Fenofibrate drug data and news

Fenofibrate drug data, resources, and news articles (when available). Onconews.org provides news on cancer research. This section, which includes profiles on medicines that may or not be cancer-related is in beta form. If things run smoothly we will be releasing a new format late in the summer of 2006.

Generic name Fenofibrate
Brand Names/Synonyms Ankebin; Antara; CCRIS 7282; CHEMBANK1172; Elasterate; Elasterin; F6020; FNF; Fenobrate; Fenofibrate; Fenofibrate [Ban:Inn]; Fenofibrato [Inn-Spanish]; Fenofibratum [Inn-Latin]; Fenogal; Fenotard; Finofibrate; LF-178; Lipanthyl; Lipantil; Lipidex; Lipidil; Lipidil Micro; Lipidil Supra; Lipifen; Lipirex; Lipoclar; Lipofene; Liposit; Lipsin; Lofibra; Luxacor; Nolipax; Procetofen; Proctofene; Protolipan; Secalip; Sedufen; Tricor; Triglide
Indication For use as adjunctive therapy to diet to reduce elevated LDL-C, Total-C,Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)
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Description Not Available
Pharmacology Fenofibrate is a lipid regulating agent indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C,Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Fenofibrate is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Fenofibric acid, the active metabolite of Fenofibrate, produces reductions in total cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides and triglyceride rich lipoprotein (VLDL) in treated patients. In addition, treatment with fenofibrate results in increases in high density lipoprotein (HDL) and apoproteins apoAI and apoAII.
Mechanism Of Action Fenofibrate exerts its therapeutic effects through activation of peroxisome proliferator activated receptor a (PPARa). This increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III. The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles, to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly.
Fenofibrate News
(When available)

Pseudoephedrine Prescriptions  07 Mar 2006
..."The ones that contain just pseudoephedrine will be on prescription," said pharmacist Sid Frank. He's getting ready for July, when ... - KVAL,

Patriot Act takes aim at meth production  07 Mar 2006
Dianne Feinstein, D-Calif., and Jim Talent, R-Mo., would blanket the nation with one policy that would put medicines containing pseudoephedrine behind the ... - Seattle Times,

Anti-meth measure gets OK'd  07 Mar 2006
The anti-meth measure would restrict the sale of common cold products containing pseudoephedrine, the main ingredient used in making meth, and require that ... - Chillicothe Gazette,

Meth battle puts ill in line  07 Mar 2006
Pharmacies have had to pull some cold medicines off the shelves to keep them away from people who buy the drugs to extract pseudoephedrine, a primary ... - Fayetteville Online,

Deputy Drug Czar: Growing Amount of Meth Coming from Mexico  07 Mar 2006
...labs.". Last March the law went into effect, moving cold medicine and products containing pseudoephedrine behind the counter. According ... - KATV,

Ohio bill allows stores to make call on storage of pseudophedrine  07 Mar 2006
The federal law appears to include a provision ask for all medicines containing pseudoephedrine behind a counter or in a locked cabinet. ... - Chillicothe Gazette,

News Roundup  07 Mar 2006
In addition, officials said 24 large trash bags were found filled with emptied pseudoephedrine tablet boxes that contained 35 pounds of pure d-psuedophredrine ... - Monsters and Critics.com,

Police, fire and courts  07 Mar 2006
Campbell. Prosecutors said the pair was spotted buying pseudoephedrine tablets and lithium batteries at the Macomb Walgreen's. INDUSTRY ... - Peoria Journal Star,

Meth threatens young people at alarming rate, officials warn  07 Mar 2006
Green said the state has made encouraging steps such as taking cold medicines that contain pseudoephedrine, meth's essential ingredient, off store shelves in ... - OregonLive.com,

Dynavax Presents Positive TOLAMBA Phase 2/3 Results at AAAAI ...  07 Mar 2006
...season; ocular symptoms scores; nasal/ocular symptom scores; combined hayfever symptom scores; medication use (fexofenadine and pseudoephedrine) and safety. ... - PR Newswire (press release),

