposure to ezetimibe in
patients with moderate to severe hepatic insufficiency, use of ezetimibe is not
recommend in these patients. The combination of ezetimibe with an HMGCoA reductase inhibitor is contraindicated in patients with active liver disease
or unexplained persistent elevations in serum transaminases.

The incidence of consecutive elevations (greater than or equal to 3 the

upper limit of normal [ULN]) in serum transaminases have not been reported
in ezetimibe studies. In studies of ezetimibe initiated concurrently with an
HMG-CoA reductase inhibitor, the incidence of consecutive elevations (greater
than or equal to 3 ULN) in serum transaminases was reported. These
elevations in transaminases were generally asymptomatic, not associated with
cholestasis, and returned to baseline after discontinuation of treatment or with
continued therapy. When ezetimibe is coadministered with an HMG-CoA
reductase inhibitor, liver function tests should be performed at initiation of
treatment and according to the recommendations of the HMG-CoA reductase
inhibitor.
In clinical trials, there was no excess of myopathy or rhabdomyolysis
associated with ezetimibe compared with the relevant control arm (placebo or
HMG-CoA reductase inhibitor alone). However, myopathy and rhabdomyolysis
are known adverse reactions to HMG-CoA reductase inhibitors and other lipidlowering drugs. In postmarketing experience with ezetimibe, cases of
myopathy and rhabdomyolysis have been reported regardless of causality.
Most patients who developed rhabdomyolysis were taking an HMG-CoA
reductase inhibitor prior to initiating ezetimibe. However, rhabdomyolysis has
been reported very rarely with ezetimibe monotherapy and very rarely with the
addition of ezetimibe to agents known to be associated with increased risk of
rhabdomyolysis, such as fibrates. 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. Ezetimibe and any HMGCoA reductase inhibitor or fibrate that the patient is taking concomitantly
should be immediately discontinued if myopathy is diagnosed or suspected.
The presence of these symptoms and a creatine phosphokinase (CPK) level
greater than 10 times the ULN indicates myopathy.
The safety and efficacy of ezetimibe in pediatric patients less than 10 years of
age have not been determined.

Dialysis
Data not available

Other Comments
Ezetimibe should be dosed 2 or more hours before or 4 or more hours after
administration of a bile acid sequestrant.
The patient should be placed on a standard cholesterol-lowering diet before
receiving ezetimibe and should continue on this diet during treatment with
ezetimibe.
Ezetimibe may be administered with an HMG-CoA reductase inhibitor (in
patients with primary hypercholesterolemia) or fenofibrate (in patients with
mixed hyperlipidemia) for incremental effect. Ezetimibe may be administered
at the same time as the HMG-CoA reductase inhibitor or fenofibrate,
depending on the dosing recommendations for the HMG-CoA reductase
inhibitor.
The package labeling reports that treatment experience in the pediatric
population is limited to four patients (9 to 17 years) in the sitosterolemia study
and five patients (11 to 17 years) in the HoFH study.

Apa Itu Ezetimibe?

Oleh Lika Aprilia Samiadi. Data medis direview oleh Thu Truong, PharmD.
Generic Name: Ezetimibe
No reviews available.

Penggunaan

Untuk Apa Ezetimibe?

Ezetimibe digunakan bersamaan dengan diet rendah kolesterol atau rendah lemak
serta olahraga untuk membantu menurunkan kadar kolesterol dalam darah.
Ezetimibe dapat digunakan secara independen atau bersama dengan obat lain
(seperti statin atau fibrat). Ezetimibe bekerja dengan mengurangi
jumlah kolesteroldalam tubuh. Mengurangi kolesterol dapat membantu mencegah
stroke dan serangan jantung
Bagaimana Cara Penggunaan Ezetimibe?

Obat ini diminum seperti yang diarahkan oleh dokter Anda, biasanya sekali sehari
dengan atau tanpa makanan.
Dosis didasarkan pada kondisi medis Anda dan respon tubuh terhadap pengobatan.
Jika Anda menggunakan asam empedu sequestrant (seperti cholestyramine
dan colestipol), gunakan ezetimibe minimal 2 jam sebelum atau 4 jam sesudah
menggunakan asam empedu sequestrant. Obat tersebut dapat mengikat ezetimibe
yang membuat tubuh Anda tidak dapat menyerap ezetimibe sepenuhnya.
Gunakan obat ini secara teratur untuk memperoleh hasil terbaik. Supaya Anda ingat,
gunakanlah selalu obat ini pada waktu yang sama setiap harinya.
Penting bagi Anda untuk terus meminum obat ini bahkan jika Anda merasa sudah
baikan. Kebanyakan penderita dengan kolesterol tinggi tidak merasakan sakit di
bagian tubuhnya. Membutuhkan waktu hingga 2 minggu bagi Anda untuk bisa
merasakan manfaat dari obat ini.

Bagaimana Cara Penyimpanan Ezetimibe?

Obat ini paling baik disimpan pada suhu ruangan, jauhkan dari cahaya langsung
dan tempat yang lembap. Jangan disimpan di kamar mandi. Jangan dibekukan.
Merek lain dari obat ini mungkin memiliki aturan penyimpanan yang berbeda.
Perhatikan instruksi penyimpanan pada kemasan produk atau tanyakan pada
apoteker Anda. Jauhkan semua obat-obatan dari jangkauan anak-anak dan hewan
peliharaan.
Jangan menyiram obat-obatan ke dalam toilet atau ke saluran pembuangan kecuali
bila diinstruksikan. Buang produk ini bila masa berlakunya telah habis atau bila
sudah tidak diperlukan lagi. Konsultasikan kepada apoteker atau perusahaan
pembuangan limbah lokal mengenai bagaimana cara aman membuang produk
Anda.

Dosis
Informasi yang diberikan bukanlah pengganti dari nasihat medis. SELALU
konsultasikan pada dokter atau apoteker Anda sebelum memulai pengobatan.
Bagaimana Dosis Ezetimibe Untuk Orang Dewasa?

Dosis Dewasa biasa untuk Hiperlipidemia

10 mg sekali sehari dengan atau tanpa makanan.
Dosis Dewasa biasa untuk Sitosterolemia
10 mg sekali sehari dengan atau tanpa makanan

Bagaimana Dosis Ezetimibe Untuk Anak-Anak?

Dosis untuk anak di bawah 10 tahun belum ditentukan. Konsultasikan dengan

dokter Anda untuk informasi lebih lanjut.
Dalam Dosis Apakah Ezetimibe Tersedia?

Tablet, diminum: 10 mg

Efek Samping
Efek Samping Apa Yang Dapat Dialami Karena Ezetimibe?

Cari bantuan medis segera jika Anda mengalami tanda-tanda reaksi alergi berikut
ini: gatal-gatal, kesulitan bernapas, pembengkakan wajah, bibir, lidah, atau
tenggorokan.
Hubungi dokter Anda segera jika Anda memiliki efek samping yang serius seperti:

lemah otot yang tidak biasa, terasa nyeri atau bahkan sakit

mual, sakit perut, demam, kehilangan nafsu makan, urin berwarna gelap
pekat, tinja berwarna tanah liat, sakit kuning (kulit atau mata menguning)

sakit dada

pankreatitis (sakit parah di perut bagian atas yang menyebar ke punggung,

terasa mual dan ingin muntah, detak jantung menjadi cepat)

demam, sakit tenggorokan, dan sakit kepala yang parah, kulit menjadi
kemerahan, mengelupas, atau muncul ruam-ruam

Efek samping yang tidak terlalu serius antara lain:

mati rasa atau muncul perasaan geli

nyeri perut ringan, diare

lelah

sakit kepala

pusing

suasana hati tidak menentu

hidung tersumbat, gejala flu

nyeri sendi, sakit punggung atau

batuk
Tidak semua orang mengalami efek samping tersebut. Kemungkinan terdapat
beberapa efek samping yang tidak tercantum di atas. Jika Anda memiliki
kekhawatiran tertentu mengenai efek samping yang ditimbulkan akibat penggunaan
obat, silakan konsultasikan dengan dokter atau apoteker.

Pencegahan & Peringatan

Apa Saja Yang Harus Diketahui Sebelum Menggunakan Ezetimibe?

Sebelum menggunakan ezetimibe, hendaknya Anda:

hubungi dokter dan apoteker jika Anda alergi terhadap ezetimibe atau obat
lain

hubungi dokter dan apoteker mengenai obat yang Anda gunakan baik dengan
atau tanpa resep, juga vitamin, suplemen gizi, dan produk herbal yang Anda
gunakan. Pastikan untuk menyebutkan salah satu dari zat berikut: antikoagulan (
pengencer darah) seperti warfarin (Coumadin) siklosporin (Neoral, Sandimmune)
fenofibrate (TriCor) dan gemfibrozil (Lopid). Kemungkinan dokter Anda perlu
mengubah dosis obat atau memantau kondisi Anda dengan hati-hati untuk
mencegah timbulnya efek samping

jika Anda menggunakan cholestyramine (Questran), colesevelam (wellchol),

atau colestipol (Colestid), minumlah 4 jam sebelum atau 2 jam sesudah
menggunakan ezetimibe

beri tahu dokter jika Anda memiliki atau pernah memiliki penyakit hati

hubungi dokter jika Anda sedang hamil, berencana untuk hamil, atau sedang
menyusui. Jika Anda hamil sewaktu menggunakan ezetimibe, hubungi dokter Anda
segera
Apakah Ezetimibe Aman Untuk Ibu Hamil Dan Menyusui?

