What is Lofibra Capsules?
Lofibra Capsules (Lofibra Capsules) 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).
Lofibra Capsules is used to treat high cholesterol and high triglyceride levels.
Lofibra Capsules may also be used for purposes not listed in this medication guide.
Lofibra Capsules indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Lofibra Capsules 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
Lofibra Capsules 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 Lofibra Capsules therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Lofibra Capsules 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 Lofibra Capsules?
Use Lofibra Capsules capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Lofibra Capsules 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 Lofibra Capsules capsules with food.
- Swallow Lofibra Capsules capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Lofibra Capsules capsules whole, tell your doctor. You may need a different medicine.
- Take Lofibra Capsules 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 Lofibra Capsules capsules. Check with your doctor if you have any questions.
- Take Lofibra Capsules capsules on a regular schedule to get the most benefit from it.
- Taking Lofibra Capsules capsules at the same time each day will help you remember to take it.
- Continue to take Lofibra Capsules capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Lofibra Capsules 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 Lofibra Capsules capsules.
Uses of Lofibra Capsules 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, Lofibra Capsules 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 Lofibra Capsules (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.
Lofibra Capsules 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.
Lofibra Capsules is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Lofibra Capsules is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Lofibra Capsules dosage
Lofibra Capsules Dosage
Generic name: Lofibra Capsules 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 Lofibra Capsules is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Lofibra Capsules and should continue this diet during treatment with Lofibra Capsules.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Lofibra Capsules tablets can be given without regard to meals. Patients should be advised to swallow Lofibra Capsules tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Lofibra Capsules (Lofibra Capsules)
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Consumer resources
- Lofibra Capsules
- Lofibra Capsules (Advanced Reading)
- Other brands: Lofibra Capsules, Lofibra, Lipofen, Lofibra Capsules, More (1) »
Professional resources
- Lofibra Capsules (FDA)
- Fenofibric Acid/Lofibra Capsules (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) »
Lofibra Capsules interactions
See also:
What other drugs will affect Lofibra Capsules?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Lofibra Capsules is given in conjunction with coumarin anticoagulants. Lofibra Capsules 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 Lofibra Capsules 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 Lofibra Capsules capsules, the lowest effective dose of Lofibra Capsules 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 Lofibra Capsules 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 Lofibra Capsules with colchicine.
Lofibra Capsules side effects
See also:
What are the possible side effects of Lofibra Capsules?
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 Lofibra Capsules. Adverse events reported by 2% or more of patients treated with Lofibra Capsules 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 Lofibra Capsules and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Lofibra Capsules treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Lofibra Capsules and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Lofibra Capsules* (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 Lofibra Capsules |
Clinical trials with Lofibra Capsules did not include a placebo-control arm. However, the adverse event profile of Lofibra Capsules was generally consistent with that of Lofibra Capsules. The following adverse events not listed above were reported in ≥ 3% of patients taking Lofibra Capsules 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 Lofibra Capsules: 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.
Lofibra Capsules contraindications
See also:
What is the most important information I should know about Lofibra Capsules?
Hypersensitivity to Lofibra Capsules or fenofibric acid or to any of the excipients of Lofibra Capsules.
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.
Lofibra Capsules contains lecithin soya as an excipient and therefore, Lofibra Capsules 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: Lofibra Capsules 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 Lofibra Capsules, taking into account the importance of Lofibra Capsules to the mother. There are no data on the excretion of Lofibra Capsules 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 Lofibra Capsules:
List of Lofibra Capsules substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Lofibra | |
| Lofibra capsule 134 mg/1 (Pharos) | |
| Lopandil (South Korea) | |
| LOTGL (India) | |
| 200 mg x 10's (Grandix) | $ 0.59 |
| Lotgl 200mg TAB / 10 (Grandix) | $ 0.59 |
| LOTGL 200MG TABLET 1 strip / 10 tablets each (Grandix) | $ 0.67 |
| LOTGL tab 200 mg x 10's (Grandix) | $ 0.59 |
| Lotgl 200mg TAB / 10 (Grandix) | $ 0.59 |
| Lotgl 200mg Tablet (Grandix) | $ 0.07 |
| Lowlip (Taiwan) | |
| Lowlip 20 mg x 3 Blister x 10 Tablet (Medikon) | |
| Lowlip 40 mg x 3 Blister x 10 Tablet (Medikon) | |
| Lowpirol (South Korea) | |
| Luxacor | |
| Capsule; Oral; Fenofibrate 100 mg | |
| Capsule; Oral; Fenofibrate 150 mg | |
| Capsule; Oral; Fenofibrate 50 mg | |
| Magnofen (Argentina) | |
| Medothyl (Vietnam) | |
| Medothyl 300 mg x 10 Blister x 3 Tablet | |
| Mint-Fenofibrate (Canada) | |
| Minuslip (Argentina) | |
| Mylan-Fenofibrate Micro | |
| Capsule; Oral; Fenofibrate 200 mg | |
| Mylan-fenofibrate Micro capsule 200 mg (Mylan Pharmaceuticals Ulc (Canada)) | |
| 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 |
See 1103 substitutes for Lofibra Capsules | |
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
