Cialis (Tadalafil) Missed-Dose Protocol: What to Do and When to Skip

At a glance

  • Daily dosing, ED / 2.5 mg, may increase to 5 mg [1]
  • Daily dosing, BPH or ED with BPH / 5 mg at approximately the same time each day [1]
  • As-needed dosing / 10 mg before sexual activity; 5 to 20 mg by response; maximum once per day [1]
  • Mean terminal half-life / 17.5 hours [1]
  • Time to steady state / About 5 days; exposure about 1.6-fold a single dose [1]
  • Missed-dose instruction / None in the label's dosing section [1]

What the Cialis label says about daily dosing

Cialis is a PDE5 inhibitor indicated for erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both conditions together [1].

Once-daily use is written three ways: 2.5 mg once daily for ED, which may be increased to 5 mg; 5 mg once daily for BPH, taken at approximately the same time every day; and 5 mg once daily for ED with BPH, also at approximately the same time every day [1]. The label says Cialis may be taken with or without food and that the tablets are not to be split; the entire dose is taken [1]. Drugs@FDA lists the Cialis 2.5 mg tablet as discontinued [2].

As-needed use is a different schedule: a starting dose of 10 mg before anticipated sexual activity, adjustable between 5 and 20 mg, with a maximum of once per day [1]. There is no fixed clock time; an as-needed dose is taken before activity, so there is no scheduled daily dose to miss.

The dosing section does not describe what to do after a forgotten daily tablet, and it does not describe taking a second tablet to replace one [1].

How tadalafil levels behave between doses

Tadalafil reaches peak concentration between 30 minutes and 6 hours after a dose (median 2 hours) and has a mean terminal half-life of 17.5 hours in healthy subjects [1]. Once-daily dosing reaches steady state within 5 days, at an exposure about 1.6-fold that of a single dose, and the label says once-daily use provides continuous plasma tadalafil levels [1].

Nitrates and other timing rules

Organic nitrates in any form are contraindicated with Cialis [1]. The label says that in a life-threatening situation where a nitrate is medically necessary, a nitrate may be considered only after at least 48 hours have elapsed since the last Cialis dose, under close medical supervision with hemodynamic monitoring [1]. In a 150-man crossover study, men took tadalafil 20 mg or placebo daily for 7 days and then sublingual nitroglycerin 0.4 mg; standing systolic blood pressure fell below 85 mm Hg in more men on tadalafil at 4, 8 and 24 hours, with no difference at 48, 72 and 96 hours [3].

The label says an erection lasting more than 4 hours, painful or not, needs emergency care, and that sudden vision loss in one or both eyes or a sudden decrease or loss of hearing calls for stopping Cialis and getting medical care [1].

Frequently asked questions

What does the label say if I forget a daily Cialis dose?
The dosing section gives no missed-dose rule. The once-daily regimens are one 2.5 mg or 5 mg tablet at approximately the same time every day [1].
Can I take two Cialis tablets to make up for a missed one?
The labeled daily regimens specify one dose per day, and the as-needed regimen has a maximum of once per day. The label gives no catch-up schedule for a missed dose [1].
Does tadalafil stay in the body if I skip a day?
The label gives a mean terminal half-life of 17.5 hours, so levels decline gradually after a dose, and steady state takes about 5 days of daily dosing to reach [1].
Is there a missed dose with as-needed Cialis?
As-needed Cialis is taken before anticipated sexual activity, starting at 10 mg and adjusted between 5 and 20 mg, with a maximum of once per day, so there is no daily schedule to miss [1].
Does missing a daily dose affect BPH symptoms?
The label writes the BPH regimen as 5 mg at approximately the same time every day [1]. In a 12-week trial, 161 men took tadalafil 5 mg daily and 164 took placebo; the symptom score improved by 5.6 points versus 3.6, with benefit apparent from week 1. The trial did not test missed doses [4].

References

  1. U.S. National Library of Medicine, DailyMed. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. Kloner RA, Hutter AM, Emmick JT, Mitchell MI, Denne J, Jackson G. Time course of the interaction between tadalafil and nitrates. J Am Coll Cardiol. 2003;42(10):1855-60. Time course of the interaction between tadalafil and nitrates
  4. Porst H, Kim ED, Casabé AR, Mirone V, Secrest RJ, Xu L, et al. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol. 2011;60(5):1105-13. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial
Evidence overview for cialis tadalafil: Cialis (Tadalafil) Missed-Dose Protocol: What to Do and When to Skip