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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 26.06.2023

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Each capsule contains Gemfibrozil 300 mg. Each tablet contains Gemfibrozil 600 mg.
Liprosil 450 is a non-halogenated phenoxypentanoic acid with a molecular weight of 250.35. The chemical name is 5-(2, 5-dimethylphenoxy)-2, 2-dimethylpentanoic acid; the empirical formula is C15H22O3.
Liprosil 450 is a white compound with a melting point of 58°C to 61°C. Its solubility is 0.0019% in water and in acid and over 1% in dilute base. Liprosil 450 is stable under ordinary conditions.
Excipients/Inactive Ingredients: Capsule: Corn starch, polysorbate 80, silicon dioxide. Tablet: Calcium stearate, NF; candelilla wax, FCC; microcrystalline cellulose, NF; hydroxypropyl cellulose, NF; hypromellose, USP; methylparaben, NF; Opaspray white; polyethylene glycol, NF; polysorbate 80, NF; propylparaben, NF; colloidal silicon dioxide, NF and pregelatinized starch, NF.
Liprosil 450 (Liprosil 450 tablets, USP) is indicated as adjunctive therapy to diet for:
- Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Liprosil 450 therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Liprosil 450 therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia.
- Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides. The National Cholesterol Education Program has defined a serum HDLcholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with Liprosil 450. In some patients with high triglyceride levels, treatment with Liprosil 450 is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALLCAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF Liprosil 450 IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. Liprosil 450 IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.
In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for Liprosil 450 and placebo subgroups.
The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Liprosil 450 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).
Liprosil 450 is used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis.
Liprosil 450 is also used to lower the risk of stroke, heart attack, or other heart complications in people with high cholesterol and triglycerides who have not been helped by other treatment methods.
Liprosil 450 may also be used for purposes not listed in this medication guide.
General: Lipid levels should be measured on >1 occasion, to ascertain that the levels are consistently abnormal. Before instituting therapy with Liprosil 450, every attempt should be made to control serum lipids with appropriate diet, limiting alcohol intake, exercise and weight loss in obese patients, as well as controlling other medical problems eg, diabetes mellitus or hypothyroidism which may contribute to the abnormal lipid levels. The patient should continue a standard cholesterol-lowering diet during treatment with Liprosil 450. Periodic determinations of serum lipids should be obtained during treatment with Liprosil 450. Liprosil 450 should be withdrawn or additional therapy instituted if the lipid response is inadequate after 3 months.
Recommended Daily Dose: 900-1,200 mg. Maximum Daily Dose: 1,500 mg.
The 900-mg dose is given as a single dose ½ hr before the evening meal. The 1,200-mg dose is given in 2 divided doses, ½ hr before the morning and evening meals.
Use in Patients with Hepatic Dysfunction: See Contraindications and Precautions.
Use in Patients with Renal Dysfunction: See Contraindications and Precautions.
Use Liprosil 450 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Liprosil 450 by mouth twice a day 30 minutes before morning and evening meals, unless otherwise directed by your doctor.
- If you also take a bile acid-binding resin (eg, colestipol), do not take it within 2 hours before or after taking Liprosil 450. Check with your doctor if you have questions.
- Take Liprosil 450 on a regular schedule to get the most benefit from it.
- If you miss a dose of Liprosil 450, 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 Liprosil 450.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Liprosil 450 along with diet and exercise is used for the treatment of high levels of triglycerides (type of fat) in the blood.
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What other drugs will affect Liprosil 450?
HMG-CoA Reductase Inhibitors
The concomitant administration of Liprosil 450 with simvastatin is contraindicated. The risk of myopathy and rhabdomyolysis is increased with combined Liprosil 450 and HMG-CoA reductase inhibitor therapy. Myopathy or rhabdomyolysis with or without acute renal failure have been reported as early as three weeks after initiation of combined therapy or after several months. There is no assurance that periodic monitoring of creatine kinase will prevent the occurrence of severe myopathy and kidney damage.
Anticoagulants
CAUTION SHOULD BE EXERCISED WHEN WARFARIN IS GIVEN IN CONJUNCTION WITH Liprosil 450. THE DOSAGE OF WARFARIN SHOULD BE REDUCED TO MAINTAIN THE PROTHROMBIN TIME AT THE DESIRED LEVEL TO PREVENT BLEEDING COMPLICATIONS FREQUENT PROTHROMBIN DETERMINATIONS ARE ADVISABLE UNTIL IT HAS BEEN DEFINITELY DETERMINED THAT THE PROTHROMBIN LEVEL HAS STABILIZED.
CYP2C8 Substrates
Liprosil 450 is an inhibitor of CYP2C8 and may increase exposure of drugs mainly metabolized by CYP2C8 (e.g., dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone). Therefore, dosing reduction of drugs that are mainly metabolized by CYP2C8 enzyme may be required when Liprosil 450 is used concomitantly.
