What is Fenosup Lidose?
Fenosup Lidose (Fenosup Lidose) 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).
Fenosup Lidose is used to treat high cholesterol and high triglyceride levels.
Fenosup Lidose may also be used for purposes not listed in this medication guide.
Fenosup Lidose indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenosup Lidose 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
Fenosup Lidose 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 Fenosup Lidose therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Fenosup Lidose 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 Fenosup Lidose?
Use Fenosup Lidose capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Fenosup Lidose 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 Fenosup Lidose capsules with food.
- Swallow Fenosup Lidose capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Fenosup Lidose capsules whole, tell your doctor. You may need a different medicine.
- Take Fenosup Lidose 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 Fenosup Lidose capsules. Check with your doctor if you have any questions.
- Take Fenosup Lidose capsules on a regular schedule to get the most benefit from it.
- Taking Fenosup Lidose capsules at the same time each day will help you remember to take it.
- Continue to take Fenosup Lidose capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Fenosup Lidose 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 Fenosup Lidose capsules.
Uses of Fenosup Lidose 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, Fenosup Lidose 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 Fenosup Lidose (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.
Fenosup Lidose 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.
Fenosup Lidose is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Fenosup Lidose is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Fenosup Lidose dosage
Fenosup Lidose Dosage
Generic name: Fenosup Lidose 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 Fenosup Lidose is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Fenosup Lidose and should continue this diet during treatment with Fenosup Lidose.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Fenosup Lidose tablets can be given without regard to meals. Patients should be advised to swallow Fenosup Lidose tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Fenosup Lidose (Fenosup Lidose)
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Consumer resources
- Fenosup Lidose
- Fenosup Lidose (Advanced Reading)
- Other brands: Fenosup Lidose, Lofibra, Lipofen, Fenosup Lidose, More (1) »
Professional resources
- Fenosup Lidose (FDA)
- Fenofibric Acid/Fenosup Lidose (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) »
Fenosup Lidose interactions
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What other drugs will affect Fenosup Lidose?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Fenosup Lidose is given in conjunction with coumarin anticoagulants. Fenosup Lidose 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 Fenosup Lidose 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 Fenosup Lidose capsules, the lowest effective dose of Fenosup Lidose 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 Fenosup Lidose 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 Fenosup Lidose with colchicine.
Fenosup Lidose side effects
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What are the possible side effects of Fenosup Lidose?
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 Fenosup Lidose. Adverse events reported by 2% or more of patients treated with Fenosup Lidose 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 Fenosup Lidose and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Fenosup Lidose treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Fenosup Lidose and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Fenosup Lidose* (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 Fenosup Lidose |
Clinical trials with Fenosup Lidose did not include a placebo-control arm. However, the adverse event profile of Fenosup Lidose was generally consistent with that of Fenosup Lidose. The following adverse events not listed above were reported in ≥ 3% of patients taking Fenosup Lidose 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 Fenosup Lidose: 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.
Fenosup Lidose contraindications
See also:
What is the most important information I should know about Fenosup Lidose?
Hypersensitivity to Fenosup Lidose or fenofibric acid or to any of the excipients of Fenosup Lidose.
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.
Fenosup Lidose contains lecithin soya as an excipient and therefore, Fenosup Lidose 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: Fenosup Lidose 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 Fenosup Lidose, taking into account the importance of Fenosup Lidose to the mother. There are no data on the excretion of Fenosup Lidose 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 Fenosup Lidose:
Fenofibrate in Malaysia, Vietnam.