QUICK STUDY : A weekly digest of new research on major health ...  07 Mar 2006
· THIS STUDY randomly assigned 58 adults with ragweed allergies to take Sudafed (pseudoephedrine hydrochloride) or the prescription drug Singulair ... - Washington Post,

DEA nets meth 'superlab'  07 Mar 2006
In addition they said 24 large trash bags were found filled with emptied pseudoephedrine tablet boxes and contained holding 35 pounds of pure d-psuedophredrine ... - United Press International

Fewer meth labs uncovered in 2005  07 Mar 2006
The reduction is credited to the Sheriff Matt Samuals Bill which restricted the over-the-counter sale of pseudoephedrine, Chinn said. ... - Pratt Tribune,

Meth law reducing number of meth labs in our state  07 Mar 2006
Among other things, the statute requires retailers to place cold medicines that contain ephedrine and pseudoephedrine in locked display cases. ... - Hattiesburg American,

Auxiliary deputy spots “pill buyingâ€? at local store  07 Mar 2006
Douglas J. Parker, 32, and Brooke M. Foltz, 25, both of West Terre Haute, Ind., purchased two boxes each of pseudoephedrine pills at the pharmacy counter and ... - Paris Beacon News (subscription),

Pseudoephedrine tablets to make P worth $300,000 found at house in ...  Feb 27, 2006
...(IRN News Via Thomson Dialog NewsEdge)Enough pseudoephedrine tablets to make $300,000-worth of P have been found at an address in Upper Hutt. ... - TMCnet

Significant pseudoephedrine seizure  Feb 27, 2006
Locally sourced pseudoephedrine tablets located at an Upper Hutt address early yesterday morning (27 February 2006) were capable being manufactured into ... - New Zealand Police,

Governor signs pseudoephedrine restrictions into law  Mar 1, 2006
Pseudoephedrine, an ingredient in some cold medicines, can be extracted in makeshift labs to prepare meth. The new law requires ... - KOB-TV,

Avondale restricts sale of pseudoephedrine products  Feb 24, 2006
Avondale is joining other cities in restricting the sale of pseudoephedrine-related products in an effort to reduce the illicit use of methamphetamine. ... - Phoenix Business Journal,

SD Law Enforcement Supports Pseudoephedrine Bill  Feb 16, 2006
...having a hard time coming to an agreement over a bill that would make it easier for law enforcement to track individuals buying large amounts of pseudoephedrine ... - KELOLAND TV,

Keeping Pseudoephedrine Behind Pharmacy Counters  Feb 17, 2006
Patriot Act Legislation. It would require common cold remedies containing pseudoephedrine to be placed behind store counters. The goal ... - WEAU-TV 13,

Perrigo's pseudoephedrine woes offset by other results  Feb 3, 2006
...is spending money to reformulate pseudoephedrine-based cough and cold medications while losing money on existing pseudoephedrine products pulled from drugstore ... - MLive.com,

Too early to judge impact of new pseudoephedrine law  Feb 4, 2006
COLDWATER — “It’s still too early to tell� if a new law limiting sales of pseudoephedrine will be effective in cutting down on meth labs Branch County ... - Coldwater Daily Reporter,

Meth law attack problem here and abroad  Mar 3, 2006
The Combat Methamphetamine Epidemic Act will impose nationwide controls on cold remedies that contain pseudoephedrine, meth's essential ingredient, and ... - OregonLive.com,

FDA Approves Clarinex-D 12 Hour (Desloratadine/Pseudoephedrine) ...  Feb 2, 2006
...today announced that the US Food and Drug Administration (FDA) has approved Clarinex-D® 12 hour (desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg ... - DG News

Meth Suits Target Cold Medicine Makers, Sellers  Mar 2, 2006
...the subject of several new lawsuits that claim manufacturers and retailers have long ignored the fact that decongestants containing pseudoephedrine are being ... - International News Service,

Over-the-counter drug works well for allergies  Mar 1, 2006
NEW YORK (Reuters Health) - Contrary to what had been expected, new research shows that non-prescription pseudoephedrine controls nasal allergy symptoms just ... - Reuters

