Gemfibrozil precautions: Difference between revisions

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#REDIRECT [[Gemfibrozil#Warnings]]
==Drug interactions==
 
<font size="4">[[Gemfibrozil precautions#Initial Therapy|Initial Therapy]]</font>
[[Category: Cardiovascular Drugs]]
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[[Category: Drug]]
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[[Category:Fibrates]]
<font size="4">[[Gemfibrozil precautions#Continued Therapy|Continued Therapy]]</font>
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<font size="4">[[Gemfibrozil precautions#Pregnancy Category C|Pregnancy Category C]]</font>
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<font size="4">[[Gemfibrozil precautions#Nursing Mothers|Nursing Mothers]]</font>
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<font size="4">[[Gemfibrozil precautions#Hematologic Changes|Hematologic Changes]]</font>
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<font size="4">[[Gemfibrozil precautions#Liver Function|Liver Function]]</font>
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<font size="4">[[Gemfibrozil precautions#Kidney Function|Kidney Function]]</font>
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<font size="4">[[Gemfibrozil precautions#Pediatric Use|Pediatric Use]]</font>
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===Initial Therapy===
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal. Before instituting LOPID therapy, every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. ''[[Gemfibrozil drug interactions#List of indications|Return to top]]''
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===Continued Therapy===
Periodic determination of serum lipids should be obtained, and the drug withdrawn if lipid response is inadequate after three months of therapy.
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===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 at2 times the human dose (based on surface area) before and throughout gestation caused a dose-related decrease in conception rate and,  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.
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===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.
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===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.
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===Liver Function===
Abnormal liver function tests have been observed occasionally during LOPID administration, including elevations of AST (SGOT), ALT (SGPT), 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.
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===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.
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===Pediatric Use===
Safety and efficacy in pediatric patients have not been established.
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{{FDA}}

Latest revision as of 16:25, 20 August 2015