Precautions
Each Fenofibrate 160 mg tablet contains lactose monohydrate 238.45mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. White to off-white oblong 15mm x 7mm tablet. 4. Clinical particulars
What are the excipients in fenofibrate 160 mg?
The melting point is 79 to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Each 67 mg Fenofibrate Capsules, USP contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone,...
What is the melting point of fenofibrate?
54 mg yellow, round shaped film coated tablet, debossed with “A388” on one side and plain on the other side. 160 mg white to off white, oval shaped, film coated tablet, debossed with “A389” on one side and plain on the other side. Fenofibrate Tablets is contraindicated in:
What does a fenofibrate tablet look like?
Fenofibrate oral tablet is available as brand-name drugs and as a generic drug. Brand names: Fenoglide, Tricor, and Triglide. Fenofibrate comes in two forms: oral tablet and oral capsule. Fenofibrate oral tablet is used to treat high cholesterol levels. It’s mainly used to treat severe high triglycerides (a type of bad cholesterol).
Is there a generic version of fenofibrate?
What is fenofibrate made of?
Fenofibrate is a fibrate derivative, a prodrug comprising fenofibric acid linked to an isopropyl ester.
Is fenofibrate a good cholesterol medicine?
Fenofibrate is used together with a proper diet to reduce and 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.
What can replace fenofibrate?
Vascepa.Lovaza.TriCor.Omega-3 polyunsaturated fatty acids.Trilipix.Lipofen.
Is fenofibrate safer than a statin?
Are fibrates safer than statins? Both fibrates and statins are safe medications. Statins are established to reduce the risk for cardiovascular disease, but this has not been consistently proven for fibrate medications. Fibrates may be mainly given to reduce the risk of pancreatitis.
What drugs should not be taken with fenofibrate?
Serious Interactions of fenofibrate include:atorvastatin.colchicine.fluvastatin.idelalisib.ivacaftor.lovastatin.pitavastatin.pravastatin.More items...
What are the most common side effects of fenofibrate?
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have bloating, sudden and severe stomach pain, chills, diarrhea, fast heartbeat, fever, indigestion. loss of appetite, nausea, pains in stomach, side, or abdomen, possibly radiating to the back, vomiting.
What is the safest drug to take for high cholesterol?
Fortunately, most side effects are mild and disappear promptly when the statin is stopped. In some cases, the problems will resolve simply by reducing the dose or switching to another statin, but care is required. Still, all in all, the statins are the safest and best tolerated of all cholesterol-lowering medications.
What is the best natural supplement to lower cholesterol?
What are the best supplements for lowering cholesterol?Phytosterols.Red yeast rice.Beta-glucans.Flaxseed.Omega-3 fatty acids.Psyllium.Green tea.Risks and side effects.More items...•
What happens if I stop taking fenofibrate?
Fenofibrate oral tablet is used for long-term treatment. It comes with risks if you don't take it as prescribed. If you stop taking the drug suddenly or don't take it at all: Your cholesterol levels may not be controlled. This raises your risk of serious health problems such as heart disease, heart attack, or stroke.
Who should not take fibrates?
Fibrates generally should be avoided in combination with statins since they can inhibit statin metabolism, causing an increased risk of myopathy. Recommendations are to always to measure serum creatinine levels and renal function before using the two drugs simultaneously.
Does fenofibrate raise blood pressure?
Fenofibrate reduces blood pressure, heart rate and renal vasoconstriction in salt-sensitive volunteers, but not in salt-resistant volunteers. These findings have implications for the treatment of hyperlipidemia in hypertensive individuals.
How long does it take for fenofibrate to lower triglycerides?
Keep taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick. It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months before you get the full benefit of this medication.
How safe is fenofibrate?
In general, fenofibrate can be considered a safe and well-tolerated lipid-lowering drug that has been scrutinized extensively for safety in clinical research and during an already long marketing period in Europe.
Does fenofibrate reduce belly fat?
Fenofibrate lowers abdominal and skeletal adiposity and improves insulin sensitivity in OLETF rats. Biochem Biophys Res Commun.
