What are the indications for the 5 mg tablet of Cialis (tadalafil) in adult men?

Indications for Tadalafil 5 mg Daily

Tadalafil 5 mg once daily is FDA-approved for three distinct indications: erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and the simultaneous treatment of both ED and BPH. 1

FDA-Approved Indications

1. Erectile Dysfunction (Once Daily Dosing)

• Tadalafil 5 mg once daily is approved for continuous treatment of ED, eliminating the need to time medication with sexual activity and allowing for spontaneous sexual encounters. 1
• The starting dose for once-daily use is 2.5 mg, which may be increased to 5 mg based on individual efficacy and tolerability. 1
• This dosing regimen is particularly appropriate for couples who prefer spontaneous rather than scheduled sexual activity. 2

2. Benign Prostatic Hyperplasia (BPH/LUTS)

• Tadalafil 5 mg once daily is approved as monotherapy for treating lower urinary tract symptoms (LUTS) associated with BPH, regardless of whether erectile dysfunction is present. 1, 3
• The American Urological Association recommends 5 mg daily tadalafil as a treatment option for patients with LUTS/BPH with moderate recommendation strength (Grade B evidence). 3
• Clinical trials demonstrate mean IPSS improvement of -5.4 to -6.1 points compared to -3.6 to -3.8 points with placebo. 3, 4
• Improvements in LUTS parameters (IPSS, voiding symptoms, storage symptoms, quality of life scores, and BPH Impact Index) are significant and clinically meaningful. 4, 5, 6

3. Combined ED and BPH Treatment

• Tadalafil 5 mg once daily is uniquely FDA-approved to treat both conditions simultaneously with a single medication, taken at approximately the same time each day without regard to timing of sexual activity. 1, 7
• This represents the only medication that can effectively address both ED and LUTS/BPH concurrently, avoiding the sexual adverse effects associated with alpha-blockers or 5-alpha reductase inhibitors. 8

Critical Pre-Treatment Safety Assessment

Absolute Contraindications

• Verify complete absence of nitrate use in any form before prescribing—this is an absolute contraindication due to risk of potentially fatal hypotension. 2, 3
• Concomitant use with riociguat (a soluble guanylate cyclase stimulator) is contraindicated due to severe hypotension risk. 2

Cardiovascular Risk Stratification Required

• Assess cardiovascular fitness by asking if the patient can walk 1 mile in 20 minutes or climb 2 flights of stairs without symptoms before prescribing. 2
• Patients unable to perform this level of moderate physical activity should be referred to cardiology before initiating treatment. 2
• High-risk patients who should defer treatment include those with unstable angina, uncontrolled hypertension, recent MI, NYHA Class II-IV heart failure, or severe valvular disease. 2

Dosing Considerations and Special Populations

Renal Impairment

• For once-daily use with BPH or combined ED/BPH: Start with 2.5 mg daily when creatinine clearance is 30-50 mL/min, with potential increase to 5 mg based on response. 1
• Once-daily tadalafil is not recommended when creatinine clearance is <30 mL/min or in patients on hemodialysis. 1

Hepatic Impairment

• Mild to moderate hepatic impairment (Child-Pugh Class A or B): Use with caution, as once-daily tadalafil has not been extensively evaluated in this population. 1
• Severe hepatic impairment (Child-Pugh Class C): Tadalafil is not recommended. 1

Important Clinical Considerations

Combination Therapy NOT Recommended

• The American Urological Association provides a Moderate Recommendation (Grade C) that clinicians should NOT offer the combination of tadalafil 5 mg daily with alpha-blockers for LUTS/BPH, as it offers no advantages over either agent alone and increases adverse events. 7, 3
• For patients currently on alpha-blockers with coexisting ED, discontinue the alpha-blocker and switch to tadalafil 5 mg monotherapy. 7

Common Adverse Effects

• Most common side effects include headache, dyspepsia, back pain, myalgia, nasal congestion, and flushing. 2, 3
• Tadalafil has lower rates of flushing compared to other PDE5 inhibitors. 2
• The medication is generally well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters. 4

Administration

• Tadalafil 5 mg may be taken without regard to food or timing of sexual activity. 1
• The entire tablet should be taken; do not split tablets. 1
• Take at approximately the same time every day for optimal efficacy. 1