Dronedarone Hydrochloride and Jantoven

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 can increase the effects of warfarin and cause you to bleed more easily. Call your doctor immediately if you have any unusual bleeding, bruising, vomiting, blood in your urine or stools, headache, dizziness, or weakness during treatment with these 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 dronedarone may occasionally increase the hypoprothrombinemic effects of warfarin. The exact mechanism of interaction is unknown. When healthy subjects were administered warfarin in combination with dronedarone 600 mg twice daily, systemic exposure to the more active S(-) enantiomer of warfarin, which is primarily metabolized by CYP450 2C9, increased by 1.2-fold compared to warfarin administered alone. Systemic exposure to R(+) warfarin, which is metabolized by CYP450 1A2 and 3A4, was unchanged. No clinically significant increases in INR were observed. Interestingly, dronedarone is a moderate inhibitor of CYP450 3A4, but has not been shown to inhibit CYP450 2C9. In one clinical trial (ATHENA), more patients taking oral anticoagulants experienced clinically significant INR elevations (>= 5) usually within 1 week after starting dronedarone as opposed to placebo, although no excess risk of bleeding was observed in the dronedarone group. Pooled data from six clinical trials including ATHENA also revealed no major differences in frequency of bleeding complications between patients treated with dronedarone versus placebo. However, postmarketing cases of INR elevations, with or without bleeding events, have been reported in warfarin-treated patients initiated on dronedarone.

MANAGEMENT: Caution is advisable if dronedarone is used in combination with warfarin. The INR should be checked frequently and warfarin dosage adjusted accordingly, particularly following initiation or discontinuation of dronedarone in patients who are stabilized on their warfarin regimen. The same precaution may be applicable during therapy with other oral anticoagulants, although clinical data are lacking. Patients should be advised to promptly report any signs of bleeding to their physician, including pain, swelling, headache, dizziness, weakness, prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or brown urine, or red or black stools.

Dronedarone Hydrochloride

Generic Name: dronedarone

Brand name: Multaq

Synonyms: Dronedarone

What is Dronedarone Hydrochloride?

Jantoven

Generic Name: warfarin

Brand name: Coumadin, Jantoven

Synonyms: n.a.

What is Jantoven?