Application Information

This drug has been submitted to the FDA under the reference 019304/001.

Names and composition

"LIPIDIL" is the commercial name of a drug composed of FENOFIBRATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
019304/001 LIPIDIL FENOFIBRATE CAPSULE/ORAL 100MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019304/001 LIPIDIL FENOFIBRATE CAPSULE/ORAL 100MG
019304/002 TRICOR (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019304/003 TRICOR (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019304/004 TRICOR (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021203/001 TRICOR FENOFIBRATE TABLET/ORAL 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021203/003 TRICOR FENOFIBRATE TABLET/ORAL 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021350/001 TRIGLIDE FENOFIBRATE TABLET/ORAL 50MG
021350/002 TRIGLIDE FENOFIBRATE TABLET/ORAL 160MG
021612/001 LIPOFEN FENOFIBRATE CAPSULE/ORAL 50MG
021612/002 LIPOFEN FENOFIBRATE CAPSULE/ORAL 100MG
021612/003 LIPOFEN FENOFIBRATE CAPSULE/ORAL 150MG
021656/001 TRICOR FENOFIBRATE TABLET/ORAL 48MG
021656/002 TRICOR FENOFIBRATE TABLET/ORAL 145MG
021695/001 ANTARA (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 43MG
021695/002 ANTARA (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 87MG
021695/003 ANTARA (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 130MG
021695/004 ANTARA (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 30MG
021695/005 ANTARA (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 90MG
022118/001 FENOGLIDE FENOFIBRATE TABLET/ORAL 40MG
022118/002 FENOGLIDE FENOFIBRATE TABLET/ORAL 120MG
075753/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 67MG
075753/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 134MG
075753/003 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 200MG
075868/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 67MG
075868/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 134MG
075868/003 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 200MG
076433/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 54MG
076433/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 160MG
076509/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 54MG
076509/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 160MG
076520/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 54MG
076520/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 107MG
076520/003 FENOFIBRATE FENOFIBRATE TABLET/ORAL 160MG
076635/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 54MG
076635/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 107MG
076635/003 FENOFIBRATE FENOFIBRATE TABLET/ORAL 160MG
090715/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 48MG
090715/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 145MG
090856/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 48MG
090856/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 145MG
090859/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 43MG
090859/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 130MG
200579/001 FENOFIBRATE FENOFIBRATE CAPSULE/ ORAL 43MG
200579/002 FENOFIBRATE FENOFIBRATE CAPSULE/ ORAL 130MG
201748/001 FENOFIBRATE FENOFIBRATE CAPSULE/ORAL 43MG
201748/002 FENOFIBRATE FENOFIBRATE CAPSULE/ORAL 130MG
202252/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 43MG
202252/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 130MG
202579/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 43MG
202579/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 130MG
202676/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 67MG
202676/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 134MG
202676/003 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 200MG
202856/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 48MG
202856/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 145MG
204019/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 54MG
204019/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 160MG
204475/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 40MG
204475/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 120MG
204598/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 48MG
204598/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 145MG
205118/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 48MG
205118/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 145MG
205566/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 67MG
205566/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 134MG
205566/003 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 200MG
207378/001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 67MG
207378/002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 134MG
207378/003 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE/ORAL 200MG
208709/001 FENOFIBRATE FENOFIBRATE TABLET/ORAL 48MG
208709/002 FENOFIBRATE FENOFIBRATE TABLET/ORAL 145MG

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Answered questions

Can the medications im on be the cause of my weight gain?
im on nexium 40mg & cipramil 40mg & lipidil 145mg but no matter how well i eat etc im gaining weight. Asked by Ramona Vonwagoner 1 year ago.

Nexium can cause gas, sometimes diarrhea, dizziness, but found no weight gain with this drug (check on MedWeb for all your meds and their adverse effects). I found a warning in taking lipidil with nexium, so I would talk with your druggist about interactions with your meds and if any, adverse reactions. They should be more than willing to help you figuring out the various contraindications. I could not find a "cipramil" drug on my med list (Medscape), but I did find some "cipro" drugs. I don't by PDR here, but I really think you should ask the druggist--as he has all the doses and how each drug works and with each other. Answered by Leeann Juliano 1 year ago.


