Vardenafil is prescribed from 2.5 to 20 mg, and the label's usual adult start is 10 mg

Buying generic vardenafil: eight 5 mg tablets, and the price gap that moves prescriptions elsewhere

Counter figures below are for the 5 mg tablet. Elysia Med is a reference and dispenses nothing.

Five milligrams in packs of eight is quoted below at Costco, Target, Kroger and Albertsons. That strength is here because it is easy to compare across counters, and it needs one clarification the coupon pages rarely make: 5 mg is a reduced start, used at 65 and over, in moderate hepatic impairment, and alongside stable alpha-blocker therapy. The usual adult opening dose is 10 mg. Nobody should read the row below as the strength a first prescription will carry.

Row links open each pharmacy's own site, never a discount platform, and the coupon services are credited in the caption where they belong.

Asking for Levitra by name produces confused answers at the window, because the brand tablets sit on the FDA's discontinued list while the molecule does not. A prescription written for Levitra is filled with generic vardenafil, rated therapeutically equivalent, in the same four strengths. The tablets look nothing like the orange Bayer originals, because other manufacturers make them now.

One figure is worth knowing before any comparison shopping starts. Vardenafil is expensive beside sildenafil: published cash and coupon ranges land in dollars a tablet where generic sildenafil often lands under a dollar, and that gap is what moves most prescriptions off this molecule. It is prescription-only in the United States, telehealth included, and a site selling it without one has skipped the medicine-list check the rest of this page describes.

Brand exit: what the FDA actually determined about Levitra

Men who searched for the brand and found nothing usually assume the worst. The paperwork says something narrower.

Bayer notified the FDA in letters dated 26 September 2019, 24 September 2020 and 20 September 2021 that Levitra oral tablets at 5, 10 and 20 mg respectively were being discontinued, and the agency moved them to the Discontinued Drug Product List section of the Orange Book. The 2.5 mg strength had already gone the same way after a notification in 2018.

A citizen petition in August 2022 asked the agency to say why. On 3 May 2023 the FDA published its determination: those tablets were not withdrawn from sale for reasons of safety or effectiveness. The petitioner had identified no data suggesting otherwise, and the agency had reviewed its own files and the postmarketing literature before saying so. That finding matters commercially more than clinically, because it lets the FDA keep approving abbreviated applications that reference the original product, which is why generic vardenafil is still dispensed while the brand is not.

Levitra was first approved on 19 August 2003. Nothing in the QT story, the nitrate contraindication or the adverse-event profile changed in 2019, 2020 or 2021. The wording of that Federal Register notice is the evidence for which of the two things happened here.

Pharmacokinetics: an hour to peak, four to five hours of half-life, and the fat problem

Short-acting, and the food rule on this molecule matters more than most men are told at the counter.

Absolute bioavailability is around 15 percent. After a single 20 mg dose in fasted volunteers, maximum plasma concentrations arrive between 30 minutes and 2 hours, median 60 minutes. Total body clearance is 56 L/h, and terminal half-life for vardenafil and its primary metabolite M1 is roughly 4 to 5 hours. Elimination is overwhelmingly faecal, 91 to 95 percent of the oral dose, with 2 to 6 percent in urine, and about 95 percent of both parent and M1 is protein-bound - which is why dialysis achieves nothing in an overdose.

Two food-effect studies found that high-fat meals reduced Cmax by 18 to 50 percent. That is a wide interval and a real effect, and it is the commonest reason a fair 10 mg dose gets written off as weak. The tablet may be taken with or without food; what matters is the fat content.

M1 carries about 28 percent of the parent's potency in vitro and roughly 7 percent of the pharmacological activity. It is a CYP3A4 product, CYP2C9 contributing less, so the interaction list here is a list of things that change CYP3A4 activity.

Useful window: a few hours. A man hoping Sunday will run on Friday's tablet is describing tadalafil.

Staxyn: the orally disintegrating 10 mg delivers more drug than the film-coated 10 mg

Two products, one molecule, and a substitution that keeps happening because the printed number matches.

Staxyn is vardenafil as an orally disintegrating tablet, placed on the tongue and taken without liquid roughly 60 minutes before sex, one tablet a day at most. Bioequivalence studies showed it is not bioequivalent to the 10 mg film-coated tablet: part of the dose is absorbed across the oral mucosa and the rest is swallowed, so systemic exposure ends up higher. The two products are not interchangeable. Taking the melt with water pulls the AUC down by 29 percent, which is exactly why the instruction is no liquid.

The consequence is narrow and it matters. Any man who needs a strength other than 10 mg - a cautious 5 mg start at 70, a 2.5 mg cap because of an azole, a step up to 20 mg - needs the film-coated tablet. The melt cannot be divided down to a lower dose.

Men ask whether it works faster. Median time to peak in fasted patients ran between 45 and 90 minutes, so no. What it offers is discretion: no glass of water, no visible swallow. Where a pharmacy substitutes one product for the other because both boxes read 10 mg, that is a same-day call to the prescriber.