Does fenofibrate raise blood pressure?
Fenofibrate reduces blood pressure, heart rate and renal vasoconstriction in salt-sensitive volunteers, but not in salt-resistant volunteers. These findings have implications for the treatment of hyperlipidemia in hypertensive individuals.
Is it better to take fenofibrate in the morning or at night?
You can generally take fenofibrate at a time of day to suit you, but it is best to take your doses with the same meal each day. This will help remind you to take your tablets/capsules regularly. If you forget to take a dose, take it as soon as you remember.
How does fenofibrate work?from webmd.com
It works by increasing the natural substance ( enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as "fibrates.". Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease ( pancreatitis ).
Why is fenofibrate used in diet?from drugs.com
Fenofibrate is used along with a proper diet to help to treat high cholesterol and high triglyceride levels.
What other drugs will affect fenofibrate?from drugs.com
Some medicines can make fenofibrate much less effective when taken at the same time. If you take any of the following medicines, take your dose 1 hour before or 4 to 6 hours after you take the other medicine.
How long before taking fenofibrate before taking bile acid sequestrant?from healthline.com
Taking fenofibrate with certain cholesterol drugs called bile acid sequestrants may make it harder for your body to absorb fenofibrate. To prevent this, you should take fenofibrate 1 hour before taking the bile acid sequestrant, or 4–6 hours after taking it. Examples of bile acid sequestrants include:
What is micronized fenofibrate?from pubmed.ncbi.nlm.nih.gov
Micronized fenofibrate: a new fibric acid hypolipidemic agent. Fenofibrate reduces serum TG, total cholesterol, and LDL-C, and raises HDL-C to clinically relevant degrees. Its spectrum of activity appears to exceed that recommended for types IV and V hyperlipidemia to encompass types IIa, IIb, and III hyperlipidemias as well.
How to report fenofibrate side effects in Canada?from webmd.com
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before taking fenofibrate, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibric acid); or if you have any other allergies.
How old do you have to be to take fenofibrate?from drugs.com
Fenofibrate is not approved for use by anyone younger than 18 years old.
What is fenofibrate a derivative of?from en.wikipedia.org
Fenofibrate is a fibric acid derivative, a prodrug comprising fenofibric acid linked to an isopropyl ester. It lowers lipid levels by activating peroxisome proliferator-activated receptor alpha (PPARα). PPARα activates lipoprotein lipase and reduces apoprotein CIII, which increases lipolysis and elimination of triglyceride-rich particles from plasma.
What is fenofibrate sold under?from en.wikipedia.org
Fenofibrate is available in several formulations and is sold under several brand names, including Tricor by AbbVie, Lipofen by Kowa Pharmaceuticals America Inc, Lofibra by Teva, Lipanthyl, Lipidil, Lipantil micro and Supralip by Abbott Laboratories, Fenocor-67 by Ordain Health Care, Fibractiv 105/35 by Cogentrix Pharma ( India), Fenogal by SMB Laboratories, Antara by Oscient Pharmaceuticals, Tricheck by Zydus (CND), Atorva TG by Zydus Medica, Golip by GolgiUSA and Stanlip by Ranbaxy (India). Different formulations may differ in terms of pharmacokinetic properties, particularly bioavailability; some must be taken with meals, whereas others may be taken without regard to food.
What other drugs will affect fenofibrate?from drugs.com
Some medicines can make fenofibrate much less effective when taken at the same time. If you take any of the following medicines, take your dose 1 hour before or 4 to 6 hours after you take the other medicine.
How does fenofibrate work?from healthline.com
Fenofibrate works by increasing the breakdown and removal of bad cholesterol from your body. This helps reduce the risk of cholesterol building up in your blood vessels and causing serious health problems, such as heart attack or stroke.
