Triglide

Name: Triglide

Commonly used brand name(s)

In the U.S.

  • Antara
  • Fenoglide
  • Lipofen
  • Lofibra
  • Tricor
  • Triglide

Available Dosage Forms:

  • Tablet
  • Capsule

Therapeutic Class: Antihyperlipidemic

Chemical Class: Fibric Acid

Uses For Triglide

Fenofibrate is used together with a proper diet to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood.

This medicine is available only with your doctor's prescription.

Proper Use of fenofibrate

This section provides information on the proper use of a number of products that contain fenofibrate. It may not be specific to Triglide. 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.

Contraindications

Triglide is contraindicated in:

  • Patients with severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3)].
  • Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warning and Precautions (5.3)].
  • Patients with preexisting gallbladder disease [see Warning and Precautions (5.5)].
  • Patients who have a known hypersensitivity to fenofibrate or fenofibric acid [see Warning and Precautions (5.9)].
  • Nursing mothers [see Use in Specific Populations (8.3)].

Overdosage

There is no specific treatment for overdose with Triglide. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

PRINCIPAL DISPLAY PANEL - 160 mg Tablet Bottle Carton

NDC: 70199-013-30

160 mg

Each tablet contains
160 mg fenofibrate

Triglide®
(fenofibrate) tablets
160 mg

Store tablets only
in the moisture
protective container.

30 Tablets

Rx Only

Triglide 
fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70199-013
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 160 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
LACTOSE MONOHYDRATE  
MANNITOL  
MALTODEXTRIN  
CARBOXYMETHYLCELLULOSE  
EGG PHOSPHOLIPIDS  
CROSCARMELLOSE SODIUM  
SODIUM LAURYL SULFATE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
SODIUM PHOSPHATE, MONOBASIC  
Product Characteristics
Color WHITE (Off White) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code FH;160
Contains     
Packaging
# Item Code Package Description
1 NDC:70199-013-30 1 BOTTLE in 1 CARTON
1 30 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021350 02/01/2017
Labeler - Casper Pharma LLC (080025838)
Establishment
Name Address ID/FEI Operations
SkyePharma Production SAS 383630456 ANALYSIS(70199-013), LABEL(70199-013), MANUFACTURE(70199-013)
Revised: 01/2017   Casper Pharma LLC

What is the most important information I should know about Triglide (fenofibrate)?

You should not use fenofibrate if you have liver disease, gallbladder disease, severe kidney disease, or if you are on dialysis.

Do not breast-feed while taking fenofibrate.

How should I take Triglide (fenofibrate)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Some brands of fenofibrate should be taken with meals to help your body better absorb the medicine. Other brands may be taken with or without food. Follow the directions on your medicine label.

Use fenofibrate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not crush, break, or dissolve the fenofibrate capsule or tablet. Swallow it whole.

If you also take cholestyramine, colesevelam, colestipol: these other medicines should be taken at least 1 hour after or 4 hours before you take fenofibrate.

Fenofibrate is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

While using fenofibrate, you may need frequent blood tests. Your liver and gallbladder function may also need to be checked.

Store at room temperature away from moisture, heat, and light. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

What happens if I overdose?

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

What should I avoid while taking Triglide (fenofibrate)?

If you also take cholestyramine, colesevelam, or colestipol: Wait 4 to 6 hours after taking any of these other medicines before you take fenofibrate. Avoid taking fenofibrate within 1 hour before taking the other medicine.

Avoid drinking alcohol. It can raise triglyceride levels, and may also damage your liver while you are taking fenofibrate.

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