Multaq and Zocor

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.

Dronedarone may significantly increase the blood levels of simvastatin. 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. Talk to your doctor if you have any questions or concerns. Your doctor may already be aware of the interaction, but has determined that this is the best course of treatment for you and has taken appropriate precautions or made dose adjustments and is monitoring you closely for any potential complications. Your doctor may also be able to prescribe alternatives that do not interact. Let your doctor know immediately if you have unexplained muscle pain, tenderness, or weakness during treatment with simvastatin 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.

ADJUST DOSE: Coadministration with dronedarone may significantly increase the plasma concentrations of simvastatin and its active metabolite, simvastatin acid. The mechanism probably involves enhanced absorption as well as reduced clearance of simvastatin and simvastatin acid due to inhibition of both intestinal P-glycoprotein (P-gp) drug efflux transporter and hepatic/intestinal CYP450 3A4 isoenzyme by dronedarone. When simvastatin is given with dronedarone 400 mg twice daily, simvastatin and simvastatin acid exposure increased by 4-fold and 2-fold, respectively. Although not studied, the interaction is also expected to occur with lovastatin due to its similar metabolic profile to simvastatin. Clinically, high levels of statin or 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 clinical trials, concomitant use of simvastatin with other moderate CYP450 3A4/P-gp inhibitors such as amiodarone, diltiazem, and verapamil has been associated with an increased risk of myopathy, especially at high dosages of simvastatin (e.g., 80 mg/day).

MANAGEMENT: The manufacturers recommend that simvastatin dosage not exceed 10 mg daily and lovastatin dosage not exceed 20 mg daily when used in combination with dronedarone. In addition, the benefits of the combination should be carefully weighed against the potentially increased risk of myopathy including rhabdomyolysis. Fluvastatin, pitavastatin, and rosuvastatin are probably safer alternatives in patients receiving dronedarone, since they are not substrates of CYP450 3A4 or P-gp. 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.

Multaq

Generic Name: dronedarone

Brand name: Multaq

Synonyms: n.a.

What is Multaq?

Zocor

Generic Name: simvastatin

Brand name: Zocor, Flolipid

Synonyms: n.a.

What is Zocor?