TRILIPIX- fenofibric acid capsule, delayed release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

FENOFIBRIC ACID (UNII: BGF9MN2HU1) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)

Pieejams no:

Physicians Total Care, Inc.

SNN (starptautisko nepatentēto nosaukumu):

FENOFIBRIC ACID

Kompozīcija:

FENOFIBRIC ACID 135 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal. CHD risk equivalents comprise: - Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease); - Diabetes; - Multiple risk factors that confer a 10-year risk for CHD > 20% Trilipix is indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied. Trilipix is indicated as adjunctive therapy to diet to reduce elevate

Produktu pārskats:

Trilipix (fenofibric acid) delayed release capsules are supplied as followed: Storage and Handling Store Trilipix 135 mg delayed release capsules at 25°C (77°F); excursions permitted to 15°-30°C (59° to 86°F) [See USP controlled room temperature]. Keep out of the reach of children. Protect from moisture.

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

Physicians Total Care, Inc.
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MEDICATION GUIDE
Trilipix
(try-lip-iks)
(fenofibric acid, delayed release capsules)
Read this Medication Guide before you start taking Trilipix and each
time you get a refill. There may be
new information. This information does not take the place of talking
to your healthcare provider about
your medical condition or your treatment.
What is the most important information I should know about Trilipix?
Trilipix can be used with other cholesterol-lowering medicines called
statins. Statins include:
•
atorvastatin (Lipitor, Caduet)
•
fluvastatin (Lescol, Lescol XL)
•
lovastatin (Altoprev, Mevacor, Advicor)
•
pitavastatin (Livalo)
•
pravastatin (Pravachol)
•
rosuvastatin (Crestor)
•
simvastatin (Zocor, Simcor, Vytorin)
Statins can cause muscle pain, tenderness or weakness, which may be
symptoms of a rare but serious
muscle condition called rhabdomyolysis. In some cases rhabdomyolysis
can cause kidney damage and
death. The risk of rhabdomyolysis may be higher when Trilipix is given
with statins. If you take a statin,
tell your healthcare provider.
Other medicines or large amounts of grapefruit juice (more than a
quart) may raise the levels of statins in
your body, and could then raise the risk of muscle problems. Tell your
healthcare provider if you are
taking any medicines listed below.
•
Heart medicine
•
Stomach medicine
•
Antibiotic
•
Anti-fungal
•
Cholesterol-lowering medicine
•
Hormones
•
HIV/AIDS medicine
•
Antidepressant
•
Immunosuppressant
•
Anti-seizure medicine
Ask your healthcare provider or pharmacist for a list of these
medicines, if you are not sure.
Tell your healthcare provider if you drink grapefruit juice.
What is Trilipix?
Trilipix is a prescription medicine used to treat cholesterol in the
blood by lowering the total amount of
triglycerides and LDL (bad) cholesterol, and increasing the HDL (good)
cholesterol. Trilipix has not been
shown to lower your risk of having heart problems or a stroke. You
should be on a low fat and low
ch

Produkta apraksts

TRILIPIX - FENOFIBRIC ACID CAPSULE, DELAYED RELEASE
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRILIPIX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRILIPIX.
TRILIPIX (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Trilipix is a peroxisome proliferator receptor alpha (PPARα)
activator indicated:
In combination with a statin to reduce TG and increase HDL-C in
patients with mixed dyslipidemia and CHD or a CHD
risk equivalent who are on optimal statin therapy to achieve their
LDL-C goal (1.1).
As monotherapy to reduce TG in patients with severe
hypertriglyceridemia (1.2).
As monotherapy to reduce elevated LDL-C, Total-C, TG and Apo B, and to
increase HDL-C in patients with primary
hyperlipidemia or mixed dyslipidemia (1.3).
Important Limitations of Use: No incremental benefit of Trilipix on
cardiovascular morbidity and mortality over and above
that demonstrated for statin monotherapy has been established.
Fenofibrate at a dose equivalent to 135 mg of Trilipix was
not shown to reduce coronary heart disease morbidity and mortality in
2 large, randomized controlled trials of patients with
type 2 diabetes mellitus.
DOSAGE AND ADMINISTRATION
Mixed dyslipidemia: 135 mg once daily (2.2).
Hypertriglyceridemia: 45 to 135 mg once daily (2.3).
Renally impaired patients: 45 mg once daily (2.5).
Maximum dose: 135 mg once daily (2.1).
May be taken without regard to food (2.1).
May be taken at the same time as a statin (2.2).
Co-administration with the maximum dose of a statin has not been
evaluated in clinical studies and should be avoided
unless the benefits are expected to outweigh the risks (2.2).
DOSAGE FORMS AND STRENGTHS
Oral Delayed Release Capsules: 45 mg and 135 mg (3).
CONTRAINDICATIONS
Severe renal dysfunction, including patients receiving dialysis (4,
12.3).
Active liver disease (4, 5.3).
Gallbladder disease (4, 5.4).
Nursing mothers (4, 8.3).
W