State program teaches retailers about meth  Mar 3, 2006
Agents will even encourage stores to put pseudoephedrine-based products behind the counter, said Justice Department spokeswoman Robin Schwanke. ... - Fresno Bee (subscription),

Bill regulates cold medicine used in meth  Mar 3, 2006
...heart of the new measure is a requirement that grocery stores and other retail outlets put Sudafed and other cold remedies that contain pseudoephedrine, a key ... - Contra Costa Times,

Loopholes seen in Missouri meth law  Feb 19, 2006
By MATTHEW HAAG. Restricting sales of the key ingredient in methamphetamine — pseudoephedrine — brought a decline in lab busts last year. ... - Columbia Missourian,

Talent says cold medicine law will hurt homegrown meth labs  Mar 3, 2006
The law, co-sponsored by Talent, R-Mo., and Sen. Dianne Feinstein, D-Calif., would limit access to cold pills like Sudafed that contain pseudoephedrine. ... - Belleville News-Democrat,

Global board sounds alarm over meth  Mar 1, 2006
...production is "spreading throughout the world at an alarming rate" as traffickers tap new overseas sources of ephedrine and pseudoephedrine, meth's necessary ... - OregonLive.com,

No Difference Between Over-the-Counter Decongestant and ...  Mar 2, 2006
CHICAGO, IL -- MARCH 2, 2006 -- A small study indicates that there was no difference between an over-the-counter decongestant (pseudoephedrine) and a ... - DG News

FDA Approves CLARINEX-D 12 HOUR (desloratadine 2.5mg ...  Feb 2, 2006
...today announced that the US Food and Drug Administration (FDA) has approved CLARINEX-D(R) 12 HOUR (desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg ... - PharmaLive.com (press release),

Testing: Generic Versus Prescription Ends in a Tie  Feb 27, 2006
Pseudoephedrine, a generic drug sold over the counter, is just as effective in treating hay fever as the prescription drug Singulair, a new study has found ... - New York Times,

OTC allergy drug keeps pace with Singulair  Feb 20, 2006
..."Our hypothesis was that montelukast would have additional benefits and pseudoephedrine would interfere with sleep, but when we compared them head-to-head, we ... - United Press International

Congress OKs landmark restrictions to fight meth  Mar 3, 2006
The Combat Methamphetamine Epidemic Act will impose nationwide controls on cold remedies that contain pseudoephedrine, meth's essential ingredient, and ... - OregonLive.com,

Bureau of Narcotic Enforcement's Merchant Program Launched in ...  Mar 1, 2006
...s (BNE) Merchant Program to educate retailers about the dangers of methamphetamine, how cold and allergy products containing pseudoephedrine are used to ... - Community Dispatch (press release)

Eye on KELOLAND Eye on KELOLAND  Feb 22, 2006
As important as Sudafed is for some people fighting the sniffles, pseudoephedrine is the essential ingredient for making methamphetamine drugs. ... - KELOLAND TV,

Ex-LB officer charged in robberies  Mar 3, 2006
...group stole television sets from an 18-wheel truck in Montebello, while another caper involved the robbery of $45,000 worth of pseudoephedrine pills outside a ... - Long Beach Press-Telegram,

Iowa meth bill part of federal legislation  Mar 3, 2006
The law forced stores to put medications that contain pseudoephedrine behind the counter and forces people to show an ID and sign a log book when they buy ... - Radio Iowa,

Meth bill to help valley?  Mar 3, 2006
Cold medicines containing the popular meth ingredients pseudoephedrine or ephedrine would have to be placed behind a counter for sale. ... - Modesto Bee,

The meth breakthrough  Mar 4, 2006
The meth legislation means that consumers of products made from ephedrine and pseudoephedrine will face restrictions on over-the-counter sales throughout the ... - OregonLive.com,

Meth education launched  Mar 3, 2006
Over-the-counter cold and allergy products often contain pseudoephedrine, a major ingredient in the production of methamphetamines. ... - Sacramento Bee,

Dosage Forms CAPSULE; TABLET
Drug_Category Antilipemic Agents; Fribic Acid Derivatives; ATC:C10AB05
Absorption Fenofibrate is well absorbed from the gastrointestinal tract. After absorption, fenofibrate is mainly excreted in the urine in the form of metabolites, primarily fenofibric acid and fenofibric acid glucuronide
Interactions -->Interactions for Fenofibrate:

Oral Anticoagulants

CAUTION SHOULD BE EXERCISED WHEN COUMARIN ANTICOAGULANTS ARE GIVEN IN CONJUNCTION WITH TRICOR. THE DOSAGE OF THE ANTICOAGULANTS SHOULD BE REDUCED TO MAINTAIN THE PROTHROMBIN TIME/INR AT THE DESIRED LEVEL TO PREVENT BLEEDING COMPLICATIONS. FREQUENT PROTHROMBIN TIME/INR DETERMINATIONS ARE ADVISABLE UNTIL IT HAS BEEN DEFINITELY DETERMINED THAT THE PROTHROMBIN TIME/INR HAS STABILIZED.

HMG-CoA reductase inhibitors

The combined use of TRICOR and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.

Resins

Since bile acid sequestrants may bind other drugs given concurrently, patients should take TRICOR at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption.

Cyclosporine

Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including TRICOR, there is a risk that an interaction will lead to deterioration. The benefits and risks of using TRICOR with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.

 

Drug-drug interactions

In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6, and mild-to-moderate inhibitors of CYP2C9 at therapeutic concentrations.

Potentiation of coumarin-type anticoagulants has been observed with prolongation of the prothrombin time/INR.

Bile acid sequestrants have been shown to bind other drugs given concurrently. Therefore, fenofibrate should be taken at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption .

Concomitant administration of fenofibrate (equivalent to 145mg TRICOR) with pravastatin (40 mg) once daily for 10 days has been shown to increase the mean Cmax and AUC values for pravastatin by 36% (range from 69% decrease to 321% increase) and 28% (range from 54% decrease to 128% increase), respectively, and for 3α-hydroxy-iso-pravastatin by 55% (range from 32% decrease to 314% increase) and 39% (range from 24% decrease to 261% increase), respectively in 23 healthy adults.

A single dose of pravastatin had no clinically important effect on the pharmacokinetics of fenofibric acid.

Concomitant administration of fenofibrate (equivalent to 145 mg TRICOR) with atorvastatin (20 mg) once daily for 10 days resulted in approximately 17% decrease (range from 67% decrease to 44% increase) in atorvastatin AUC values in 22 healthy males. The atorvastatin Cmax values were not significantly affected by fenofibrate. The pharmacokinetics of fenofibric acid were not significantly affected by atorvastatin.

 

Toxicity Oral LD50 (mouse):1600 mg/kg. Investigated as a teratogen and reproductive hazard.
Organisms Affected Humans and other mammals
Chemical IUPAC Name 1-methylethyl2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propanoate
Chemical Formula C20H21ClO4
Molecular Weight 360.831 g/mol
Smiles String CC(C)OC(=O)C(C)(C)OC1=CC=C(C=C1)C(=O)C2=CC=C(C=C2)Cl
Melting Point 80.5 °C
Water Solubility 0.25mg/ml at 25 °C
State Solid
LogP/Hphobicity 5.575
Isoelectric Point Not Available
Biotransformation Not Available
Half Life 20 hours
Protein Binding [%] ~99% (Serum protein binding)
RxList Link RXlist
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Drug Reference http://www.pdrhealth.com/drug_info/rxdrugprofiles/drugs/cx1550.shtml
http://www.drugs.com/cons/Fenofibrate.html
http://www.rxlist.com/cgi/generic3/fenofibrate.htm
Drug Type Approved Drug
Accession No APRD00405
CAS Registry Number 49562-28-9
KEGG Compound ID C07586
PubChem ID SID:180502
PharmGKB ID PA449594
SwissProt ID Not Available
GenBank ID Not Available
Drug ID Number [DIN] 2250039

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