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Medication Safety Issues
Sound-alike/look-alike issues:
Tadalafil may be confused with sildenafil, vardenafil
Adcirca™ may be confused with Advair® Diskus®, Advair® HFA, Advicor®
Pronunciation
(tah DA la fil)
U.S. Brand Names
Index Terms
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Adcirca™: Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability
Cialis®: Treatment of erectile dysfunction (ED)
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.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Known serious hypersensitivity to tadalafil; concurrent use (regularly/intermittently) of organic nitrates in any form (eg, nitroglycerin, isosorbide dinitrate)
Warnings/Precautions
Concerns related to adverse effects:
• Anginal chest pain: Patients experiencing anginal chest pain after tadalafil administration should seek immediate medical attention (also see "Concurrent drug therapy issues").
• 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. 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 or substantial alcohol consumption may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose.
• Priapism: Painful erection >6 hours in duration; rare. 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 may occur rarely and be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Risk may be increased with history of vision loss or NAION in one eye. 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. 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's 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 for erectile dysfunction 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 due to 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:
• Alpha-blockers: Use with caution in patients taking alpha-blockers; may cause hypotension. Safety of this combination may be affected by other antihypertensives and intravascular volume depletion. Patients should be hemodynamically stable prior to initiating therapy. Initiate tadalafil at the lowest recommended dose. Alpha-blockers should be initiated at the lowest recommended dose in patients currently taking tadalafil.
• High potential for interactions: Erectile dysfunction: Use with caution in patients taking strong CYP3A4 inhibitors (see Drug Interactions); consider alternative agents that avoid or lessen the potential for CYP-mediated interactions. Once-daily tadalafil dosing results in continuous plasma levels; use caution when administered concurrently with these medications. PAH: Avoid use in patients taking strong CYP3A4 inducers/inhibitors. Use in patients receiving or about to receive ritonavir requires dosage adjustment or interruption of therapy, respectively.
• 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 either 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 phosphodiesterase-5 (PDE-5) inhibitors: Safety and efficacy with other tadalafil brands or other PDE-5 inhibitors (ie, sildenafil and vardenafil) have not been established. Patients should be informed not to take with other tadalafil brands or other PDE-5 inhibitors.
• Other treatments for erectile dysfunction: Safety and efficacy with other treatments for erectile dysfunction have not been established; use is not recommended.
Special populations:
• Elderly: Use with caution.
• Pediatrics: Safety and efficacy have not been established in children ?18 years of age.
Other warnings/precautions:
• Appropriate use: When used to treat erectile dysfunction, potential underlying causes of erectile dysfunction should be evaluated prior to treatment.
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%)
Genitourinary: Urinary tract infection (?2%)
Respiratory: Nasal congestion (?9%), cough (2% to 4%)
<2%, postmarketing, and/or case reports (limited to important or life-threatening): Abdominal pain (upper), amnesia (transient global), angina pectoris, arthralgia, blurred vision, chest pain, color perception change, color vision decreased, conjunctival hyperemia, conjunctivitis, diaphoresis, diarrhea, dizziness, dysphagia, dyspnea, epistaxis, esophagitis, exfoliative dermatitis, eye pain, eyelid swelling, facial edema, fatigue, gastritis, hearing decreased, hearing loss, hepatic enzymes increased, hypoesthesia, hypotension, GGTP increased, lacrimation, migraine, MI, neck pain, nonarteritic ischemic optic neuropathy (NAION), pain, palpitation, paresthesia, photophobia, postural hypotension, priapism, pruritus, rash, retinal artery occlusion, retinal vein occlusion, seizure, somnolence, Stevens-Johnson syndrome, stroke, sudden cardiac death, syncope, tachycardia, tinnitus, urticaria, vertigo, visual field loss, vomiting, weakness, xerostomia
Metabolism/Transport Effects
Substrate of CYP3A4 (major)
Drug Interactions
Alpha1-Blockers: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers. Management: Ensure patient is stable on alpha 1 blocker before starting PDE5 inhibitor; initiate PDE5 inhibitor at lowest possible dose. If patient stable on PDE5 inhibitor, initiate alpha 1 blocker at lowest dose. Exceptions: Dapiprazole [Off Market]. Risk D: Consider therapy modification
Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Phosphodiesterase 5 Inhibitors. Risk D: Consider therapy modification
Antihypertensives: Phosphodiesterase 5 Inhibitors may enhance the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy
Bosentan: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Phosphodiesterase 5 Inhibitors may increase the serum concentration of Bosentan. Risk C: Monitor therapy
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. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Tadalafil. Management: Erectile dysfunction: tadalafil max = 2.5 mg/day (daily use) or 10 mg/72 hrs (as needed use). Avoid use of tadalafil for treatment of pulmonary arterial hypertension in patients also receiving a strong CYP3A4 inhibitor. Exceptions: Ritonavir. Risk D: Consider therapy modification
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: 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. Risk C: Monitor therapy
Macrolide Antibiotics: May decrease the metabolism of Phosphodiesterase 5 Inhibitors. Exceptions: Azithromycin; Dirithromycin [Off Market]; Spiramycin. Risk D: Consider therapy modification
Phosphodiesterase 5 Inhibitors: May enhance the adverse/toxic effect of other Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Ritonavir: May increase the serum concentration of Tadalafil. Management: Erectile dysfunction: tadalafil max = 2.5 mg/day (daily use) or 10 mg/72 hrs (as needed use). Pulmonary arterial hypertension: use initial dose of 20 mg/day; increase to 40 mg/day as tolerated. Avoid during ritonavir initiation. Risk D: Consider therapy modification
Sapropterin: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Vasodilators (Organic Nitrates): Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Vasodilators (Organic Nitrates). Risk X: Avoid combination
Ethanol/Nutrition/Herb Interactions
Ethanol: Substantial consumption of ethanol may increase the risk of hypotension and orthostasis. Lower ethanol consumption has not been associated with significant changes in blood pressure or increase in orthostatic symptoms.
