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| __NOTOC__
| | #REDIRECT [[Fenofibrate]] |
| {{Fenofibrate}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use In Specific Populations==
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| ===Pregnancy===
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| '''Pregnancy Category C'''
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| Safety in pregnant women has not been established. There are no adequate and well controlled studies of fenofibrate in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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| In female rats given oral dietary doses of 15, 75, and 300 mg/kg/day of fenofibrate from 15 days prior to mating through weaning, maternal toxicity was observed at 0.3 times the maximum recommended human dose (MRHD), based on body surface area comparisons; mg/m2.
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| In pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6-15 during the period of organogenesis, adverse developmental findings were not observed at 14 mg/kg/day (less than 1 times the MRHD, based on body surface area comparisons; mg/m2). At higher multiples of human doses, evidence of maternal toxicity was observed.
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| In pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, aborted litters were observed at 150 mg/kg/day (10 times the MRHD, based on body surface area comparisons: mg/m2). No developmental findings were observed at 15 mg/kg/day (at less than 1 times the MRHD, based on body surface area comparisons; mg/m2).
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| In pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), maternal toxicity was observed at less than 1 times the MRHD, based on body surface area comparisons; mg/m2.
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| ===Nursing Mothers===
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| Fenofibrate should not be used in nursing mothers. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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| ===Pediatric Use===
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| Safety and effectiveness have not been established in pediatric patients.
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| ===Geriatric Use===
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| Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Fenofibric acid exposure is not influenced by age. Since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)]. Elderly patients with normal renal function should require no dose modifications. Consider monitoring renal function in elderly patients taking Antara.
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| ===Renal Impairmen===
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| Fenofibrate should be avoided in patients with severe [[renal impairment]] [see Contraindications (4)]. Dose reduction is required in patients with mild to moderate renal impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. Monitoring renal function in patients with renal impairment is recommended.
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| ===Hepatic Impairment===
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| The use of Antara has not been evaluated in subjects with hepatic impairment [see Contraindications (4) and Clinical Pharmacology (12.3)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TRIGLIDE (FENOFIBRATE) TABLET [SHIONOGI INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94a4a99b-24df-4e81-b409-5325d36647d2#nlm34067-9 | publisher = | date = | accessdate = 12 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| {{Lipid modifying agents}}
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| {{Antigout preparations}}
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| [[Category:Fibrates]] | |
| [[Category:Prodrugs]]
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| [[Category:Organochlorides]]
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| [[Category:Benzophenones]]
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| [[Category:Phenol ethers]]
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| [[Category:Carboxylate esters]]
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