Prescription only
Vardenafil
Sold as Levitra.
What the label states
For most patients, the recommended starting dose of vardenafil is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day.
Quoted from the approved product label. Clinics commonly prescribe differently — more frequent, smaller injections of the same weekly total are routine — and where this site describes that, it is named as practice rather than as labelling.
- Route
- Oral, taken as needed before sexual activity
- Vehicle
- None — a film-coated tablet swallowed whole. There is nothing to reconstitute, dilute or draw up.
- Usual barrel
- None — this compound is not drawn into a syringe
- Strengths covered
- No strength page yet
Why there is no syringe
There is no syringe. Vardenafil is an oral film-coated tablet in strengths of 2.5 / 5 / 10 / 20 mg, swallowed whole, and the only "dose conversion" it involves is picking the right tablet. Naming a barrel here would invent an instrument the reader does not have. What does need converting on this drug is time, not volume: the label's lead time (approximately 60 minutes before) and the window after it are the numbers that decide whether a dose works, and /tools/ed-medication-timing does that arithmetic from these same figures.
Administration
- 1
Rule out nitrates before anything else
This is the step that kills people when it is skipped. “Administration of vardenafil with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated” (section 4.1 Nitrates). That covers nitroglycerin tablets, sprays, ointments, pastes and patches, isosorbide mononitrate and dinitrate, and the recreational nitrites sold as “poppers”. Guanylate cyclase stimulators such as riociguat are contraindicated too: “Do not use vardenafil in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil may potentiate the hypotensive effects of GC stimulators.” (section 4.2 Guanylate Cyclase (GC) Stimulators).
- 2
Check the interval before any nitrate is given
Label states none — "has not been determined". “A suitable time interval following dosing of vardenafil for the safe administration of nitrates or nitric oxide donors has not been determined.” (section 4.1 Nitrates). Two of the four labels name an interval that must elapse before a nitrate can even be considered in a life-threatening situation: 12 hours for avanafil, 48 hours for tadalafil. The sildenafil label says it is unknown, and the vardenafil label says it has not been determined. None of the four says a nitrate is ever safe alongside a dose.
- 3
Take it the lead time the label gives
“For most patients, the recommended starting dose of vardenafil is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity.” (section 2.1 General Dose Information). Note what that figure is: dosage section instruction; no earlier time permitted. No label of the four states an “onset of action”, so nothing on this page presents one.
- 4
Account for food
A high-fat meal cuts the peak by 18–50%. No delay to the peak is stated. “Two food-effect studies were conducted which showed that high-fat meals caused a reduction in Cmax by 18% to 50%.” (section 12.3 Pharmacokinetics).
- 5
Sexual stimulation is required
The dosage section says so directly: “Sexual stimulation is required for a response to treatment” (section 2.1 General Dose Information). A PDE5 inhibitor amplifies a response; it does not create one.
- 6
Do not repeat the dose the same day
“The maximum recommended dosing frequency is once per day.” (section 2.1 General Dose Information). The label states no duration of effect. The vardenafil label states no duration of effect. The bar shows the upper end of the terminal half-life instead.
Storage
- —Store at 20 °C to 25 °C (68 °F to 77 °F) [see USP Controlled Room Temperature] — quoted from section 16 of the vardenafil label.
- —Keep the tablets in the original container, out of reach of children.
- —Tablets ordered from an unlicensed overseas seller are outside all of this. FDA has repeatedly found products sold as PDE5 inhibitors that contain undeclared active ingredient at undeclared strengths; nothing on this page describes those.
Monitoring
| Marker | When | Why |
|---|---|---|
| Nitrates, nitrites and GC stimulators | Before the first prescription, at every renewal, and before any emergency nitrate | An absolute contraindication, not a caution. “Administration of vardenafil with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated” (section 4.1 Nitrates). The same label bars guanylate cyclase stimulators: “Do not use vardenafil in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil may potentiate the hypotensive effects of GC stimulators.” (section 4.2 Guanylate Cyclase (GC) Stimulators). |
| Alpha-blocker therapy and blood pressure | Before starting, and again whenever either drug changes | Start at 5 mg; be stable on the alpha-blocker first. “In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil is 5 mg” (section Highlights of Prescribing Information — Dosage and Administration (2.4, 5.6)). Starting dose on the chart: 5 mg. |
| Fitness for sexual activity | Before starting | The label directs prescribers to consider cardiovascular status before treating erectile dysfunction, because sexual activity itself carries cardiac risk. This is a clinical assessment, not a self-assessment. |
| Sudden vision or hearing loss | Any time during treatment — stop and seek care the same day | The label instructs patients to stop the drug and seek medical attention on sudden loss of vision in one or both eyes, which can signal non-arteritic anterior ischaemic optic neuropathy, and on sudden decrease or loss of hearing. |
| An erection lasting more than four hours | Immediately — emergency care | Priapism can cause irreversible damage to erectile tissue. Every one of the four labels tells patients to seek emergency treatment at four hours, whether the erection is painful or not. |
Frequently asked questions
- What dose does the FDA label actually state?
