EZETIMIBE AND SIMVASTATIN- ezetimibe and simvastatin tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24), SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

थमां उपलब्ध:

Impax Generics

INN (इंटरनेशनल नाम):

EZETIMIBE

रचना:

EZETIMIBE 10 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments

उत्पाद समीक्षा:

Ezetimibe and simvastatin tablets, 10 mg/10 mg are pink, oval film-coated tablets debossed with "P61" on both sides. They are supplied as follows: Ezetimibe and simvastatin tablets, 10 mg/20 mg are yellow, oval film-coated tablets debossed with "P62" on both sides. They are supplied as follows: Ezetimibe and simvastatin tablets, 10 mg/40 mg are beige, oval film-coated tablets debossed with "P63" on both sides. They are supplied as follows: Ezetimibe and simvastatin tablets, 10 mg/80 mg are white, oval film-coated tablets debossed with "P64" on both sides. They are supplied as follows: Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].  Keep container tightly closed. Dispense in a tightly closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Keep out of reach of children.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

EZETIMIBE AND SIMVASTATIN- EZETIMIBE AND SIMVASTATIN TABLET, FILM
COATED
IMPAX GENERICS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EZETIMIBE AND SIMVASTATIN TABLETS
SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR EZETIMIBE AND SIMVASTATIN
TABLETS.
EZETIMIBE AND SIMVASTATIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Ezetimibe and simvastatin tablets, which contain a cholesterol
absorption inhibitor and an HMG-CoA reductase inhibitor
(statin), is indicated as adjunctive therapy to diet to:
reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to
increase HDL-C in patients with primary
(heterozygous familial and non-familial) hyperlipidemia or mixed
hyperlipidemia. (1.1)
reduce elevated total-C and LDL-C in patients with homozygous familial
hypercholesterolemia (HoFH), as an adjunct to
other lipid-lowering treatments. (1.2)
Limitations of Use (1.3)
No incremental benefit of ezetimibe and simvastatin tablets on
cardiovascular morbidity and mortality over and above
that demonstrated for simvastatin has been established.
Ezetimibe and simvastatin tablets have not been studied in Fredrickson
Type I, III, IV, and V dyslipidemias.
DOSAGE AND ADMINISTRATION
Dose range is 10mg/10 mg/day to 10 mg/40 mg/day. (2.1)
Recommended usual starting dose is 10 mg/10 mg or 10 mg/20 mg/day.
(2.1)
Due to the increased risk of myopathy, including rhabdomyolysis, use
of the 10 mg/80 mg dose of ezetimibe and
simvastatin tablets should be restricted to patients who have been
taking ezetimibe and simvastatin tablets 10
mg/80 mg chronically (e.g., for 12 months or more) without evidence of
muscle toxicity. (2.2)
Patients who are currently tolerating the 10 mg/80 mg dose of
ezetimibe and simvastatin tablets who need to be
initiated on an interacting drug that is contraindicated or is
associated with a dose cap for simvastatin should be switched
to an alternative statin or statin-based regimen with less potential
for the drug