|
|
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Gemfibrozil#Use in Specific Populations]] |
| {{Gemfibrozil}}
| |
| {{CMG}}; {{AE}} {{SS}}
| |
| | |
| ==Use In Specific Populations==
| |
| | |
| ===Pregnancy Category C===
| |
| | |
| LOPID has been shown to produce adverse effects in rats and rabbits at doses between 0.5 and 3 times the human dose (based on surface area). There are no adequate and well-controlled studies in pregnant women. LOPID should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
| |
| | |
| Administration of LOPID to female rats at 2 times the human dose (based on surface area) before and throughout gestation caused a dose-related decrease in conception rate, an increase in stillborns, and a slight reduction in pup weight during lactation. There were also dose-related increased skeletal variations. Anophthalmia occurred, but rarely.
| |
| | |
| Administration of 0.6 and 2 times the human dose (based on surface area) of LOPID to female rats from gestation day 15 through weaning caused dose-related decreases in birth weight and suppressions of pup growth during lactation.
| |
| | |
| Administration of 1 and 3 times the human dose (based on surface area) of LOPID to female rabbits during organogenesis caused a dose-related decrease in litter size and, at the high dose, an increased incidence of parietal bone variations.
| |
| | |
| ===Nursing Mothers===
| |
| | |
| It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for LOPID in animal studies, 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.
| |
| | |
| ===Hematologic Changes===
| |
| | |
| Mild hemoglobin, hematocrit and white blood cell decreases have been observed in occasional patients following initiation of LOPID therapy. However, these levels stabilize during long-term administration. Rarely, severe [[anemia]], [[leukopenia]], [[thrombocytopenia]], and [[bone marrow hypoplasia]] have been reported. Therefore, periodic blood counts are recommended during the first 12 months of LOPID administration.
| |
| | |
| ===Liver Function===
| |
| | |
| Abnormal liver function tests have been observed occasionally during LOPID administration, including elevations of [[AST]],[[ ALT]], [[LDH]], [bilirubin]], and [[alkaline phosphatase]]. These are usually reversible when LOPID is discontinued. Therefore, periodic liver function studies are recommended and LOPID therapy should be terminated if abnormalities persist.
| |
| | |
| ===Kidney Function===
| |
| | |
| There have been reports of worsening [[renal insufficiency ]]upon the addition of LOPID therapy in individuals with baseline plasma creatinine >2.0 mg/dL. In such patients, the use of alternative therapy should be considered against the risks and benefits of a lower dose of LOPID.
| |
| | |
| ===Pediatric Use===
| |
| | |
| Safety and efficacy in pediatric patients have not been established.<ref>{{Cite web | last = | first = | title = DailyMed: Search | url = http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=+Lopid&x=11&y=10 | publisher = | date = | accessdate = 13 February 2014 }}</ref>
| |
| | |
| ==References==
| |
| | |
| {{Reflist|2}}
| |
|
| |
|
| | [[Category: Cardiovascular Drugs]] |
| | [[Category: Drug]] |
| [[Category:Fibrates]] | | [[Category:Fibrates]] |
| [[Category:Phenol ethers]]
| |
| [[Category:Cardiovascular Drug]]
| |
| [[Category:Drug]]
| |