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Tadalafil

Pronunciation

Pronunciation

(tah DA la fil)

Index Terms

  • GF196960

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Adcirca: 20 mg

Cialis: 2.5 mg, 5 mg, 10 mg, 20 mg

Brand Names: U.S.

  • Adcirca
  • Cialis

Pharmacologic Category

  • Phosphodiesterase-5 Enzyme Inhibitor

Pharmacology

BPH: Exact mechanism unknown; effects likely due to PDE-5 mediated reduction in smooth muscle and endothelial cell proliferation, decreased nerve activity, and increased smooth muscle relaxation and tissue perfusion of the prostate and bladder

Erectile dysfunction: Does not directly cause penile erections, but affects the response to sexual stimulation. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum. Tadalafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by tadalafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. At recommended doses, it has no effect in the absence of sexual stimulation.

PAH: Inhibits phosphodiesterase type 5 (PDE-5) in smooth muscle of pulmonary vasculature where PDE-5 is responsible for the degradation of cyclic guanosine monophosphate (cGMP). Increased cGMP concentration results in pulmonary vasculature relaxation; vasodilation in the pulmonary bed and the systemic circulation (to a lesser degree) may occur.

Distribution

Vd: 63 to 77 L

Metabolism

Hepatic, via CYP3A4 to metabolites (inactive)

Excretion

Feces (~61%, predominantly as metabolites); urine (~36%, predominantly as metabolites)

Onset of Action

Within 1 hour; Peak effect: Pulmonary artery vasodilation: 75 to 90 minutes (Ghofrani 2004)

Time to Peak

Plasma: ~2 hours (range: 30 minutes to 6 hours)

Duration of Action

Erectile dysfunction: Up to 36 hours

Half-Life Elimination

15 to 17.5 hours; Pulmonary hypertension (not receiving bosentan): 35 hours

Protein Binding

94%

Special Populations: Renal Function Impairment

Tadalafil exposure (AUC) doubled in subjects with CrCl 31 to 80 mL/minute. In patients with ESRD on hemodialysis, there was a 2-fold increase in Cmax and 2.7- to 4.8-fold increase in AUC.

Special Populations: Hepatic Function Impairment

Tadalafil exposure (AUC) after a 10 mg dose in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) was comparable with exposure in healthy subjects. There are insufficient data for subjects with severe hepatic impairment.

Special Populations: Elderly

Subjects older than 65 years have a 25% higher exposure compared with subjects 19 to 45 years of age.

Special Populations Note

Diabetes mellitus AUC was reduced approximately 19% and Cmax was 5% lower in patients with diabetes mellitus than in healthy subjects.

Use: Labeled Indications

Benign prostatic hyperplasia (Cialis only): Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Erectile dysfunction (Cialis only): Treatment of erectile dysfunction.

Erectile dysfunction and benign prostatic hyperplasia (Cialis only): Treatment of erectile dysfunction and the signs and symptoms of BPH.

Pulmonary arterial hypertension (Adcirca only): Treatment of pulmonary arterial hypertension (World Health Organization group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with New York Heart Association (NYHA) functional class II to III symptoms and etiologies of idiopathic or heritable pulmonary arterial hypertension (61%) or pulmonary arterial hypertension associated with connective tissue diseases (23%).

Contraindications

Serious hypersensitivity to tadalafil or any component of the formulation; concurrent use of organic nitrate (regularly and/or intermittently) or guanylate cyclase stimulators (eg, riociguat).

Canadian labeling: Additional contraindications (not in US labeling): Previous episode of nonarteritic anterior ischemic optic neuropathy

Dosing: Adult

Benign prostatic hyperplasia (with or without concomitant erectile dysfunction) (Cialis): Oral: 5 mg once daily. Note: When tadalafil is used with finasteride to initiate BPH therapy, the recommended duration of therapy is ≤26 weeks.

Dosing adjustment with concomitant medications:

Alpha1-blockers: Not recommended for use in combination with alpha-blockers for the treatment of BPH.

CYP3A4 inhibitors (strong):

US labeling: 2.5 mg once daily; maximum: 2.5 mg once daily

Canadian labeling: No initial dosage adjustment necessary; may decrease dose to 2.5 mg once daily based on tolerability.

