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Flolipid and Prestalia

Determining the interaction of Flolipid and Prestalia and the possibility of their joint administration.

Check result:
Flolipid <> Prestalia
Relevance: 09.11.2022 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 simvastatin together with amLODIPine. 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.

Professional:

ADJUST DOSE: Coadministration with amlodipine may significantly increase the plasma concentrations of simvastatin and its active metabolite, simvastatin acid, and potentiate the risk of statin-induced myopathy. The proposed mechanism is amlodipine inhibition of simvastatin metabolism via intestinal and hepatic CYP450 3A4. When a single 80 mg dose of simvastatin was administered on day 10 of amlodipine given at a dosage of 10 mg once daily, simvastatin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by an average of 1.5- and 1.8-fold, respectively, while simvastatin acid Cmax and AUC increased by an average of 1.6-fold each. 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.

MANAGEMENT: Simvastatin dosage should not exceed 20 mg daily when used in combination with amlodipine. The benefits of this combination should be carefully weighed against the potentially increased risk of myopathy including rhabdomyolysis. Fluvastatin, pravastatin, and rosuvastatin are probably safer alternatives in patients receiving amlodipine, 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.

References
  • "Product Information. Zocor (simvastatin)." Merck & Co, Inc, West Point, PA.
Flolipid

Generic Name: simvastatin

Brand name: Flolipid, Zocor

Synonyms: n.a.

Prestalia

Generic Name: amlodipine / perindopril

Brand name: Prestalia

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.

Interaction with food and lifestyle
Disease interaction