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Cialis (tadalafil)

In this drug monograph:

• Cialis (tadalafil) Indications
• Dosage and Administration of Cialis (tadalafil)
• Contraindications, Warnings, and Precautions
• Side Effects or Adverse Reactions
• Drug Interactions
• Efficacy of Cialis (tadalafil)
• Pharmacology (Mechanism of Action)
• Cialis Pill Identification and Imprint Code
• Cialis User Reviews

Cialis (tadalafil) Indications

Cialis has the following indications:

• Treatment of erectile dysfunction (ED)
• Treatment of signs and symptoms of benign prostatic hyperplasia (BPH)
• Treatment of patients with both erectile dysfunction, and signs and symptoms of benign prostatic hyperplasia.

Dosage and Administration of Cialis (tadalafil)

Cialis is a selective phosphodiesterase type 5 (PDE5) inhibitor available as 2.5, 5, 10, or 20 mg tablets for oral administration

Erectile Dysfunction (used as needed)

• For most patients the recommended starting dose is 10 mg as needed prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg based on efficacy or tolerability.
• The maximum dosing frequency is once daily for most patients. Cialis is effective for up to 36 hours.
• Renal dysfunction:
  • Creatinine clearance 30 to 50 ml/min: The recommended starting dose is 5 mg no more than once daily, and the maximum dose is 10 mg every 48 hours.
  • Creatinine clearance less than 30 ml/min or on hemodialysis: The maximum dose is 5 mg every 72 hours.
• Hepatic dysfunction:
  • Mild or moderate dysfunction: Use has not been extensively evaluated. Do not exceed 10 mg daily.
  • Severe dysfunction: Use is not recommended.

Erectile Dysfunction (used daily without regard to sexual activity)

• The recommended dose for scheduled once daily use is 2.5 mg taken at approximately the same time daily without regard to timing of sexual activity.
• The dose may be increased to 5 mg daily based on efficacy and tolerability.
• For patients with renal dysfunction:
  • Creatinine clearance less than 30 ml/min or on hemodialysis: Cialis is not recommended for scheduled once daily use.
• Hepatic dysfunction:
  • Mild or moderate dysfunction: Use has not been extensively evaluated. Therefore, use with caution.
  • Severe dysfunction: Use is not recommended.

Benign prostatic hyperplasia

• The recommended dose is 5 mg taken at approximately the same time every day.
• Renal dysfunction:
  • Creatinine clearance 30 to 50 ml/min: Start with 2.5 mg and increase to 5 mg daily as needed and tolerated.
  • Creatinine clearance less than 30 ml/min or on hemodialysis: Cialis is not recommended for scheduled once daily use.

Combined Erectile Dysfunction and Benign prostatic hyperplasia

• The recommended dose is 5 mg at approximately the same time every day without regard to sexual activity.
• For patients with renal dysfunction:
  • Creatinine clearance 30 to 50 ml/min: Start with 2.5 mg and increase to 5 mg daily as needed and tolerated.
  • Creatinine clearance less than 30 ml/min or on hemodialysis: Cialis is not recommended for scheduled once daily use.
• Hepatic dysfunction:
  • Mild or moderate dysfunction: Use has not been extensively evaluated. Therefore, use with caution.
  • Severe dysfunction: Use is not recommended.

Use with CYP3A4 inhibitors (see drug interactions)

• Maximum dose is 10 mg every 72 hours as needed or 2.5 mg daily without regard to timing of sexual activity.

Contraindications, Warnings, and Precautions

Contraindications

• Use of nitrates (for example, nitroglycerine, isosorbide): Cialis may increase hypotensive effects of nitrates.
• Hypersensitivity reactions to tadalafil (Cialis or Adcirca)

Warnings and Precautions

• Angina: Patients with angina should not use Cialis because sexual activity may precipitate angina.
• Use of scheduled daily Cialis in combination with nitrates, alpha blockers, antihypertensives, and potent CYP3A4 inhibitors.
• Prolonged erections and priapism
• Sudden loss of vision: NAION (non-arteritic anterior ischemic optic neuropathy)
• Sudden hearing loss.
• Alpha blockers and antihypertensives: Cialis potentiates the antihypertensive effects of alpha blockers and antihypertensives.
• Renal impairment: See dosing section.
• Hepatic impairment: See dosing section.
• Alcohol: Cialis potentiates the vasodilatory action of alcohol. Combining Cialis with substantial consumption of alcohol may result in orthostatic hypotension.
• CYP3A4 inhibitors (for example, ritonavir, ketoconazole, itraconazole): Limit dose. (See drug interactions.)
• Other PDE5 inhibitors: Cialis should not be combined with other PDE5 inhibitors.
• Bleeding: PDE5 is found on platelets. Use of Cialis in patients with bleeding disorders or active peptic ulcers should be based on careful risk-benefit assessment and caution.