Food: Rate and extent of absorption are not affected by food. Grapefruit juice may increase serum levels/toxicity of tadalafil. When used on an as-needed basis, do not give more than a single 10 mg dose of tadalafil more frequently than every 72 hours in patients who regularly consume grapefruit juice. When used on a once-daily basis, the dose of tadalafil should not exceed 2.5 mg/day in patients who regularly consume grapefruit juice.
Herb/Nutraceutical: St John's wort: Use caution with concomitant use.
Storage
Store at controlled room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Mechanism of Action
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.
Pharmacodynamics/Kinetics
Onset of action: Within 1 hour
Peak effect (pulmonary artery vasodilation): 75-90 minutes (Ghofrani, 2004)
Duration: Erectile dysfunction: Up to 36 hours
Distribution: Vd: 63-77 L
Protein binding: 94%
Metabolism: Hepatic, via CYP3A4 to metabolites (inactive)
Half-life elimination: 15-17.5 hours; Pulmonary hypertension (not receiving bosentan): 35 hours
Time to peak, plasma: ~2-4 hours (range: 30 minutes to 8 hours)
Excretion: Feces (~61%, predominantly as metabolites); urine (~36%, predominantly as metabolites)
Dosage
Oral: Adults:
Erectile dysfunction (Cialis®):
As-needed dosing: 10 mg at least 30 minutes prior to anticipated sexual activity (dosing range: 5-20 mg); to be given as one single dose and not given more than once daily. Note: Erectile function may be improved for up to 36 hours following a single dose; adjust dose.
Once-daily dosing: 2.5 mg once daily (dosing range: 2.5-5 mg/day) to be given at approximately the same time daily without regard to timing of sexual activity
Dosing adjustment with concomitant medications:
Alpha1-blockers: If stabilized on either alpha-blockers or tadalafil therapy, initiate new therapy with the other agent at the lowest possible dose.
CYP3A4 inhibitors: Dose reduction of tadalafil is recommended with strong CYP3A4 inhibitors. When used on an as-needed basis, the dose of tadalafil should not exceed 10 mg, and tadalafil should not be taken more frequently than once every 72 hours. When used on a once-daily basis, the dose of tadalafil should not exceed 2.5 mg. Examples of such inhibitors include amprenavir, atazanavir, clarithromycin, conivaptan, delavirdine, diclofenac, fosamprenavir, imatinib, indinavir, isoniazid, itraconazole, ketoconazole, miconazole, nefazodone, nelfinavir, nicardipine, propofol, quinidine, ritonavir, and telithromycin.
Pulmonary arterial hypertension (Adcirca™): 40 mg once daily
Dosing adjustment with concomitant medications:
Concomitant ritonavir:
If patient receiving ritonavir for at least 1 week: Initiate tadalafil at 20 mg once daily; increase to 40 mg once daily based on individual tolerability.
If patient receiving tadalafil when initiating ritonavir: Stop tadalafil at least 24 hours prior to starting ritonavir. After at least 1 week following the initiation of ritonavir, resume tadalafil at 20 mg once daily; increase to 40 mg once daily based on individual tolerability.
Other potent CYP3A4 inhibitors: Avoid concurrent use when tadalafil used for PAH. Examples of such inhibitors include amprenavir, atazanavir, clarithromycin, conivaptan, delavirdine, diclofenac, fosamprenavir, imatinib, indinavir, isoniazid, itraconazole, ketoconazole, miconazole, nefazodone, nelfinavir, nicardipine, propofol, quinidine, and telithromycin.
Potent CYP3A4 inducers (eg, rifampin): Avoid concurrent use when tadalafil used for PAH.
