1.TRICOR HISTORY
How was Tricor discovered?

Tricor is a product of Abbott Laboratories.

The US FDA approved Tricor in September 2001.

Note: World-drugs.net sells generic version of Tricor

2.TRICOR FACTS

Abbott Laboratories was founded in 1888. It is a research based health care company that discovers, develops, manufactures and markets products that span the continuum of care from prevention and diagnosis to treatment and cure.

Chicago physician Dr. Wallace C. Abbott established Abbott Laboratories more than 100 years ago. It has emerged as one of the world's top health care companies. Today, Abbott discovers, develops, manufactures, and markets products and services that span the continuum of care from prevention and diagnosis, to treatment and cure. Abbott casts a keen focus on areas with the greatest unmet medical need, such as oncology, infectious diseases, diabetes, obesity, immunology and cardiovascular disease. 

3.ABOUT TRICOR MEDICATION

What is cholesterol and what does it have to do with heart disease?

Cholesterol is a waxy, fat-like material that is found in all parts of the body. It comes from two sources: the liver produces it, and we consume it in meat and dairy products.

Cholesterol is a chemical that can do both good and harm in the body. On the good side, Cholesterol plays important roles in the structure of cells and in the production of hormones. But too much Cholesterol in the blood can lead to heart and blood vessel disease. To complicate matters, not all Cholesterol contributes to heart and blood vessel problems.

One type, called high-density lipoprotein (HDL) cholesterol, or "good cholesterol," actually lowers the risk of these problems. High-density lipoproteins (HDL) remove Cholesterol from the bloodstream. The other type, low-density lipoprotein (LDL) cholesterol, or "bad cholesterol," is the type that threatens people's health. Low-density lipoproteins (LDL) deliver Cholesterol to the body. To travel through the bloodstream, Cholesterol must attach itself to a protein. The combination of a protein and a fatty substance like Cholesterol is called a lipoprotein.

Many factors may contribute to the fact that some people have higher Cholesterol levels than others. A diet high in certain types of fats is one factor. Medical problems such as poorly controlled diabetes, an under active thyroid gland, an overactive pituitary gland, liver disease or kidney failure also may cause high Cholesterol levels. And some people have inherited disorders that prevent their bodies from properly using and eliminating fats. This allows Cholesterol to build up in the blood.

Treatment for high Cholesterol levels usually begins with changes in habits. By losing weight, stopping smoking, exercising more and reducing the amount of fat and Cholesterol in the diet, many people can bring their Cholesterol levels down to acceptable levels. However, some may need to use Cholesterol-reducing drugs to reduce their risk of health problems.

While some Cholesterol is needed for good health, too much Cholesterol in your blood can raise your risk of having a heart attack or stroke.

The extra Cholesterol in your blood may be stored in your arteries (blood vessels) and cause them to narrow. (This is called atherosclerosis.) Large deposits of Cholesterol can completely block an artery, so the blood cannot flow through.

If an artery that supplies blood to your heart becomes blocked, a heart attack can occur. If an artery that supplies blood to your brain becomes blocked, a stroke can occur.

Cholesterol Levels:
Total cholesterol level

• Less than 200 is best.
• Between 200 to 239 is borderline high.
• 240 or more means you're at increased risk for heart disease.

LDL cholesterol levels

• Less than 130 is best.
• Between 130 to 159 is borderline high.
• 160 or more means you're at higher risk for heart disease.

HDL cholesterol levels

• Less than 40 means you're at higher risk for heart disease.
• 60 or higher reduces your risk of heart disease.

What are Cholesterol Lowering agents?

Cholesterol-reducing drugs are medicines that lower the amount of Cholesterol in the blood.

•  Bile acid sequestrants

They are drugs that act by binding with the bile produced by the liver. Bile helps the digestion and absorption of fats in the intestine. By blocking the digestion of fats, bile acid sequesterants prevent the formation of Cholesterol. Drugs in this class include:

• Cholestyramine,
• Colestipol, and
• Colesevelam.  

•  HMG-CoA inhibitors, often called "statins,"

They are drugs that block an enzyme called "3-hydroxy-3-methyl-glutaryl-coenzyme A reductase." This blocks one of the steps in converting fat to Cholesterol. These are the most effective Cholesterol lowering agents available and in recent years have received increased attention for their benefits beyond helping patients with high Cholesterol. In 2003, researchers reported that people with heart failure but no coronary artery disease received benefits after only 14 weeks of statin therapy. In addition, some research has connected the drugs to reduced risk for depression and dementia.

Drugs in this group include:

• Atorvastatin,
• Cerivastatin,
• Fluvastatin,
• Lovastatin,
• Pravastatin,
• Simvastatin, and
• Rosuvastatin
• Fibric acid derivatives

They include

• Clofibrate,
• Gemfibrozil, and
• Fenofibrate.

