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Probe · tadalafil · 3 min read

Does age 65 change the Cialis milligram by itself?

No. Age 65 alone does not cut the Cialis milligram. Healthy men 65 or over had lower oral clearance, about 25% higher AUC, and no change in Cmax versus men 19 to 45. About 19% of ED trial subjects were 65 or over. No overall efficacy or safety split showed up by age. Greater sensitivity in some older people should still be considered. Kidneys and CYP inhibitors still rewrite the dose.

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

Last reviewed

Updated

01How many trial subjects were 65 or over?

Forest-green still life: worn brass hourglass beside one tablet, no numbers

About 19% of subjects in ED clinical studies of tadalafil were 65 and over, and about 2% were 75 and over. No overall differences in efficacy or safety were observed between older and younger subjects in those trials.

BPH studies had a higher older share (about 40% over 65). That is a different indication. BPH dosing is 5 mg daily.

02If 10 mg feels heavy at 70, is that the AUC?

A heavy 10 mg at 70 can be sensitivity, alcohol, or a kidney number nobody checked. The AUC fact does not by itself demand 5 mg. The labelled step down still exists after a real read.

A kitchen knife is not the labelled 5 mg step down.

03Does that 25% AUC force a 5 mg start?

No dose adjustment is warranted based on age alone. This vault's as-needed start can stay 10 mg when the rest of the chart is clean.

Greater sensitivity to medications in some older individuals should still be considered. That is a clinical judgment, not an automatic halving.

04What still rewrites the milligram after 65?

Creatinine clearance still rewrites spacing. Ketoconazole or ritonavir still caps as-needed use at 10 mg every 72 hours. Those rows do not wait for a birthday. See CrCl and keto.

Alpha-blockers still want a stable first dose and the lowest Cialis start. See alpha-blocker stability.

05What happens to AUC after 65?

Healthy male elderly subjects (65 years or over) had a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) with no effect on Cmax relative to healthy subjects 19 to 45 years of age.

Cmax staying flat means the peak height did not climb with that AUC. The extra exposure is a larger area, not a taller spike.

06Did any adverse event show up more often after 65?

In placebo-controlled studies with Cialis for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Cialis (2.5% of patients).

That is one labelled split. It is not a reason to invent a new milligram for every 65th birthday.

Sources

  1. DailyMed CIALIS (tadalafil) Clinical Pharmacology 12.3 Geriatric: 25% higher AUC, no effect on Cmax
  2. DailyMed / Lilly CIALIS 8.5: ~19% of ED subjects ≥65, ~2% ≥75; no dose adjustment based on age alone; diarrhea 2.5% as-needed ≥65

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

Vault consult

Answers follow the U.S. Cialis label.

Teresa N. I am 68. Do I have to start at 5 mg?

Vault reply

Sixty-five by itself does not force 5 mg. AUC is about 25% higher and Cmax is flat. The as-needed start can stay 10 mg if the rest of the chart is clean.

Hugo W. Does the higher AUC mean a taller peak?

Vault reply

Cmax did not change in the elderly PK work. The extra exposure is AUC, not a higher spike.

Amira Z. My CrCl is 40 and I am 70. Which row wins?

Vault reply

The kidney row wins. CrCl 30 to 50 starts as-needed use at 5 mg and caps 10 mg every 48 hours. Age alone would not have cut it.

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.