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Immunosuppressant agents such as cyclosporine and tacrolimus may be of particular importance because they are known to be the primary route of elimination. When immunosuppressants and other potentially nephrotoxic agents are co-administered with LIPOFEN, the lowest effective dose of LIPOFEN should be used and should be monitored.
After multiple dosing of fenofibrate, fenofibric acid steady state is achieved after 5 days. Plasma concentrations of fenofibric acid at steady state are slightly higher than those following a single dose. Serum protein binding binding 99% in normal and hyperlipidemic subjects.
Caution should be exercised when LIPOFEN is given in conjunction with coumarin anticoagulants. LIPOFEN may potentiate the anticoagulant effect of these agents in prolongation of the PT / INR. To prevent bleeding complications, frequent monitoring of PT / INR and dose adjustment of the oral anticoagulant (see WARNINGS AND PRECAUTIONS).
The absorption of fenofibrate is increased when administered with food. With LIPOFEN, the extent of absorption is increased by approximately 58% and 25% under high-fat fed and low-fat fed conditions as compared to fasting conditions, respectively..
HMG-CoA reductase inhibitors (eg, simvastatin) because of the risk of serious muscle problems may be increased Immunosuppressants (eg, cyclosporine) or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may decrease Tricor's excretion and increase the risk of its side effects Anticoagulants (eg, warfarin) or sulfonylureas (eg, glipizide) because the risk can be increased by Tricor.
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or notprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have diabetes, an underactive thyroid, heart blood vessel problems, gallstones, kidney problems, or some muscle problems (myopathy) if you have a history of pancreatitis or blood in your veins (deep vein thrombosis or pulmonary embolism) if you are very overweight, have an inactive lifestyle beta-blocker (eg, propranolol), estrogen, or thiazide diuretic (eg, hydrochlorothiazide).
Approximately 600 mg of pellets was ground to fine powder using a mortar and pestle before quantification. Approximately 30 mg of powder was then fully weighed and added to a 100 mL volumetric flask containing 80 mL of mobile phase. After ultrasonic extraction for 10 minutes, the volume was adjusted to 100 mL with mobile phase. The sample solution was prepared by diluting 1 mL of the above solution with 9 mL of mobile phase and analyzed by HPLC.
Dissolution testing of fenofibrate pellets was conducted using the USP 37 Apparatus II dissolution method (Tianjin, Tianjin Tianda Tianfa Tianma Technology Co., Ltd., Tianjin, China). Briefly,
The drug-loaded cores were transferred to a mini-Glatt fluidized-bed coater (Glatt, Binzen, Germany). Four different coating systems (R1 - R4 in Table 1) have been applied to the same drug - loaded cores to achieve the desired cumulative release profile. The polymer dispersions (R1 - R3) were prepared by adding the polymers to 80% (v / v) ethanol solution, followed by stirring overnight. R4 was used as its aqueous dispersion. After coating with polymer dispersion, the pellets were removed and dried at 40 ° C for 2 hours in an air-circulated oven for further study. Where necessary, Aerosil ® 200 was added to prevent sticking of pellets during storage.
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- Subjects with decision of nonparticipation through investigator's review.
The drug brand named Lipikind-AM contains generic salt-Amlodipine Besylate and is manufactured by Mankind Pharma. Lipikind-AM is mainly associated with symptoms and indications-The International Classification of Diseases (ICD) - C10BX03-Atorva.
Lipi contains generic salt-Glipizide and is manufactured by Dey's Medical Stores. Lipi is mainly associated with symptoms and indications-The International Classification of Diseases (ICD) - A10BB07-Glipizide.
The drug brand named Lipikind-EZ contains generic salt-Atorvastatin Calcium and is manufactured by Mankind Pharma. Lipikind-EZ is mainly associated with symptoms and indications-The International Classification of Diseases (ICD) - C10AA05-Atorv.