Repaglinide
In healthy volunteers, co-administration with Liprosil 450 (600 mg twice daily for 3 days) resulted in an 8.1-fold (range 5.5- to 15.0- fold) higher repaglinide AUC and a 28.6-fold (range 18.5- to 80.1-fold) higher repaglinide plasma concentration 7 hours after the dose. In the same study, Liprosil 450 (600 mg twice daily for 3 days) + itraconazole (200 mg in the morning and 100 mg in the evening at Day 1, then 100 mg twice daily at Day 2-3) resulted in a 19.4- (range 12.9- to 24.7-fold) higher repaglinide AUC and a 70.4-fold (range 42.9- to 119.2-fold) higher repaglinide plasma concentration 7 hours after the dose. In addition, Liprosil 450 alone or Liprosil 450 + itraconazole prolonged the hypoglycemic effects of repaglinide. Co-administration of Liprosil 450 and repaglinide increases the risk of severe hypoglycemia and is contraindicated.
Dasabuvir
Co-administration of Liprosil 450 with dasabuvir increased dasabuvir AUC and Cmax (ratios: 11.3 and 2.01, respectively) due to CYP2C8 inhibition. Increased dasabuvir exposure may increase the risk of QT prolongation, therefore, co-administration of Liprosil 450 with dasabuvir is contraindicated.
OATP1B1 Substrates
Liprosil 450 is an inhibitor of OATP1B1 transporter and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan).
Therefore, dosing reductions of drugs that are substrates of OATP1B1 may be required when Liprosil 450 is used concomitantly. Combination therapy of Liprosil 450 with simvastatin or with repaglinide, which are OATP1B1 substrates, is contraindicated.
In Vitro Studies Of CYP Enzymes, UGTA Enzymes And OATP1B1 Transporter
In vitro studies have shown that Liprosil 450 is an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, OATP1B1, and UDP-glucuronosyltransferase (UGT) 1A1 and 1A3.
Bile Acid-Binding Resins
Liprosil 450 AUC was reduced by 30% when Liprosil 450 was given (600 mg) simultaneously with resin-granule drugs such as colestipol (5 g). Administration of the drugs two hours or more apart is recommended because Liprosil 450 exposure was not significantly affected when it was administered two hours apart from colestipol.
Colchicine
Myopathy, including rhabdomyolysis, has been reported with chronic administration of colchicine at therapeutic doses. Concomitant use of Liprosil 450 may potentiate the development of myopathy. Patients with renal dysfunction and elderly patients are at increased risk. Caution should be exercised when prescribing Liprosil 450 with colchicine, especially in elderly patients or patients with renal dysfunction.
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What are the possible side effects of Liprosil 450?
In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received Liprosil 450 for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the Liprosil 450 group.
For adverse events reported by more than 1% of subjects, but without a significant difference between groups, see Table 5.
Capsule: Additional adverse reactions that have been reported where a causal relationship to treatment with Liprosil 450 is probable are: Hepatobiliary Disorders: Cholestatic jaundice.
Gastrointestinal Disorders: Pancreatitis.
Nervous System Disorders: Dizziness, somnolence, paresthesia, peripheral neuritis, headache.
Psychiatric Disorders: Decreased libido, depression.
Eye Disorders: Blurred vision.
Reproductive System and Breast Disorders: Impotence.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, synovitis, myalgia, myopathy, myasthenia, painful extremities, rhabdomyolysis.
Skin and Subcutaneous Tissue Disorders: Exfoliative dermatitis, rash, dermatitis, pruritus, angioedema, urticaria.
Respiratory, Thoracic and Mediastinal Disorders: Laryngeal edema.
Blood and Lymphatic System Disorders: Severe anemia, leukopenia, thrombocytopenia, eosinophilia, bone marrow hypoplasia.
Additional adverse reactions that have been reported included photosensitivity, alopecia, cholecystitis and cholelithiasis.
Tablet: Gallbladder surgery was performed in 0.9% of Liprosil 450 and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the Liprosil 450 group compared to the placebo group (1.9% versus 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the Liprosil 450 group was seen also in the secondary prevention component (6 on Liprosil 450 versus 0 on placebo, p=0.014).
Nervous system and special senses adverse reactions were more common in the Liprosil 450 group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among Liprosil 450 treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.
From other studies it seems probable that Liprosil 450 is causally related to the occurrence of musculoskeletal symptoms, and to abnormal liver function tests and hematologic changes.
Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in Liprosil 450 treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for Liprosil 450 are listed as follows by system. These are categorized according to whether a causal relationship to treatment with Liprosil 450 is probable or not established:
Additional adverse reactions that have been reported include cholecystitis and cholelithiasis.