What is Novo-Fenofibrate Micronized?
Novo-Fenofibrate Micronized (Novo-Fenofibrate Micronized) 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).
Novo-Fenofibrate Micronized is used to treat high cholesterol and high triglyceride levels.
Novo-Fenofibrate Micronized may also be used for purposes not listed in this medication guide.
Novo-Fenofibrate Micronized indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Novo-Fenofibrate Micronized 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
Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized?
Use Novo-Fenofibrate Micronized capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized capsules with food.
- Swallow Novo-Fenofibrate Micronized capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Novo-Fenofibrate Micronized capsules whole, tell your doctor. You may need a different medicine.
- Take Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized capsules. Check with your doctor if you have any questions.
- Take Novo-Fenofibrate Micronized capsules on a regular schedule to get the most benefit from it.
- Taking Novo-Fenofibrate Micronized capsules at the same time each day will help you remember to take it.
- Continue to take Novo-Fenofibrate Micronized capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized capsules.
Uses of Novo-Fenofibrate Micronized 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, Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized (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.
Novo-Fenofibrate Micronized 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.
Novo-Fenofibrate Micronized is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Novo-Fenofibrate Micronized is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Novo-Fenofibrate Micronized dosage
Novo-Fenofibrate Micronized Dosage
Generic name: Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Novo-Fenofibrate Micronized and should continue this diet during treatment with Novo-Fenofibrate Micronized.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Novo-Fenofibrate Micronized tablets can be given without regard to meals. Patients should be advised to swallow Novo-Fenofibrate Micronized tablets whole. Do not crush, break, dissolve, or chew tablets.
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Consumer resources
- Novo-Fenofibrate Micronized
- Novo-Fenofibrate Micronized (Advanced Reading)
- Other brands: Novo-Fenofibrate Micronized, Lofibra, Lipofen, Novo-Fenofibrate Micronized, More (1) »
Professional resources
- Novo-Fenofibrate Micronized (FDA)
- Fenofibric Acid/Novo-Fenofibrate Micronized (AHFS Monograph)
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Novo-Fenofibrate Micronized interactions
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What other drugs will affect Novo-Fenofibrate Micronized?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Novo-Fenofibrate Micronized is given in conjunction with coumarin anticoagulants. Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized capsules, the lowest effective dose of Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized with colchicine.
Novo-Fenofibrate Micronized side effects
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What are the possible side effects of Novo-Fenofibrate Micronized?
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 Novo-Fenofibrate Micronized. Adverse events reported by 2% or more of patients treated with Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Novo-Fenofibrate Micronized treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Novo-Fenofibrate Micronized and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Novo-Fenofibrate Micronized* (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 Novo-Fenofibrate Micronized |
Clinical trials with Novo-Fenofibrate Micronized did not include a placebo-control arm. However, the adverse event profile of Novo-Fenofibrate Micronized was generally consistent with that of Novo-Fenofibrate Micronized. The following adverse events not listed above were reported in ≥ 3% of patients taking Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized: 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.
Novo-Fenofibrate Micronized contraindications
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What is the most important information I should know about Novo-Fenofibrate Micronized?
Hypersensitivity to Novo-Fenofibrate Micronized or fenofibric acid or to any of the excipients of Novo-Fenofibrate Micronized.
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.
Novo-Fenofibrate Micronized contains lecithin soya as an excipient and therefore, Novo-Fenofibrate Micronized 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: Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized, taking into account the importance of Novo-Fenofibrate Micronized to the mother. There are no data on the excretion of Novo-Fenofibrate Micronized 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 Novo-Fenofibrate Micronized:
| Unit description / dosage (Manufacturer) | Price, USD |
| 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)) | |
List of Novo-Fenofibrate Micronized substitutes (brand and generic names): | |
| Novo-Fenofibrate-S | |
| 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) | |
| PMS-Fenofibrate Micro (Canada) | |
| Capsule; Oral; Fenofibrate 200 mg | |
| PMS-fenofibrate Micro capsule 200 mg (Pharmascience Inc (Canada)) | |
| pms-Lipisans (Vietnam) | |
| pms-Lipisans 300 mg x 3 Blister x 10 Tablet | |
| Pro-Feno-Super (Canada) | |
| Tablet; Oral; Fenofibrate 100 mg | |
| Tablet; Oral; Fenofibrate 160 mg | |
| Procetofen | |
| Procetoken (Argentina) | |
| Proctofene | |
| Promeral (Dominican Republic, El Salvador, Honduras) | |
| Protolipan | |
| Qi Shu (China) | |
| Qualecon (Argentina) | |
| Qualipantyl (Hong Kong) | |
| Qualipantyl 100 mg x 1, 000's (Quality) | $ 420.00 |
| Qualipantyl 300 mg x 1, 000's (Quality) | $ 980.00 |
| ratio-Fenofibrate (Canada) | |
| Ratio-Fenofibrate MC (Canada) | |
| Capsule; Oral; Fenofibrate 200 mg | |
| Ratio-fenofibrate Mc capsule 200 mg (Teva Canada Limited (Canada)) | |
| Reducofen (Brazil) | |
| Riva-Fenofibrate (Canada) | |
| Riva-Fenofibrate Micro | |
| Capsule; Oral; Fenofibrate 200 mg | |
| Riva-fenofibrate Micro capsule 200 mg (Laboratoire Riva Inc (Canada)) | |
| Sandoz Fenofibrate (Canada) | |
| Sandoz Fenofibrate E (Canada) | |
| Sandoz Fenofibrate E tablet 48.0 mg (Sandoz Canada Incorporated (Canada)) | |
| Sandoz Fenofibrate E tablet 145.0 mg (Sandoz Canada Incorporated (Canada)) | |
| Sandoz Fenofibrate S (Canada) | |
| Tablet; Oral; Fenofibrate 100 mg | |
| Tablet; Oral; Fenofibrate 160 mg | |
| Sandoz Fenofibrate S tablet 160 mg (Sandoz Canada Incorporated (Canada)) | |
| Sandoz Fenofibrate S tablet 200 mg (Sandoz Canada Incorporated (Canada)) | |
| Sandoz Fenofibrate S tablet 100 mg (Sandoz Canada Incorporated (Canada)) | |
| Scleril (Italy) | |
See 1100 substitutes for Novo-Fenofibrate Micronized | |
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
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Information checked by Dr. Sachin Kumar, MD Pharmacology
