Fenofibrat Stada (Fenofibrat Stada) 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).
Fenofibrat Stada is used to treat high cholesterol and high triglyceride levels.
Fenofibrat Stada may also be used for purposes not listed in this medication guide.
Fenofibrat Stada 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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Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrat Stada Capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
Severe Hypertriglyceridemia
Fenofibrat Stada Capsules are 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 Fenofibrat Stada therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Fenofibrat Stada at a dose equivalent to 150 mg was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.
How should I use Fenofibrat Stada?
Use Fenofibrat Stada capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Some brands of Fenofibrat Stada 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 Fenofibrat Stada capsules with food.
Swallow Fenofibrat Stada capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Fenofibrat Stada capsules whole, tell your doctor. You may need a different medicine.
Take Fenofibrat Stada 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 Fenofibrat Stada capsules. Check with your doctor if you have any questions.
Take Fenofibrat Stada capsules on a regular schedule to get the most benefit from it.
Taking Fenofibrat Stada capsules at the same time each day will help you remember to take it.
Continue to take Fenofibrat Stada capsules even if you feel well. Do not miss any doses.
If you miss a dose of Fenofibrat Stada 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 Fenofibrat Stada capsules.
Uses of Fenofibrat Stada 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, Fenofibrat Stada 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 Fenofibrat Stada (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.
Fenofibrat Stada 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.
Fenofibrat Stada is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Fenofibrat Stada is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Fenofibrat Stada dosage
Fenofibrat Stada Dosage
Generic name: Fenofibrat Stada 160mg
Dosage form: tablet
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
The dose of Fenofibrat Stada is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Fenofibrat Stada and should continue this diet during treatment with Fenofibrat Stada.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Fenofibrat Stada tablets can be given without regard to meals. Patients should be advised to swallow Fenofibrat Stada tablets whole. Do not crush, break, dissolve, or chew tablets.
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Hyperlipoproteinemia
Hyperlipoproteinemia Type IIa, Elevated LDL
Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
Hyperlipoproteinemia Type IV, Elevated VLDL
Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Fenofibrat Stada is given in conjunction with coumarin anticoagulants. Fenofibrat Stada may potentiate the anticoagulant effect of these agents resulting in prolongation of the PT/INR. To prevent bleeding complications, frequent monitoring of PT/INR and dose adjustment of the oral anticoagulant as recommended until the PT/INR has stabilized.
Immunosuppressants
Immunosuppressant agents such as cyclosporine and tacrolimus can impair renal function and because renal excretion is the primary elimination route of fibrate drugs including Fenofibrat Stada capsules, there is a risk that an interaction will lead to deterioration of renal function. When immunosuppressants and other potentially nephrotoxic agents are co-administered with Fenofibrat Stada capsules, the lowest effective dose of Fenofibrat Stada capsules should be employed and renal function should be monitored.
Bile-Acid Binding Resins
Since bile-acid binding resins may bind other drugs given concurrently, patients should take Fenofibrat Stada at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.
Colchicine
Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing Fenofibrat Stada with colchicine.
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 Fenofibrat Stada. Adverse events reported by 2% or more of patients treated with Fenofibrat Stada 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 Fenofibrat Stada and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Fenofibrat Stada treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Fenofibrat Stada and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
BODY SYSTEM Adverse Event
Fenofibrat Stada*
(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 Fenofibrat Stada
Clinical trials with Fenofibrat Stada did not include a placebo-control arm. However, the adverse event profile of Fenofibrat Stada was generally consistent with that of Fenofibrat Stada. The following adverse events not listed above were reported in ≥ 3% of patients taking Fenofibrat Stada 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 Fenofibrat Stada: 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 Fenofibrat Stada or fenofibric acid or to any of the excipients of Fenofibrat Stada.
Severe renal impairment/insufficiency, including those receiving dialysis.
Active liver disease/dysfunction/insufficiency, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities eg, persistent elevations in serum transaminases. Pre-existing gallbladder disease.
Photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
Fenofibrat Stada contains lecithin soya as an excipient and therefore, Fenofibrat Stada should not be taken with allergic to peanut or arachis oil or soya lecithin, or related products due to the risk of hypersensitivity reactions.
Use in lactation: Fenofibrat Stada should not be used in nursing mothers. Because of the potential for tumorigenicity seen in animal studies, a decision should be made whether to discontinue nursing or to discontinue Fenofibrat Stada, taking into account the importance of Fenofibrat Stada to the mother. There are no data on the excretion of Fenofibrat Stada and/or its metabolites into breast milk.
Use in children: Safety and effectiveness in pediatric patients aged <18 years have not been established.
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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