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Fenofibrate (Fenofibrate)

Trade Name : Fenofibrate

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 48 mg/1

FENOFIBRATE Peroxisome Proliferator Receptor alpha Agonist [EPC]

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Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fenofibrate (Fenofibrate) which is also known as Fenofibrate and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 48 mg/1 per ml. Read more

Fenofibrate (Fenofibrate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Fenofibrate tablets are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
  • Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ().
  • No data
  • Fenofibrate Tablets, USP are available containing 48 mg or 145 mg of fenofibrate, USP.
  • Oral Tablets: 48 mg and 145 mg ().
  • Fenofibrate tablets are contraindicated in:
  • 4n- 8.6n- 12.3
  • 4n- 5.3
  • 4n- 5.5
  • 4n- 8.2
  • No data
  • 5.4n- 8.6
  • Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ().n
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • No data
  • There is no specific treatment for overdose with fenofibrate tablets. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.
  • Fenofibrate tablets, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:
  • The molecular formula is CHOCl and the molecular weight is 360.8; fenofibrate is insoluble in water. The melting point is 79-82u00b0C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions.
  • Inactive Ingredients:
  • No data
  • Two dietary carcinogenicity studies have been conducted in rats with fenofibrate. In the first 24-month study, Wistar rats were dosed with fenofibrate at 10, 45, and 200 mg/kg/day, approximately 0.3, 1, and 6 times the maximum recommended human dose (MRHD) of 300 mg fenofibrate daily, equivalent to 145 mg fenofibrate tablets daily, based on body surface area comparisons. At a dose of 200 mg/kg/day (at 6 times the MRHD), the incidence of liver carcinomas was significantly increased in both sexes. A statistically significant increase in pancreatic carcinomas was observed in males at 1 and 6 times the MRHD; an increase in pancreatic adenomas and benign testicular interstitial cell tumors was observed at 6 times the MRHD in males. In a second 24-month rat carcinogenicity study in a different strain of rats (Sprague-Dawley), doses of 10 and 60 mg/kg/day (0.3 and 2 times the MRHD) produced significant increases in the incidence of pancreatic acinar adenomas in both sexes and increases in testicular interstitial cell tumors in males at 2 times the MRHD.
  • A 117-week carcinogenicity study was conducted in rats comparing three drugs: fenofibrate 10 and 60 mg/kg/day (0.3 and 2 times the MRHD, based on body surface area comparisons), clofibrate (400 mg/kg/day; 2 times the human dose), and gemfibrozil (250 mg/kg/day; 2 times the human dose, based on mg/m surface area). Fenofibrate increased pancreatic acinar adenomas in both sexes. Clofibrate increased hepatocellular carcinoma and pancreatic acinar adenomas in males and hepatic neoplastic nodules in females. Gemfibrozil increased hepatic neoplastic nodules in males and females, while all three drugs increased testicular interstitial cell tumors in males.
  • In a 21-month study in CF-1 mice, fenofibrate 10, 45, and 200 mg/kg/day (approximately 0.2, 1, and 3 times the MRHD, based on body surface area comparisons) significantly increased the liver carcinomas in both sexes at 3 times the MRHD. In a second 18-month study at 10, 60, and 200 mg/kg/day, fenofibrate significantly increased the liver carcinomas in male mice and liver adenomas in female mice at 3 times the MRHD.
  • Electron microscopy studies have demonstrated peroxisomal proliferation following fenofibrate administration to the rat. An adequate study to test for peroxisome proliferation in humans has not been done, but changes in peroxisome morphology and numbers have been observed in humans after treatment with other members of the fibrate class when liver biopsies were compared before and after treatment in the same individual.
  • Fenofibrate has been demonstrated to be devoid of mutagenic potential in the following tests: Ames, mouse lymphoma, chromosomal aberration and unscheduled DNA synthesis in primary rat hepatocytes.
  • In fertility studies rats were given oral dietary doses of fenofibrate, males received 61 days prior to mating and females 15 days prior to mating through weaning which resulted in no adverse effect on fertility at doses up to 300 mg/kg/day (10 times the MRHD, based on body surface area comparisons).
  • No data
  • Fenofibrate Tablets, USP are available containing 48 mg or 145 mg of fenofibrate, USP.
  • The 48 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-3065-77bottles of 90 tablets
  • NDC 0378-3065-05bottles of 500 tablets
  • The 145 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-3066-77bottles of 90 tablets
  • NDC 0378-3066-05bottles of 500 tablets
  • Storage: Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Keep out of the reach of children. Protect from moisture.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Patients should be advised:
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabadu2014500 096, India
  • Revised: 5/2019MX:FNFBR:R5
  • NDC 0378-3065-77
  • Fenofibraten- Tablets, USPn- 48 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a090 Tablets
  • Each film-coated tablet contains:Fenofibrate, USPu00a0u00a0u00a0u00a0u00a048 mg
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Protect from moisture.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX3065MM2
  • Do not accept if seal over bottleopening is broken or missing.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • NDC 0378-3066-77
  • Fenofibraten- Tablets, USPn- 145 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a090 Tablets
  • Each film-coated tablet contains:Fenofibrate, USPu00a0u00a0u00a0u00a0u00a0145 mg
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Protect from moisture.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX3066MM2
  • Do not accept if seal over bottleopening is broken or missing.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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