Difficulty Swallowing / Dysphagia Support
Oral suspensionOralNon sterile Rx only

Amiodarone Oral Suspension

Oral Suspension Vehicle

A compounded amiodarone HCl oral suspension, a liquid alternative to tablets, prepared in Chino, CA to a prescriber's order. Not FDA approved.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

  • USP <795> compliant
  • USP <800> hazardous drug lab
  • PCCA member

Clinical Advantages

  • Alternative to swallowing tablets
  • Custom strength available
  • Weight based dosing
  • Non sterile preparation

How It Works

What is amiodarone?

  • Amiodarone hydrochloride is a prescription heart rhythm medicine. FDA approved amiodarone tablets are labeled for life threatening recurrent ventricular fibrillation and life threatening recurrent hemodynamically unstable ventricular tachycardia in adults who have not responded to, or cannot tolerate, other antiarrhythmic drugs [1].
  • The label carries a boxed warning. It says amiodarone is reserved for life threatening arrhythmias because of its toxicity [1].

FDA approved amiodarone tablets come in 100 mg, 200 mg, 300 mg, and 400 mg strengths [1].

What is the dosage form?

Amiodarone Oral Suspension is a liquid medicine you swallow, made by a compounding pharmacy to a prescriber's order. The tablets are ground and the medicine is mixed into a suspending liquid at the concentration the prescriber orders. It is shaken before each dose and measured with an oral syringe.

What the suspending base provides

A suspension needs a base that keeps the medicine evenly spread, so each measured dose after shaking has the intended amount. Mixwell chooses the base with the prescriber for each order and lists its ingredients on request. Bases can also be made without sugar or dyes for patients who need that. No FDA labeling covers how a compounded amiodarone suspension is absorbed compared with the tablets.

When prescribers choose it

  • Cardiologists and hospital teams treating patients who cannot swallow tablets
  • Prescribers who need a dose that tablet strengths do not allow, such as a weight based dose for a child
  • Prescribers whose patients use a feeding tube

Clinical Details

What does the evidence show?
  • FDA approved amiodarone tablets are labeled for life threatening recurrent ventricular fibrillation and life threatening recurrent hemodynamically unstable ventricular tachycardia in adults who have not responded to other antiarrhythmics or cannot tolerate them [1].
  • No FDA approved amiodarone product is an oral liquid. The FDA has not reviewed this preparation [1].

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

FDA approved amiodarone tablets come in four fixed strengths [1]. A prescriber whose patient cannot swallow tablets, or needs a dose the tablets cannot give, orders a liquid compounded.

Dosage forms and strengths

  • Concentration set by the prescriber
  • Oral suspension, measured with an oral syringe
  • Volumes matched to the prescription

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this suspension in Chino, California under USP 795 standards for non sterile preparations [2]. Our pharmacist confirms the concentration and base with the prescriber before compounding. Batch records document every preparation, and finished suspensions ship across California.

Safety information

The amiodarone tablet label has a boxed warning. It says amiodarone is reserved for life threatening arrhythmias because it can cause pulmonary toxicity that can be fatal, liver injury that can be fatal, and worsening of arrhythmias. The label calls for baseline chest imaging, lung function tests, and liver monitoring [1].

The label also lists thyroid problems, vision changes including optic nerve damage, and photosensitivity. It says amiodarone may cause fetal harm and that breastfeeding is not recommended. It contraindicates use in cardiogenic shock, sick sinus syndrome, and certain heart block or slow heart rate without a pacemaker, and with known hypersensitivity, including to iodine [1].

Grapefruit juice raises amiodarone levels and should be avoided. The label says food changes how much is absorbed, so each dose should be taken the same way with respect to meals. It lists interactions with warfarin, digoxin, some statins, other heart rhythm medicines, and drugs that slow the heart [1].

No FDA labeling states how this suspension is absorbed compared with the tablets, or whether the food effect is the same. Tell your prescriber about every medicine you take. Mixwell can provide the ingredient list for your preparation. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References
  1. Amiodarone Hydrochloride Tablets, USP. Prescribing information. DailyMed. DailyMed
  2. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

  • APIs and strengths
  • Base or vehicle
  • Quantity
  • Directions for use
  • Refills
  • Allergies or dye free needs
Call (909) 378-7301 Fax (909) 378-7071

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Compounded in Chino, CA. Delivered across California.

  • Chino
  • Chino Hills
  • Ontario
  • Pomona
  • Diamond Bar
  • Rancho Cucamonga
  • Eastvale
Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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Want to learn more about Amiodarone Oral Suspension

Are you a healthcare provider or patient in Chino, Chino Hills, Ontario, Eastvale, Rancho Cucamonga, or Upland? Mixwell Pharmacy provides specialized pharmaceutical support throughout San Bernardino, Los Angeles, and Orange Counties. Contact our Chino laboratory to learn how we facilitate customized Amiodarone Oral Suspensionfor practitioners across Southern California.

(909) 378-7301

Serving Los Angeles County, Orange County, San Bernardino County, Riverside County, Ventura County, and the Inland Empire