Erectile dysfunction (Cialis):

As-needed dosing: 10 mg (U.S. labeling) or 20 mg (Canadian labeling) at least 30 minutes prior to anticipated sexual activity as one single dose and not more than once daily. Dose may be adjusted based on tolerability (dosing range: 5 to 20 mg [US labeling] or 10 to 20 mg [Canadian labeling]). Note: Erectile function may be improved for up to 36 hours following a single dose.

Once-daily dosing: 2.5 mg once daily (U.S. labeling) or 5 mg once daily (Canadian labeling) at approximately the same time daily without regard to timing of sexual activity. Dose may be adjusted based on tolerability (dosage range: 2.5 to 5 mg/day).

Dosing adjustment with concomitant medications: Oral:

U.S. labeling: Alpha1-blockers: Patients should be stable on alpha-blocker therapy prior to initiating tadalafil treatment, and tadalafil should be initiated at the lowest recommended dose.

Canadian labeling: Nonselective alpha-blockers (eg, doxazosin): As-needed dosing: 10 mg at least 30 minutes prior to anticipated sexual activity

CYP3A4 inhibitors (strong):

As-needed dosing:

U.S. labeling: Maximum: 10 mg, not more frequently than every 72 hours

Canadian labeling: 10 mg, not more frequently than every 48 hours (maximum: 3 doses/week); may increase to 20 mg if lower dose is tolerated but ineffective. Discontinue use if 10 mg dose is not tolerated.

Once-daily dosing:

U.S. labeling: Maximum: 2.5 mg once daily

Canadian labeling: 2.5 to 5 mg once daily

Pulmonary arterial hypertension (Adcirca): Oral: 40 mg once daily

Dosing adjustment with concomitant medications:

Concurrent use with ritonavir:

Initiation of tadalafil in patients currently receiving ritonavir for at least 1 week: Initiate tadalafil at 20 mg once daily; increase to 40 mg once daily based on individual tolerability.

Initiation of ritonavir in patients currently receiving tadalafil: Discontinue tadalafil at least 24 hours prior to the initiation of ritonavir. After at least 1 week of ritonavir, resume tadalafil at 20 mg once daily; increase to 40 mg once daily based on individual tolerability.

Dosing: Geriatric

Refer to adult dosing. No dose adjustment for patients >65 years of age in the absence of renal or hepatic impairment.

Dosing: Renal Impairment

Benign prostatic hyperplasia (with or without concomitant erectile dysfunction) (Cialis):

CrCl ≥51 mL/minute: No dosage adjustment necessary.

CrCl 30 to 50 mL/minute: Initial: 2.5 mg once daily; maximum: 5 mg once daily.

CrCl <30 mL/minute: Use not recommended.

ESRD requiring hemodialysis: Use not recommended.

Erectile dysfunction (Cialis):

As-needed use:

U.S. labeling:

CrCl ≥51 mL/minute: No dosage adjustment necessary.

CrCl 30 to 50 mL/minute: Initial: 5 mg once daily; maximum: 10 mg (not more frequently than every 48 hours).

CrCl <30 mL/minute: Maximum: 5 mg (not more frequently than every 72 hours).

ESRD requiring hemodialysis: Maximum: 5 mg (not more frequently than every 72 hours).

Canadian labeling:

CrCl >80 mL/minute: No dosage adjustment necessary.

CrCl ≥31 to 80 mL/minute: 10 mg, not more frequently than every 48 hours (maximum: 3 doses/week); may increase to 20 mg if lower dose is tolerated but ineffective. Discontinue use if 10 mg dose is not tolerated.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; has not been adequately studied.

ESRD requiring hemodialysis: There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; has not been adequately studied.

Once-daily use:

CrCl ≥31 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Use not recommended.

ESRD requiring hemodialysis: Use not recommended.

Pulmonary arterial hypertension (Adcirca):

CrCl 31 to 80 mL/minute: Initial: 20 mg once daily; increase to 40 mg once daily based on individual tolerability.

CrCl ≤30 mL/minute: Avoid use due to increased tadalafil exposure, limited clinical experience, and lack of ability to influence clearance by dialysis.

ESRD requiring hemodialysis: Avoid use due to increased tadalafil exposure, limited clinical experience, and lack of ability to influence clearance by dialysis.

Dosing: Hepatic Impairment

Benign prostatic hyperplasia (with or without concomitant erectile dysfunction) (Cialis):

Mild to moderate hepatic impairment (Child-Pugh class A or B): Use with caution; the use of tadalafil for once-daily use has not been extensively evaluated in patients with hepatic impairment.

