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Advicor and Gemfibrozil

Determining the interaction of Advicor and Gemfibrozil and the possibility of their joint administration.

Check result:
Advicor <> Gemfibrozil
Relevance: 15.06.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Talk to your doctor before using lovastatin together with gemfibrozil. Combining these medications may significantly increase the blood levels of lovastatin. This can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. In some cases, rhabdomyolysis can cause kidney damage and even death. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications, or your doctor may prescribe alternative medications that do not interact. Let your doctor know immediately if you have unexplained muscle pain, tenderness, or weakness during treatment with lovastatin or similar medications, especially if these symptoms are accompanied by fever or dark colored urine. You should also seek immediate medical attention if you develop fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

GENERALLY AVOID: Coadministration with gemfibrozil has been shown to significantly increase the plasma concentrations of lovastatin acid, the active metabolite of lovastatin. The mechanism of interaction has not been described. In 11 healthy volunteers, administration of a single 40 mg dose of lovastatin in combination with gemfibrozil (600 mg twice a day for 3 days) increased the mean lovastatin acid peak plasma concentration (Cmax) and 24-hour systemic exposure (AUC) by approximately 2.8-fold each. High levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity. Myopathy manifested as muscle pain and/or weakness associated with grossly elevated creatine kinase exceeding ten times the upper limit of normal has been reported occasionally. Rhabdomyolysis has also occurred rarely, which may be accompanied by acute renal failure secondary to myoglobinuria and may result in death. In the same study, bezafibrate 400 mg/day for 3 days had no significant effect on the pharmacokinetics of lovastatin acid. Preliminary data also suggest that the addition of gemfibrozil to lovastatin therapy is not associated with greater reduction in LDL cholesterol than that achieved with lovastatin alone. In uncontrolled clinical studies, most of the patients who have developed myopathy were receiving concomitant therapy with cyclosporine, gemfibrozil or niacin (nicotinic acid).

MANAGEMENT: The use of lovastatin with gemfibrozil or other fibrates should generally be avoided. All patients receiving statin therapy should be advised to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever, malaise and/or dark-colored urine. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed.

References
  • Pierce LR, Wysowski DK, Gross TP "Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy." JAMA 264 (1990): 71-5
  • Lozada A, Dujovne CA "Drug interactions with fibric acids." Pharmacol Ther 63 (1994): 163-76
  • Schwandt P "Drug interactions and side effects of hypolipidemic drugs." Int J Clin Pharmacol Biopharm 17 (1979): 351-6
  • "Product Information. Mevacor (lovastatin)." Merck & Co, Inc, West Point, PA.
  • Kyrklund C, Backman JT, Kivisto KT, Neuvonen M, Laitila J, Neuvonen PJ "Plasma concentrations of active lovastatin acid are markedly increased by gemfibrozil but not by bezafibrate." Clin Pharmacol Ther 69 (2001): 340-5
Advicor

Generic Name: lovastatin / niacin

Brand name: Advicor

Synonyms: n.a.

Gemfibrozil

Generic Name: gemfibrozil

Brand name: Lopid

Synonyms: n.a.

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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