TriCor

TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:

The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions.

Inactive Ingredients

Each tablet contains colloidal silicon dioxide, crospovidone, lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. In addition, 54 mg individual tablets contain: D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue No. 2.

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adverse events reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1 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 fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 1. Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, asthenia, and severely depressed HDL-cholesterol levels. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Using fenofibrate with certain other medicines can affect the way these medicines work and other medicines may affect how fenofibrate works. In some cases, using fenofibrate with other medicines can cause serious side effects.

It is especially important to tell your healthcare provider if you take:

• heart medicine
• anticoagulants, also known as blood thinners such as warfarin (Coumadin, Jantoven)
• bile acid resins

Fenofibrate can be used with other cholesterol-lowering medicines called statins. 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:

• heart medicine
• stomach medicine
• antibiotic
• anti-fungal
• cholesterol-lowering medicine
• hormones
• HIV/AIDS medicine
• antidepressant
• immunosuppressant
• anti-seizure medicine

This is not a complete list of fenofibrate drug interactions. Ask your doctor or pharmacist for more information.

• You should be on a low fat and low cholesterol diet while you take fenofibrate.
• Take fenofibrate one time each day as prescribed by your healthcare provider.
• Take fenofibrate with or without food.
• Swallow fenofibrate capsules whole. Do not break, crush, dissolve, or chew fenofibrate capsules before swallowing. If you cannot swallow the capsules whole, tell your healthcare provider, you may need a different medicine.
• If you take a medicine called a statin, you can take fenofibrate and your statin at the same time of day.
• If you miss a dose of fenofibrate, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. If you are not sure about your dosing, call your healthcare provider. Do not take more than one dose of fenofibrate a day unless your healthcare provider tells you to.
• If you take too much fenofibrate, contact your healthcare provider or your local emergency department.
• Do not change your dose or stop fenofibrate unless your healthcare provider tells you to.
• Your healthcare provider may do blood tests before you start taking fenofibrate and during treatment. See your healthcare provider regularly to check your cholesterol and triglyceride levels and to check for side effects.

This section provides information on the proper use of a number of products that contain fenofibrate. It may not be specific to Tricor. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.

This medicine is usually taken once a day. Take the medicine at the same time each day to maintain the medication's effect.

Fenoglide®, Lipofen®, Lofibra™, and Tricor® should be taken with a meal. Antara® and Triglide® can be taken with or without a meal.

Swallow Antara® capsules, Tricor® tablets, or Triglide® tablets whole. Do not open, crush, break, chew, or dissolve them. Do not take chipped or broken Triglide® tablets.

If you are also using cholestyramine, colesevelam, or colestipol, you must take Triglide® at least 1 hour before or 4 to 6 hours after you take these medicines.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For high cholesterol:
    • Adults—
      • Antara®: At first, 130 milligrams (mg) once a day with a meal.
      • Lipofen®: At first, 150 mg once a day with a meal. Your doctor may adjust your dose as needed.
      • Lofibra™: 200 mg once a day with a meal.
    • Children—Use and dose must be determined by your doctor.
  • For high triglycerides or fats:
    • Adults—
      • Antara®: At first, 43 to 130 milligrams (mg) once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 130 mg per day.
      • Lipofen®: At first, 50 to 150 mg once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day.
      • Lofibra™: At first, 67 mg once a day with a meal. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.

• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults—
      • Fenoglide®: At first, 120 milligrams (mg) per day. Your doctor may adjust your dose as needed.
      • Tricor®: At first, 160 mg once a day. Your doctor may adjust your dose as needed.
      • Triglide®: 160 mg once a day.
    • Children—Use and dose must be determined by your doctor.
  • For high triglycerides or fats:
    • Adults—
      • Fenoglide®: At first, 40 to 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day.
      • Tricor®: At first, 54 to 160 mg once a day. Your doctor may adjust your dose as needed.
      • Triglide®: 160 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep Triglide® tablets in its original container. Protect from heat, light, and moisture.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy.

Check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain with nausea and vomiting.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, or loose skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Check with your doctor right away if you have signs of a fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts, which may be caused by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Some brands of Tricor are to be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you need to take your brand with food.
• If you have trouble swallowing, talk with your doctor.
• Take with a full glass of water.
• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Swallow whole. Do not chew, break, or crush.
• Do not take chipped or broken tablets.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Do not take more than 1 dose in the same day, unless your doctor tells you to.

Primary Hypercholesterolemia or Mixed Dyslipidemia

Tricor is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Severe Hypertriglyceridemia

Tricor is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Important Limitations of Use

Fenofibrate at a dose equivalent to 145 mg of Tricor was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].

Tricor (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:

The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions.

Inactive Ingredients

Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate.

In addition, individual tablets contain:

48 mg tablets

polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake.

145 mg tablets

polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.

Applies to fenofibrate: oral capsule, oral tablet

Along with its needed effects, fenofibrate (the active ingredient contained in TriCor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fenofibrate:

• Chills or fever
• hives, itching, or skin rash
• muscle aches and pains
• nausea or vomiting

• Chronic indigestion
• dark urine
• muscle cramps, pain, stiffness, swelling, or weakness
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness
• yellow eyes or skin

• Agitation
• bloating
• bloody urine
• decreased frequency or amount of urine
• lower back or side pain
• pains in the stomach, side, or abdomen, possibly radiating to the back
• swelling of the face, fingers, or lower legs
• swollen joints
• upper right abdominal or stomach pain

Some side effects of fenofibrate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Runny nose
• sneezing
• stuffy nose

• Back pain
• diarrhea
• eye irritation
• gas
• increased sensitivity of the skin to sunlight

• Lack or loss of strength

You should not use fenofibrate if you are allergic to it, or if you have:

• liver disease;

• severe kidney disease (or if you are on dialysis);

• gallbladder disease; or

• if you are breast-feeding a baby.

To make sure fenofibrate is safe for you, tell your doctor if you have:

• kidney disease;

• diabetes;

• heart disease;

• a thyroid disorder; or

• a history of pancreatitis or liver disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Fenofibrate can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking fenofibrate.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.