Severe hepatic impairment (Child-Pugh class C): Use is not recommended.

Erectile dysfunction (Cialis):

As-needed use:

U.S. labeling:

Mild to moderate impairment (Child-Pugh class A or B): Use with caution; dose should not exceed 10 mg once daily. The use of tadalafil once per day has not been evaluated extensively in patients with hepatic impairment.

Severe impairment (Child-Pugh class C): Use is not recommended.

Canadian labeling:

Mild to moderate impairment (Child-Pugh class A or B): 10 mg, not more frequently than every 48 hours (maximum: 3 doses/week); may increase to 20 mg if lower dose is tolerated but ineffective. Discontinue use if 10 mg dose is not tolerated.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; has not been adequately studied.

Once-daily use:

U.S. labeling:

Mild to moderate impairment (Child-Pugh class A or B): Use with caution; the use of tadalafil for once-daily use has not been extensively evaluated in patients with hepatic impairment.

Severe impairment (Child-Pugh class C): Use is not recommended.

Canadian labeling:

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): Use is not recommended.

Pulmonary arterial hypertension (Adcirca):

Mild to moderate hepatic impairment (Child-Pugh class A or B): Use with caution; consider initial dose of 20 mg once daily.

Severe hepatic impairment (Child-Pugh class C): Avoid use; has not been studied in patients with severe hepatic cirrhosis.

Extemporaneously Prepared

A 5 mg/mL tadalafil oral suspension may be made with tablets in a 1:1 mixture of Ora-Plus® and Ora-Sweet®. Crush fifteen 20 mg tadalafil tablets in a glass mortar and reduce to a fine powder. Prepare the vehicle by mixing 30 mL of Ora-Plus® and 30 mL of Ora-Sweet®; stir vigorously. Add 30 mL of the vehicle in geometric proportions to the powder and mix to form a smooth suspension. Transfer the mixture to a 2 ounce amber plastic prescription bottle. Rinse mortar with a quantity of the vehicle sufficient to make a final volume of 60 mL. Label “shake well.” Stable for 91 days when stored in amber plastic prescription bottles at room temperature.

Pettit RS, Johnson CE, and Caruthers RL, “Stability of an Extemporaneously Prepared Tadalafil Suspension,” Am J Health Syst Pharm, 2012, 69(7):592-4.22441791

Administration

May be administered with or without food.

Adcirca: Administer daily dose all at once; dividing doses throughout the day is not advised.

Cialis: When used on an as-needed basis, should be taken at least 30 minutes prior to sexual activity. When used on a once-daily basis, should be taken at the same time each day, without regard to timing of sexual activity.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Alcohol (Ethyl): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Monitor therapy

Alpha1-Blockers: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers. Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Consider therapy modification

Alprostadil: Phosphodiesterase 5 Inhibitors may enhance the adverse/toxic effect of Alprostadil. Avoid combination

Amyl Nitrite: Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Amyl Nitrite. Avoid combination

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Blood Pressure Lowering Agents: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Boceprevir: May increase the serum concentration of Tadalafil. Management: Avoid tadalafil when used for treatment of pulmonary arterial hypertension in patients receiving boceprevir. Tadalafil for erectile dysfunction should be limited to 10 mg every 72 hours with close monitoring for tadalafil toxicity. Consider therapy modification

Bosentan: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Phosphodiesterase 5 Inhibitors may increase the serum concentration of Bosentan. Monitor therapy

Cobicistat: May increase the serum concentration of Tadalafil. Management: Recommendations for use of tadalafil in patients also receiving cobicistat vary by tadalafil indication and country. See full drug interaction monograph for details. Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Strong): May decrease the serum concentration of Tadalafil. Management: Erectile dysfunction: monitor for decreased effectiveness - no standard dose adjustments recommended. Avoid use of tadalafil for pulmonary arterial hypertension in patients receiving a strong CYP3A4 inducer. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Tadalafil. Management: Recommendations regarding use of tadalafil in patients also receiving strong CYP3A4 inhibitors may vary based on indication and/or international labeling. Consult appropriate product labeling. Exceptions: Ritonavir. Consider therapy modification

Dapoxetine: May enhance the orthostatic hypotensive effect of Phosphodiesterase 5 Inhibitors. Avoid combination

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Etravirine: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Management: No empiric dosage adjustments are recommended with concomitant therapy; however, dose of the phosphodiesterase inhibitor may need to be altered based on clinical response. Monitor therapy

