What is Mylan-Fenofibrate Micro?
Mylan-Fenofibrate Micro (Mylan-Fenofibrate Micro) 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).
Mylan-Fenofibrate Micro is used to treat high cholesterol and high triglyceride levels.
Mylan-Fenofibrate Micro may also be used for purposes not listed in this medication guide.
Mylan-Fenofibrate Micro indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Mylan-Fenofibrate Micro 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
Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro?
Use Mylan-Fenofibrate Micro capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro capsules with food.
- Swallow Mylan-Fenofibrate Micro capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Mylan-Fenofibrate Micro capsules whole, tell your doctor. You may need a different medicine.
- Take Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro capsules. Check with your doctor if you have any questions.
- Take Mylan-Fenofibrate Micro capsules on a regular schedule to get the most benefit from it.
- Taking Mylan-Fenofibrate Micro capsules at the same time each day will help you remember to take it.
- Continue to take Mylan-Fenofibrate Micro capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro capsules.
Uses of Mylan-Fenofibrate Micro in details
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, Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro (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.
Mylan-Fenofibrate Micro 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.
Mylan-Fenofibrate Micro is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Mylan-Fenofibrate Micro is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Mylan-Fenofibrate Micro dosage
Mylan-Fenofibrate Micro Dosage
Generic name: Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Mylan-Fenofibrate Micro and should continue this diet during treatment with Mylan-Fenofibrate Micro.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Mylan-Fenofibrate Micro tablets can be given without regard to meals. Patients should be advised to swallow Mylan-Fenofibrate Micro tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Mylan-Fenofibrate Micro (Mylan-Fenofibrate Micro)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Espanol
- 0 Reviews - Add your own review/rating
Consumer resources
- Mylan-Fenofibrate Micro
- Mylan-Fenofibrate Micro (Advanced Reading)
- Other brands: Mylan-Fenofibrate Micro, Lofibra, Lipofen, Mylan-Fenofibrate Micro, More (1) »
Professional resources
- Mylan-Fenofibrate Micro (FDA)
- Fenofibric Acid/Mylan-Fenofibrate Micro (AHFS Monograph)
Related treatment guides
- Hyperlipoproteinemia
- Hyperlipoproteinemia Type IIa, Elevated LDL
- Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
- Hyperlipoproteinemia Type IV, Elevated VLDL
- Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
- More (1) »
Mylan-Fenofibrate Micro interactions
See also:
What other drugs will affect Mylan-Fenofibrate Micro?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Mylan-Fenofibrate Micro is given in conjunction with coumarin anticoagulants. Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro capsules, the lowest effective dose of Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro with colchicine.
Mylan-Fenofibrate Micro side effects
See also:
What are the possible side effects of Mylan-Fenofibrate Micro?
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 Mylan-Fenofibrate Micro. Adverse events reported by 2% or more of patients treated with Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Mylan-Fenofibrate Micro treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Mylan-Fenofibrate Micro and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Mylan-Fenofibrate Micro* (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 Mylan-Fenofibrate Micro |
Clinical trials with Mylan-Fenofibrate Micro did not include a placebo-control arm. However, the adverse event profile of Mylan-Fenofibrate Micro was generally consistent with that of Mylan-Fenofibrate Micro. The following adverse events not listed above were reported in ≥ 3% of patients taking Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro: 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.
Mylan-Fenofibrate Micro contraindications
See also:
What is the most important information I should know about Mylan-Fenofibrate Micro?
Hypersensitivity to Mylan-Fenofibrate Micro or fenofibric acid or to any of the excipients of Mylan-Fenofibrate Micro.
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.
Mylan-Fenofibrate Micro contains lecithin soya as an excipient and therefore, Mylan-Fenofibrate Micro 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: Mylan-Fenofibrate Micro 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 Mylan-Fenofibrate Micro, taking into account the importance of Mylan-Fenofibrate Micro to the mother. There are no data on the excretion of Mylan-Fenofibrate Micro and/or its metabolites into breast milk.
Use in children: Safety and effectiveness in pediatric patients aged <18 years have not been established.