Has anyone been prescribed Xeloda for metastatic breast cancer?
to the Madator, the reason why I include the year 1997 was because I had never needed any medications, that everything started after my work injury. My blood sugars went up after my first bout with cancer. still suffer with dystonia from the RSD and over the last 3 days it has gone completely out of control and my... Asked by Nora Myhre 1 year ago.

I was diagnosed with metastatic breast cancer in 2002, it was invasive ductal carcinoma stage 3, one lymph node was positive. I had lumpectomy, chemotherapy and radiation. I took tamoxifen for 5 years. I was then put on Femera. I changed oncologists who ordered a bone scan in 2008 but failed to look at the scan. I had a MRI of my spine done because of increases in pain, incontinence and an abnormal emg test. I had a severe work injury in which I tore my left rotator cuff damaged my right shoulder, avulsed my spinal nerves and developed reflex sympathetic dystrophy and bursitis of both hips, myofascial pain of my neck back legs.The cancer has now metastasized to my liver. I threw a pulmonary embolus . The pain was managed quite well on my current medications. I was receiving Abraxane and Pamidronate until I had a serious side effect to Abraxane. I have been taking Xeloda for 9 days and I have so much pain, more than I have ever had. I have taken 160 mgs of Oxycontin and 8 Percocet just to get up. I have put a call out for my oncologist. I am just asking is this normal? I'm not taking my morning dose. She started me on 2000 mg. twice day. Matador 89 I would greatly appreciate your medical opinion. I am a RN. Medications: I had never used my drug plan until 1997 so here I go Gabapentin 1500 mg BID for pain Lipidil 160 mg OD Zofran Flexaril Ditropan Effexor Clonidine Ramapril Glyburide Metformin Prandase Percocet Oxycontin Omeprazole Hydroclorathiazide Heparin 20,000 units Xeloda Pamindronate All answers thank you so much for taking the time to answer my question Answered by Lenny Sudderth 1 year ago.

to the Madator, the reason why I include the year 1997 was because I had never needed any medications, that everything started after my work injury. My blood sugars went up after my first bout with cancer. still suffer with dystonia from the RSD and over the last 3 days it has gone completely out of control and my pain has increased sooo badly that this morning I took a total of 160 mg of oxycontin and 8 percocet. I was fortunate that my oncologist did call me back. She refers to my RSD as that " wonky" disorder. She is wonderful and agreed with me increasing my pain medication to take the Xeloda. She told me that she feels the Xeloda is working and will increase my pain medication.My 2 week cycle is over this Friday and on that day I will drink an alcoholic beverage. Answered by Deandre Ewell 1 year ago.

to the Madator, the reason why I include the year 1997 was because I had never needed any medications, that everything started after my work injury. My blood sugars went up after my first bout with cancer. still suffer with dystonia from the RSD and over the last 3 days it has gone completely out of control and my pain has increased sooo badly that this morning I took a total of 160 mg of oxycontin and 8 percocet. I was fortunate that my oncologist did call me back. She refers to my RSD as that " wonky" disorder. She is wonderful and agreed with me increasing my pain medication to take the Xeloda. She told me that she feels the Xeloda is working and will increase my pain medication.My 2 week cycle is over this Friday and on that day I will drink an alcoholic beverage. Answered by Lida Spittle 1 year ago.