Fluconazole: May increase the serum concentration of Tadalafil. Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Itraconazole: May increase the serum concentration of Tadalafil. Consider therapy modification

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Ketoconazole (Systemic): May increase the serum concentration of Tadalafil. Consider therapy modification

Lorcaserin: May enhance the adverse/toxic effect of Phosphodiesterase 5 Inhibitors. Specifically, the risk of developing priapism may be increased. Monitor therapy

Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Mifepristone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Avoid combination

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Osimertinib: May increase the serum concentration of CYP3A4 Substrates. Osimertinib may decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the adverse/toxic effect of other Phosphodiesterase 5 Inhibitors. Avoid combination

Posaconazole: May increase the serum concentration of Tadalafil. Consider therapy modification

Riociguat: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Riociguat. Avoid combination

Ritonavir: May increase the serum concentration of Tadalafil. Management: Recommendations regarding use of tadalafil in patients also receiving ritonavir may vary based on indication and/or international labeling. Consult appropriate product labeling. Consider therapy modification

Sapropterin: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of Phosphodiesterase 5 Inhibitors. Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Telaprevir: May increase the serum concentration of Tadalafil. Management: Concurrent use of tadalafil for treatment of pulmonary arterial hypertension is contraindicated with telaprevir. Tadalafil for erectile dysfunction should be limited to 10 mg per 72 hours, with close monitoring for tadalafil toxicity. Consider therapy modification

Tipranavir: May increase the serum concentration of Tadalafil. Avoid combination

Vasodilators (Organic Nitrates): Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Vasodilators (Organic Nitrates). Avoid combination

Voriconazole: May increase the serum concentration of Tadalafil. Consider therapy modification

Adverse Reactions

Based upon usual doses for either indication. For erectile dysfunction, similar adverse events are reported with once-daily versus intermittent dosing, but are generally lower than with doses used intermittently.

>10%:

Cardiovascular: Flushing (1% to 13%; dose related)

Central nervous system: Headache (3% to 42%; dose related)

Gastrointestinal: Dyspepsia (1% to 13%), nausea (10% to 11%)

Neuromuscular & skeletal: Myalgia (1% to 14%; dose related), back pain (2% to 12%), extremity pain (1% to 11%)

Respiratory: Respiratory tract infection (3% to 13%), nasopharyngitis (2% to 13%)

2% to 10%:

Cardiovascular: Hypertension (1% to 3%)

Gastrointestinal: Gastroenteritis (viral; 3% to 5%), GERD (1% to 3%), abdominal pain (1% to 2%), diarrhea (1% to 2%)

Genitourinary: Urinary tract infection (≤2%)

Respiratory: Nasal congestion (≤9%), cough (2% to 4%), bronchitis (≤2%)

Miscellaneous: Flu-like syndrome (2% to 5%)

<2% (Limited to important or life-threatening): Amnesia (transient global), angina pectoris, arthralgia, basal cell carcinoma (Loeb 2015), blurred vision, chest pain, color vision decreased, conjunctival hyperemia, conjunctivitis, diaphoresis, dizziness, dysphagia, dyspnea, epistaxis, esophagitis, exfoliative dermatitis, eye pain, eyelid swelling, facial edema, fatigue, gastritis, GGTP increased, hearing decreased, hearing loss, hepatic enzymes increased, hypoesthesia, hypotension, insomnia, lacrimation, melanoma (Loeb 2015), migraine, MI, neck pain, nonarteritic ischemic optic neuropathy (NAION), orthostatic hypotension, pain, palpitation, paresthesia, pharyngitis, priapism, pruritus, rash, retinal artery occlusion, retinal vein occlusion, seizure, somnolence, spontaneous penile erection, Stevens-Johnson syndrome, stroke, sudden cardiac death, syncope, tachycardia, tinnitus, urticaria, vertigo, visual field loss, vomiting, weakness, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Anginal chest pain: Patients experiencing anginal chest pain after tadalafil administration should seek immediate medical attention.

• Color discrimination: May cause dose-related impairment of color discrimination. Use caution in patients with retinitis pigmentosa; a minority have genetic disorders of retinal phosphodiesterases (no safety information available).

• Hearing loss: Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. Instruct patients to seek medical assistance for sudden decrease in hearing or loss of hearing. A direct relationship between therapy and hearing loss has not been determined.

