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Fenofibrate (Fenofibrate)

Trade Name : Fenofibrate

Teva Pharmaceuticals USA Inc

TABLET

Strength 48 mg/1

FENOFIBRATE Peroxisome Proliferator Receptor alpha Agonist [EPC]

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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 Teva Pharmaceuticals USA 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

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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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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
  • No data
  • Fenofibrate tablets for oral use 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 .
  • To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia .
  • For treatment of adult patients with severe hypertriglyceridemia .
  • No data
  • Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 145 mg once daily .
  • Severe hypertriglyceridemia: Initial dose of 48 to 145 mg once daily. Maximum dose is 145 mg .
  • Renally impaired patients: Initial dose of 48 mg once daily .
  • Geriatric patients: Select the dose on the basis of renal function.
  • Maybe taken without regard to meals .
  • Oral Tablets: 48 mg and 145 mg .
  • Fenofibrate tablets for oral use are contraindicated in:
  • Severe renal dysfunction, including dialysis patients , , .
  • Active liver disease , .
  • Gallbladder disease , .
  • Known hypersensitivity to fenofibrate .
  • Nursing mothers , .
  • No data
  • Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. Risks are increased during co-administration with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism .
  • Fenofibrate tablets for oral use can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy .
  • Fenofibrate tablets for oral use can reversibly increase serum creatinine levels . Monitor renal function periodically in patients with renal impairment .
  • Fenofibrate tablets for oral use increase cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated .
  • Use caution in concomitant treatment with oral coumarin anticoagulants. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications .
  • Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment. Discontinue fenofibrate and treat patients appropriately if reactions occur .
  • Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis .n n n
  • No data
  • Coumarin anticoagulants: .
  • Immunosuppressants: .
  • Bile acid resins: .
  • No data
  • Geriatric Use: Determine dose selection based on renal function .
  • Renal Impairment: Avoid use in severe renal impairment patients. Dose reduction is required in mild to moderate renal impairment patients .
  • There is no specific treatment for overdose with Fenofibrate tablets for oral use. 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 for oral use 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 empirical formula is CHOCl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82u00b0C. Fenofibrate is a white solid which is stable under ordinary conditions.
  • Inactive Ingredients
  • Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate.
  • In addition, individual tablets contain:
  • 48 mg tablets
  • polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake.
  • 145 mg tablets
  • polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.
  • 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 for oral use 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 for oral use are available in two strengths:
  • 48 mg
  • Yellow tablets, imprinted with the code identification letters u201cFIu201d, available in bottles of 90 (NDC 0093-7755-98).
  • Yellow tablets, imprinted with the u201cau201d logo and code identification letters u201cFIu201d, available in bottles of 90 (NDC 0093-2061-98).
  • 145 mg
  • White tablets, imprinted with the code identification letters u201cFOu201d, available in bottles of 90 (NDC 0093-7756-98).
  • White tablets, imprinted with the u201cau201d logo and code identification letters u201cFOu201d, available in bottles of 90 (NDC 0093-2060-98).
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F).
  • [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
  • No data
  • 03-B821 November, 2018
  • NDC 0093-2061-98
  • FENOFIBRATE Tablets 48 mg
  • NDC 0093-2060-98
  • FENOFIBRATE Tablets 145 mg
  • NDC 0093-7755-98
  • FENOFIBRATE Tablets 48 mg
  • Rx only
  • 90 TABLETS
  • TEVA
  • NDC 0093-7756-98
  • FENOFIBRATE Tablets 145 mg
  • Rx only
  • 90 TABLETS
  • TEVA

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