Spironolactone Oral Suspension (SuspendIt®)

Oral Suspension Vehicle

A sugar free spironolactone oral suspension in SuspendIt, compounded in Chino, CA to a prescriber's order when the approved liquid does not fit.

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

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

At a Glance

Preparation details for Spironolactone Oral Suspension (SuspendIt®)
Dosage form	Oral suspension
Route	Oral
Active ingredients	Spironolactone
Technology	Oral Suspension Vehicle
Strengths in literature	Spironolactone 5 mg/mL in SuspendIt, the concentration tested for microbiological stability
Commercial product	Commercial product in fixed strengths only
Strength and directions	Per prescriber
Dispensing	Valid prescription

Speak with our pharmacist Send a prescription

Phone (909) 378-7301. Fax (909) 378-7071

Clinical Advantages

Weight based dosing
Custom strength available
Sugar free
Dye free option
Alternative to swallowing pills

How It Works

What is Spironolactone Oral Suspension (SuspendIt)?

Spironolactone Oral Suspension (SuspendIt) is a compounded liquid form of spironolactone, a potassium sparing diuretic that blocks aldosterone. It is prepared by prescription in a sugar free suspending vehicle, at the concentration the prescriber specifies, for patients who cannot take tablets or need a dose the approved liquid does not offer.

How it works

Spironolactone blocks aldosterone at the mineralocorticoid receptor in the kidney [1].
Blocking aldosterone increases sodium and water excretion while the body retains potassium [1].
The drug also has antiandrogen activity, which is the source of effects such as gynecomastia [1].
SuspendIt holds the drug in an even suspension, so a measured volume delivers a consistent dose after shaking [2].

When prescribers choose it

Pediatric cardiologists and nephrologists who dose infants and children by weight
Neonatal and pediatric teams needing a concentration below or above 5 mg/mL
Prescribers whose patients need a sugar free or dye free liquid
Prescribers whose adult patients cannot swallow tablets and need a dose outside the approved liquid's range

Clinical Details

What does the evidence show?

The FDA approved CaroSpir (spironolactone) oral suspension, 25 mg/5 mL, in 2017. Its labeling states it is not therapeutically equivalent to spironolactone tablets, sets its own dosing, and says doses above 100 mg may produce higher than expected drug concentrations [1].
In FDA's review of that suspension, a high fat meal raised total drug exposure (AUC) by about 90% and delayed the time to peak concentration, so the label asks that it be taken consistently with respect to food [1][3].
Graves and colleagues (2017, International Journal of Pharmaceutical Compounding) stored spironolactone in SuspendIt at 5, 25, and 40 degrees C for 180 days. Drug concentration stayed at or above 90% of the starting value at all three temperatures, with no significant change in pH or viscosity [2].
A follow up study reported that spironolactone at 5 mg/mL in SuspendIt was also microbiologically stable for 180 days, refrigerated and at room temperature. The authors noted USP had adopted the formula as an official compounded preparation monograph with a 90 day beyond use date before microbiological data were available [4].
An earlier study of spironolactone suspensions made from tablets in cherry syrup, at 2.5, 5, and 10 mg/mL, found no appreciable drug loss after two weeks of storage [5].

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

An FDA approved spironolactone liquid exists, in one concentration of 5 mg/mL, labeled for adults [1]. Federal law restricts compounding a preparation that is essentially a copy of it. A compounded suspension fits when the prescriber documents a significant difference for the patient, such as a different concentration for an infant, a sugar free or dye free formula, or a flavor a child will accept [6].

Dosage forms and strengths

Concentration set by the prescriber for the patient's weight
Sugar free SuspendIt vehicle, with flavoring on request
Dye free versions on request
Starting material and beyond use date confirmed by our pharmacist for each prescription

The published stability data cover 5 mg/mL in SuspendIt [2][4]. Because liquid and tablet spironolactone are not interchangeable [1], dosing, monitoring, and any switch between forms are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this suspension in Chino, California under USP 795 standards for non sterile preparations [7]. Our pharmacist confirms the concentration, flavor, and beyond use date before compounding, and the label carries shake well and storage instructions. Batch records document every preparation, and finished suspensions ship across California.

Safety information

Spironolactone can cause hyperkalemia, and it is contraindicated in patients with hyperkalemia, Addison's disease, or concurrent use of eplerenone [1]. Risk rises with kidney impairment and with drugs that raise potassium, such as ACE inhibitors, angiotensin receptor blockers, and potassium supplements, so prescribers monitor potassium and kidney function [1].

Gynecomastia is dose related. In the RALES heart failure trial, about 9% of men taking a mean of 26 mg daily developed it, usually reversibly [1]. Liquid and tablet forms are not therapeutically equivalent, so switching between them without new dosing instructions can change drug exposure [1]. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References

CAROSPIR (spironolactone) oral suspension, 25 mg/5 mL. Prescribing information. U.S. Food and Drug Administration, 2017. FDA label
Graves R, Phan KV, Bostanian LA, Mandal TK, Pramar YV. Stability of spironolactone oral suspension in PCCA base, SuspendIt. Int J Pharm Compd. 2017;21(4):334 to 338. PubMed 28719376
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Summary review, application 209478 (CaroSpir). 2017. FDA review
Microbiological stability of allopurinol, clindamycin hydrochloride, naltrexone hydrochloride, spironolactone and ursodiol oral liquids compounded in PCCA base, SuspendIt. PubMed 39094043
Stability of extemporaneously compounded spironolactone suspensions. PubMed 2816959
U.S. Food and Drug Administration. Compounding when drugs are on FDA's drug shortages list. FDA human drug compounding
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

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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