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What dose of vardenafil does the US label start?

4 min read · Reviewed

Medically reviewed by Dr. Priya Natarajan, MD - Clinical pharmacology, Dublin

Ten milligrams for most patients. That is the US start, once a day. This shelf locks 10 mg. Later nights can move the tablet if efficacy or side effects say so. Age 65 often starts at 5 mg.

01What ceiling do ritonavir and the azoles force?

Ritonavir, indinavir, ketoconazole, and itraconazole are strong CYP3A4 inhibitors. The vardenafil ceiling with those drugs is 2.5 mg. With ritonavir, that 2.5 mg sits in a 72-hour period, not the next calendar night. Ritonavir 600 mg twice daily with LEVITRA 5 mg raised vardenafil AUC 49-fold and Cmax 13-fold and stretched half-life to 26 hours.

Erythromycin, and the lower 200 mg daily ketoconazole or itraconazole bands, cap the tablet at 5 mg in 24 hours. Indinavir 800 mg three times daily with LEVITRA 10 mg raised AUC 16-fold and Cmax 7-fold. Name the inhibitor before anyone writes 10 mg.

02Why do men 65 and older often start at 5 mg?

In a healthy-volunteer comparison, men 65 and older had a mean Cmax 34% higher and a mean AUC 52% higher than men 18 to 45. The label therefore starts them at 5 mg. That 5 mg is still as needed, once that day, not a morning habit.

Turning 65 does not retire the 10 mg tablet forever. It changes the first night. Later nights can still move if efficacy and side effects say so, the same way a younger start can move to 20 mg or back to 5 mg. Strong CYP3A4 inhibitors still override age and drop the ceiling to 2.5 mg.

03How do alpha-blockers change the first tablet?

Stay stable on the alpha-blocker first. Start vardenafil at the lowest labelled strength. Separating the two swallows is the caution the interaction studies keep pointing at. One man on terazosin 10 mg plus vardenafil 5 mg at the same time dropped standing pressure to 80/60 mm Hg. Hypotension was not seen when those two were six hours apart. Tamsulosin 0.4 mg with 5 mg at the same time still produced standing systolic values under 85 mm Hg in two men.

The vardenafil shelf still presents 10 mg as the usual start. Once a day is the frequency cap, not a second starting dose. Volume depletion makes that stack worse.

04What if the liver is Child-Pugh B or C?

Moderate hepatic impairment starts at 5 mg. The ceiling there is 10 mg. After a 10 mg dose in Child-Pugh B volunteers, Cmax rose 130% and AUC rose 160% versus healthy controls. Child-Pugh A, after 10 mg, only raised Cmax 22% and AUC 17%, so no cut is written.

Severe hepatic impairment - Child-Pugh C - is a do-not-use line. Vardenafil was not evaluated there. End-stage renal disease on dialysis is the other unstudied clearance setting. A CLcr under 30 ml/min that is not dialysis does not write a new milligram.

05What start does the US label write for most men?

For most patients the recommended starting dose is 10 mg, taken as needed. One tablet that day. Sexual stimulation is required. The four marketed strengths are 2.5 mg, 5 mg, 10 mg, and 20 mg.

Readers on this site meet the 10 mg start first. Child-Pugh A does not change that start. Mild, moderate, or severe renal impairment that is not dialysis also keeps the labelled start. Dialysis itself was not studied. A CLcr under 30 ml/min still does not write a new milligram on the renal line.

06When does the tablet go to 20 mg or back to 5 mg?

Efficacy and side effects decide the next step. The dose may be increased to a maximum of 20 mg or decreased to 5 mg. That change is a later visit, not a same-night experiment. Headache and flush were the effects that rose along that ladder in the trials.

Do not add a second 10 mg tablet to invent 20 mg on your own if the bottle in the cabinet is 10 mg and the order was 10 mg. Splitting a 20 mg tablet to make 10 mg is also not how the start was written.

Before you start, stop, or change any medicine, speak with your prescriber or pharmacist. They hold your chart. This bin card does not. Open the bin disclaimer.

Sources

  1. US LEVITRA (vardenafil HCl) tablets prescribing information, DailyMed (Dosage and Administration 2.1-2.4; Clinical Pharmacology, geriatrics and hepatic; Drug Interactions, CYP3A4)

Checked against the current label and reviewed by Dr. Priya Natarajan. See Pick → Check → Tag → Bin.

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Answers follow the U.S. LEVITRA label.

Arlo asks

I'm 67 and my friend takes 10 mg. Can I start there?

The geriatric line starts you at 5 mg. Cmax ran 34% higher and AUC 52% higher in men 65 and older versus 18 to 45. A friend's 10 mg bottle is not your first night. That 5 mg is still once that day.

Duke asks

I'm on ritonavir. They wrote 10 mg anyway. What does the label say?

With ritonavir the ceiling is 2.5 mg, and that single tablet sits in a 72-hour window. Ritonavir 600 mg twice daily with LEVITRA 5 mg raised AUC 49-fold. Ten milligrams is the usual start for people who are not on that inhibitor. Take the script back.

Glen asks

Child-Pugh B, they said 5 mg. Can I later ask for 20?

Moderate hepatic impairment caps at 10 mg. After 10 mg in Child-Pugh B volunteers, Cmax rose 130% and AUC rose 160%. Twenty milligrams is not on that ladder. Child-Pugh C is a stop, not a lower tablet.