| Unit description / dosage (Manufacturer) | Price, USD |
| Fenosup Lidose 160 mg x 30's | |
| Fenosup Lidose 160 mg x 3 Blister x 10 Tablet | |
| Fenosup Lidose cap 160 mg 30's (Hyphens) | |
List of Fenosup Lidose substitutes (brand and generic names): | |
| Fenosup (Belgium, Singapore, Thailand) | |
| Fenoswiss (Hungary) | |
| Fenoswiss 160 mg (Hungary) | |
| Fenoswiss Forte 267 mg (Hungary) | |
| Fenotard | |
| Fenothyl (Tunisia) | |
| Fenotor | |
| Fenotor 145mg Tablet (Prevento Pharma) | $ 0.12 |
| Fernolid (Vietnam) | |
| Fernolid 200 mg x 4 Blister x 10 Tablet | |
| Fibra (Pakistan) | |
| Fibrafen (Philippines) | |
| Fibrafen 200M 200 mg x 30's (Patriot) | $ 35.30 |
| Fibrafen 200M (Philippines) | |
| Fibral (India, Myanmar) | |
| FIBRAL Capsule/ Tablet / 200mg / 10 units (Cardicare (Micro Labs Ltd)) | $ 0.99 |
| Fibral 200mg CAP / 10 (Cardicare (Micro Labs Ltd)) | $ 0.82 |
| 200 mg x 10's (Cardicare (Micro Labs Ltd)) | $ 0.82 |
| Fibral 200 mg Tablet (Cardicare (Micro Labs Ltd)) | $ 0.11 |
| FIBRAL 200 MG CAPSULE 1 strip / 10 capsules each (Cardicare (Micro Labs Ltd)) | $ 1.43 |
| FIBRAL cap 200 mg x 10's (Cardicare (Micro Labs Ltd)) | $ 0.82 |
| Fibral 200mg Capsule (Cardicare (Micro Labs Ltd)) | $ 0.14 |
| Fibramed (Indonesia) | |
| Fibramed 300 mg x 5 x 6's (Promed) | $ 22.32 |
| Fibranor (Bulgaria) | |
| Fibrate (India) | |
| Fibrate 200mg CAP / 10 (Avinash Health Products Pvt Ltd) | $ 0.84 |
| 200 mg x 10's (Avinash Health Products Pvt Ltd) | $ 0.84 |
| Fibrate 200 mg Capsule (Avinash Health Products Pvt Ltd) | $ 0.08 |
| FIBRATE 200 MG TABLET 1 strip / 10 tablets each (Avinash Health Products Pvt Ltd) | $ 1.02 |
| FIBRATE cap 200 mg x 10's (Avinash Health Products Pvt Ltd) | $ 0.84 |
| Fibrate 200mg Tablet (Avinash Health Products Pvt Ltd) | $ 0.10 |
| Fibre (Bangladesh) | |
| Tablet; Oral; Fiber 500 mg | |
| Fibril (Bangladesh, Philippines, Thailand) | |
| FIBRIL Granules/ Powder / 65%w/w / 100gm units (Pinnacle (Lupin Laboratories Ltd.)) | $ 0.66 |
| Fibril 100 mg x 100's (Pinnacle (Lupin Laboratories Ltd.)) | $ 20.41 |
| Fibril 160 mg x 3 x 10's (Pinnacle (Lupin Laboratories Ltd.)) | |
| 65 % w/w x 100g (Pinnacle (Lupin Laboratories Ltd.)) | $ 0.66 |
| Fibril 100 gm Powder (Pinnacle (Lupin Laboratories Ltd.)) | $ 0.13 |
| Fibril cap 160 mg 3 x 10's (Pinnacle (Lupin Laboratories Ltd.)) | |
| FIBROFEN | |
| FIBROFEN 160 MG TABLET 1 strip / 10 tablets each (Orchid Chemicals & Pharmaceuticals Ltd) | $ 0.64 |
| Fibrofen 160mg Tablet (Orchid Chemicals & Pharmaceuticals Ltd) | $ 0.06 |
| Fibronil (Chile) | |
| Finabate (India) | |
| Finabate 145mg TAB / 10 (Johnlee (Vista)) | $ 1.14 |
| Finabate 160mg TAB / 10 (Johnlee (Vista)) | $ 1.33 |
| Finabate 200mg TAB / 10 (Johnlee (Vista)) | $ 1.81 |
| FINABATE tab 145 mg x 10's (Johnlee (Vista)) | $ 1.14 |
| FINABATE tab 160 mg x 10's (Johnlee (Vista)) | $ 1.33 |
| FINABATE tab 200 mg x 10's (Johnlee (Vista)) | $ 1.81 |
See 1101 substitutes for Fenosup Lidose | |
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 Fenosup Lidose 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 Fenosup Lidose. 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 yet2 consumers reported age
| Users | % | ||
|---|---|---|---|
| 30-45 | 1 | 50.0% | |
| > 60 | 1 | 50.0% | |
Consumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
