What is Lipsin retard?
Lipsin retard (Lipsin retard) 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).
Lipsin retard is used to treat high cholesterol and high triglyceride levels.
Lipsin retard may also be used for purposes not listed in this medication guide.
Lipsin retard indications
Primary Hypercholesterolemia or Mixed Dyslipidemia
Lipsin retard 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
Lipsin retard 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 Lipsin retard therapy on reducing this risk has not been adequately studied.
Important Limitations of Use
Lipsin retard 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 Lipsin retard?
Use Lipsin retard capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Some brands of Lipsin retard 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 Lipsin retard capsules with food.
- Swallow Lipsin retard capsules whole. Do not open, crush, dissolve, or chew before swallowing. If you cannot swallow Lipsin retard capsules whole, tell your doctor. You may need a different medicine.
- Take Lipsin retard 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 Lipsin retard capsules. Check with your doctor if you have any questions.
- Take Lipsin retard capsules on a regular schedule to get the most benefit from it.
- Taking Lipsin retard capsules at the same time each day will help you remember to take it.
- Continue to take Lipsin retard capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Lipsin retard 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 Lipsin retard capsules.
Uses of Lipsin retard 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, Lipsin retard 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 Lipsin retard (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.
Lipsin retard 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.
Lipsin retard is a lipid-regulating agent. The empirical formula is C20H21O4Cl and the molecular weight is 360.83. Lipsin retard is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Lipsin retard dosage
Lipsin retard Dosage
Generic name: Lipsin retard 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 Lipsin retard is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Lipsin retard and should continue this diet during treatment with Lipsin retard.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Lipsin retard tablets can be given without regard to meals. Patients should be advised to swallow Lipsin retard tablets whole. Do not crush, break, dissolve, or chew tablets.
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Consumer resources
- Lipsin retard
- Lipsin retard (Advanced Reading)
- Other brands: Lipsin retard, Lofibra, Lipofen, Lipsin retard, More (1) »
Professional resources
- Lipsin retard (FDA)
- Fenofibric Acid/Lipsin retard (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) »
Lipsin retard interactions
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What other drugs will affect Lipsin retard?
Coumarin Anticoagulants
Potentiation of coumarin-type anticoagulant effect has been observed with prolongation of the PT/INR.
Caution should be exercised when Lipsin retard is given in conjunction with coumarin anticoagulants. Lipsin retard 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 Lipsin retard 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 Lipsin retard capsules, the lowest effective dose of Lipsin retard 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 Lipsin retard 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 Lipsin retard with colchicine.
Lipsin retard side effects
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What are the possible side effects of Lipsin retard?
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 Lipsin retard. Adverse events reported by 2% or more of patients treated with Lipsin retard 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 Lipsin retard and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Lipsin retard treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Lipsin retard and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Lipsin retard* (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 Lipsin retard |
Clinical trials with Lipsin retard did not include a placebo-control arm. However, the adverse event profile of Lipsin retard was generally consistent with that of Lipsin retard. The following adverse events not listed above were reported in ≥ 3% of patients taking Lipsin retard 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 Lipsin retard: 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.
Lipsin retard contraindications
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What is the most important information I should know about Lipsin retard?
Hypersensitivity to Lipsin retard or fenofibric acid or to any of the excipients of Lipsin retard.
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.
Lipsin retard contains lecithin soya as an excipient and therefore, Lipsin retard 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: Lipsin retard 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 Lipsin retard, taking into account the importance of Lipsin retard to the mother. There are no data on the excretion of Lipsin retard 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 Lipsin retard:
Fenofibrate in Austria.
| Unit description / dosage (Manufacturer) | Price, USD |
| Capsule; Oral; Fenofibrate 250 mg | |
List of Lipsin retard substitutes (brand and generic names): | |
| Lipsin (Austria, Italy) | |
| Capsule; Oral; Fenofibrate 100 mg (Aventis) | |
| Liptuin (Argentina) | |
| Lipway (Philippines) | |
| Lipway SR 250 mg x 30's (Cathay) | $ 22.00 |
| Lipway SR (Philippines) | |
| Lipway SR MR cap 250 mg 30's (Cathay Drug) | $ 23.15 |
| Livesan (France) | |
| Lofat (Bangladesh) | |
| Lofibra | |
| 100 capsule in 1 bottle (Pharos) | |
| Lofibra 250 mg x 3 x 10's (Pharos) | $ 25.30 |
| Lofibra 200 mg x 50's (Pharos) | $ 22.02 |
| Lofibra capsule 200 mg/1 (Pharos) | |
| Lofibra tablet, film coated 54 mg/1 (Pharos) | |
| Lofibra capsule 67 mg/1 (Pharos) | |
| Lofibra tablet, film coated 160 mg/1 (Pharos) | |
| Lofibra capsule 134 mg/1 (Pharos) | |
| Lofibra Capsules | |
| 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) | |
See 1103 substitutes for Lipsin retard | |
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
