Actoplus Met and Gemfibrozil

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.

Gemfibrozil may significantly increase the blood levels of pioglitazone. You may be more likely to experience hypoglycemia, or low blood sugar, when these medications are used together. Symptoms of hypoglycemia include headache, dizziness, drowsiness, nervousness, weakness, tremor, nausea, hunger, sweating, and palpitation. The risk of other serious but uncommon side effects of pioglitazone such as fluid retention, macular edema (swelling in the back of the eye), new or worsening heart failure, bone fractures, anemia, and liver problems may also be increased. Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. Contact your doctor immediately if you experience blurred vision or other visual abnormalities; excessive or rapid weight gain; swelling in the ankles or legs; shortness of breath or difficulty breathing; unusual tiredness; chest pain or tightness; or worsening of existing heart problems. You should also seek prompt medical attention if you develop signs and symptoms of liver damage such as fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, light colored stools, and yellowing of the skin or eyes. 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 gemfibrozil may significantly increase the plasma concentrations of pioglitazone. The proposed mechanism is gemfibrozil inhibition of the CYP450 2C8-mediated metabolism of pioglitazone. In 10 healthy volunteers given gemfibrozil 600 mg twice daily for two days prior to coadministration with a single 30 mg dose of pioglitazone on day 3, mean pioglitazone systemic exposure (AUC) increased by 3.4-fold and elimination half-life from 6.5 to 15.1 hours. In two other studies of 12 and 30 healthy volunteers, gemfibrozil administered similarly increased the mean AUC of a single 15 mg dose of pioglitazone by 3.2- and 4.3-fold, respectively, and nearly tripled the mean elimination half-life. The interaction is subject to a high degree of interpatient variability, which may be at least partially attributable to CYP450 2C8 polymorphism.

MANAGEMENT: Given the potential for dose-related adverse events, a lower dosage of pioglitazone may be necessary when used with gemfibrozil. The labeling recommends a maximum dosage of 15 mg daily when used with gemfibrozil or other potent CYP450 2C8 inhibitors. Close monitoring for the development of hypoglycemia and other adverse effects is recommended, such as fluid retention; weight gain; new or worsening heart failure; pulmonary, peripheral, and macular edema; bone fractures; anemia; and liver enzyme elevations. Patients should regularly monitor their blood sugar and learn how to recognize and treat hypoglycemia, which may include symptoms such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, and palpitation. Likewise, patients should be observed for potential loss of glycemic control following discontinuation of gemfibrozil, and the pioglitazone dosage adjusted as necessary.

Actoplus Met

Generic Name: metformin / pioglitazone

Brand name: Actoplus Met, Actoplus Met XR

Synonyms: n.a.

What is Actoplus Met?

Gemfibrozil

Generic Name: gemfibrozil

Brand name: Lopid

Synonyms: n.a.

What is Gemfibrozil?