Donna B, Briefly, YES! I shall try to explain. XELODA is usually taken together with another medicine called docetaxel for metastatic breast cancer - mBC - that has not improved after treatment with other medicines. These medicines include paclitaxel (taxol; onxol), which is classified as an antimicrotubule agent; it stops the growth of the tumour by inhibiting cell division // During mitosis, the cell uses structures called micotubules to move around the chromosomes; [in the 1990s, members of a family of drugs called the taxanes – which include docetaxel (Taxotere) and paclitaxel (Taxol) - were shown to be effective in the first-line treatment of advanced breast cancer as well as in the treatment of women who had developed resistance to the anthracyclines.] // and anthracycline-containing medicine such as doxorubicin. There is some controversy with regard to anthracycline. Studies have shown that there is only a small subpopulation of women who incrementally benefit from anthracyclines over non-anthracyclines in breast cancer. However you should be guided by your oncologist/specialist(s). I am not sure of your meaning when you state that you never used your drug plan until 1997. As you do not indicate why you had a drug plan before the date which you give for your mBC diagnosis, I must assume that your ‘severe work injury’ occurred previously to that date, and may be part of the reason, but this would not indicate why you had some diabetic meds on the list. (Unless of course, you have induced diabetes due to the cancer’s effects). Obviously anti depressants are understandable, given the circumstances. High BP can be a result of disease and medications. The omeprazole is likely for the “poly-pharmacy” and the protection of your stomach lining due to their combined effects. I have outlined, in brief, the uses for those meds on your list – about which I feel sure that as an RN, you are already aware! However, I am not sure if you are able to check adverse drug reactions. Utilising all those on your list, I note that there are some serious adverse reactions between some of those drugs. This you need to check with your prescribing doctor(s) and your pharmacist. I could list them here, but I am sure that, being quite extensive, space would not permit their inclusion. Gabapentin 1500 mg BID for pain = usually for epilepsy, diabetic neuropathy, postherpetic neuralgia, etc. Lipidil 160 mg OD= lipid level modifying. Zofran = prevents nausea and vomiting caused by surgery or cancer medicines. Flexaril = is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain. Ditropan = an anticholinergic medication used to relieve urinary and bladder difficulties. Effexor = is an antidepressant of the serotonin-norepinephrine reuptake inhibitor. Clonidine = used to treat high blood pressure, ADHD and anxiety/panic disorder. Ramapril = ACE (angiotensin-converting enzyme) inhibitor used for High BP, heart failure and prevention of heart attack and stroke. Glyburide = is used to treat type 2 diabetes. Metformin = is an oral antidiabetic drug. Prandase = is used in non insulin dependant diabetes to lower blood glucose levels. Percocet = is used to relieve moderate to severe pain. Oxycontin = is a narcotic pain reliever used to treat moderate to severe pain. Omeprazole = is a proton pump inhibitor. Hydroclorathiazide = for fluid retention in people with congestive heart failure, cirrhosis of the liver, or kidney disorders. Heparin = for preventing blood clots in the veins, arteries, or lungs. Xeloda = for metastatic breast and colorectal cancers. Pamindronate = used to prevent osteoporosis, and which may also be used when cancer has spread to the bone. As your last “Additional Details” specify this, that is why it is on your list. I wish you well. ALL ANSWERS SHOULD BE THOROUGHLY RESEARCHED, IN ANY FORUM AND ESPECIALLY IN THIS ONE. - MANY ANSWERS ARE FLAWED. It is extremely important to obtain an accurate diagnosis before trying to find a cure. Many diseases and conditions share common symptoms. The information provided here should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed physician should be consulted for diagnosis and treatment of any and all medical conditions. Hope this helps matador 89 Answered by Grover Desilvo 1 year ago.

This Site Might Help You. RE: Has anyone been prescribed Xeloda for metastatic breast cancer? I was diagnosed with metastatic breast cancer in 2002, it was invasive ductal carcinoma stage 3, one lymph node was positive. I had lumpectomy, chemotherapy and radiation. I took tamoxifen for 5 years. I was then put on Femera. I changed oncologists who ordered a bone scan in 2008 but failed to... Answered by Alexandria Balceiro 1 year ago.

Well it is really hard to tell what the doctor may have been talking about from your question, but there are pills for metastatic BC and there are injections for osteoporosis (weak bones) so it is certainly possible that your mother might be having both of those especially if her cancer has metastasized to the bones. It is also possible that the doctor told her that her metastatic BC might lead to her death in the future, particularly if she asked about possible outcomes. There really isn't a usual time, some people live with metastatic BC for years, sometimes the treatments reduce metastases and sometimes the cancer spreads to other organs. There is no time-line. Answered by Margherita Schwamberger 1 year ago.


Can the medications im on be the cause of my weight gain?
im on nexium 40mg & cipramil 40mg & lipidil 145mg but no matter how well i eat etc im gaining weight. Asked by Rhoda Quilliam 1 year ago.

The medication alone can not make you gain weight. What it can do is increase the activity of your ghrelin cells in your intestines and stomach to trigger your hunger which in turn can result in you eating more. Watch your caloric intake and if you think that this is becoming an issue, talk to your doctor about it. He or she should be able to make some alterations in your medications if necessary. However, if the medications are effective, they will probably try to help you adjust your diet, or see a dietician to help plan a healthy eating plan. Answered by Alline Cleere 1 year ago.


