Tadalafil is the active ingredient in FDA-approved conventional oral tablets; Bayview also uses it in patient-specific compounded troches and rapid-dissolve tablets, which are not FDA-approved.
Tadalafil is the active ingredient in FDA-approved conventional oral tablets.[1] Bayview also uses tadalafil in patient-specific compounded troches and rapid-dissolve tablets when prescribed for an individual patient. Bayview's compounded tadalafil preparations are not FDA-approved and have not been reviewed by FDA for safety, effectiveness, quality, bioavailability, or therapeutic equivalence to approved tadalafil tablets.[2]
Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor. During sexual stimulation it supports blood flow to the penis by increasing levels of cyclic GMP; it has no effect in the absence of sexual stimulation.[1] The FDA-approved conventional tablets are also labeled for the signs and symptoms of benign prostatic hyperplasia.[1] Only a licensed prescriber decides whether tadalafil, and which dosage form, is appropriate for a given patient.
Prescribers should screen for nitrates and guanylate cyclase stimulators such as riociguat (contraindicated), additive hypotension with alpha-blockers and antihypertensives, hepatic or renal impairment, CYP3A4 inhibitors, and cardiovascular status before prescribing.[1] Published pharmacokinetic data, including onset and duration of effect, derive from the FDA-approved conventional tablets and do not automatically apply to compounded dosage forms.
At Bayview, tadalafil is used in compounded troches and rapid-dissolve tablets prepared pursuant to an individual patient prescription under USP standards. See compounded tadalafil and tadalafil oral dissolve tablets.
Manufactured medication dispensed by Bayview
Conventional tadalafil tablets are FDA-approved manufactured prescription products.[1] Bayview dispenses these tablets but does not compound them. See Tadalafil Tablets.
Compounded at Bayview
Patient guides for the preparations we make most often. Each one is compounded to order and requires a prescription.
For prescribers
Every preparation in our formulary that contains this ingredient. Strength, base and dose form are set by the prescription.
Anyone taking nitrates or riociguat, or allergic to tadalafil. The nitrate interaction can persist for an extended time after a dose. Tell your provider about heart conditions.
Conventional tadalafil tablets are FDA-approved manufactured products. Bayview dispenses those manufactured tablets, and separately compounds tadalafil as cheek-and-gum troches and under-the-tongue rapid-dissolve tablets in the strength your provider specifies. Compounded preparations are not FDA-approved and have not been evaluated by FDA for safety, effectiveness, bioequivalence, or therapeutic equivalence to approved tadalafil tablets. Your prescriber decides which form is appropriate for you.
Other salt forms of this molecule, and ingredients commonly compounded alongside it.
This page describes an active pharmaceutical ingredient, not a finished drug product. Bayview Pharmacy compounds preparations containing it only on a prescriber's order for an individual patient.
Compounded preparations are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. Nothing on this page is a claim that any preparation is effective for any condition.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice — discuss your situation with a licensed healthcare provider.
Our pharmacists work with prescribers to build preparations around a patient's dose, form and tolerances. Ask us what is possible with this ingredient.