FENOFIBRIC ACID capsule, delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

CHOLINE FENOFIBRATE (UNII: 4BMH7IZT98) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)

Доступна з:

A-S Medication Solutions

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (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 fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease

Огляд продуктів:

Product: 50090-4373 NDC: 50090-4373-0 90 CAPSULE, DELAYED RELEASE in a BOTTLE

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

FENOFIBRIC ACID- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE
A-S Medication Solutions
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MEDICATION GUIDE
Fenofibric Acid (fen-oh-FYE-brik AS-id)
Delayed-Release Capsules, 45 mg and 135 mg
Rx only
Read this Medication Guide before you start taking fenofibric acid
delayed-release capsules 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 Fenofibric
Acid Delayed-Release Capsules?
Fenofibric acid delayed-release capsules 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 Fenofibric acid
delayed-release capsules are given with statins. If you take a statin,
tell your healthcare provider.
What are Fenofibric Acid Delayed-Release Capsules?
Fenofibric acid delayed-release capsules are 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. Fenofibric acid delayed-release capsules have not been
shown to lower your risk of having
heart problems or a stroke. You should be on a low fat and low
cholesterol diet while you take fenofibric
acid delayed-release capsules.
The safety and effectiveness of fenofibric acid delayed-release
capsule in children is not known.
Who should not take Fenofibric Acid Delayed-Release Capsules?
Do not take fenofibric acid delayed-release capsules if you:
•
are allergic to fenofibric acid, or any of the ingredients in
fenofibric acid delayed-release capsules.
See the end of this Medication Guide for a list of all the ingredients
in fenofibric acid delayed-
release capsules.
•
have severe kidney disease
•
have liver disease
•
have gallbladder disease
•
are a nursing mother
Talk to

Характеристики продукта

FENOFIBRIC ACID- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRIC ACID
DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FENOFIBRIC ACID DELAYED-RELEASE CAPSULES.
FENOFIBRIC ACID DELAYED-RELEASE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity Reactions (5.9) 05/2018
INDICATIONS AND USAGE
Fenofibric acid delayed-release capsule is a peroxisome
proliferator-activated receptor (PPAR) alpha
agonist indicated as adjunctive therapy to diet to:
Reduce TG in patients with severe hypertriglyceridemia (1.1).
Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in
patients with primary
hypercholesterolemia or mixed dyslipidemia (1.2).
Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of
fenofibric acid delayed-release capsule
did not reduce coronary heart disease morbidity and mortality in
patients with type 2 diabetes mellitus
(5.1).
DOSAGE AND ADMINISTRATION
Hypertriglyceridemia: 45 to 135 mg once daily (2.2).
Primary hypercholesterolemia or mixed dyslipidemia: 135 mg once daily
(2.3).
Renally impaired patients: 45 mg once daily (2.4).
Maximum dose: 135 mg once daily (2.1).
May be taken without regard to food (2.1).
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, 5.5).
Nursing mothers (4, 8.2).
Known hypersensitivity to fenofibric acid or fenofibrate (4, 5.9)
WARNINGS AND PRECAUTIONS
Myopathy and rhabdomyolysis have been reported in patients taking
fenofibrate. Risks increased in
elderly patients and patients with diabetes, renal failure,
hypothyroidism, or statin co-administration
(5.2).
Fenofibric acid can increase serum transaminases. Liver tests should
be monitored periodica