What are the effects of fenofibrate on liver function?from ncbi.nlm.nih.gov
Fibrates such as fenofibrate activate peroxisome proliferator-activated receptors alpha (PPAR-alpha), which upregulate lipoprotein lipase, induce high-density lipoprotein (HDL) synthesis, and decrease liver production of apolipoprotein C. Fibrates ultimately enhance the clearance of triglyceride-rich particles and plasma catabolism. Fibrates also enhance fatty acid oxidation via acyl CoA synthetase and other enzymes, which further reduce the synthesis of triglycerides. The end result is an overall reduction of plasma triglyceride and very-low-density lipoprotein (VLDL) levels. The decrease in VLDL can cause plasma triglyceride levels to decrease by 30% to 60%. Fenofibrate may facilitate an increase in uric acid excretion and reduction of fibrinogen, which may help patients with gout and thrombosis.
What is the best way to manage fenofibrate?from ncbi.nlm.nih.gov
An interprofessional healthcare team including clinicians, mid-level practitioners (NPs and PAs), nurses, and pharmacists, is the optimal approach for managing fenofibrate. Medical professionals should be aware of the signs and symptoms that accompany fenofibrate toxicity. The involvement of other specialized professionals, including a nephrologist or toxicologist, should be considered to ensure an optimal patient result. Clinicians must counsel patients regarding any symptoms associated with liver damage (weakness, weight change, abdominal pain, jaundice). Interprofessional care coordination with open communication among team members will result in the best possible outcomes with the fewest adverse events. [Level 5]
How long does fenofibrate treatment last?from en.wikipedia.org
The large scale, international FIELD and ACCORD-Eye trials found that fenofibrate therapy reduced required laser treatment for diabetic retinopathy by 31%, as well as reducing progression by 3.7% over 4 years.
How much fenofibrate is in a tablet?from medicines.org.uk
Fenofibrate 160 mg is a tablet containing 160 mg of micronised fenofibrate and is suprabioavailable (larger bioavailability) compared to the previous formulations.
How does fenofibrate work?from webmd.com
Fenofibrate 160 mg Tablet works by increasing the natural lipid (fat) breakdown process with the help of an enzyme. This removes the bad cholesterol and triglycerides from your blood and increases the levels of good cholesterol.
What other drugs will affect fenofibrate?from drugs.com
Some medicines can make fenofibrate much less effective when taken at the same time. If you take any of the following medicines, take your dose 1 hour before or 4 to 6 hours after you take the other medicine.
What to do if you miss a fenofibrate dose?from practo.com
If you miss a dose of Fenofibrate 160 mg Tablet, take the missed dose as soon as you remember. If it is time for your next dose, skip the missed dose. Do not double your dose to make up for the missed dose.
What is fenofibrate 160 mg used for?from practo.com
Description. Fenofibrate 160 mg Tablet is used to decrease high cholesterol and triglycerides levels in the blood. It increases high-density lipoproteins (HDL) which reduce the risk of heart attacks. This medicine used along with a proper diet to control high cholesterol and triglyceride levels. This medicine should be used with caution in elderly ...
How long does it take for fenofibrate to be eliminated?from medicines.org.uk
The drug is excreted mainly in the urine. Practically all the drug is eliminated within 6 days. Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate. In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
Why is fenofibrate used in diet?from drugs.com
Fenofibrate is used along with a proper diet to help to treat high cholesterol and high triglyceride levels.
Why is fenofibrate used in diet?from drugs.com
Fenofibrate is used along with a proper diet to help to treat high cholesterol and high triglyceride levels.
What other drugs will affect fenofibrate?from drugs.com
Some medicines can make fenofibrate much less effective when taken at the same time. If you take any of the following medicines, take your dose 1 hour before or 4 to 6 hours after you take the other medicine.
How old do you have to be to take fenofibrate?from drugs.com
Fenofibrate is not approved for use by anyone younger than 18 years old.
Can you take fenofibrate if you are allergic to it?from drugs.com
You should not take fenofibrate if you are allergic to it, or if you have:
Can you share fenofibrate with children?from drugs.com
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use fenofibrate only for the indication prescribed.
Description
Fenofibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood.
