Actoplus Met and Ketoconazole (Systemic)

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.

Ketoconazole may increase the blood levels and effects of pioglitazone. This can increase the risk of hypoglycemia (low blood sugar). Symptoms include headache, dizziness, drowsiness, nervousness, weakness, tremor, nausea, hunger, sweating, and fast or pounding heartbeats. You may need a dose adjustment or more frequent monitoring of your blood sugar to safely use both medications. 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.

MONITOR: Coadministration with ketoconazole may increase the plasma concentrations of pioglitazone. The proposed mechanism is ketoconazole inhibition of the metabolism of pioglitazone via CYP450 2C8 and 3A4. According to the product labeling, administration of pioglitazone in combination with ketoconazole 200 mg twice daily for 7 days increased the pioglitazone peak plasma concentration (Cmax), systemic exposure and minimum plasma concentration (Cmin) by 14%, 34% and 87%, respectively. No clinical effects attributable to the interaction were reported. However, clinical significance of the interaction in diabetics cannot be precluded due to potentially reduced counter-regulatory response to hypoglycemia in these patients.

MANAGEMENT: Because the antidiabetic effect of pioglitazone is dose- and concentration-dependent, pharmacologic response to pioglitazone should be monitored more closely following the addition or discontinuation of ketoconazole. Patients should be advised to regularly monitor their blood sugar and counseled on how to recognize and treat hypoglycemia, which may include symptoms such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, and palpitations. The pioglitazone dosage may require adjustment if an interaction is suspected.

Actoplus Met

Generic Name: metformin / pioglitazone

Brand name: Actoplus Met, Actoplus Met XR

Synonyms: n.a.

What is Actoplus Met?

Ketoconazole (Systemic)

Generic Name: ketoconazole

Brand name: Nizoral

Synonyms: Ketoconazole

What is Ketoconazole (Systemic)?