Ketek and Simvastatin

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.

Using telithromycin together with simvastatin is not recommended. Combining these medications 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. 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 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.

CONTRAINDICATED: Coadministration with telithromycin may significantly increase the plasma concentrations of simvastatin and lovastatin and their active acid metabolites. The mechanism is decreased clearance due to inhibition of CYP450 3A4 by telithromycin. Coadministration of telithromycin and simvastatin has resulted in a 5.3-fold increase in the simvastatin peak plasma concentration (Cmax), an 8.9-fold increase in the simvastatin systemic exposure (AUC), a 15-fold increase in the simvastatin acid Cmax, and a 12-fold increase in the simvastatin acid AUC. These values were still increased 3- to 4-fold when the drugs were administered 12 hours apart. Although not studied, the interaction is also expected to occur at a comparable level with lovastatin due to its similar metabolic profile to simvastatin. 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.

MANAGEMENT: Due to the potential for severe interaction, concomitant use of simvastatin or lovastatin with potent CYP450 3A4 inhibitors including telithromycin is considered contraindicated. Fluvastatin, pravastatin, pitavastatin, and rosuvastatin are probably safer alternatives, since they are not metabolized by CYP450 3A4. 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.

Ketek

Generic Name: telithromycin

Brand name: Ketek

Synonyms: n.a.

What is Ketek?

Simvastatin

Generic Name: simvastatin

Brand name: Zocor, Flolipid

Synonyms: n.a.

What is Simvastatin?