Vardenafil (Generic Levitra) Dosing Schedule: FDA Label
[Dosing schedule · Vardenafil]

Vardenafil dosing schedule

vardenafil hydrochloride · oral film-coated tablet taken as needed, 2.5, 5, 10 or 20 mg · Label checked

Short answer: The vardenafil label starts most men at 10 mg by mouth, as needed, about 60 minutes before sexual activity, with or without food. The dose can go up to 20 mg or down to 5 mg, and the maximum is once per day. A 5 mg start is considered at age 65 and older and used with moderate liver impairment or alpha-blockers. Some CYP3A4 inhibitors cap it at 2.5 or 5 mg.

This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.

What Vardenafil is approved for: Vardenafil hydrochloride tablets are approved to treat erectile dysfunction (section 1). Vardenafil is the medicine in Levitra; there is no current Levitra-brand label on DailyMed, so this page uses Teva's generic film-coated tablet label in the same strengths. The orally disintegrating tablet (Staxyn) is a different product.

Source
Vardenafil hydrochloride tablets, for oral use, prescribing information and Patient Information. Teva Pharmaceuticals. DailyMed, version published January 25, 2024. DailyMed setid e593ab58-70a4-4095-8091-16a4b6d49e4d

How is Vardenafil taken?

Vardenafil is a film-coated tablet taken by mouth, in 2.5 mg, 5 mg, 10 mg and 20 mg strengths (section 3). It can be taken with or without food (section 2.2).

One tablet is taken about 60 minutes before sexual activity, and sexual stimulation is needed for a response (sections 2.1 and 17).

The Patient Information says not to take more than one tablet a day, with doses at least 24 hours apart. Tablets are stored at 20 to 25 C (section 16).

What is the Vardenafil dosing schedule on the label?

The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.

Built from the text of sections 2.1, 2.3 and 2.4 [Section 2.1]
SituationDose on the label
Most patientsStart 10 mg about 60 minutes before sexual activity; may increase to 20 mg or decrease to 5 mg; at most once per day
Age 65 or olderStarting dose of 5 mg should be considered
Moderate liver impairment (Child-Pugh B)Start 5 mg; maximum 10 mg
Severe liver impairment (Child-Pugh C) or kidney dialysisDo not use
Stable on an alpha-blockerStart 5 mg (2.5 mg with certain CYP3A4 inhibitors)
Ritonavir or cobicistatNo more than 2.5 mg in a 72-hour period
Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycinNo more than 2.5 mg in a 24-hour period
Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycinNo more than 5 mg in a 24-hour period
Nitrates, nitric oxide donors or riociguatContraindicated

Other dosing rules on the label

  • Section 2.4

    With an alpha-blocker, vardenafil is started only if the man is stable on the alpha-blocker, and a time gap between the two doses should be considered.

  • Section 5.10

    Using vardenafil with other ED treatments is not recommended because the combination has not been studied.

  • Section 12.3

    Peak levels after a 20 mg dose usually come between 30 minutes and 2 hours (median 60 minutes) when fasting. High-fat meals lowered the peak by 18% to 50%. The half-life is about 4 to 5 hours.

  • Section 17

    Men are advised to contact their healthcare provider for a dose change if they are not satisfied with the result or have an unwanted effect.

What does the label say about a missed dose?

  • No rule

    Vardenafil is taken as needed before sexual activity, so the label has no missed-dose rule. It says the maximum is one dose per day, and the Patient Information says doses should be at least 24 hours apart.

What does the label say about switching?

  • Section 1

    This is the generic film-coated tablet. The vardenafil orally disintegrating tablet (sold as Staxyn) is a separate product with its own label and is not covered here.

How can Dose Track follow this schedule?

In Dose Track you set up Vardenafil as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

Dosing schedules for similar medicines

Frequently asked questions

What is the usual vardenafil starting dose?+
10 mg, taken about 60 minutes before sexual activity, for most men. It can be raised to 20 mg or lowered to 5 mg based on effect and side effects (section 2.1).
How long before sex should vardenafil be taken?+
About 60 minutes before sexual activity, and sexual stimulation is needed for it to work (sections 2.1 and 17).
Can vardenafil be taken with food?+
Yes, with or without food (section 2.2). The label notes that high-fat meals lowered peak blood levels by 18% to 50% (section 12.3).
How often can vardenafil be taken?+
The maximum recommended frequency is once per day (section 2.1). The Patient Information says not to take more than one tablet a day, with doses at least 24 hours apart.
What is the vardenafil dose for men over 65?+
The label says a 5 mg starting dose should be considered in men 65 and older (section 2.3).