Vardenafil After Levitra Left the Shelf: 10 mg and QT

Is Levitra still available

Bayer’s discontinuation letters went in by strength: 5 mg on September 26, 2019, 10 mg on September 24, 2020, 20 mg on September 20, 2021. FDA moved those products to the Orange Book discontinued list.²

May 3, 2023 Federal Register: Levitra 5, 10, and 20 mg were not withdrawn from sale for reasons of safety or effectiveness. That finding keeps abbreviated applications that refer to Levitra eligible for approval.²

June 3, 2024 notice is a different act. FDA withdrew approval of NDA 021400 (Levitra tablets, including 2.5 mg) and NDA 200179 (Staxyn ODT 10 mg), effective July 3, 2024, because Bayer no longer marketed them. Generic film-coated vardenafil from other makers stays on DailyMed, not the same filing as those withdrawn brand NDAs.³

So “is Levitra still available?” splits: brand carton, no; generic vardenafil hydrochloride tablets, yes where a pharmacy stocks them under a prescription.²³

10 mg start and the 20 mg ceiling

Starting dose for most patients: 10 mg as needed, about 60 minutes before sexual activity. Maximum 20 mg; step down to 5 mg if needed. One tablet per day. Supplied strengths count vardenafil base: 2.5, 5, 10, and 20 mg.¹

Use 5 mg first at age 65 or older, with moderate hepatic impairment (Child-Pugh B, and 10 mg is the cap there), or when already stable on an alpha-blocker. Child-Pugh C and dialysis sit outside labelled use.¹

Ritonavir or cobicistat: no more than 2.5 mg in 72 hours. Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin: no more than 2.5 mg in 24 hours on the same table. Those caps beat any “try 20 mg anyway” search habit.¹

QT caution and blood-pressure stops

Skip vardenafil if QT prolongation is congenital, or if the regimen already includes Class IA drugs (quinidine, procainamide) or Class III drugs (amiodarone, sotalol). The QT study used 10 mg and a supratherapeutic 80 mg dose in healthy men; the warning stayed on film-coated labels after Staxyn left.¹

Nitrates and nitric oxide donors in any form are a contraindication. Placebo-controlled trials: headache 15% vs 4%, flushing 11% vs 1%, nasal congestion 9% vs 3%. Dose-related bumps showed up for headache, flushing, dyspepsia, nausea, and rhinitis across 5, 10, and 20 mg.¹

Priapism past 4 hours, sudden vision loss, or sudden hearing loss, emergency route, not a higher tablet tomorrow.¹

How long a Levitra-strength tablet lasts

Terminal half-life of vardenafil and metabolite M1 is about 4 to 5 hours. After 20 mg fasted, peaks usually land between 30 minutes and 2 hours (median near 60). The labelled swallow is about 60 minutes before sex; arousal still has to be present.¹

Short clock next to tadalafil’s 17.5-hour mean half-life and 36-hour as-needed window. Same short band as sildenafil, different food numbers and a QT row the Viagra ED carton does not carry the same way.¹

Levitra versus Viagra, what the label will not claim

No head-to-head superiority trial against sildenafil sits on the U.S. vardenafil label. Both need sexual stimulation. Combining two ED PDE5 tablets has not been studied and is not recommended.¹

What men actually sort: Levitra’s brand-exit story and QT avoid list versus sildenafil’s clearer high-fat delay (mean Tmax +60 minutes, Cmax -29% on the Viagra label). Meal mechanics for that molecule belong on the sildenafil page; this URL stays on status, dose, and QT.¹

Not a daily Levitra path

Search traffic asks whether Levitra can be taken every day. The film-coated ED label is as-needed with a once-daily maximum, not a 2.5-5 mg morning regimen like tadalafil’s separate daily carton.¹

If the ask is really “something in the system without picking an hour,” that is a different molecule discussion with the prescriber, not a home reinterpretation of 10 mg vardenafil nightly.¹

Staxyn is gone; film-coated generics remain

Staxyn was Bayer’s 10 mg orally disintegrating tablet. NDA withdrawn effective July 3, 2024 with brand Levitra. Numbers below follow a current film-coated generic (Zydus, DailyMed setid 5876e062-e604-42a7-99c3-5da30b8dac06, rev. 05/25), not the old ODT leaflet.³¹

Two food-effect studies on that tablet label: high-fat meals cut Cmax by 18% to 50%. With or without food is still allowed. Peak-height change, not the same +60 minute Tmax figure printed for sildenafil.¹

Prescription only in the U.S. Online sellers that skip Rx fail BeSafeRx checks. No invented coupon price for ten tablets on this page.⁴

Sources

Portrait of Dr. Ethan Cole at a urology consult desk

Consultation

Your questions, answered

Answered by Dr. Ethan Cole, MD · Urology & men's sexual health

Answers follow U.S. generic vardenafil labeling and Federal Register notices on Levitra and Staxyn.

Marcus asked: is Levitra still available in the US? asksBrand Levitra is gone. In 2023 FDA said the stop was not for safety or effectiveness. Separately, brand NDAs were withdrawn effective July 3, 2024. Generic film-coated vardenafil remains for prescription fills.

Is Levitra still available in the US?

Owen asked: what happened to Staxyn? asksStaxyn was the 10 mg ODT. NDA withdrawn effective July 3, 2024 with brand Levitra. Dose numbers here follow swallowed film-coated tablets.

What happened to Staxyn?

Derek asked: how long does Levitra last? asksHalf-life of vardenafil and M1 is about 4 to 5 hours. Labelled swallow about 60 minutes before sex.

How long does Levitra last?

Luis asked: is Levitra better than Viagra? asksThe U.S. label has no head-to-head win claim. Sort QT risk, meal sensitivity, and brand-exit status with the prescriber, not a ranking on this carton.

Is Levitra better than Viagra?

Jonah asked: can I take Levitra every day? asksFilm-coated ED use is as-needed, one tablet a day maximum. It is not tadalafil’s separate daily 2.5-5 mg path.

Can I take Levitra every day?

Nate asked: can you take Levitra with alcohol? asksAlcohol can add hypotension and blunt arousal. Keep drinking modest. Nitrates stay off entirely.

Can you take Levitra with alcohol?

Chris asked: where can you buy Levitra? asksAsk for generic vardenafil with a U.S. prescription. Sellers that skip Rx fail BeSafeRx checks.

Where can you buy Levitra?

Rina asked: does food affect Levitra? asksWith or without food is allowed. High-fat meals cut Cmax 18-50% in two food-effect studies on the generic tablet label.

Does food affect Levitra?

General education from a clinician, not personal medical advice. Bring your own history to your own prescriber.

Vardenafil After Levitra Left the Shelf: Dose Ladder and QT