EZETIMIBE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ezetimibe (UNII: EOR26LQQ24) (Ezetimibe - UNII:EOR26LQQ24)

Available from:

Prasco Laboratories

INN (International Name):

Ezetimibe

Composition:

Ezetimibe 10 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

EZETIMIBE- EZETIMIBE TABLET
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EZETIMIBE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR EZETIMIBE TABLETS.
EZETIMIBE TABLETS
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Ezetimibe is an inhibitor of intestinal cholesterol (and related
phytosterol) absorption indicated as an adjunct to diet to:
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with
primary hyperlipidemia, alone or in combination
with an HMG-CoA reductase inhibitor (statin) (1.1)
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with
mixed hyperlipidemia in combination with
fenofibrate (1.1)
Reduce elevated total-C and LDL-C in patients with homozygous familial
hypercholesterolemia (HoFH), in combination
with atorvastatin or simvastatin (1.2)
Reduce elevated sitosterol and campesterol in patients with homozygous
sitosterolemia (phytosterolemia) (1.3)
Limitations of Use (1.4)
The effect of ezetimibe on cardiovascular morbidity and mortality has
not been determined.
Ezetimibe has not been studied in Fredrickson Type I, III, IV, and V
dyslipidemias.
DOSAGE AND ADMINISTRATION
One 10-mg tablet once daily, with or without food (2.1)
Dosing of ezetimibe should occur either ≥2 hours before or ≥4
hours after administration of a bile acid sequestrant. (2.3,
7.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg (3)
CONTRAINDICATIONS
Statin contraindications apply when ezetimibe is used with a statin:
Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels (4, 5.2)
Women who are pregnant or may become pregnant (4, 8.1)
Nursing mothers (4, 8.3)
Known hypersensitivity to product components (4, 6.2)
WARNINGS AND PRECAUTIONS
Ezetimibe is not recommended in patients with moderate or severe
hepatic impairment. (5.4, 8.7, 12.3)
Liver enzyme abnormalities and monitoring: Persistent elevations in
hepatic transaminase can occur when ezetim