Lipoplasmin Uses

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What is Lipoplasmin?

Lipoplasmin (Lipoplasmin) 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).

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

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

Lipoplasmin indications

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Primary Hypercholesterolemia or Mixed Dyslipidemia

Lipoplasmin 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

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

Important Limitations of Use

Lipoplasmin 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 Lipoplasmin?

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

Ask your health care provider any questions you may have about how to use Lipoplasmin capsules.

Uses of Lipoplasmin in details

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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, Lipoplasmin 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 Lipoplasmin (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.

Lipoplasmin description

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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.

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

Lipoplasmin dosage

Lipoplasmin Dosage

Generic name: Lipoplasmin 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 Lipoplasmin is 160 mg once daily.

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

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 Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.

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

More about Lipoplasmin (Lipoplasmin)

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Lipoplasmin interactions

See also:
What other drugs will affect Lipoplasmin?

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Coumarin Anticoagulants

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

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

Lipoplasmin side effects

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

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

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

BODY SYSTEM Adverse Event Lipoplasmin*

(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 Lipoplasmin

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

Lipoplasmin contraindications

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

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

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.

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

Fenofibrate in Argentina.


List of Lipoplasmin substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Lipoprothyl 160 mg
Lipothin 200 200 mg x 3 x 10's
Capsule; Oral; Fenofibrate 100 mg (Aventis)
Capsule; Oral; Fenofibrate 250 mg
Lipway SR 250 mg x 30's (Cathay)$ 22.00
Lipway SR MR cap 250 mg 30's (Cathay Drug)$ 23.15
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)
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 20 mg x 3 Blister x 10 Tablet (Medikon)
Lowlip 40 mg x 3 Blister x 10 Tablet (Medikon)
Capsule; Oral; Fenofibrate 100 mg
Capsule; Oral; Fenofibrate 150 mg
Capsule; Oral; Fenofibrate 50 mg
Medothyl 300 mg x 10 Blister x 3 Tablet
Capsule; Oral; Fenofibrate 200 mg
Mylan-fenofibrate Micro capsule 200 mg (Mylan Pharmaceuticals Ulc (Canada))

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).

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