• Lipil indications
• Uses of Lipil in details
• Lipil description
• Lipil dosage
• Lipil interactions
• Lipil side effects
• Lipil contraindications

What is Lipil?

Lipil (Lipil) 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).

Lipil is used to treat high cholesterol and high triglyceride levels.

Lipil may also be used for purposes not listed in this medication guide.

Lipil indications

Primary Hypercholesterolemia or Mixed Dyslipidemia

Lipil 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

Lipil 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 Lipil therapy on reducing this risk has not been adequately studied.

Important Limitations of Use

Lipil 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 Lipil?

Use Lipil capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Some brands of Lipil 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 Lipil capsules with food.
• Swallow Lipil capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Lipil capsules whole, tell your doctor. You may need a different medicine.
• Take Lipil 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 Lipil capsules. Check with your doctor if you have any questions.
• Take Lipil capsules on a regular schedule to get the most benefit from it.
• Taking Lipil capsules at the same time each day will help you remember to take it.
• Continue to take Lipil capsules even if you feel well. Do not miss any doses.
• If you miss a dose of Lipil 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 Lipil capsules.

Uses of Lipil 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, Lipil 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 Lipil (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.

Lipil 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.

Lipil is a lipid-regulating agent. The empirical formula is C₂₀H₂₁O₄Cl and the molecular weight is 360.83. Lipil is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.

Lipil dosage

Lipil Dosage

Generic name: Lipil 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 Lipil is 160 mg once daily.

​Patients should be placed on an appropriate lipid-lowering diet before receiving Lipil and should continue this diet during treatment with Lipil.

​Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.

​Lipil tablets can be given without regard to meals. Patients should be advised to swallow Lipil tablets whole. Do not crush, break, dissolve, or chew tablets.

More about Lipil (Lipil)

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Consumer resources

• Lipil
• Lipil (Advanced Reading)

• Other brands: Lipil, Lofibra, Lipofen, Lipil, More (1) »

Professional resources

• Lipil (FDA)
• Fenofibric Acid/Lipil (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) »

Lipil interactions

See also:
What other drugs will affect Lipil?

Coumarin Anticoagulants

Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.

Caution should be exercised when Lipil is given in conjunction with coumarin anticoagulants. Lipil 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 Lipil 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 Lipil capsules, the lowest effective dose of Lipil 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 Lipil 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 Lipil with colchicine.

Lipil side effects

See also:
What are the possible side effects of Lipil?

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 Lipil. Adverse events reported by 2% or more of patients treated with Lipil 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 Lipil and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Lipil treatment in 1.6% of patients in double-blind trials.

Table 1: Adverse Events Reported by 2% or More of Patients Treated with Lipil and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM Adverse Event	Lipil* (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 Lipil

Clinical trials with Lipil did not include a placebo-control arm. However, the adverse event profile of Lipil was generally consistent with that of Lipil. The following adverse events not listed above were reported in ≥ 3% of patients taking Lipil 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 Lipil: 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.

Lipil contraindications

See also:
What is the most important information I should know about Lipil?

Hypersensitivity to Lipil or fenofibric acid or to any of the excipients of Lipil.

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.

Lipil contains lecithin soya as an excipient and therefore, Lipil 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: Lipil 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 Lipil, taking into account the importance of Lipil to the mother. There are no data on the excretion of Lipil 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 Lipil:

Fenofibrate in Italy.

List of Lipil substitutes (brand and generic names)	Sort by popularity
Unit description / dosage (Manufacturer)	Price, USD
Lipiduce (Philippines)
Lipiduce FC tab 160 mg 10 x 10's (Hovid)
Lipilfen (China, South Korea)
Lipilfen 160 mg x 30's	$ 25.74
Lipilo (China)
Lipirate (Vietnam)
Lipirate 100 mg x 4 Blister x 12 Tablet
Lipirate 100 mg x 3 Blister x 10 Tablet
Lipirate 100 mg x 5 Blister x 10 Tablet
Lipirate 160 (Vietnam)
Lipirate 160 160 mg x 5 Blister x 10 Tablet
Lipired (Bangladesh)
LIPIREG
LIPIREG 160 MG TABLET 1 strip / 10 tablets each (Alembic Pharmaceuticals Ltd)	$ 0.82
Lipireg 160mg Tablet (Alembic Pharmaceuticals Ltd)	$ 0.08
Lipirex (Czech Republic)
Capsule; Oral; Fenofibrate 200 mg (Sanofi-aventis)
Capsule; Oral; Fenofibrate 67 mg (Sanofi-aventis)
Lipivim (Romania)
Lipo Plus (Argentina)
Lipo Plus C (Argentina)
Lipo Red (Spain)
Lipoclar (Italy)
Lipofen (Portugal, Turkey, United States)
Capsule; Oral; Fenofibrate 100 mg (Nobel)
Capsule; Oral; Fenofibrate 150 mg (Nobel)
Capsule; Oral; Fenofibrate 50 mg (Nobel)
30 capsule in 1 bottle, plastic (Nobel)
90 capsule in 1 bottle, plastic (Nobel)
Lipofen capsule 150 mg/1 (Nobel)
Lipofen capsule 50 mg/1 (Nobel)
LIPOFEN SR
Lipofen-SR (Turkey)
Lipofene (Italy)
Lipofib (Romania)
Lipohexal (Czech Republic)
Lipolex (Egypt)
Lipomax 105 (Argentina)
Lipomax 35 (Argentina)
Lipomin 100
Lipomin 300
Lipoplasmin (Argentina)
Lipoprothyl (Taiwan)
Lipoprothyl 160 mg
Liposyr 100
Liposyr 300
Lipothin (Thailand)
Lipothin 200 200 mg x 3 x 10's
Lipozor 250
Lipsin (Austria, Italy)
Capsule; Oral; Fenofibrate 100 mg (Aventis)
Lipsin retard (Austria)
Capsule; Oral; Fenofibrate 250 mg
See 1103 substitutes for Lipil

References

1. 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).
2. PubChem. "fenofibrate". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "fenofibrate". http://www.drugbank.ca/drugs/DB01039 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Lipil 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 Lipil. 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