Tidak ada penelitian yang memadai mengenai risiko penggunaan obat ini pada ibu
hamil atau menyusui. Selalu konsultasikan kepada dokter Anda untuk
mempertimbangkan potensi manfaat dan risiko sebelum menggunakan obat ini.
Obat ini termasuk ke dalam risiko kehamilan kategori C menurut US Food and
Drugs Administration (FDA).

Berikut referensi kategori risiko kehamilan menurut FDA :

A= Tidak berisiko,

B=Tidak berisiko pada beberapa penelitian,

C=Mungkin berisiko,

D=Ada bukti positif dari risiko,

X=Kontraindikasi,

N=Tidak diketahui

Tidak ada penelitian yang memadai pada wanita untuk mencari tahu risiko pada bayi
saat sang ibu mengonsumsi obat ini selama menyusui. Pertimbangkan potensi
manfaat dan potensi risikonya sebelum mengonsumsi obat ini selama menyusui.

Interaksi
Obat-Obatan Apa Yang Mungkin Berinteraksi Dengan Ezetimibe?

Walau beberapa obat tidak boleh dikonsumsi bersamaan sama sekali, pada kasus
lain beberapa obat juga bisa digunakan bersamaan meskipun interaksi mungkin
saja terjadi. Pada kasus seperti ini, dokter mungkin akan mengganti dosisnya, atau
melakukan hal-hal pencegahan lain yang dibutuhkan. Beri tahu dokter jika Anda
sedang mengonsumsi obat lain baik yang dijual bebas maupun dari resep dokter.

Penggunaan obat ini dengan salah satu obat berikut tidak dianjurkan, namun
kemungkinan diperlukan untuk beberapa kasus. Jika kedua obat diresepkan
bersama-sama, dokter Anda dapat mengubah dosis atau menjadwalkan seberapa
sering Anda harus menggunakan salah satu atau kedua obat tersebut.

Clofibrate

Gemfibrozil

Simeprevir

Teriflunomide
Penggunaan obat ini dengan salah satu obat berikut dapat meningkatkan risiko
terjadinya efek samping tertentu, tetapi kemungkinan penggunaan kedua obat
tersebut merupakan pengobatan terbaik bagi Anda. Jika kedua obat diresepkan
bersama-sama, dokter Anda dapat mengubah dosis atau menjadwalkan seberapa
sering Anda menggunakan salah satu atau kedua obat tersebut.

Cholestyramine

Colestipol

Cyclosporine

Fenofibrate

Apakah Makanan Atau Alkohol Dapat Berinteraksi Dengan Ezetimibe?

Obat-obatan tertentu tidak boleh digunakan pada saat makan atau saat makan
makanan tertentu karena interaksi obat dapat terjadi. Mengonsumsi alkohol atau
tembakau dengan obat-obatan tertentu juga dapat menyebabkan interaksi terjadi.
Diskusikan penggunaan obat Anda dengan makanan, alkohol, atau tembakau
dengan penyedia layanan kesehatan Anda.

Kondisi Kesehatan Apa Yang Dapat Berinteraksi Dengan Ezetimibe?

Adanya masalah medis lain dapat mempengaruhi penggunaan obat ini. Pastikan
Anda memberi tahu dokter bila Anda memiliki penyakit lain, terutama:

penyakit hati (atau pernah memiliki)

enzim hati terus meningkat. Penggunaan obat ini justru akan memperburuk
kondisi hati Anda

Overdosis
Apa Yang Harus Saya Lakukan Pada Keadaan Gawat Darurat Atau Overdosis?

Pada kasus gawat darurat atau overdosis, hubungi penyedia layanan gawat darurat
lokal (112) atau segera ke unit gawat darurat rumah sakit terdekat.

Apa Yang Harus Saya Lakukan Bila Melewatkan Satu Dosis?

Apabila Anda melupakan satu dosis obat ini, minum sesegera mungkin. Namun bila
sudah mendekati waktu dosis berikutnya, lewati dosis yang terlupakan dan kembali
ke jadwal dosis yang biasa. Jangan menggandakan dosis.

Hello Health Group tidak menyediakan nasihat medis, diagnosis, atau

pengobatan.
Review Date: January 3, 2016 | Last Modified: March 12, 2016