Fenbrat 300 (Fenbrat 300) helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).
Fenbrat 300 is used to treat high cholesterol and high triglyceride levels.
Fenbrat 300 may also be used for purposes not listed in this medication guide.
Fenbrat 300 indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Treatment of Severe Hypertriglyceridemia
Fenbrat 300 is indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Fenbrat 300 therapy on reducing this risk has not been adequately studied.
Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenbrat 300 is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Limitations of Use
Fenbrat 300 at a dose equivalent to 135 mg of Fenbrat 300 did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.
General Considerations for Treatment
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Fenbrat 300 therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
How should I use Fenbrat 300?
Use Fenbrat 300 capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Some brands of Fenbrat 300 capsules should be taken with food. Some brands may be taken with or without food. Ask your pharmacist if you should take your brand of Fenbrat 300 capsules with food.
Swallow Fenbrat 300 capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Fenbrat 300 capsules whole, tell your doctor. You may need a different medicine.
Take Fenbrat 300 capsules with a full glass of water (8 oz [240 mL]).
If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Fenbrat 300 capsules. Check with your doctor if you have any questions.
Take Fenbrat 300 capsules on a regular schedule to get the most benefit from it.
Taking Fenbrat 300 capsules at the same time each day will help you remember to take it.
Continue to take Fenbrat 300 capsules even if you feel well. Do not miss any doses.
If you miss a dose of Fenbrat 300 capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Fenbrat 300 capsules.
Uses of Fenbrat 300 in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Hypercholesterolemia or mixed dyslipidemia: Adjunctive therapy to diet for the reduction of 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 adults with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb). Use lipid-altering agents in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.
Note: While FDA-approved for hypercholesterolemia, Fenbrat 300 is not a first- or second-line choice; other agents may be more suitable (ACC/AHA [Stone 2013]). In addition, use is not recommended to lower LDL-C or raise HDL-C in the absence of hypertriglyceridemia.
Hypertriglyceridemia: Adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).
Off Label Uses
Primary biliary cholangitis
Data from a single-center, retrospective cohort study support the use of Fenbrat 300 (in combination with ursodiol) in patients with primary biliary cholangitis (PBC) who have had an incomplete biochemical response to ursodiol monotherapy and showed significant improvement in alkaline phosphatase, a reduction in hepatic decompensation, and transplant-free survival improvement.
Fenbrat 300 description
Each film-coated tablet contains Fenofibrate BP 160 mg. It also contains the following excipients: Pregelatinized starch maize, povidone, sodium lauryl sulphate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate, purified water and opadry AMB OY-B-28920.
Fenbrat 300 is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Fenbrat 300 is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Fenbrat 300 dosage
Patients should be placed on an appropriate lipid-lowering diet before receiving Fenbrat 300, and should continue this diet during treatment with Fenbrat 300. Fenbrat 300 capsules can be given without regard to meals.
Patients should be advised to swallow Fenbrat 300 capsules whole. Do not open, crush, dissolve or chew capsules.
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.
Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Fenbrat 300 if lipid levels fall significantly below the targeted range.
Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 90 mg once daily.
Primary Hypercholesterolemia And Mixed Dyslipidemia
The initial dose of Fenbrat 300 is 90 mg per day.
The initial dose is 30 to 90 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 90 mg per day.
Impaired Renal Function
Treatment with Fenbrat 300 should be initiated at a dose of 30 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Fenbrat 300 should be avoided in patients with severe renal impairment.
Dose selection for the elderly should be made on the basis of renal function.
Dosage Forms And Strengths
Fenbrat 300®(Fenbrat 300) capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.
Fenbrat 300®(Fenbrat 300) capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.
Storage And Handling
Fenbrat 300® (Fenbrat 300) Capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.
NDC 27437 -107 -06 30's Bottle
Fenbrat 300® (Fenbrat 300) Capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenbrat 300” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.
NDC 27437 -108 -06 30's Bottle
NDC 27437 -108 -09 90's Bottle
NDC 27437 -108 -01 100's Bottle
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) in a tightly closed container.
Manufactured for: Lupin Pharma, Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited, Goa -403 722 INDIA OR Lupin Limited, Pithampur (M.P.) -454 775 INDIA. Address Medical Inquiries to: Lupin Pharma Medical Inquiries, 111 South Calvert Street, 21Floor Baltimore, MD 21202 or Call: 1-800-399-2561. Revised: August 2015
Anticoagulants: Fenbrat 300 enhances oral anticoagulant effect and may increase risk of bleeding. Therefore, this combination is not recommended.
Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR.
Caution should be exercised when coumarin anticoagulants are given in conjunction with Fenbrat 300. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized.
Hydroxy methylglutaryl coenzyme A (HMG-CoA) Reductase Inhibitors (Statins): The combined use of Fenbrat 300 and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.
The risk of serious muscle toxicity is increased if Fenbrat 300 is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity.
Bile Acid Resins: Since bile acid sequestrants may bind other drugs given concurrently, patients should take Fenbrat 300 at least 1 hr before or 4-6 hrs after a bile acid binding resin to avoid impeding its absorption.
Immunosuppressants: Immunosuppressants eg, cyclosporine and tacrolimus can produce nephrotoxicity with decreases in CrCl and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including Fenbrat 300, there is a risk that an interaction will lead to deterioration. The benefits and risks of using Fenbrat 300 with immunosuppressants and other potentially nephrotoxic agents should be carefully considered and the lowest effective dose employed and renal function monitored.
Some severe cases of reversible renal function impairment have been reported during concomitant administration of Fenbrat 300 and cyclosporine. The renal function of these patients must therefore be closely monitored and the treatment with Fenbrat 300 stopped in the case of severe alteration of laboratory parameters.
Cytochrome P450 (CYP450) Enzymes:In vitro studies using human liver microsomes indicate that Fenbrat 300 and fenofibric acid are not inhibitors of CYP450 isoforms CYP3A4, CYP2D6, CYP2E1 or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6 and mild to moderate inhibitors of CYP2C9 at therapeutic concentrations. Patients co-administered Fenbrat 300 and CYP2C19, CYP2A6 and especially CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and if necessary, dose adjustment of these drugs is recommended.
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.
Fenofibric acid is the active metabolite of Fenbrat 300. Adverse events reported by 2% or more of patients treated with Fenbrat 300 and greater than placebo during double-blind, placebocontrolled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with Fenbrat 300 and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Fenbrat 300 treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Fenbrat 300 and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
BODY SYSTEM Adverse Event
(N = 439)
(N = 365)
BODY AS A WHOLE
Abnormal Liver Tests
Increased Creatine Phosphokinase
* Dosage equivalent to 135 mg Fenbrat 300
Clinical trials with Fenbrat 300 did not include a placebo-control arm. However, the adverse event profile of Fenbrat 300 was generally consistent with that of Fenbrat 300. The following adverse events not listed above were reported in ≥ 3% of patients taking Fenbrat 300 alone:
Gastrointestinal Disorders: Diarrhea, dyspepsia
General Disorders and Administration Site Conditions: Pain
Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity
Nervous System Disorders: Dizzinesss
The following adverse events have been identified during postapproval use of Fenbrat 300: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels.
Because these events 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.
Hypersensitivity to Fenbrat 300 or to any of the excipients of Fenbrat 300, Fenbrat 300 Supra 160 mg and Fenbrat 300 67M.
Patients with hepatic insufficiency (including biliary cirrhosis, and unexplained persistent liver function abnormality) and renal insufficiency.
Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia, gallbladder disease and severe chronic kidney disease.
Fenbrat 300/Fenbrat 300 Supra 160 mg:It should not be taken by patients allergic to peanut or arachis oil or soya/soybean lecithin or related products due to the risk of hypersensitivity reactions.
Use in pregnancy: Fenbrat 300/Fenbrat 300 67M: There are no adequate data from the use of Fenbrat 300 in pregnant woman. Animal studies have not demonstrated and teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity. The potential risk for humans is unknown. Therefore, film-coated tablet should only be used during pregnancy after a careful benefit/risk assessment.
Fenbrat 300 Supra 160 mg is contraindicated during pregnancy, in the absence of data. If unexpected pregnancy occurs while taking Fenbrat 300, treatment should be interrupted and consult a doctor.
Use in lactation: It is unknown whether Fenbrat 300 is excreted in human milk. A risk to the newborns/infants cannot be excluded. Fenbrat 300 Supra 160 mg is contraindicated during breastfeeding in the absence of data. Therefore, Fenbrat 300 should not be used during breastfeeding in nursing mother.
Use in children: Fenbrat 300 67M: The safety and efficacy of Fenbrat 300 in children have not yet been established. Only limited pediatric data are available. Therefore, the use of Fenbrat 300 is not recommended in pediatric subjects <18 years.
DailyMed. "FENOFIBRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology