Fenobrat 250 mg retard Uses

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What is Fenobrat 250 mg retard?

Fenobrat 250 mg retard (Fenobrat 250 mg retard) 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).

Fenobrat 250 mg retard is used to treat high cholesterol and high triglyceride levels.

Fenobrat 250 mg retard may also be used for purposes not listed in this medication guide.

Fenobrat 250 mg retard 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.
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Treatment of Severe Hypertriglyceridemia

Fenobrat 250 mg retard 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 Fenobrat 250 mg retard therapy on reducing this risk has not been adequately studied.

Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia

Fenobrat 250 mg retard 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

​ Fenobrat 250 mg retard at a dose equivalent to 135 mg of Fenobrat 250 mg retard 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 Fenobrat 250 mg retard 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 Fenobrat 250 mg retard?

Use Fenobrat 250 mg retard capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Some brands of Fenobrat 250 mg retard 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 Fenobrat 250 mg retard capsules with food.
  • Swallow Fenobrat 250 mg retard capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Fenobrat 250 mg retard capsules whole, tell your doctor. You may need a different medicine.
  • Take Fenobrat 250 mg retard 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 Fenobrat 250 mg retard capsules. Check with your doctor if you have any questions.
  • Take Fenobrat 250 mg retard capsules on a regular schedule to get the most benefit from it.
  • Taking Fenobrat 250 mg retard capsules at the same time each day will help you remember to take it.
  • Continue to take Fenobrat 250 mg retard capsules even if you feel well. Do not miss any doses.
  • If you miss a dose of Fenobrat 250 mg retard 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 Fenobrat 250 mg retard capsules.

Uses of Fenobrat 250 mg retard 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.
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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, Fenobrat 250 mg retard 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 Fenobrat 250 mg retard (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.

Fenobrat 250 mg retard description

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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.

Fenobrat 250 mg retard is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Fenobrat 250 mg retard is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.

Fenobrat 250 mg retard dosage

General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving Fenobrat 250 mg retard, and should continue this diet during treatment with Fenobrat 250 mg retard. Fenobrat 250 mg retard capsules can be given without regard to meals.

Patients should be advised to swallow Fenobrat 250 mg retard 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 Fenobrat 250 mg retard 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 Fenobrat 250 mg retard is 90 mg per day.

Severe Hypertriglyceridemia

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 Fenobrat 250 mg retard 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 Fenobrat 250 mg retard should be avoided in patients with severe renal impairment.

Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function.

How supplied

Dosage Forms And Strengths

  • Fenobrat 250 mg retard®(Fenobrat 250 mg retard) capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenobrat 250 mg retard” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.
  • Fenobrat 250 mg retard®(Fenobrat 250 mg retard) capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenobrat 250 mg retard” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.

Storage And Handling

Fenobrat 250 mg retard® (Fenobrat 250 mg retard) Capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “Fenobrat 250 mg retard” 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

Fenobrat 250 mg retard® (Fenobrat 250 mg retard) Capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “Fenobrat 250 mg retard” 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

Storage

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

Fenobrat 250 mg retard interactions

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What other drugs will affect Fenobrat 250 mg retard?

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Anticoagulants: Fenobrat 250 mg retard 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 Fenobrat 250 mg retard. 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 Fenobrat 250 mg retard 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 Fenobrat 250 mg retard 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 Fenobrat 250 mg retard 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 Fenobrat 250 mg retard, there is a risk that an interaction will lead to deterioration. The benefits and risks of using Fenobrat 250 mg retard 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 Fenobrat 250 mg retard and cyclosporine. The renal function of these patients must therefore be closely monitored and the treatment with Fenobrat 250 mg retard stopped in the case of severe alteration of laboratory parameters.

Cytochrome P450 (CYP450) Enzymes: In vitro studies using human liver microsomes indicate that Fenobrat 250 mg retard 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 Fenobrat 250 mg retard 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.

Fenobrat 250 mg retard side effects

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What are the possible side effects of Fenobrat 250 mg retard?

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.

Fenofibric acid is the active metabolite of Fenobrat 250 mg retard. Adverse events reported by 2% or more of patients treated with Fenobrat 250 mg retard 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 Fenobrat 250 mg retard and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Fenobrat 250 mg retard treatment in 1.6% of patients in double-blind trials.

Table 1: Adverse Events Reported by 2% or More of Patients Treated with Fenobrat 250 mg retard and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM Adverse Event Fenobrat 250 mg retard*

(N = 439)

Placebo

(N = 365)

BODY AS A WHOLE
Abdominal Pain 4.6% 4.4%
Back Pain 3.4% 2.5%
Headache 3.2% 2.7%
DIGESTIVE
Nausea 2.3% 1.9%
Constipation 2.1% 1.4%
INVESTIGATIONS
Abnormal Liver Tests 7.5% 1.4%
Increased AST 3.4% 0.5%
Increased ALT 3.0% 1.6%
Increased Creatine Phosphokinase 3.0% 1.4%
RESPIRATORY
Respiratory Disorder 6.2% 5.5%
Rhinitis 2.3% 1.1%
* Dosage equivalent to 135 mg Fenobrat 250 mg retard

Clinical trials with Fenobrat 250 mg retard did not include a placebo-control arm. However, the adverse event profile of Fenobrat 250 mg retard was generally consistent with that of Fenobrat 250 mg retard. The following adverse events not listed above were reported in ≥ 3% of patients taking Fenobrat 250 mg retard 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

Postmarketing Experience

The following adverse events have been identified during postapproval use of Fenobrat 250 mg retard: 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.