• Hypotension: Decreases in blood pressure may occur due to vasodilator effects; use with caution in patients with left ventricular outflow obstruction (aortic stenosis or hypertrophic obstructive cardiomyopathy); may be more sensitive to hypotensive actions. Concurrent use with alpha-adrenergic antagonist therapy may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Patients should avoid or limit concurrent substantial ethanol consumption as this may increase the risk of symptomatic hypotension.

• Priapism: Painful erection >6 hours in duration has been reported (rarely). Instruct patient to seek medical assistance for erection lasting >4 hours. Use with caution in patients who have conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, leukemia).

• Vision loss: Vision loss (rare) may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Instruct patients to seek medical assistance for sudden loss of vision in one or both eyes. Patients who have already experienced NAION are at an increased risk of recurrence. Other risk factors for NAION include low cup-to-disc ratio ("crowded disc"), coronary artery disease, diabetes, hypertension, hyperlipidemia, smoking, and >50 years of age. Use with caution in these patients only when the benefits outweigh the risks. The Canadian labeling contraindicates use in patients with previous episodes of NAION. Safety has not been evaluated in patients with known degenerative retinal disorders (eg, retinitis pigmentosa); use is not recommended.

Disease-related concerns:

• Anatomical penis deformation: Use with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie disease).

• Bleeding disorders: Use with caution in patients with bleeding disorders; safety and efficacy have not been established. In vitro studies have suggested a decreased effect on platelet aggregation.

• Cardiovascular disease: Use is not recommended in patients with hypotension (<90/50 mm Hg), uncontrolled hypertension (>170/100 mm Hg), NYHA class II-IV heart failure within the last 6 months, uncontrolled arrhythmias, stroke within the last 6 months, MI within the last 3 months, unstable angina or angina during sexual intercourse; safety and efficacy have not been evaluated in these patients. Safety and efficacy in PAH have not been evaluated in patients with clinically significant aortic and/or mitral valve disease, life-threatening arrhythmias, hypotension (<90/50 mm Hg), uncontrolled hypertension, significant left ventricular dysfunction, pericardial constriction, restrictive or congestive cardiomyopathy, symptomatic coronary artery disease. Use caution in patients with left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy); may be more sensitive to vasodilator effects. There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.

• Hepatic impairment: Use with caution in patients with mild to moderate hepatic impairment; dosage adjustment/limitation is needed. Use is not recommended in patients with severe hepatic impairment or cirrhosis.

• Peptic ulcer disease: Use with caution in patients with active peptic ulcer disease because of effect on platelets (bleeding); safety and efficacy have not been established.

• Pulmonary veno-occlusive disease (PVOD): Pulmonary vasodilators may exacerbate the cardiovascular status in patients with PVOD. Use is not recommended; no clinical data exists in patients with PVOD. In patients with unrecognized PVOD, signs of pulmonary edema should prompt investigation into this diagnosis.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment/limitation is needed.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Nitrates: Concomitant use (regularly/intermittently) with all forms of nitrates is contraindicated. Nitrate-mediated vasodilation is markedly exaggerated and prolonged in the presence of PDE-5 inhibitors. When tadalafil is used for BPH, erectile dysfunction, or PAH and nitrate administration is medically necessary (eg, chest pain refractory to other treatments) following the use of tadalafil, at least 48 hours should elapse after the tadalafil dose and nitrate administration. When used for PAH, per the manufacturer, nitrate may be administered within 48 hours of tadalafil. For both situations, administration of nitrates should only be done under close medical supervision with hemodynamic monitoring.

Other warnings/precautions:

• Appropriate use: Potential underlying causes of erectile dysfunction or BPH should be evaluated prior to treatment.

Monitoring Parameters

Blood pressure, response and adverse effects; urine flow, PSA

Pregnancy Risk Factor

B

Pregnancy Considerations

Teratogenic events were not reported in animal reproduction studies. Postnatal development and pup survival was decreased at some doses. There are no adequate and well-controlled studies in pregnant women. Less than 0.0005% is found in the semen of healthy males.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flushing, dyspepsia, pyrosis, rhinitis, rhinorrhea, or painful extremities. Have patient report immediately to prescriber angina, tachycardia, arrhythmia, severe dizziness, syncope, significant headache, considerable nausea, strength differences from one side to another, difficulty speaking or thinking, change in balance, blurred vision, vision changes, blindness, tinnitus, intolerable myalgia, severe back pain, dyspnea, or priapism (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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