Active ingredient matches for Mylan-Fenofibrate Micro:
| Unit description / dosage (Manufacturer) | Price, USD |
| Capsule; Oral; Fenofibrate 200 mg | |
| Mylan-fenofibrate Micro capsule 200 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
List of Mylan-Fenofibrate Micro substitutes (brand and generic names): | |
| Minuslip (Argentina) | |
| Naftilan (China) | |
| Nanofib (Lebanon) | |
| Neo-Disterin (Greece) | |
| Nofiate (Bangladesh) | |
| Noficon (Bangladesh) | |
| Nolipax (Italy) | |
| Nopid (South Korea) | |
| Normalip Pro (Germany) | |
| Capsule; Oral; Fenofibrate 200 mg (Abbott) | |
| Normolip (Colombia, Dominican Republic, El Salvador, Honduras, India) | |
| NORMOLIP Capsule/ Tablet / 300mg / 10 units (Sun Pharmaceutical Industries Ltd.) | $ 1.33 |
| Normolip 300mg CAP / 10 (Sun Pharmaceutical Industries Ltd.) | $ 1.14 |
| 300 mg x 10's (Sun Pharmaceutical Industries Ltd.) | $ 1.14 |
| Capsules; Oral; Gemfibrozil 300 mg (Sun Pharmaceutical Industries Ltd.) | |
| Normolip 300 mg Capsule (Sun Pharmaceutical Industries Ltd.) | $ 0.12 |
| NORMOLIP 300MG CAPSULE 1 strip / 10 capsules each (Sun Pharmaceutical Industries Ltd.) | $ 1.48 |
| NORMOLIP cap 300 mg x 10's (Sun Pharmaceutical Industries Ltd.) | $ 1.14 |
| Nortricol (Colombia) | |
| Novalip (Tunisia) | |
| Novalip LM (Tunisia) | |
| Novastat TG | |
| Novastat TG 10+160 Tablet (Lupin Laboratories Ltd.) | $ 0.16 |
| NOVASTAT TG 160 MG/10 MG TABLET 1 strip / 10 tablets each (Lupin Laboratories Ltd.) | $ 2.07 |
| NOVASTAT TG 160 MG/20 MG TABLET 1 strip / 10 tablets each (Lupin Laboratories Ltd.) | $ 3.37 |
| NOVASTAT TG 160 MG/5 MG TABLET 1 strip / 10 tablets each (Lupin Laboratories Ltd.) | $ 1.25 |
| Novo-Fenofibrate | |
| Capsule; Oral; Fenofibrate 100 mg | |
| Novo-fenofibrate capsule 100 mg (Novopharm Limited (Canada)) | |
| Novo-Fenofibrate Micronized | |
| Capsule; Oral; Fenofibrate 200 mg | |
| Capsule; Oral; Fenofibrate 67 mg | |
| Novo-fenofibrate Micronized capsule 200 mg (Novopharm Limited (Canada)) | |
| Novo-fenofibrate Micronized capsule 67 mg (Novopharm Limited (Canada)) | |
| Novo-Fenofibrate-S | |
| Tablet; Oral; Fenofibrate 100 mg | |
| Tablet; Oral; Fenofibrate 160 mg | |
| Nu-Fenofibrate | |
| Capsule; Oral; Fenofibrate 100 mg | |
| Nu-fenofibrate capsule 100 mg (Nu Pharm Inc (Canada)) | |
| Nubrex (Philippines) | |
| Nubrex 100 mg x 100's (Sandoz) | $ 39.71 |
| Nubrex 300 mg x 30's (Sandoz) | $ 33.00 |
| Nubrex cap 100 mg 100's (Sandoz) | $ 39.71 |
| Nubrex cap 300 mg 30's (Sandoz) | $ 21.00 |
| Nuozhituo (China) | |
| Philbisrol (Vietnam) | |
| Philbisrol 250 mg x 10 Blister x 10 Tablet | |
| PHL-Fenofibrate Micro | |
| Capsule; Oral; Fenofibrate 200 mg | |
| PHL-fenofibrate Micro capsule 200 mg (Pharmel Inc (Canada)) | |
| Planitrix (Greece) | |
See 1102 substitutes for Mylan-Fenofibrate Micro | |
References
- 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).
- PubChem. "fenofibrate". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "fenofibrate". http://www.drugbank.ca/drugs/DB01039 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Mylan-Fenofibrate Micro are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Mylan-Fenofibrate Micro. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yetConsumer reported age
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
