How Cialis (Tadalafil) is Typically Ordered
Cialis is ordered in one of two distinct regimens: as-needed dosing (10-20 mg taken 30 minutes to 36 hours before sexual activity, maximum once daily) or daily dosing (2.5-5 mg taken at the same time each day regardless of sexual activity timing). 1
Dosing Regimens
As-Needed (PRN) Dosing
- Starting dose is typically 10 mg, taken at least 30 minutes before anticipated sexual activity 1
- The medication provides a window of effectiveness lasting up to 36 hours after dosing 1
- Maximum frequency is once per 24 hours 1
- Dose can be increased to 20 mg or decreased to 5 mg based on efficacy and tolerability 1
- Sexual stimulation is required for the medication to work 1
Daily Dosing
- Starting dose is 2.5-5 mg taken once daily at approximately the same time each day 1
- This regimen eliminates the need to time medication with sexual activity, allowing for spontaneous intimacy 2
- Sexual activity can be attempted at any time between doses 1
- Maximum dose is 5 mg once daily 1
- Daily dosing is FDA-approved for treating both erectile dysfunction and benign prostatic hyperplasia (BPH) symptoms simultaneously when using the 5 mg dose 2
Critical Pre-Prescribing Requirements
Absolute Contraindications to Screen For
- Any form of nitrate use (oral, sublingual, transdermal, or inhaled) is an absolute contraindication due to risk of fatal hypotension 2, 1
- Concurrent use of guanylate cyclase stimulators like riociguat 1
- Patients already taking other PDE5 inhibitors or ADCIRCA (tadalafil for pulmonary hypertension) 1
Cardiovascular Risk Assessment
- Assess whether the patient can perform moderate physical activity (equivalent to climbing two flights of stairs) 2
- Low-risk patients who can perform moderate activity can safely receive tadalafil without cardiology consultation 2
- Refer to cardiology before prescribing if the patient cannot perform moderate exercise or has indeterminate cardiovascular risk 2
- Low-risk patients include those with asymptomatic coronary artery disease with <3 risk factors, controlled hypertension, mild stable angina, successful coronary revascularization, uncomplicated past MI, mild valvular disease, and CHF NYHA class I 2
Drug Interaction Screening
- Alpha-blockers can cause dangerous blood pressure drops when combined with tadalafil 1
- HIV protease inhibitors (ritonavir), antifungals (ketoconazole, itraconazole), and certain antibiotics (clarithromycin, erythromycin) require dose adjustments 1
- Severe hepatic impairment generally contraindicates PDE5 inhibitor use 2
Dose Selection Strategy
Choosing Between As-Needed vs. Daily Dosing
- For couples preferring spontaneous rather than scheduled sexual activity, daily dosing (2.5-5 mg) is the preferred regimen 2
- For patients with both ED and BPH symptoms, prescribe tadalafil 5 mg once daily as it treats both conditions simultaneously 2
- As-needed dosing is appropriate for patients with infrequent sexual activity or those who prefer to time medication with planned intimacy 1
Dose Titration Principles
- Unlike sildenafil and vardenafil, tadalafil does NOT show dose-dependent improvement between 5 mg, 10 mg, and 20 mg doses 3, 2, 4
- The choice between 10 mg and 20 mg for as-needed dosing should be based primarily on tolerability rather than expecting dramatically better efficacy at higher doses 2
- Titrate doses up or down to find the optimal balance between efficacy and side effects 2
Defining an Adequate Trial
An adequate trial consists of at least 5 separate attempts at the maximum dose before declaring treatment failure 2
Common reasons for apparent treatment failure include:
- Inadequate number of attempts (fewer than 5) 2
- Improper timing of the dose 2
- Lack of sexual stimulation (which is required for the medication to work) 2, 1
- Unaddressed hormonal abnormalities, particularly testosterone deficiency 2
- Food or drug interactions 2
- Heavy alcohol use (more than 5 drinks) 1
Special Populations
Patients with Diabetes or Post-Prostatectomy
- These patients have more severe ED at baseline and may respond less robustly to PDE5 inhibitors 2
- However, tadalafil remains effective in these populations 3
Patients with Testosterone Deficiency
- For men with both ED and testosterone deficiency, combining tadalafil with testosterone therapy is more effective than tadalafil alone 2
- Testosterone therapy alone is not effective monotherapy for ED 2
Patients Previously on Other PDE5 Inhibitors
- Switching to daily tadalafil can restore normal erectile function (IIEF-EF ≥26) in men who had incomplete response to maximum-dose as-needed PDE5 inhibitors 5
- In one study, 39-40% of men achieved normal erectile function with daily tadalafil after failing to achieve this with maximum-dose as-needed therapy 5
Patient Counseling Points
Critical Information to Prevent Treatment Failure
- Sexual stimulation is necessary for tadalafil to work 2, 1
- More than one trial may be required to establish efficacy 2
- For as-needed dosing, the medication can be effective from 30 minutes up to 36 hours after taking it 1
- Avoid excessive alcohol consumption (more than 5 drinks) as this increases risk of headache, dizziness, and hypotension 1
Common Side Effects
- Most common adverse effects are headache, dyspepsia, back pain, flushing, nasal congestion, and myalgia 2, 1
- Back pain and muscle aches typically occur 12-24 hours after dosing and resolve within 2 days 1
- Most adverse events are transient and mild to moderate in severity 4
Emergency Nitrate Protocol
- If emergency nitrate administration is required, wait at least 48 hours after the last tadalafil dose before giving nitrates 2
- This must be done under close medical supervision with continuous patient monitoring 2
Follow-Up Management
- Schedule follow-up within 4-12 weeks after initiating therapy to assess efficacy and tolerability 6
- Verify that cardiovascular health hasn't changed 2
- Review any new medications for potential interactions 2
- Assess treatment effectiveness and side effects 2
- Before switching therapies, evaluate whether the trial was adequate by addressing hormonal abnormalities, drug interactions, timing/frequency of dosing, adequacy of sexual stimulation, alcohol use, and relationship issues 2