- The Levitra label's dosage section states: “For most patients, the recommended starting dose of vardenafil is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity.” It then states: “The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects.” and “The maximum recommended dosing frequency is once per day.” The approved as-needed range is therefore 5–20 mg, and the tablet strengths supplied are 2.5 / 5 / 10 / 20 mg. The 2.5 mg tablet exists for dose reduction with CYP3A4 inhibitors, not as a starting dose for ED.
- How long before sex should it be taken, and how long does it last?
- The label says to take it approximately 60 minutes before, and be clear what that figure is — the basis is dosage section instruction; no earlier time permitted. For duration: The label states no duration of effect. The vardenafil label states no duration of effect. The bar shows the upper end of the terminal half-life instead. “The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4 to 5 hours.” (section 12.3 Pharmacokinetics). None of the four labels states an “onset of action”; they state a lead time or a time-to-peak, which are different quantities.
- Can it be taken with nitrates if enough time has passed?
- Label states none — "has not been determined". The label's own words: “A suitable time interval following dosing of vardenafil for the safe administration of nitrates or nitric oxide donors has not been determined.” (section 4.1 Nitrates). All four labels contraindicate concomitant use with organic nitrates or nitric oxide donors in any form — nitroglycerin, isosorbide mononitrate or dinitrate, and amyl or butyl nitrite "poppers". A PDE5 inhibitor taken with a nitrate can drop blood pressure to a dangerous level. Guanylate cyclase stimulators such as riociguat are contraindicated on all four labels as well. Where a label declines to name a safe interval, that is not the same as saying none is needed — it is the label saying the answer is not known, and this page does not fill it in.
- What if I am already on an alpha-blocker for my prostate?
- Start at 5 mg; be stable on the alpha-blocker first. The label states: “In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil is 5 mg” (section Highlights of Prescribing Information — Dosage and Administration (2.4, 5.6)). Section 2.4 itself does not repeat the 5 mg figure; it says only that "PDE5 inhibitors should be initiated at the lowest recommended starting dose". The 5 mg number appears in the Highlights, and 5 mg is the lowest ED starting dose the label supports. Both drugs lower blood pressure, so the combination is a dose decision for your prescriber, not an adjustment to make on your own.
- Why is there no Levitra label to read?
- Because there is no current one. Drugs@FDA lists every LEVITRA strength under NDA 021400 as discontinued, with a Federal Register determination that the withdrawal was not for safety or effectiveness reasons, and DailyMed carries no innovator LEVITRA label — its LEVITRA entries are repackager copies of the withdrawn pre-2011-format Bayer document, which has no numbered sections and no Dosage Forms and Strengths section. Everything quoted on this page therefore comes from the current-format generic vardenafil label from Zydus Pharmaceuticals USA, which is the same document the comparison chart and the timing tool quote.
- How long does vardenafil last?
- The label does not say. It states no duration of effect anywhere, which is why this page prints the terminal half-life in its place and labels it as such: “The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4 to 5 hours” (section 12.3). A half-life is not a duration of effect, and substituting one for the other silently is how a four-hour figure becomes an eight-hour claim. Sildenafil and tadalafil labels do state a duration; vardenafil and avanafil do not.
- Is the 2.5 mg tablet a low starting dose?
- No. The vardenafil label supplies a 2.5 mg tablet, but its dosage section never offers 2.5 mg as a starting dose for erectile dysfunction — the range it supports runs 5 to 20 mg. The 2.5 mg strength exists for dose reduction when a CYP3A4 inhibitor is on board. A tablet strength existing is not the same as that strength being an approved dose, and the comparison chart flags exactly this case.
- Does this page tell me which one to take?
- No. It quotes one label. Choosing between the four is a clinical decision that turns on what else you take — nitrates and guanylate cyclase stimulators rule all four out absolutely — on your cardiovascular status, on whether you want a tablet for an occasion or one every day, and on cost. The side-by-side comparison of all four labels is at /charts/ed-medication-comparison-chart.
Sources
- [1]FDA label — VARDENAFIL tablet, film coated, Zydus Pharmaceuticals USA Inc. (DailyMed SPL 5876e062-e604-42a7-99c3-5da30b8dac06). Dosage, nitrate contraindication, alpha-blocker dosing, pharmacokinetics and storage all quoted from this document. Drugs@FDA: LEVITRA is NDA 021400 (Bayer HealthCare) and every strength of it is listed in Drugs@FDA as discontinued, with a Federal Register determination that it was not withdrawn for safety or effectiveness reasons. Vardenafil is dispensed as a generic.
- [2]Drugs@FDA — LEVITRA (vardenafil hydrochloride) tablets, NDA 021400, Bayer HealthCare. All strengths listed as discontinued with a Federal Register determination that the product was not discontinued or withdrawn for safety or effectiveness reasons
- [3]Drugs@FDA: FDA-Approved Drugs — the searchable record of every approved application, used to confirm the application number, the approved strengths and the marketing status of each brand named on this page
Related
Educational reference, not medical advice. Dose, route and whether this compound is appropriate at all are decisions for your clinician.