Elderly: No dose adjustment for patients >65 years of age in the absence of renal or hepatic impairment
Dosage adjustment in renal impairment:
Erectile dysfunction (Cialis®):
As-needed use:
Clcr ?51 mL/minute: Dosage adjustment not required
Clcr 31-50 mL/minute: Initial: 5 mg once daily; maximum: 10 mg (not to be given more frequently than every 48 hours)
Clcr <30 mL/minute and on hemodialysis: Maximum: 5 mg (not to be given more frequently than every 72 hours)
Once-daily use:
Clcr ?31 mL/minute: Dose adjustment not required
Clcr <30 mL/minute and on hemodialysis: Use not recommended
Pulmonary arterial hypertension (Adcirca™):
Clcr 31-80 mL/minute: Initial: 20 mg once daily; increase to 40 mg once daily based on individual tolerability
Clcr <30 mL/minute and on hemodialysis: Avoid use due to increased tadalafil exposure, limited clinical experience, and lack of ability to influence clearance by dialysis.
Dosage adjustment in hepatic impairment:
Erectile dysfunction (Cialis®):
As-needed use:
Mild-to-moderate hepatic impairment (Child-Pugh class A or B): Use with caution; dose should not exceed 10 mg once daily
Severe hepatic impairment (Child-Pugh class C): Use is not recommended
Once-daily use:
Mild-to-moderate hepatic impairment (Child-Pugh class A or B): Use with caution
Severe hepatic 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.
Administration: Oral
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.
Monitoring Parameters
Blood pressure; response and adverse effects
Dietary Considerations
May be taken with or without food.
Patient Education
Inform prescriber of all other prescriptions, OTC medications, or herbal products you are taking and any allergies you have; serious side effects can result when tadalafil is used with some other medications. Avoid substantial consumption of alcohol. Do not combine tadalafil with other approaches to treating erectile dysfunction without consulting prescriber. Note: This drug provides no protection against sexually-transmitted diseases, including HIV. Take exactly as directed; do not take more often than prescribed. You may experience headache, fatigue, dizziness, or blurred vision (use caution when driving or engaging in hazardous tasks until response to drug is known); back or limb pain (consult prescriber for appropriate analgesic). Report immediately chest pain, palpitations; respiratory difficulty; unusual dizziness; change in vision; change in hearing or ringing in the ears; sign of urinary tract infection; skin rash; genital swelling or priapism, erection lasting >4 hours, or other persistent adverse reactions.
Geriatric Considerations
No significant differences in pharmacokinetics were seen in elderly men versus younger men. Dosing should be adjusted for renal function. Since older adults often have concomitant diseases, many of which may be contraindicated with the use of tadalafil, prescriber should complete a thorough review of diseases and medications prior to prescribing tadalafil.
Anesthesia and Critical Care Concerns/Other Considerations
Clinical Pearls/Comments:
Cardiovascular effects of PDE-5 inhibitors may be potentially hazardous in patients with:
• active coronary ischemia (not on nitrates)
• heart failure and with borderline low blood pressure and borderline low volume status
• complicated, multidrug antihypertensive regimens
• potential for drug-drug interactions that may prolong PDE-5 inhibitor half-life (eg, drugs that inhibit cytochrome P450 3A4)
Use of tadalafil is contraindicated in patients currently taking nitrate preparations.
When nitrate administration becomes medically necessary in patients who received tadalafil, the ACC/AHA 2004 guidelines on treatment of ST-segment elevation MI and the ACC/AHA 2007 guidelines on treatment of unstable angina/non ST-segment elevation MI support administration of nitrates only if 48 hours have elapsed after use of tadalafil.
Cardiovascular Considerations
Tadalafil, when used in conjunction with nitrates, may be associated with severe hypotension, myocardial infarction, and possibly death. While there are no clear significant increased cardiovascular events with PDE-5 inhibitors alone, these drugs should be absolutely avoided in conjunction with nitrates and may also induce significant and possibly fatal hypotension in patients with heart failure. Hemodynamic effects of PDE-5 inhibitors alone include a very slight drop in blood pressure without significant changes in heart rate. The most recent guidelines on the use of sildenafil (prototype PDE-5 inhibitor) in patients with cardiovascular disease are outlined in detail (Cheitlin, 1999). The general clinical recommendations are as follows.
Use of PDE-5 inhibitors is contraindicated in patients currently taking nitrate preparations.
