What is Hipofithy?
Hipofithy (Hipofithy) 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).
Hipofithy is used to treat high cholesterol and high triglyceride levels.
Hipofithy may also be used for purposes not listed in this medication guide.
Hipofithy indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Hipofithy 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
Hipofithy 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 Hipofithy therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Hipofithy 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 Hipofithy?
Use Hipofithy capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Hipofithy 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 Hipofithy capsules with food.
- Swallow Hipofithy capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Hipofithy capsules whole, tell your doctor. You may need a different medicine.
- Take Hipofithy 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 Hipofithy capsules. Check with your doctor if you have any questions.
- Take Hipofithy capsules on a regular schedule to get the most benefit from it.
- Taking Hipofithy capsules at the same time each day will help you remember to take it.
- Continue to take Hipofithy capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Hipofithy 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 Hipofithy capsules.
Uses of Hipofithy 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, Hipofithy 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 Hipofithy (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.
Hipofithy 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.
Hipofithy is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Hipofithy is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Hipofithy dosage
Hipofithy Dosage
Generic name: Hipofithy 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 Hipofithy is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Hipofithy and should continue this diet during treatment with Hipofithy.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Hipofithy tablets can be given without regard to meals. Patients should be advised to swallow Hipofithy tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Hipofithy (Hipofithy)
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Consumer resources
- Hipofithy
- Hipofithy (Advanced Reading)
- Other brands: Hipofithy, Lofibra, Lipofen, Hipofithy, More (1) »
Professional resources
- Hipofithy (FDA)
- Fenofibric Acid/Hipofithy (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) »
Hipofithy interactions
See also:
What other drugs will affect Hipofithy?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Hipofithy is given in conjunction with coumarin anticoagulants. Hipofithy 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 Hipofithy 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 Hipofithy capsules, the lowest effective dose of Hipofithy 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 Hipofithy 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 Hipofithy with colchicine.
Hipofithy side effects
See also:
What are the possible side effects of Hipofithy?
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 Hipofithy. Adverse events reported by 2% or more of patients treated with Hipofithy 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 Hipofithy and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Hipofithy treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Hipofithy and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
BODY SYSTEM Adverse Event | Hipofithy* (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 Hipofithy |
Clinical trials with Hipofithy did not include a placebo-control arm. However, the adverse event profile of Hipofithy was generally consistent with that of Hipofithy. The following adverse events not listed above were reported in ≥ 3% of patients taking Hipofithy 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 Hipofithy: 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.
Hipofithy contraindications
See also:
What is the most important information I should know about Hipofithy?
Hypersensitivity to Hipofithy or fenofibric acid or to any of the excipients of Hipofithy.
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.
Hipofithy contains lecithin soya as an excipient and therefore, Hipofithy 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: Hipofithy 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 Hipofithy, taking into account the importance of Hipofithy to the mother. There are no data on the excretion of Hipofithy 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 Hipofithy:
Fenofibrate in Brazil.
List of Hipofithy substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Hicholfen (Indonesia) | |
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) | |
Kemifib (Egypt) | |
Lexemin (Hong Kong, Malaysia, Singapore, Thailand) | |
Lexemin 300 mg x 10 x 10's (Unison) | |
Lexemin 100 mg x 10 x 10's (Unison) | |
Lexemin / micronized 200 mg x 10 x 10's (Unison) | |
Lexemin 300 mg x 10 x 10's (Unison) | |
Lexemin / micronized 160 mg x 10 x 10's (Unison) | |
Lexemin 160 mg x 10 x 10's (Unison) | |
Lexemin cap 100 mg 10 x 10's (Unison) | |
Lexemin cap 300 mg 10 x 10's (Unison) | |
Lexemin tab 160 mg / micronized 10 x 10's (Unison) | |
Lexemin FC tab 160 mg 10 x 10's (Unison) | |
Lexemin-M (Hongkong) | |
Lifemore (Vietnam) | |
Lifemore 200 mg x 10 Blister x 10 Tablet | |
Lifemore 200 mg x 1 Bottle 100 Tablet | |
Lifen (Indonesia, Taiwan) | |
Lifen 500 mg | |
Lifen 200M 200 mg x 3 x 10's | $ 33.48 |
Lifen 200M (Indonesia) | |
Lifenoz-U (Taiwan) | |
Lifenoz-U 160 mg | |
Lifibrat (Vietnam) | |
Lifibrat 100 mg x 4 Blister x 10 Tablet, 10 Blister x 10 Tablet | |
Lifibrat 200 mg x 3 Blister x 10 Tablet, 10 Blister x 10 Tablet | |
Lifibrat 300 mg x 3 Blister x 10 Tablet, 10 Blister x 10 Tablet | |
Lifibrat 100 mg x 4 Blister x 10 Tablet | |
Lifibrat 100 mg x 10 Blister x 10 Tablet | |
Lifibrat 200 mg x 3 Blister x 10 Tablet | |
Lifibrat 200 mg x 10 Blister x 10 Tablet | |
Lifibrat 300 mg x 3 Blister x 10 Tablet | |
Lifibrat 300 mg x 10 Blister x 10 Tablet | |
Linlip (Taiwan) | |
Linlip 200 mg x 1000's | |
Lipa 100 | |
Lipa 300 | |
Lipanon (Brazil) | |
Lipanthyl (Austria, Bahrain, Belgium, Bulgaria, China, Cyprus, Czech Republic, Estonia, Finland, France, Georgia, Greece, Hong Kong, Indonesia, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Oman, Poland, Portugal, Qatar, Romania, Russian Federation, Singapore, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Vietnam) | |
Capsule, Retard; Oral; Fenofibrate 250 mg (Abbott) | |
Capsule; Oral; Fenofibrate 100 mg (Abbott) | |
Capsule; Oral; Fenofibrate 200 mg (Abbott) | |
See 1103 substitutes for Hipofithy |
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 Hipofithy 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 Hipofithy. 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
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Information checked by Dr. Sachin Kumar, MD Pharmacology