Although these drugs are less effective than the statins at lowering total Cholesterol, they may be able to lower the low-density lipoprotein (LDL) cholesterol while raising the high-density lipoprotein (HDL) cholesterol. They probably act by inhibiting lipoprotein lipase activity.

4. Niacin, or vitamin B-3, also is effective in lowering Cholesterol levels. Although the normal vitamin dose of niacin is only 20 mg, the dose required to reduce Cholesterol levels is at least 500 mg each day. Niacin probably helps reduce Cholesterol by inhibiting very low-density lipoprotein (VLDL) secretion in the bloodstream.  

How does Tricor work?
Tricor increases the breakdown of LDL cholesterol and other 'bad fats' in the blood called triglycerides. Tricor also increases the levels of HDL cholesterol. This results in lowered levels of 'bad fats' and raised levels of 'good fats'.

Tricor have an important role in the prevention of heart disease. They reduce the risk of fats being deposited in the major blood vessels of the heart. Any blockage in the blood vessels limits the amount of blood and therefore oxygen being carried to the heart muscle. In severe cases this can result in a heart attack (myocardial infarction).

Tricor is only used when blood lipid levels cannot be lowered by diet and exercise alone. It is important to follow a diet and exercise regime when taking Tricor.

.

4.TRICOR EFFECTIVENESS
When is Tricor best taken?

Plasma concentrations of Tricor after administration of three 48 mg or one 145 mg tablets are equivalent under fed conditions to one 200 mg capsule.

Absorption
The absolute bioavailability of Tricor cannot be determined as the compound is virtually insoluble in aqueous media suitable for injection. However, fenofibrate is well absorbed from the gastrointestinal tract. Following oral administration in healthy volunteers, approximately 60% of a single Tricor dose of radiolabelled fenofibrate appeared in urine, primarily as Tricor and its glucuronate conjugate, and 25% was excreted in the feces. Peak plasma levels of Tricor occur within 6 to 8 hours after administration.

Exposure to Tricor in plasma, as measured by Cmax and AUC, is not significantly different when a single 145 mg dose of Tricor is administered under fasting or nonfasting conditions.

Distribution
In healthy volunteers, steady-state plasma levels of Tricor were shown to be achieved within 5 days of dosing and did not demonstrate accumulation across time following multiple dose administration. Serum protein binding was approximately 99% in normal and hyperlipidemic subjects.

Metabolism
Following oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite, Tricor; no unchanged fenofibrate is detected in plasma

Tricor is primarily conjugated with glucuronic acid and then excreted in urine. A small amount of Tricor is reduced at the carbonyl moiety to a benzhydrol metabolite which is, in turn, conjugated with glucuronic acid and excreted in urine.

In vivo metabolism data indicate that neither fenofibrate nor fenofibric acid undergo oxidative metabolism (e.g.,cytochrome P450) to a significant extent.

Excretion
After absorption, Tricor is mainly excreted in the urine in the form of metabolites, primarily fenofibric acid and fenofibric acid glucuronide. After administration of radiolabelled fenofibrate, approximately 60% of the dose appeared in the urine and 25% was excreted in the feces.

Tricor is eliminated with a half-life of 20 hours, allowing once daily administration in a clinical setting. 

5.TRICOR EFFECTS ON SPECIAL POPULATION
(How do different people react to Tricor?

Geriatrics
In elderly volunteers 77 - 87 years of age, the oral clearance of Tricor following a single oral dose of fenofibrate was 1.2 L/h, which compares to 1.1 L/h in young adults. This indicates that a similar dosage regimen can be used in the elderly, without increasing accumulation of the drug or metabolites.

Pediatrics
Tricor has not been investigated in adequate and well-controlled trials in pediatric patients.

Gender
No pharmacokinetic difference between males and females has been observed for Tricor.

Race
The influence of race on the pharmacokinetics of fenofibrate has not been studied, however Tricor is not metabolized by enzymes known for exhibiting inter-ethnic variability. Therefore, inter-ethnic pharmacokinetic differences are very unlikely.

6.TRICOR EFFECTS ON MEDICAL CONDITIONS
(How does Tricor affect your existing condition/ailment?)

Renal insufficiency

In a study in patients with severe renal impairment (creatinine clearance < 50 mL/min), the rate of clearance of Tricor was greatly reduced, and the compound accumulated during chronic dosage. However, in patients having moderate renal impairment (creatinine clearance of 50 to 90 mL/min), the oral clearance and the oral volume of distribution of Tricor are increased compared to healthy adults (2.1 L/h and 95 L versus 1.1 L/h and 30 L, respectively). Therefore, the dosage of Tricor should be minimized in patients who have severe renal impairment, while no modification of dosage is required in patients having moderate renal impairment.

