What is Finabate?
Finabate (Finabate) 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).
Finabate is used to treat high cholesterol and high triglyceride levels.
Finabate may also be used for purposes not listed in this medication guide.
Finabate indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Finabate 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
Finabate 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 Finabate therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Finabate 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 Finabate?
Use Finabate capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Finabate 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 Finabate capsules with food.
- Swallow Finabate capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Finabate capsules whole, tell your doctor. You may need a different medicine.
- Take Finabate 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 Finabate capsules. Check with your doctor if you have any questions.
- Take Finabate capsules on a regular schedule to get the most benefit from it.
- Taking Finabate capsules at the same time each day will help you remember to take it.
- Continue to take Finabate capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Finabate 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 Finabate capsules.
Uses of Finabate 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, Finabate 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 Finabate (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.
Finabate 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.
Finabate is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Finabate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Finabate dosage
Finabate Dosage
Generic name: Finabate 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 Finabate is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Finabate and should continue this diet during treatment with Finabate.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Finabate tablets can be given without regard to meals. Patients should be advised to swallow Finabate tablets whole. Do not crush, break, dissolve, or chew tablets.
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Consumer resources
- Finabate
- Finabate (Advanced Reading)
- Other brands: Finabate, Lofibra, Lipofen, Finabate, More (1) »
Professional resources
- Finabate (FDA)
- Fenofibric Acid/Finabate (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) »
Finabate interactions
See also:
What other drugs will affect Finabate?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Finabate is given in conjunction with coumarin anticoagulants. Finabate 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 Finabate 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 Finabate capsules, the lowest effective dose of Finabate 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 Finabate 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 Finabate with colchicine.
Finabate side effects
See also:
What are the possible side effects of Finabate?
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 Finabate. Adverse events reported by 2% or more of patients treated with Finabate 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 Finabate and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Finabate treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Finabate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Finabate* (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 Finabate |
Clinical trials with Finabate did not include a placebo-control arm. However, the adverse event profile of Finabate was generally consistent with that of Finabate. The following adverse events not listed above were reported in ≥ 3% of patients taking Finabate 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 Finabate: 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.
Finabate contraindications
See also:
What is the most important information I should know about Finabate?
Hypersensitivity to Finabate or fenofibric acid or to any of the excipients of Finabate.
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.
Finabate contains lecithin soya as an excipient and therefore, Finabate 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: Finabate 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 Finabate, taking into account the importance of Finabate to the mother. There are no data on the excretion of Finabate 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 Finabate:
Fenofibrate in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| Finabate 145mg TAB / 10 | $ 1.14 |
| Finabate 160mg TAB / 10 | $ 1.33 |
| Finabate 200mg TAB / 10 | $ 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 |
| Finabate 160mg Tablet (Johnlee Pharmaceuticals Pvt Ltd) | $ 0.13 |
List of Finabate substitutes (brand and generic names): | |
| Fibronil (Chile) | |
| Finabrat 100/300 (Vietnam) | |
| Finabrat 100/300 100 mg x 4 Blister x 12 Tablet | |
| Finabrat 100/300 300 mg x 3 Blister x 10 Tablet | |
| Finacor (Lebanon) | |
| FINATE (India) | |
| FINATE Capsule/ Tablet / 200mg / 10 units (Franco Indian Remedies) | $ 0.91 |
| Finate 200mg CAP / 10 (Franco Indian Remedies) | $ 1.01 |
| 200 mg x 10's (Franco Indian Remedies) | $ 1.01 |
| Finate 200 mg Capsule (Franco Indian Remedies) | $ 0.10 |
| Finate 160 mg Tablet (Franco Indian Remedies) | $ 0.08 |
| FINATE 160 MG TABLET 1 strip / 10 tablets each (Franco Indian Remedies) | $ 0.95 |
| FINATE cap 200 mg x 10's (Franco Indian Remedies) | $ 1.01 |
| FINATE tab 160 mg x 10's (Franco Indian Remedies) | $ 0.95 |
| Finate 200mg CAP / 10 (Franco Indian Remedies) | $ 1.01 |
| Finate 160mg Tablet (Franco Indian Remedies) | $ 0.11 |
| Finobrate | |
| Finobrate 160mg Tablet (Knoll Pharmaceuticals Ltd) | $ 0.14 |
| Finorate (Egypt) | |
| Finorate Retard (Egypt) | |
| Fortilip (Czech Republic) | |
| Fulcro (Italy, Malta) | |
| Fulcrosupra (Italy) | |
| Gadolip (Argentina) | |
| Gadolip 135 (Argentina) | |
| Gadolip 45 (Argentina) | |
| Gardenal Sodium (Lebanon) | |
| Gen-Fenofibrate (Canada) | |
| Gen-Fenofibrate 200 mg x 100's | |
| Gen-Fenofibrate Micro (Malaysia) | |
| Capsule; Oral; Fenofibrate 200 mg | |
| Gen-Fenofibrate Micro 200 mg x 100's | |
| Grofibrat (Poland) | |
| Guan Zhi Ning (China) | |
| Hafenthyl (Vietnam) | |
| Hafenthyl Supra 160 mg x 3 Blister x 10 Tablet | |
| Hafenthyl 100 mg x 3 Blister x 10 Tablet | |
| Hafenthyl 200 mg x 3 Blister x 10 Tablet | |
| Hafenthyl 300 mg x 3 Blister x 10 Tablet | |
| Hicholfen (Indonesia) | |
| Hipofithy (Brazil) | |
| Hyperchol (Indonesia) | |
| Hyperchol 100 mg x 4 x 12's (Ikapharmindo) | $ 16.74 |
| Hyperchol 300 mg x 3 x 10's (Ikapharmindo) | $ 27.90 |
| Hyperchol 200 M 200 mg x 5 x 6's (Ikapharmindo) | $ 31.00 |
| Hyperchol/Hyperchol 200 M (Indonesia) | |
| Hypolip (Hungary, Tunisia) | |
| Katalip (Slovenia) | |
| Ke Li Qing (China) | |
See 1097 substitutes for Finabate | |
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