Cardiovascular effects of PDE-5 inhibitors may be potentially hazardous in patients with:
• active coronary ischemia (not on nitrates)
• heart failure and with borderline low blood pressure and borderline low volume status
• complicated, multidrug antihypertensive regimens
• potential for drug-drug interactions that may prolong PDE-5 inhibitor half-life (eg, drugs that inhibit cytochrome P450 3A4)
Additional guidelines for the treatment of ED in patients with cardiovascular disease have also been published (Jackson, 2006). These guidelines, referred to as the Princeton II Guidelines, support the use of PDE-5 inhibition only in patients with asymptomatic coronary disease and <3 of the following risk factors: Controlled hypertension, mild stable angina, successful coronary revascularization, previous uncomplicated MI (>6-8 weeks), mild valvular disease, and left ventricular dysfunction (with or without NYHA Class I limitations).
When nitrate administration becomes medically necessary, the ACC/AHA 2004 guidelines on treatment of ST-segment elevation MI and the ACC/AHA 2007 guidelines on treatment of unstable angina/non ST-segment elevation MI supports administration of nitrates only if 24 hours have elapsed after use of sildenafil and 48 hours after use of tadalafil. The appropriate delay for the use of nitrates after vardenafil has not been determined.
Tadalafil is selective for PDE-5 and has limited effect on PDE-3, which controls cardiac contractility.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause dizziness, insomnia, or fatigue
Mental Health: Effects on Psychiatric Treatment
Concurrent use with antidepressants (eg, TCAs) and antipsychotics may produce significant hypotension secondary to alpha-receptor blockade; alpha-blockers contraindicated with tadalafil (except tamsulosin). Nefazodone may increase levels of tadalafil; dosage adjustment needed.
Nursing: Physical Assessment/Monitoring
Assess potential for interactions with other prescription, OTC medications, or herbal products patient may be using. Assess for therapeutic effectiveness and adverse reactions. Instruct patient on appropriate use and cautions, possible side effects, and symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet:
Adcirca™: 20 mg
Cialis®: 2.5 mg, 5 mg, 10 mg, 20 mg
Pricing: U.S. (www.drugstore.com)
Tablets (Cialis)
2.5 mg (10): $49.99
5 mg (10): $49.99
5 mg (30): $133.97
10 mg (10): $159.99
20 mg (10): $159.99
References
Anderson JL, Adams CD, Antman EM, et al, “ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction: Executive Summary. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction) Developed in Collaboration With the American College of Emergency Physicians, The Society of Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons,” J Am Coll Cardiol, 2007, 50(7):1-157. Available at http://content.onlinejacc.org/cgi/reprint/50/7/e1
Antman EM, Anbe DT, Armstrong PW, et al, “ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction),” Circulation, 2004, 110(9):e82-292.
Cheitlin MD, Hutter AM Jr, Brindis RG, et al, “Use of Sildenafil (Viagra®) in Patients With Cardiovascular Disease,” J Am Coll Cardiol, 1999, 33(1):273-82.
Curran M and Keating G, “Tadalafil,” Drugs, 2003, 63(20):2203-12; discussion 2213-4.
Daugan A, Grondin P, Ruault C, et al, “The Discovery of Tadalafil: A Novel and Highly Selective PDE-5 Inhibitor. 2: 2,3,6,7,12,12a-hexahydropyrazino[1?,2?:1,6]pyrido[3,4-b]indole-1,4-dione Analogues,” J Med Chem, 2003, 46(21):4533-42.
Fraunfelder FW, “Visual Side Effects Associated With Erectile Dysfunction Agents,” Am J Ophthal, 2005, 140 (4):723-24.
Galie N, Brundage BH, Ghofrani HA, et al, “Tadalafil Therapy for Pulmonary Arterial Hypertenstion,” Circulation, 2009, 119 [epub ahead of print]
Ghofrani HA, Voswinckel R, Reichenberger F, et al, “Differences in Hemodynamic and Oxygenation Responses to Three Different Phosphodiesterase-5 Inhibitors in Patients with Pulmonary Arterial Hypertension,” J Am Coll Cardiol, 2004, 44(7):1488-96.
Jackson G, Rosen RC, Kloner RA, et al, “The Second Princeton Consensus on Sexual Dysfunction and Cardiac Risk: New Guidelines for Sexual Medicine,” J Sex Med, 2006, 3(1):28-36.
Kloner RA, Mitchell M, and Emmick JT, “Cardiovascular Effects of Tadalafil,” Am J Cardiol, 2003, 92(9A):37M-46M.
Kloner RA, Mitchell M, and Emmick JT, “Cardiovascular Effects of Tadalafil in Patients on Common Antihypertensive Therapies,” Am J Cardiol, 2003, 92(9A):47M-57M.
McVary KT, “Clinical Practice. Erectile Dysfunction,” N Engl J Med, 2007, 357(24):2472-81.
Padma-Nathan H, “Efficacy and Tolerability of Tadalafil, A Novel Phosphodiesterase 5 Inhibitor, in Treatment of Erectile Dysfunction,” Am J Cardiol, 2003, 92(9A):19M-25M.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2009
Content last modified August 2009
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