TrocheOralNon sterile Rx only

Sildenafil/Tadalafil Oral Troche (Dissolving)

Troche Formulation

A compounded dissolving troche made with sildenafil, tadalafil, or both, 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

At a Glance

Preparation details for Sildenafil/Tadalafil Oral Troche (Dissolving)
Dosage form	Troche
Route	Oral
Active ingredients	Sildenafil, Tadalafil
Technology	Troche Formulation
Commercial product	Commercial product in a different dosage form
Strength and directions	Per prescriber
Dispensing	Valid prescription

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

Clinical Advantages

Custom strength available
Alternative to swallowing pills
Flavored for palatability
Multiple actives in one base
Non sterile preparation

How It Works

What are sildenafil and tadalafil?

Sildenafil and tadalafil are prescription medicines called PDE5 inhibitors. FDA approved sildenafil tablets (Viagra) and tadalafil tablets (Cialis) are labeled for the treatment of erectile dysfunction [1][2]. Cialis is also labeled for the signs and symptoms of benign prostatic hyperplasia [2]. Both medicines are also sold under other names for pulmonary arterial hypertension, which is a different use [1][2].

What is a troche, and what does compounding into one provide?

A troche, also called a lozenge, is a solid dose that dissolves slowly in the mouth instead of being swallowed whole. Sildenafil/Tadalafil Oral Troche is made by a compounding pharmacy to a prescriber's order, with sildenafil, tadalafil, or both. Compounding into a troche allows:

A dose that dissolves in the mouth, for patients who prefer not to swallow a tablet or have trouble swallowing one
No water needed to take a dose
Strengths of each medicine set by the prescriber, instead of the fixed strengths of tablets
One or both medicines in a single dose, as the prescriber orders
Flavoring chosen to the patient's preference

How a troche is absorbed, and how it compares with a swallowed tablet, is not described in FDA labeling.

When prescribers choose it

Urologists, primary care providers, and men's health clinics treating erectile dysfunction in patients who prefer a dissolving form
Prescribers whose patients have trouble swallowing tablets
Prescribers who want a strength the approved tablets do not offer

Clinical Details

What does the evidence show?

FDA approved sildenafil is a tablet (Viagra) labeled for the treatment of erectile dysfunction [1].
FDA approved tadalafil is a tablet (Cialis) labeled for the treatment of erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, or both [2].
Neither medicine is FDA approved as a troche, and no FDA approved product combines the two. The FDA has not reviewed this preparation.
Both labels state that the safety and efficacy of combining the medicine with other PDE5 inhibitors have not been studied [1][2].

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

Sildenafil and tadalafil are FDA approved as tablets in fixed strengths, and no approved product is a troche or combines the two [1][2]. A prescriber who wants a dissolving form or a strength the tablets do not offer orders it compounded.

Dosage forms and strengths

Strength of each medicine set by the prescriber
Troche base, with flavoring on request
Quantities matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds these troches in Chino, California under USP 795 standards for non sterile preparations [3]. Our pharmacist confirms the strengths and flavor with the prescriber before compounding. Batch records document every preparation, and finished troches ship across California.

Safety information

Viagra and Cialis labeling both contraindicate use with nitrates in any form, because these medicines can increase the blood pressure lowering effect of nitrates, and with guanylate cyclase stimulators such as riociguat [1][2]. The Cialis label states that if a nitrate becomes medically necessary in a life threatening situation, at least 48 hours should pass after the last tadalafil dose. The mean half life of tadalafil is 17.5 hours [2].

The Viagra label states that the safety and efficacy of combining it with other PDE5 inhibitors have not been studied, and it tells patients not to take Viagra with other PDE5 inhibitors [1]. The Cialis label says the same about combinations with other PDE5 inhibitors, including Adcirca, which is tadalafil [2]. A troche that contains both sildenafil and tadalafil is outside what either label has studied.

Viagra labeling advises patients to seek medical care for an erection that will not go away, to stop and seek care for sudden vision loss in one or both eyes, or sudden decrease or loss of hearing, and to use caution with alpha blockers and blood pressure medicines [1].

No FDA labeling describes how much medicine is absorbed from a troche. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References

VIAGRA (sildenafil citrate) tablets. Prescribing information. DailyMed
CIALIS (tadalafil) tablets. Prescribing information. DailyMed
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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