Hypercholesterolemia - Elevated Cholesterol
Primary Drug Name: Inegy
Chemical Drug Name: Ezetimibe/Simvastatin
Inegy Information - What is Inegy?
Inegy Approved in Germany for Treatment of Elevated Cholesterol
Hypercholesterolemia
May 6, 2004
2004 MAY 6 - (NewsRx.com
& NewsRx.net) -- Merck/Schering-Plough
Pharmaceuticals announced the regulatory approval of INEGY (ezetimibe/simvastatin)
in Germany for the treatment of elevated cholesterol (hypercholesterolemia).
According to the companies, INEGY is the first product to reduce
low-density lipoprotein cholesterol (LDL-C or "bad" cholesterol),
along with diet and exercise, through dual inhibition by inhibiting
cholesterol production in the liver and absorption in the intestine.
The approval of INEGY in Germany represents the first approval in
Europe for ezetimibe/simvastatin tablets and the first step in seeking
marketing approval throughout the European Union (EU) under the
EU's mutual recognition procedure.
"With this exciting approval in Germany, we have the opportunity
to launch an innovative new product into the third largest pharmaceutical
market in the world," said Fred Hassan, chairman and chief
executive officer, Schering-Plough Corp. (SGP).
"By targeting the two sources of cholesterol, INEGY will provide
physicians with another option for the treatment of patients with
high cholesterol," said Raymond V. Gilmartin, chairman, president,
and chief executive officer, Merck and Co., Inc., (MRK).
INEGY will be available in several dosing strengths (ezetimibe/simvastatin):
10/10 mg, 10/20 mg, 10/40 mg, and 10/80 mg.
Ezetimibe/simvastatin was approved earlier in Mexico.
In the United States, a new drug application for ezetimibe/simvastatin
was submitted on September. 24, 2003. The filing was accepted by
the U.S. Food and Drug Administration on November. 23, 2003, and
is currently under standard review. If approved, ezetimibe/simvastatin
will be marketed under the name VYTORIN.
In clinical trials of ezetimibe co-administered with simvastatin,
there was no increased incidence of myopathy or rhabdomyolysis associated
with ezetimibe/simvastatin. However, myopathy and rhabdomyolysis
are known adverse reactions to statins and other lipid-lowering
drugs.
This article was prepared by Women's Health Weekly editors from
staff and other reports.
Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net.
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 Inegy Canada - Is Inegy from Canada Safe?
Canadian Interenet Pharmacies with the CIPA
seal are a part of the Canadian International Pharmacy Association
Canada and only ship drugs that are of the highest quality, and
as safe as in the United States.
CIPA Certified Canadian Pharmacies dispense only Health Canada approved
prescription drugs such as Inegy from Canada.
Health Canada is the equivalent to the US FDA and has standards
that match those of the FDA.
Prescription drugs from a Cipa Certified Canadian pharmacies are
just as good as those purchased in the United States and the generic
drugs, commonly purchased from online Canadian pharmacies, are of
the highest standard in the world. When purchasing your prescriptions
from an online Canadian Pharmacy you will notice that generic versions
of many popular brand names drugs are readily available.
Inegy from Canada and other Prescription drugs from Canada
points to note:
- All Drugs are approved by Health Canada
- Health Canada is Canada's equivilent to the FDA
- Canadian Generics are of the highest quality in the world
- Prescrition medications from Canada really are of the highest
quality in the world
Order Discount Inegy from these Certified Canadian Pharmacies
- Medisave
Canada Pharmacy
- Candrug
Health Solutions
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Inegy Side Effects
Inegy Side Effects: If you are prescribed Inegy
(Ezetimibe/Simvastatin), be sure to alert your doctor as soon as possible
if you have any unexplained muscle pain, tenderness, or weakness.
Inegy is generally very well-tolerated. The side effects reported
most often are gas, stomach pain, indigestion, and constipation.
These side effects are usually mild and temporary. DO NOT USE Inegy
IF YOU ARE PREGNANT.