May Treat: Hypercholesterolemia · Hyperlipidemia · Hypertriglyceridemia · Heterozygous familial hypercholesterolemia · High density lipoprotein deficiency and more
Brand Names: Tricor · Triglide · Fenoglide · Lipofen · Lofibra
Drug Class: Antihyperlipidemic - Fibric Acid Derivatives
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: This drug should not be given to breastfeeding mothers
- Not recommended when breast feeding
- Do not change brands without checking with Dr.
- Ask RPh if your brand is best taken with food.
- Not recommended when breast feeding
- Do not change brands without checking with Dr.
- Ask RPh if your brand is best taken with food.
- Report unexplained muscle pain, weakness, or fever
- May increase the risk of developing gallstones
- Lab tests may be ordered to monitor therapy
- Diet and exercise will improve therapy response
- May take 8 weeks for full benefit of therapy
Clinical significance
Mechanism of action
Chemistry
Pharmacology
- Fenofibrate Capsules, USP (micronized) is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg and 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: Each 67 ...
Side effects
- A variety of clinical studies have demonstrated that elevated levels of total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apo B), an LDL membrane complex, are associated with human atherosclerosis. Similarly, decreased levels of high density lipoprotein cholesterol (HDL-C) and its transport complex, apolipoprotein A (apo AI and apo AII) …
Synthesis
- The effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducin…
Society and culture
- Clinical experience has been obtained with two different formulations of fenofibrate: a \"micronized\" and \"non-micronized\" formulation, which have been demonstrated to be bioequivalent. Comparisons of blood levels following oral administration of both formulations in healthy volunteers demonstrate that a single capsule containing 67 mg of the \"micronized\" for…
Contraindications
- The absolute bioavailability of fenofibrate 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 dose of radiolabelled fenofibrate appeared in urine, primarily as fenofibric acid and its glu…
Interactions
- In healthy volunteers, steady-state plasma levels of fenofibric acid were shown to be achieved within 5 days of dosing with single oral doses equivalent to 67 mg fenofibrate and did not demonstrate accumulation across time following multiple dose administration. Serum protein binding was approximately 99% in normal and hyperlipidemic subjects.
Safety
- Fenofibric acid is primarily conjugated with glucuronic acid and then excreted in urine. A small amount of fenofibric acid is reduced at the carbonyl moiety to a benzhydrol metabolite which is, in turn, conjugated with glucuronic acid and excreted in urine.
Administration
- In elderly volunteers 77 to 87 years of age, the oral clearance of fenofibric acid 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.
Effects
- Fenofibrate has not been investigated in adequate and well-controlled trials in pediatric patients. No pharmacokinetic studies have been conducted in patients having hepatic insufficiency. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotei…
Results
- In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C8, CYP2C19 and CYP2A6, and mild-to-moderate inhibitors of CYP2C9 at therapeutic concentrations. Concomitant administration of a single dose of fenofibrate (adminis…
Research
- Bile acid sequestrants have been shown to bind other drugs given concurrently. Therefore, fenofibrate should be taken at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption. (See WARNINGS and PRECAUTIONS).
Medical uses
- Concomitant administration of fenofibrate (equivalent to fenofibrate 200 mg) once daily for 14 days with rosiglitazone tablet (rosiglitazone maleate) (8 mg) once daily for 5 days, Day 10 through Day 14, resulted in no significant changes in the pharmacokinetics of fenofibric acid and rosiglitazone when compared with the two drugs administered alone in healthy subjects.
Treatment
- The effects of fenofibrate at a dose equivalent to 200 mg fenofibrate per day were assessed from four randomized, placebo-controlled, double-blind, parallel-group studies including patients with the following mean baseline lipid values: total-C 306.9 mg/dL; LDL-C 213.8 mg/dL; HDL-C 52.3 mg/dL; and triglycerides 191.0 mg/dL. Fenofibrate therapy lowered LDL-C, total-C, and the LDL-C…
Prevention
- In a subset of the subjects, measurements of apo B were conducted. Fenofibrate treatment significantly reduced apo B from baseline to endpoint as compared with placebo (-25.1% vs. 2.4%, p<0.0001, n=213 and 143 respectively).