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Sirturo Tablets and Zithromax Tri-Pak

Determining the interaction of Sirturo Tablets and Zithromax Tri-Pak and the possibility of their joint administration.

Check result:
Sirturo Tablets <> Zithromax Tri-Pak
Relevance: 28.11.2022 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:

Using bedaquiline together with azithromycin can increase the risk of an irregular heart rhythm that may be serious and potentially life-threatening, although it is a relatively rare side effect. You may be more susceptible if you have a heart condition called congenital long QT syndrome, other cardiac diseases, conduction abnormalities, or electrolyte disturbances (for example, magnesium or potassium loss due to severe or prolonged diarrhea or vomiting). Talk to your doctor if you have any questions or concerns. Your doctor may already be aware of the risks, but has determined that this is the best course of treatment for you and has taken appropriate precautions and is monitoring you closely for any potential complications. You should seek immediate medical attention if you develop sudden dizziness, lightheadedness, fainting, shortness of breath, or heart palpitations during treatment with these medications, whether together or alone. 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:

MONITOR CLOSELY: Bedaquiline can cause dose-related prolongation of the QT interval. Theoretically, coadministration with other agents that can prolong the QT interval may result in additive effects and increased risk of ventricular arrhythmias including torsade de pointes and sudden death. In one clinical study, the mean increase in Fridericia-corrected QT interval (QTcF) was 9.9 msec in subjects receiving bedaquiline and 3.5 msec in subjects receiving placebo after the first week of treatment. The largest mean increase in QTc during the 24 weeks of bedaquiline treatment was 15.7 msec, compared to 6.2 msec for placebo at week 18. QT increases from baseline in the bedaquiline group persisted even after treatment was stopped. In another study where patients with no treatment options received other QT-prolonging drugs used to treat tuberculosis, concurrent use of bedaquiline resulted in additive QT prolongation proportional to the number of QT-prolonging drugs in the treatment regimen. Patients receiving bedaquiline alone with no other QT-prolonging drugs developed a mean QTcF increase over baseline of 23.7 msec. There was no QT segment duration in excess of 480 msec in this group, whereas patients receiving at least two other QT-prolonging drugs developed a mean QTcF prolongation of 30.7 msec over baseline, resulting in QTcF segment durations in excess of 500 msec in one patient. Mean increases in QTc were also larger in the 17 subjects who were using clofazimine with bedaquiline than in those who were not using clofazimine with bedaquiline (31.9 msec versus 12.3 msec at week 24). There were no documented cases of torsade de pointes in the safety database. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).

MANAGEMENT: Caution is recommended if bedaquiline is used in combination with other drugs that can prolong the QT interval. ECG and serum electrolytes, including potassium, magnesium and calcium, should be monitored before starting bedaquiline therapy and periodically during treatment in accordance with the product labeling. Hypokalemia, hypomagnesemia, and hypocalcemia must be corrected prior to bedaquiline administration. All QT-prolonging drugs including bedaquiline should be interrupted in patients who develop clinically significant ventricular arrhythmia or a QTcF interval greater than 500 msec confirmed by repeat ECG. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.

References
  • "Product Information. Sirturo (bedaquiline)." Janssen Pharmaceuticals, Titusville, NJ.
Sirturo Tablets

Generic Name: bedaquiline

Brand name: Sirturo

Synonyms: Bedaquiline, Bedaquiline Fumarate

Zithromax Tri-Pak

Generic Name: azithromycin

Brand name: Zithromax, Zmax, AzaSite, Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax Tri-Pak, Zithromax Z-Pak, Zithromax IV

Synonyms: Zithromax

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.

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