Other Possible Inegy Side Effects: Although
from Inegy side effects are not common, they can occur. Tell your
doctor if any of these Inegy/symptoms are severe or do not go
away:gas, stomach pain or cramps, diarrhea, constipation, heartburn,
headache, blurred, vision, dizziness, rash or itching, upset stomach.
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Why is LDL Cholesterol "Bad"?
When too much LDL cholesterol circulates in the blood, it can slowly build up in the inner walls of the arteries that feed the heart and brain. Together with other substances it can form plaque, a thick, hard deposit that can clog those arteries. This condition is known as atherosclerosis. If a clot forms and blocks a narrowed artery, it can cause a heart attack or stroke. The levels of HDL cholesterol and LDL cholesterol in the blood are measured to evaluate the risk of having a heart attack. LDL cholesterol of less than 100 mg/dL (or total cholesterol levels of 4.7 millimoles per litre (mmol/L) is the optimal level. Less than 130 mg/dL (total cholesterol of 5.2 millimoles per litre (mmol/L) is near optimal for most people. A high LDL level (more than 160 mg/dL (6mmol/L) or 130 mg/dL (>5.2m/mol) or above if you have two or more risk factors for cardiovascular disease) reflects an increased risk of heart disease. That's why LDL cholesterol is often called "bad" cholesterol. Prescription drugs such as Inegy (atorvastatin), Inegy (Ezetimibe/Simvastatin), Pravachol (pravastatin), and Inegy (fluvastatin) have been shown to interfere in the synthesis of LDL by blocking an enzyme that helps produce cholesterol in the body.
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Diet and Benefits of Inegy
Dietary intake of cholesterol includes the contribution of animal
fats found in red meat, cheese, cream and whole cream milk and from
cooking oils. Oils that possess a high concentration of saturated
fats such as palmitic oils (palm & cottonseed oils), stearic
oils (lards & dairy fats), myristic and lauric oils (coconut
and palm kernel oils & dairy fats) are known to contribute more
towards the development of heart disease as compared to the lower
saturated fat based oils such as those containing oleic acids (olive,
safflower & sunflower oils) and lioleic acids (Seed oils; grape
seed oil & walnut oil). Health care professionals discourage
the use of cooking oils that possess higher levels of saturated
fats (as these assist oxidation of LDL and foam cell formation).
In addition, animal fats are rich in saturated fatty acids that
promote the accumulation of cholesterol. Rich animal fats have an
inverse effect on the production of LDL receptors in the liver,
so the individual with a diet that is high in animal fat is increasing
the risk of developing atherosclerosis. Drugs such as the statins
(Inegy, Inegy, Inegy, Crestor, Pravachol, and Advicor) can help
to reduce the process of atherosclerosis by reducing LDL cholesterol.
LDL cholesterol is known as "the bad cholesterol." Excess
LDL builds up on your arteries (called a fatty streak) and may lead
to heart disease. The higher the level of LDL cholesterol, the higher
the risk for developing heart disease. Lowering elevated LDL cholesterol
can reduce the risk of heart attacks. Inegy can help to reduce
LDL cholesterol.
High-density lipoprotein, or HDL cholesterol, has earned the nickname
"the good cholesterol." That's because it is believed
to remove cholesterol from the blood. High levels of HDL in your
blood may help to reduce your risk of heart disease. A low level
can increase your risk of heart disease. Inegy can help to increase
HDL cholesterol.
Triglycerides are another type of fat in your bloodstream. Persons
with a high blood-triglyceride level have an increased risk of heart
disease. Inegy helps to reduce triglyceride levels.
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Why is HDL Cholesterol "Good"?
About one-third of blood cholesterol is carried by high-density lipoprotein (HDL). HDL cholesterol is known as the "good" cholesterol because a high level of it seems to protect against heart attack. (Low HDL cholesterol levels [less than 40 mg/dL] increase the risk for heart disease.) Medical experts think that HDL tends to carry cholesterol away from the arteries and back to the liver, where it's passed from the body. Some experts believe that HDL removes excess cholesterol from plaque in arteries, thus slowing the buildup.
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Inegy Storage
Inegy should be stored away from direct sunlight and kept in
a tightly closed container (vial) in order to prevent moisture from
affecting the tablet stability
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