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Probe · vardenafil · 3 min read

Does age 65 change the Levitra start?

Age 65 and older should be considered for a 5 mg start. Elderly men (65 and up) had mean Cmax 34 percent higher and AUC 52 percent higher than men 18 to 45. Phase 3 trials included more than 834 elderly patients, and safety and effectiveness of 5, 10, or 20 mg were not different versus younger men in that comparison. The higher concentrations are why 5 mg is the consider-start. Twenty milligrams remains the labelled maximum, not the automatic first tablet.

Medically reviewed by Dr. Mateo Ruiz, MD - Clinical pharmacology, Barcelona

Last reviewed

Updated

01What if the liver is also impaired?

Forest-green still life: smallest amber tablet on a brass dish

Child-Pugh B starts at 5 mg and caps at 10 mg. Child-Pugh C is do not use. Age 65 plus Child-Pugh B is not a 20 mg night. The hepatic probe holds those grades.

Renal dialysis is also a do-not-use row. Creatinine clearance down to below 30 mL/min raised AUC only 20 to 30 percent in volunteers, and no dose cut is written for that group except dialysis.

02Can a man over 65 later use 20 mg?

Twenty milligrams remains the labelled maximum if the clinician titrates after a tolerated lower start. The insert does not forbid 20 mg by age alone. It asks for a 5 mg consider-start.

Headache and flush already showed a dose effect. A first-night 20 mg in a 70-year-old is the cart talking, not the consider-start.

03Did 834 elderly men get a different effectiveness read?

More than 834 elderly patients sat in Phase 3. No differences in safety or effectiveness of Levitra 5, 10, or 20 mg were noted versus younger patients in that comparison. The 5 mg consider-start still stands because concentrations were higher.

Do not read that sentence as 'start at 20 mg, age does not matter'. The dosing section already wrote consider 5 mg.

04What if the same man is on ritonavir?

Strong CYP3A4 inhibitors force 2.5 mg. Ritonavir's gap is 72 hours. Age 65 does not waive that cap. The two rows stack; they do not cancel.

Ketoconazole 400 mg daily is also a 2.5 mg in 24 hours row. The CYP probe keeps the list.

05Why are concentrations higher after 65?

Compared with males 18 to 45 years, elderly males had mean Cmax 34 percent higher and AUC 52 percent higher. The insert points to those concentrations as the reason to consider 5 mg.

Phase 3 still used 5, 10, and 20 mg in the elderly group. The consider-start is about exposure, not about a missing efficacy file.

06What words does the insert use at 65?

A starting dose of 5 mg Levitra should be considered in patients 65 years of age and older. That is a consider-start, not a ban on 10 mg or 20 mg after a clinician has seen the chart.

This site still follows 20 mg as the ceiling tablet. A 65-year-old first script that opens at 20 mg because a cart photographed that count has skipped the consider-start.

Sources

  1. DailyMed LEVITRA (vardenafil)
  2. LEVITRA 2.3 / 8.5: consider 5 mg at >=65; Cmax +34%, AUC +52%; Phase 3 n>834 elderly.

Checked against the current label and reviewed by Dr. Mateo Ruiz. See Probe, Assay, Glow-check, Seal.

Vault consult

Answers follow the U.S. Levitra label.

Arun S. I am 68. Is 20 mg the first tablet?

Vault reply

Consider 5 mg as the first swallow at 65 and older. Twenty milligrams is the labelled maximum after a tolerated climb, not the consider-start.

Grete D. Did older men do worse in the trials?

Vault reply

Phase 3 included more than 834 elderly patients. Safety and effectiveness of 5, 10, or 20 mg were not different versus younger men in that comparison. Concentrations were still higher, which is why 5 mg is considered first.

Pablo F. I am 66 and on ketoconazole 400 mg. Five or 20?

Vault reply

Ketoconazole 400 mg daily caps Levitra at 2.5 mg in 24 hours. Age does not raise that cap. Twenty milligrams is off that chart.

Before you start, stop, or change any medicine, speak with your prescriber or pharmacist - they hold your chart, this vault card does not. Open the vault disclaimer.