Hepatic insufficiency
No pharmacokinetic studies have been conducted in patients having hepatic insufficiency. 

7.OTHER/ALTERNATE USES OF TRICOR
(What else does Tricor treat?)

Tricor is used to reduce the amounts of LDL (bad) cholesterol, total Cholesterol, triglycerides (another type of fat), and apolipoprotein B (a protein needed to make Cholesterol) in your blood. Tricor is also used to increase the level of HDL (good) cholesterol in your blood. These actions are important in reducing the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.

8.ADVERSE/SIDE EFFECTS of TRICOR
(What are the side effects of Tricor?)

Adverse events reported by 2% or more of patients treated with fenofibrate during the double-blind, placebo-controlled trials, regardless of causality, are listed in the table below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of Tricor treatment in 1.6% of patients in double-blind trials.

BODY SYSTEM	TRICOR	Placebo
Adverse Event	(N=439)	(N=365)
BODY AS A WHOLE
Abdominal Pain	4.6%	4.4%
Back Pain	3.4%	2.5%
Headache	3.2%	2.7%
Asthenia	2.1%	3.0%
Flu Syndrome	2.1%	2.7%
DIGESTIVE
Liver Function Tests Abnormal	7.5%**	1.4%
Diarrhea	2.3%	4.1%
Nausea	2.3%	1.9%
Constipation	2.1%	1.4%
METABOLIC AND NUTRITIONAL DISORDERS
SGPT Increased	3.0%	1.6%
Creatine Phosphokinase Increased	3.0%	1.4%
SGOT Increased	3.4%**	0.5%
RESPIRATORY
Respiratory Disorder	6.2%	5.5%
Rhinitis	2.3%	1.1%

 

Additional adverse events reported by three or more patients in placebo-controlled trials or reported in other controlled or open trials, regardless of causality are listed below. 

BODY AS A WHOLE : Chest pain, pain (unspecified), infection, malaise, allergic reaction, cyst, hernia, fever, photosensitivity reaction, and accidental injury. 

CARDIOVASCULAR SYSTEM : Angina pectoris, hypertension, vasodilatation, coronary artery disorder, electrocardiogram abnormal, ventricular extrasystoles, myocardial infarct, peripheral vascular disorder, migraine, varicose vein, cardiovascular disorder, hypotension, palpitation, vascular disorder, arrhythmia, phlebitis, tachycardia, extrasystoles, and atrial fibrillation.

DIGESTIVE SYSTEM : Dyspepsia, flatulence, nausea, increased appetite, gastroenteritis, cholelithiasis, rectal disorder, esophagitis, gastritis, colitis, tooth disorder, vomiting, anorexia, gastrointestinal disorder, duodenal ulcer, nausea and vomiting, peptic ulcer, rectal hemorrhage, liver fatty deposit, cholecystitis, eructation, gamma glutamyl transpeptidase, and diarrhea.

ENDOCRINE SYSTEM : Diabetes mellitus

HEMIC AND LYMPHATIC SYSTEM : Anemia, leukopenia, ecchymosis, eosinophilia, lymphadenopathy, and thrombocytopenia.

METABOLIC AND NUTRITIONAL DISORDERS : Creatinine increased, weight gain, hypoglycemia, gout, weight loss, edema, hyperuricemia, and peripheral edema.

MUSCULOSKELETAL SYSTEM : Myositis, myalgia, arthralgia, arthritis, tenosynovitis, joint disorder, arthrosis, leg cramps, bursitis, and myasthenia.

NERVOUS SYSTEM : Dizziness, insomnia, depression, vertigo, libido decreased, anxiety, paresthesia, dry mouth, hypertonia, nervousness, neuralgia, and somnolence.

RESPIRATORY SYSTEM : Pharyngitis, bronchitis, cough increased, dyspnea, asthma, allergic pulmonary alveolitis, pneumonia, laryngitis, and sinusitis. 

SKIN AND APPENDAGES : Rash, pruritus, eczema, herpes zoster, urticaria, acne, sweating, fungal dermatitis, skin disorder, alopecia, contact dermatitis, herpes simplex, maculopapular rash, nail disorder, and skin ulcer.

SPECIAL SENSES : Conjunctivitis, eye disorder, amblyopia, ear pain, otitis media, abnormal vision, cataract specified, and refraction disorder.

UROGENITAL SYSTEM : Urinary frequency, prostatic disorder, dysuria, abnormal kidney function, urolithiasis, gynecomastia, unintended pregnancy, vaginal moniliasis, and cystitis.