Drug Catalog - Product Detail
EZETIMIBE USP 10MG TAB 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 51660-0200-30 | OHM LABS | 30 | 10MG | TABLET |
PACKAGE FILES
Generic Name
EZETIMIBE
Substance Name
EZETIMIBE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207311
Description
11 DESCRIPTION Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe 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 409.42 and its structural formula is: Ezetimibe is a white to off white, crystalline powder that is freely soluble in methanol, and acetone, soluble in ethanol, and practically insoluble in water. Ezetimibe has a melting point of about 165.13°C and is stable at ambient temperature. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (maize) and sodium lauryl sulfate. Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ezetimibe tablets, USP, 10 mg, are white to off-white, capsule-shaped uncoated tablets with “ E 10 ” debossed on one side and plain on other side. They are supplied as follows: NDC 51660-200-30 Bottles of 30 NDC 51660-200-90 Bottles of 90 NDC 51660-200-05 Bottles of 500 Storage Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Protect from moisture.
Indications & Usage
1 INDICATIONS AND USAGE Ezetimibe tablets are 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 are 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. Ezetimibe tablets are indicated ( 1 ): • 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 are 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 ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of ezetimibe tablet 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 orally once daily, with or without food (2) Administer ezetimibe tablets either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. (2) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe tablets. (2)