I began taking Diovan approximatly 4 years ago after experiencing a major M.I.?
At the time I was also on Ranexa, Metropolol 25mgs. baby asperin 81mgs and Plavix 75 mgs. Asked by Lea Esfahani 1 year ago.

after about a year of being on the Diovan I was diagnosed with Rhybomyolosis and had to be hospitalized and treated. The doctors did not associate it with the Diovan and neither did they associate it with any other medicine that I was taking at the time. Then within months of being down with the Rhybdo, my big toe on my right foot began hurting like hell along with my hands, my left knee that I had surgery on back in 1973 and in my chest at the site where I had had major surgery. six years ago. Three months ago I quit the Diovan, my toe has stopped hurting, my knee has stopped hurting as has my chest. My hands have calmed down somewhat but they still bother me. My doctor now blames the Rhybdo. on the Diovan along with all of the other aforementioned issues that I've had. Anybody care to comment? Answered by Latoria Kurohara 1 year ago.

Pain is a known side effect of Diovan. Could you please add all the medications that you were taking at the time this occurred. I think that you are writing about rhabdomyolysis? I'm curious so please add more info. EDIT; I developed rhabdomyolysis from Lipidtor and everywhere that I had ever had pain suddenly became horrible and unbearable. I stopped the Lipidtor and all the new pain ceased. It is supposed to be a rare side effect but when it happens too you you want to swear off any medications for the rest of your life. I had a serious work injury which left me in terrible pain from muscle damage and everywhere I had experienced pain from that became excruciating and then normalized when the lipidtor was stopped. I take Lipidil now without any problems. It would be interesting to find out if surgery or injury puts you at a higher risk to develop that problem. So I am in complete agreement with your DR. You should post your question again in another category. Go to the SCIENCE AND MATHEMATICS, category then choose medicine and post it there. I find that alot of pharmacists answer questions there, take care Donna Answered by Marty Bartch 1 year ago.


Can a person take too much statins?
What are the long term effects of taking statins for reducing cholesterol? Asked by Bruno Devilbiss 1 year ago.

Statins are a class of drugs often prescribed by doctors to help lower cholesterol levels in the blood. In doing so, they help prevent heart attacks and stroke,may reduce the risk of heart attack, and the chances of recurrent strokes. There are many big problems with taking too much statins: Myositis, Creatine Phosphokinase,Liver problems, and Rhabdomyolysis,. Myositis, which is inflammation of the muscles, can occur with statins. The risk of muscle injury increases when certain other medications are coupled with statin use. For example, if you take a combination of a statin and a fibrate,another cholesterol-reducing drug,the risk of muscle damage increases greatly compared to someone who takes a statin alone. Other dangers of statins include other muscle conditions, which can be serious in rare cases. First, there can be statin muscle pain,known as myalgia, this pain can generally be resolved quickly by discontinuing the medication. Statins can also cause your CPK(Creatine Phosphokinase) levels to be mildly elevated. CPK or Creatine Phosphokinase is a muscle enzyme that can be measured in the bloodstream. Muscle pain, mild inflammation, and possibly weakness are also seen. This condition, though uncommon, can take a long while to resolve. The third and most severe serious side effect of statins is called rhabdomyolysis. Muscles all over the body become painful and weakened because of extreme muscle inflammation and damage. CPK(Creatine Phosphokinase) levels are extremely elevated as well. The kidneys can become overworked trying to eliminate a large amount of muscle breakdown caused by statin use. The severely damaged muscles release proteins into the blood that collect in the kidneys, thereby causing damage. This can ultimately lead to kidney failure or even death. I suffer from high cholesterol:I have been taking Lipitor (atorvastatin), Zocor (simvastatin) and Lipidil Supra(fenofibrate).I am trying now Zocor (simvastatin) alone. If you experience any unexplained joint or muscle pain, tenderness, or weakness while taking statins, you should call your doctor immediately. Take care as always! Answered by Jefferey Sood 1 year ago.

should you enter 2000 energy an afternoon and output 1999 you're going to achieve fats,medical walk in the park....alternatively should you've received the calorie steadiness proper and feature sloshing round 10 litres of water on your stomach (which is not calorific) you're wearing yet another 10 kilo.So you can be keeping fluid.See your health care professional Answered by Alena Daus 1 year ago.


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