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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Erectile Dysfunction

To facilitate attainment of a sexually functional erection in males with erectile dysfunction (ED, impotence).

Dosage and Administration

General

• Dosage must be individualized carefully according to the patient’s tolerance and erectile response.
• Sexual stimulation is required for response to therapy.

Administration

Oral Administration

Administer orally, no more than once daily, without regard to meals.

Some patients achieve an erection sufficient for successful intercourse within 30 minutes after tadalafil administration; ability to have sexual activity has been improved for up to 36 hours. Timing of administration relative to anticipated sexual activity is less important than with relatively short-acting drugs for erectile dysfunction.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Adults

Erectile Dysfunction

Oral

Initially, 10 mg. Depending on effectiveness and tolerance, increase dosage to a maximum of 20 mg or decrease to 5 mg.

Prescribing Limits

Adults

Erectile Dysfunction

Oral

Maximum 20 mg daily.

Special Populations

Hepatic Impairment

In patients with mild to moderate hepatic impairment (Child-Pugh class A or B), maximum dosage is 10 mg once daily. Use not recommended in patients with severe hepatic impairment (Child-Pugh class C).

Renal Impairment

If Cl_cr is 31–50 mL/minute, reduce initial dosage to 5 mg once daily; maximum dosage is 10 mg administered no more frequently than once every 48 hours. If Cl_cr is <30 mL/minute), including patients undergoing hemodialysis, maximum dosage is 5 mg administered no more frequently than once daily.

Geriatric Patients

No dosage adjustments necessary based solely on age.

Cautions

Contraindications

• Known hypersensitivity to tadalafil or any ingredient in the formulation.
• Concomitant use of any form of organic nitrates (e.g., nitrates, nitrites, or nitric oxide donors). (See Specific Drugs and Food under Interactions.)
• Should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Cardiovascular Effects

Serious, potentially fatal cardiovascular events reported.

Use not recommended in patients with a recent MI (within 90 days) or stroke (within 6 months); uncontrolled arrhythmias, hypotension (<90/50 mm Hg systolic/diastolic BP) or uncontrolled hypertension (170/110 mm Hg systolic/diastolic BP); heart failure (>NYHA class II) in the previous 6 months; or those with unstable angina or angina occurring during sexual intercourse.

Possible hypotension, particularly in patients with left-ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and in patients with severely impaired autonomic control of blood pressure.

Potentiation of hypotensive effect with organic nitrates may result in life-threatening hypotension and/or hemodynamic compromise; manufacturers state that concomitant use with vardenafil is contraindicated. (See Specific Drugs and Food under Interactions.)

Consider whether patients with underlying cardiovascular disease could be adversely affected by tadalafil’s vasodilatory activity, especially in combination with sexual activity.

Ocular Effects

Visual disturbances (e.g., blurred vision, changes in color vision, conjunctivitis, eye pain, increased lacrimation, periorbital edema, nonarteritic anterior ischemic optic neuropathy, visual field defect, retinal vein occlusion) reported rarely.

Use not recommended in patients with hereditary degenerative retinal disorders, including retinitis pigmentosa.

Priapism

Possible prolonged erections (>4 hours) and priapism (painful erection >6 hours).

May result in penile tissue damage and permanent loss of potency if priapism is not treated immediately. Use with caution in patients with conditions that may predispose to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Patient Assessment

Thorough medical history and physical examination is recommended to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment options.

GU Precautions

Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease).

Concomitant Therapies for Erectile Dysfunction

Safety and efficacy not established for use in combination with other treatments for erectile dysfunction; combined therapy is not recommended.

Concomitant Administration with α-Adrenergic Blocking Agents

Potentiation of hypotensive effect in patients receiving concomitant therapy with α-adrenergic blocking agents, due to vasodilatory action.

Stabilize hemodynamic parameters in patients receiving an α-adrenergic blocking agent prior to initiating a PDE type 5 inhibitor at the lowest possible dosage. In patients receiving a PDE type 5 inhibitor, initiate concomitant therapy with an α-adrenergic blocking agent at the lowest dosage. Incremental increases in the dosage of the α-adrenergic blocking agent during concomitant therapy may be associated with a further lowering of BP. Safety of concomitant therapy also may be affected by intravascular volume depletion and use of additional anti-hypertensive agents. (See Specific Drugs and Foods under Interactions.)

Concomitant Administration with Potent CYP3A4 Inhibitors

Increased plasma tadalafil concentrations with concomitant administration; dosage reduction of tadalafil recommended. (See Specific Drugs and Food under Interactions.)

Specific Populations

Pregnancy

Category B. Not labeled for use in women.

Lactation

Not labeled for use in women; use not recommended in nursing women.

Pediatric Use

Safety and efficacy not established in patients <18 years of age.

Geriatric Use

Safety and efficacy in those ≥65 years of age is similar to that in younger men. Possibility exists of greater sensitivity to the drug in some geriatric individuals. (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use not recommended in patients with severe hepatic impairment (Child-Pugh C). Dosage adjustment for moderate hepatic impairment. (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Clearance decreased in patients with mild (Cl_cr 51–80 mL/minute) to severe renal insufficiency (end-stage renal disease on hemodialysis), and may result in increased adverse effects (e.g., back pain). No dosage adjustments are necessary in those with mild renal impairment. Dosage adjustments based on degree of renal impairment. (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing (facial and other areas).