Adverse effects: headache in 15 percent, and a retina largely left alone

The common effects are vascular and short-lived. The eye story is the one worth reading in detail, because it is the reason some men are switched onto this drug in the first place.

Pooled across fixed and flexible dose trials in 2203 men against 1199 on placebo: headache 15 percent against 4, flushing 11 against 1, rhinitis 9 against 3, dyspepsia 4 against 1, sinusitis 3 against 1, dizziness 2 against 1. Every one showed a dose effect across 5, 10 and 20 mg, which is the argument for staying on the lowest strength that works.

The eye is where this molecule genuinely differs from sildenafil. In a placebo-controlled trial giving at least fifteen 20 mg doses over eight weeks to 52 men, retinal function measured by electroretinography and the Farnsworth-Munsell 100-hue test at 2, 6 and 24 hours after dosing showed no clinically significant change; the trial was designed to pick up changes affecting more than 10 percent of patients. Two men reported transient cyanopsia, objects appearing blue. Single doses of the class do produce dose-related blue-green impairment on that test, most evident an hour after dosing, so this is a matter of degree - and for a printer or a pilot, the degree is the point.

Milligram for milligram vardenafil is more potent than sildenafil, which is why the numbers on the tablets are smaller: 10 mg here compares with 50 mg there. Potency per milligram says nothing about clinical superiority, and all three PDE5 inhibitors land in a similar band of response rates.

Vision that disappears from an eye, or hearing that goes with or without ringing, means the tablet stops and somebody examines him the same day. NAION has been reported post-marketing across this class, mostly in men who already had a crowded optic disc, age over 50, diabetes, hypertension, coronary disease or hyperlipidaemia in the picture. Four hours of erection is an emergency department, same night.

Treadmill data: two trials in men with stable exercise-induced angina

Fitness for sex gates the entire class. For this molecule there happens to be exercise data to quote at the appointment.

Two independent trials gave 10 mg (n=41) and 20 mg (n=39) to men aged 40 to 80 with stable exercise-induced angina documented by at least one of a prior infarct, bypass, angioplasty or stent, an angiogram showing 60 percent or more narrowing of a major coronary artery, or a positive stress echocardiogram or nuclear perfusion study. Total treadmill exercise time was no different from placebo: 433 seconds against 426 at 10 mg, 414 against 411 at 20 mg. Time to angina and time to 1 mm or more of ST-segment depression were likewise unchanged.

That result clears nobody for sex. It answers a narrower question that men with heart disease ask constantly: in stable coronary disease, the tablet itself did not bring ischaemia on sooner. Sex remains exertion, roughly two flights of stairs, and unstable disease pauses the discussion before any strength gets chosen.

Blood pressure belongs in the same section. In men with erectile dysfunction, a single 20 mg dose produced a mean maximum fall in supine pressure of 7/8 mmHg against placebo and a mean maximum rise in heart rate of 4 beats a minute, peaking one to four hours after the dose. After 31 days of dosing the responses looked like day one. Add an antihypertensive and those small numbers combine: with slow-release nifedipine, an additional 6/5 mmHg. That is the whole explanation for the lightheaded stand-up men describe, and the reason a 5 mg start exists at all.

Doses: 10 mg for most men, 5 mg in three named situations, 2.5 mg as an interaction ceiling

Four strengths exist because clearance varies between men considerably more than confidence does.

For most patients the recommended starting dose is 10 mg taken orally approximately 60 minutes before sexual activity, increased to a maximum of 20 mg or decreased to 5 mg based on efficacy and side effects, with once per day the maximum frequency. It can be taken with or without food, and sexual stimulation is still required for any response.

The 5 mg start rests on three grounds, each with numbers attached. Age 65 and over, where mean Cmax and AUC ran 34 and 52 percent higher than in men of 18 to 45. Moderate hepatic impairment, Child-Pugh B, where a 10 mg dose produced Cmax and AUC increases of 130 and 160 percent, and where the maximum dose is additionally capped at 10 mg. And stable alpha-blocker therapy, started only once the man is steady on the alpha-blocker itself. Severe hepatic impairment has never been evaluated, and neither has dialysis.

Twenty milligrams is the ceiling, and the fixed-dose data show what the last step buys. In the North American trial of 762 men, maintenance of erection to successful intercourse ran 51 percent on 5 mg, 64 percent on 10 mg and 65 percent on 20 mg against 32 percent on placebo; penetration rates were 65, 75 and 80 percent against 52. The move from 5 to 10 mg is clearly worth making.

The move from 10 to 20 mg shifted that same endpoint by one percentage point in that trial, while headache, flushing, dyspepsia and rhinitis all rose with dose. It stays the right step for a man who has given 10 mg an honest run at sensible timing. It is a poor opening dose for a man who simply likes the bigger number. European product information allows a wider window than most readers expect: 25 minutes to four or five hours ahead.

