EZETIMIBE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24)

Available from:

direct rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. 1.1 Primary Hyperlipidemia Monotherapy Ezetimibe Tablets, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins) Ezetimibe Tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to die

Product summary:

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: 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

EZETIMIBE- EZETIMIBE TABLET
direct rx
----------
Ezetimibe Tablets, USP 10 mg
Patient Information about Ezetimibe (ĕ-zĕt´-ĕ-mīb) 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 is Ezetimibe Tablets?
Ezetimibe Tablet is a medicine used to lower levels of total
cholesterol and LDL (bad) cholesterol in the
blood. Ezetimibe Tablet is 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 works 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 breast-feeding, 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

Summary of Product characteristics

EZETIMIBE- EZETIMIBE TABLET
DIRECT RX
----------
EZETIMIBE
Therapy with lipid-altering agents should be only one component of
multiple risk factor
intervention in individuals at significantly increased risk for
atherosclerotic vascular
disease due to hypercholesterolemia. Drug therapy is indicated as an
adjunct to diet
when the response to a diet restricted in saturated fat and
cholesterol and other
nonpharmacologic measures alone has been inadequate.
1.1 Primary Hyperlipidemia
Monotherapy
Ezetimibe Tablets, administered alone, is indicated as adjunctive
therapy to diet for the
reduction of elevated total cholesterol (total-C), low-density
lipoprotein cholesterol (LDL-
C), apolipoprotein B (Apo B), and non-high-density lipoprotein
cholesterol (non-HDL-C) in
patients with primary (heterozygous familial and non-familial)
hyperlipidemia.
Combination Therapy with HMG-CoA Reductase Inhibitors (Statins)
Ezetimibe Tablets, administered in combination with a
3-hydroxy-3-methylglutaryl-
coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as
adjunctive therapy to
diet for the reduction of elevated total-C, LDL-C, Apo B, and
non-HDL-C in patients with
primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with Fenofibrate
Ezetimibe Tablets, administered in combination with fenofibrate, is
indicated as adjunctive
therapy to diet for the reduction of elevated total-C, LDL-C, Apo B,
and non-HDL-C in
adult patients with mixed hyperlipidemia.
1.2 Homozygous Familial Hypercholesterolemia (HoFH)
The combination of Ezetimibe Tablets and atorvastatin or simvastatin
is indicated for the
reduction of elevated total-C and LDL-C levels in patients with HoFH,
as an adjunct to
other lipid-lowering treatments (e.g., LDL apheresis) or if such
treatments are
unavailable.
1.3 Homozygous Sitosterolemia
Ezetimibe Tablet is indicated as adjunctive therapy to diet for the
reduction of elevated
sitosterol and campesterol levels in patients with homozygous familial
sitosterolemia.
1.4 Limitations of Use
The