EZETIMIBE AND SIMVASTATIN tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Actavis Pharma, Inc.

INN (International Name):

EZETIMIBE

রচনা:

EZETIMIBE 10 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

Ezetimibe and Simvastatin Tablets are supplied as follows: 10 mg/10 mg – Each light tan, slightly speckled, round, unscored, biconvex tablet debossed with 511 on one side and  on opposite side contains 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-565-30), and 90 (NDC 45963-565-08).   10 mg/20 mg – Each light tan, slightly speckled, round, unscored, biconvex tablet debossed with 512 on one side and  on opposite side contains 10 mg of ezetimibe, USP and 20 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-566-30), and 90 (NDC 45963-566-08). 10 mg/40 mg – Each light tan, slightly speckled, round, unscored, biconvex tablet debossed with 513 on one side and  on opposite side contains 10 mg of ezetimibe, USP and 40 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-567-30), and 90 (NDC 45963-567-08). 10 mg/80 mg – Each light tan, slightly speckled, capsule shaped, unscored, biconvex tablet debossed with 515 on one side and  on opposite side contains 10 mg of ezetimibe, USP and 80 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-568-30), and 90 (NDC 45963-568-08). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container tightly closed. Dispense in a tight, light-resistant container as defined in the USP.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

EZETIMIBE AND SIMVASTATIN- EZETIMIBE AND SIMVASTATIN TABLET
ACTAVIS PHARMA, INC.
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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 10 mg/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 should be restricted to patients who have
been taking ezetimibe and
simvastatin 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 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-drug interaction. (2.2)
Due t