Nitrates: contraindicated, and here the label never set an interval

The gap is genuine, and it is the single thing about this molecule worth knowing before the first tablet.

Nitrates and nitric oxide donors are contraindicated with vardenafil whether they are taken regularly or occasionally: nitroglycerin, isosorbide, and the amyl or butyl nitrite poppers. Riociguat and other guanylate cyclase stimulators are contraindicated on the same pathway. Together with a PDE5 inhibitor, these can drop blood pressure to a level that causes dizziness, syncope, infarction or stroke.

Here the three labels part company in a way that almost never gets mentioned. Sildenafil carries a 24-hour figure and tadalafil a 48-hour figure for the emergency in which a nitrate becomes necessary. The vardenafil label says a suitable time interval following dosing for the safe administration of nitrates or nitric oxide donors has not been determined. The study behind that sentence gave 18 healthy subjects 0.4 mg sublingual nitroglycerin at intervals after vardenafil 20 mg: blood pressure effects at 1 and 4 hours, heart rate effects at 1, 4 and 8 hours, nothing additional at 24. Potentiation in men with ischaemic heart disease was never evaluated. So there is a measurement, and the label declines to convert it into a permission.

Which leaves an emergency team with the drug name, the hour, and a monitor.

Alpha-blockers are permitted with care, and the numbers behind that care are unusually concrete. In healthy volunteers force-titrated onto terazosin 10 mg daily over 14 days, outlier standing values - systolic under 85 mmHg, or a fall of more than 30 mmHg - occurred in 19 of 29 subjects, and the arm in which vardenafil and terazosin were timed to peak together was terminated early. With tamsulosin it was 9 of 24. Separating the doses by six hours reduced the effect. Hence the label sequence: stable on the alpha-blocker, vardenafil at 5 mg, dose separation considered. The vascular picture that often sits underneath the original complaint is in why an erection fails.

QT interval: eight milliseconds in one study, two drug classes in the warning

This is the one question this tablet asks that the other two PDE5 drugs never ask.

The label's electrophysiology work was a single-dose, double-blind, placebo- and moxifloxacin-controlled crossover study in 59 healthy men aged 45 to 60, with the interval measured an hour after dosing because that approximates peak concentration. Vardenafil 10 mg lengthened QT by 8 msec using Fridericia correction and 4 msec using an individual linear correction; 80 mg, four times the maximum dose, gave 10 and 6 msec. Moxifloxacin 400 mg gave 8 and 7. A separate postmarketing study in 44 volunteers put 10 mg at 5 msec of placebo-subtracted QTcF change, gatifloxacin 400 mg at 4 msec, and the two together at 9 - additive rather than multiplied. The label states outright that the clinical impact of these changes is unknown.

What the label does not leave open is who avoids the drug altogether. Congenital QT prolongation. Class IA antiarrhythmics such as quinidine or procainamide. Class III agents such as amiodarone or sotalol. Those men should avoid vardenafil, and the instruction applies at 2.5 mg as much as at 20, so there is no low dose to try instead.

For a heart on no rhythm drug, 8 msec never becomes a symptom. An ECG is not required before every prescription, though a history of syncope, a family history of sudden cardiac death or a known long interval turns it into one.

Calling vardenafil hard on the heart over a few milliseconds gets the proportions wrong. The treadmill data further down this page is the counterweight, and what actually stops prescriptions is the nitrate contraindication.

Markings, ceilings, and why this molecule leans on the pharmacist

Vardenafil looks different depending on who made it. Bayer's originals were orange, round and film-coated, with a debossed BAYER cross on one face and 2.5, 5, 10 or 20 on the other. Generics carry different codes, so a tablet unlike the one in the last box usually means a change of manufacturer and is worth confirming at the counter. A tablet with no marking at all, bought from a website, cannot be identified by anybody.

The reason to keep a pharmacist in the loop is that the ceilings here are numeric and product-specific in a way sildenafil's are not: 2.5 mg in 72 hours with ritonavir; 2.5 mg in 24 hours with indinavir, saquinavir, atazanavir, clarithromycin, or ketoconazole or itraconazole at 400 mg daily; 5 mg in 24 hours with ketoconazole or itraconazole at 200 mg daily or with erythromycin; 5 mg on stable alpha-blocker therapy; a 10 mg maximum in Child-Pugh B impairment; and the film-coated tablet for every one of those. Those figures are the first casualty when a repeat prescription is written by a service that never sees the rest of the list.

Dr Marc Vidal reviewed this page, and his background is on the reviewer page. Where a rhythm drug, an azole or a protease inhibitor is on the list, that is how to open the appointment. If the requirement is a window covering a weekend, this is the wrong molecule and tadalafil is the page to read; if the requirement is a cheaper evening, sildenafil is. All three are set beside each other in the vardenafil briefing.