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dronedarone

dronedarone

Brand names: Multaq

Form	Strength
TABLET, ORAL	400 mg

Display Antiarrhythmic Agents, Class II Antiarrhythmics, Class III Antiarrhythmics Class: 240404, 24040416, 24040420

Medication comments:

USP <800> Hazardous Drug Assessment of Risk (AOR)
Per policy, these drugs are exempt from USP <800> handling requirements under normal circumstances. The following outlines must be followed.
generic (Brand) Route [Packaging: Manufacturer ⇒ Dispense]	Activities
dronedarone (Multaq) PO [UD ⇒ UD]	400 mg tablet	Stock @ IDBH? Y NIOSH Table 2^B↑
Pharmacy: Receiving / Storage / Preparation Exposure Risk: minimal	• Handling/preparation PPE Requirements: n/a
	• Receiving from Distributor: Standard
	• Pharmacy Storage Area: Carousel
	• Packaging/Reconstitution Location: n/a
	• Compounding (Non-Sterile/Sterile) Location: n/a
	• Omnicell Load: Yes
Transport	• Transport (dose is placed inside a plastic sealable bag): Standard
Nursing: Storage / Administration Exposure Risk: low	• Handling/administration PPE Requirements: Single pair of CX approved gloves. Wash hands after handling
	• Storage of Finished dose in Nursing Area/Procedural Area: Omnicell
	• Signage on Patient Door Required: No
	• Manipulation of Dosage Form: Standard
	• Special Manipulation for Administration: Do not handle while pregnant or trying to get pregnant
Disposal / Spills	• Disposal of Drug Waste: Full- blue bin Trace/packaging- trash
	• Disposol of Used PPE: trash bin (inside plastic bag)
	• Spill management: n/a
NIOSH Supplemental Information: Teratogenic in laboratory studies at 1/2 MRHD
Reason for exemption of USP<800> Containment Requirements: Purchased in final dosage form; packaged as unit dose. Does not require additional manipulation for dispensing.

2023 American Geriatrics Society Beers Criteria^® for potentially inappropriate medication use in older adults.
Medication:	dronedarone (Multaq)
Criteria 1: Potentially inappropriate medication use in older adults. (Table 2)
Drug(s)	dronedarone
Rationale	Worse outcomes in people who have permanent atrial fibrillation or severe or recently decompensated heart failure. In some circumstances, worse outcomes have also been reported in people with HFrEF (e.g., left ventricular ejection fraction ~35%) who have milder symptoms (NYHA class I or II).
Recommendation	Avoid in individuals with permanent atrial fibrillation or severe or recently decompensated heart failure. Use caution in patients with HFrEF with less severe symptoms (NYHA class I or II).
Quality of evidence: High, Strength of Recommendation: Strong

Criteria 2: Potentially inappropriate medication use in older adults due to drug–disease or drug–syndrome interactions that may exacerbate the disease or syndrome. (Table 3)
Drug(s) ⇆ disease or syndrome	dronedarone ⇄ Heart failure
Rationale	Potential to increase mortality in older adults with heart failure.
Recommendation	Use with caution in patients with heart failure who are asymptomatic; avoid in patients with symptomatic heart failure.
Quality of evidence: High, Strength of Recommendation: Strong

Last updated: Sep. 18, 2025

Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug / Assessment of Risk
Black Box Warnings Contraindication in certain CHF conditions

UpToDate Lexidrug

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556

This site is intended for the staff of Iredell Health System. While others may view accessible pages, Iredell Health System makes no warranty, express or implied, as to the use of this information outside of Iredell Health System. The content of this policy and procedure document serves as guidance to the delivery of quality patient care. Care providers are expected to exercise critical thinking and situational awareness skills, and in specific situations to take such action as is necessary for the delivery of quality patient care.