Fenobrat 250 mg retard contraindications

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What is the most important information I should know about Fenobrat 250 mg retard?

Hypersensitivity to Fenobrat 250 mg retard or to any of the excipients of Fenobrat 250 mg retard, Fenobrat 250 mg retard Supra 160 mg and Fenobrat 250 mg retard 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.

Fenobrat 250 mg retard/Fenobrat 250 mg retard 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: Fenobrat 250 mg retard/Fenobrat 250 mg retard 67M: There are no adequate data from the use of Fenobrat 250 mg retard 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.

Fenobrat 250 mg retard Supra 160 mg is contraindicated during pregnancy, in the absence of data. If unexpected pregnancy occurs while taking Fenobrat 250 mg retard, treatment should be interrupted and consult a doctor.

Use in lactation: It is unknown whether Fenobrat 250 mg retard is excreted in human milk. A risk to the newborns/infants cannot be excluded. Fenobrat 250 mg retard Supra 160 mg is contraindicated during breastfeeding in the absence of data. Therefore, Fenobrat 250 mg retard should not be used during breastfeeding in nursing mother.

Use in children: Fenobrat 250 mg retard 67M: The safety and efficacy of Fenobrat 250 mg retard in children have not yet been established. Only limited pediatric data are available. Therefore, the use of Fenobrat 250 mg retard is not recommended in pediatric subjects <18 years.



Active ingredient matches for Fenobrat 250 mg retard:

Fenofibrate in Hungary.


List of Fenobrat 250 mg retard substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Fenocard 40mg Tablet (Avinash Health Products Pvt Ltd)$ 0.08
FENOCARD 20MG TABLET 1 strip / 10 tablets each (Avinash Health Products Pvt Ltd)$ 0.44
FENOCARD 40MG TABLET 1 strip / 10 tablets each (Avinash Health Products Pvt Ltd)$ 0.79
FENOCARD H TABLET 1 strip / 10 tablets each (Avinash Health Products Pvt Ltd)$ 0.95
Fenocor 67mg CAP / 10 (Ordain Health Care (P) Ltd.)$ 0.79
Fenocor 200mg CAP / 10 (Ordain Health Care (P) Ltd.)$ 3.17
67 mg x 10's (Ordain Health Care (P) Ltd.)$ 0.79
200 mg x 10's (Ordain Health Care (P) Ltd.)$ 3.17
Fenocor 67 mg Capsule (Ordain Health Care (P) Ltd.)$ 0.08
Fenocor 200 mg Capsule (Ordain Health Care (P) Ltd.)$ 0.32
FENOCOR 105 MG TABLET 1 strip / 10 tablets each (Ordain Health Care (P) Ltd.)$ 2.36
FENOCOR 200 MG CAPSULE 1 strip / 10 capsules each (Ordain Health Care (P) Ltd.)$ 2.29
FENOCOR 35 MG TABLET 1 strip / 10 tablets each (Ordain Health Care (P) Ltd.)$ 1.31
FENOCOR 67 MG CAPSULE 1 strip / 10 capsules each (Ordain Health Care (P) Ltd.)$ 1.30
FENOCOR 67 MG TABLET 1 strip / 20 tablets each (Ordain Health Care (P) Ltd.)$ 3.35
FENOCOR cap 67 mg x 10's (Ordain Health Care (P) Ltd.)$ 0.79
FENOCOR cap 200 mg x 10's (Ordain Health Care (P) Ltd.)$ 3.17
Fenocor 105mg Tablet (Ordain Health Care (P) Ltd.)$ 0.29
Fenocor 200mg Capsule (Ordain Health Care (P) Ltd.)$ 0.23
Fenocor 35mg Tablet (Ordain Health Care (P) Ltd.)$ 0.14
Fenocor 67mg Capsule (Ordain Health Care (P) Ltd.)$ 0.14
FENODAC 135 MG CAPSULE 1 strip / 10 capsules each (Cadila)$ 1.90
FENODAC suscap 45 mg x 10's (Cadila)$ 6.60
FENODAC suscap 135 mg x 10's (Cadila)$ 1.73
Fenodac 135mg Capsule (Cadila)$ 0.19
Fenof 200 200 mg x 20's$ 11.11
Capsule, Retard; Oral; Fenofibrate 250 mg (Juta)
Capsule, Retard; Oral; Fenofibrate 250 mg
Fenofib 100 mg x 5 Blister x 4 Tablet
Fenofib 100 mg x 5 Blister x 6 Tablet
Fenofib 100 mg x 7 Blister x 4 Tablet
Fenofib 200 mg x 5 Blister x 4 Tablet
Fenofib 200 mg x 4 Blister x 7 Tablet
Fenofib 300 mg x 5 Blister x 4 Tablet
Fenofib 300 mg x 5 Blister x 6 Tablet
Fenofib 300 mg x 7 Blister x 4 Tablet

References

  1. 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).
  2. PubChem. "fenofibrate". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "fenofibrate". http://www.drugbank.ca/drugs/DB01039 (accessed September 17, 2018).

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