What is Hypolip?
Hypolip (Hypolip) 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).
Hypolip is used to treat high cholesterol and high triglyceride levels.
Hypolip may also be used for purposes not listed in this medication guide.
Hypolip indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypolip 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
Hypolip 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 Hypolip therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Hypolip 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 Hypolip?
Use Hypolip capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Hypolip 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 Hypolip capsules with food.
- Swallow Hypolip capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Hypolip capsules whole, tell your doctor. You may need a different medicine.
- Take Hypolip 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 Hypolip capsules. Check with your doctor if you have any questions.
- Take Hypolip capsules on a regular schedule to get the most benefit from it.
- Taking Hypolip capsules at the same time each day will help you remember to take it.
- Continue to take Hypolip capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Hypolip 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 Hypolip capsules.
Uses of Hypolip 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, Hypolip 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 Hypolip (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.
Hypolip 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.
Hypolip is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Hypolip is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Hypolip dosage
Hypolip Dosage
Generic name: Hypolip 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 Hypolip is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Hypolip and should continue this diet during treatment with Hypolip.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Hypolip tablets can be given without regard to meals. Patients should be advised to swallow Hypolip tablets whole. Do not crush, break, dissolve, or chew tablets.
More about Hypolip (Hypolip)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Espanol
- 0 Reviews - Add your own review/rating
Consumer resources
- Hypolip
- Hypolip (Advanced Reading)
- Other brands: Hypolip, Lofibra, Lipofen, Hypolip, More (1) »
Professional resources
- Hypolip (FDA)
- Fenofibric Acid/Hypolip (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) »
Hypolip interactions
See also:
What other drugs will affect Hypolip?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Hypolip is given in conjunction with coumarin anticoagulants. Hypolip 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 Hypolip 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 Hypolip capsules, the lowest effective dose of Hypolip 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 Hypolip 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 Hypolip with colchicine.
Hypolip side effects
See also:
What are the possible side effects of Hypolip?
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 Hypolip. Adverse events reported by 2% or more of patients treated with Hypolip 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 Hypolip and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Hypolip treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Hypolip and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
BODY SYSTEM Adverse Event | Hypolip* (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 Hypolip |
Clinical trials with Hypolip did not include a placebo-control arm. However, the adverse event profile of Hypolip was generally consistent with that of Hypolip. The following adverse events not listed above were reported in ≥ 3% of patients taking Hypolip 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 Hypolip: 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.
Hypolip contraindications
See also:
What is the most important information I should know about Hypolip?
Hypersensitivity to Hypolip or fenofibric acid or to any of the excipients of Hypolip.
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.
Hypolip contains lecithin soya as an excipient and therefore, Hypolip 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: Hypolip 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 Hypolip, taking into account the importance of Hypolip to the mother. There are no data on the excretion of Hypolip 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 Hypolip:
Fenofibrate in Hungary, Tunisia.
Atorvastatin in Hungary, Tunisia.
Atorvastatin calcium in Hungary.
List of Hypolip substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Hypolin (India) | |
HYPOLIN tab 40 mg x 10's (Dycine) | $ 1.81 |
Hypolip 10 mg (Hungary) | |
Hypolip 20 mg (Hungary) | |
Hypolip 40 mg (Hungary) | |
Hypolip 80 mg (Hungary) | |
HYTOR | |
HYTOR 10MG TABLET 1 strip / 10 tablets each (HYGEN HEALTHCARE PVT LTD) | $ 0.85 |
HYTOR 20MG TABLET 1 strip / 10 tablets each (HYGEN HEALTHCARE PVT LTD) | $ 1.76 |
Hytor 20mg Tablet (Hygen Healthcare Pvt Ltd) | $ 0.18 |
Ilyang Atorvastatin (South Korea) | |
Inastor (Mexico) | |
Inovas F | |
Inovas F 10+160 Tablet (Invision Medi Sciences) | $ 0.11 |
INSTORVA | |
INSTORVA 10MG TABLET 1 strip / 10 tablets each (Instanz Life Sciences Pvt Ltd) | $ 0.72 |
INSTORVA 20MG TABLET 1 strip / 10 tablets each (Instanz Life Sciences Pvt Ltd) | $ 1.81 |
Instorva 20mg Tablet (Instanz Life Sciences Pvt Ltd) | $ 0.18 |
Intor (India) | |
Intor 10mg TAB / 10 (Fenestra) | $ 0.35 |
Intor 20mg TAB / 10 (Fenestra) | $ 0.71 |
Intor 40mg TAB / 10 (Fenestra) | $ 1.07 |
Intor 80mg TAB / 10 (Fenestra) | $ 2.04 |
INTOR tab 10 mg x 10's (Fenestra) | $ 0.37 |
INTOR tab 20 mg x 10's (Fenestra) | $ 0.78 |
INTOR tab 40 mg x 10's (Fenestra) | $ 1.07 |
INTOR tab 80 mg x 10's (Fenestra) | $ 2.11 |
INVASTIN 10MG TABLET | |
INVASTIN 10MG TABLET 1 strip / 30 tablets each (Instant Remedies Pvt Ltd) | $ 5.44 |
Itorvaz (Philippines) | |
Itorvaz film-coated tab 40 mg 30's (Bell-Kenz Pharma) | $ 0.51 |
Itorvaz film-coated tab 80 mg 30's (Bell-Kenz Pharma) | $ 0.62 |
Ivistatyna (Poland) | |
Jamp Atorvastatin (Canada) | |
Jovastatin (India) | |
Jovastatin 10mg TAB / 10 (Johnlee (Vista)) | $ 1.08 |
Jovastatin 20mg TAB / 10 (Johnlee (Vista)) | $ 2.29 |
Jovastatin 40mg TAB / 10 (Johnlee (Vista)) | $ 3.37 |
Jovastatin 80mg TAB / 10 (Johnlee (Vista)) | $ 4.22 |
JOVASTATIN tab 10 mg x 10's (Johnlee (Vista)) | $ 1.08 |
JOVASTATIN tab 20 mg x 10's (Johnlee (Vista)) | $ 2.29 |
JOVASTATIN tab 40 mg x 10's (Johnlee (Vista)) | $ 3.37 |
JOVASTATIN tab 80 mg x 10's (Johnlee (Vista)) | $ 4.22 |
JOYTHINE (India) | |
JOYTHINE tab 10 mg x 10's (Unique Life Sciences) | |
JOYTHINE tab 20 mg x 10's (Unique Life Sciences) | |
Jstat Capsule | |
Jstat Capsule (Indo French Marketing Company) | $ 0.11 |
JUBICAD | |
JUBICAD 10MG TABLET 1 strip / 10 tablets each (Jubilant Life Sciences) | $ 0.61 |
JUBICAD 20MG TABLET 1 strip / 10 tablets each (Jubilant Life Sciences) | $ 1.49 |
JUBICAD 40MG TABLET 1 strip / 10 tablets each (Jubilant Life Sciences) | $ 2.16 |
JUBICAD 80MG TABLET 1 strip / 10 tablets each (Jubilant Life Sciences) | $ 3.19 |
See 5452 substitutes for Hypolip |
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).
- DailyMed. "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM: 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. "atorvastatin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Hypolip 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 Hypolip. 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 yet1 consumer reported age
Users | % | ||
---|---|---|---|
46-60 | 1 | 100.0% |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology