Also found in: Dictionary, Thesaurus, Wikipedia.
Pharmacologic class: Phosphodiesterase type 5 (PDE5) inhibitor
Therapeutic class: Anti-erectile dysfunction agent
Pregnancy risk category B
Inhibits PDE5, increasing cyclic guanosine monophosphate level and enhancing erectile function; also relaxes pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg
Indications and dosages
➣ Erectile dysfunction (for as-needed use)
Adults: Initially, 10 mg (Cialis) P.O. before anticipated sexual activity; may increase to 20 mg or decrease to 5 mg based on patient response and tolerance. For most patients, maximum recommended dosing frequency is once daily.
➣ Erectile dysfunction (for daily use)
Adults: 2.5 mg (Cialis) P.O. once daily, given at approximately the same time without regard to sexual activity; may increase to 5 mg P.O. once daily based on efficacy and tolerability
➣ Benign prostatic hyperplasia (BPH); concurrent erectile dysfunction and BPH
Adults: 5 mg (Cialis) P.O. daily at approximately the same time each day.
➣ Pulmonary hypertension
Adults: 40 mg (Adcirca) P.O. daily
• Mild to moderate hepatic impairment or renal impairment
• Administration with alpha blockers or potent CYP3A4 inhibitors such as ketoconazole or ritonavir
• Hypersensitivity to drug or its components
• Concurrent use of organic nitrates (regularly or intermittently)
Use cautiously in:
• mild to moderate hepatic or renal impairment
• severe renal impairment (avoid Adcirca use; once-daily Cialis use not recommended)
• severe hepatic impairment (Cialis use not recommended; avoid Adcirca use)
• cardiac risk that makes sexual activity inadvisable, left ventricular outflow obstruction, myocardial infarction within last 90 days, unstable angina or angina occurring during sexual intercourse, New York Heart Association Class II or greater heart failure in last 6 months, uncontrolled arrhythmias, blood pressure below 90/50 mm Hg, uncontrolled hypertension (blood pressure above 170/100 mm Hg), stroke within last 6 months, pulmonary veno-occlusive disease), erectile dysfunction whose cause hasn't been evaluated, conditions that increase risk of priapism (use not recommended)
• concurrent use of potent CYP450-3A4 inhibitors or inducers, or other PDE5 inhibitors (avoid use)
• concurrent use of alpha blockers (except tamsulosin 0.4 mg/day), antihypertensives, or alcohol
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• Know that patient should take drug with or without food and that patient should take Cialis before anticipated sexual activity when given on an as-needed basis.
CNS: headache, fatigue, dizziness, insomnia, hyperesthesia, paresthesia, drowsiness, vertigo, asthenia, transient global amnesia
CV: angina pectoris, chest pain, hypertension, hypotension, orthostatic hypotension, palpitations, syncope, tachycardia, myocardial infarction
EENT: blurred vision, color vision changes, conjunctivitis, eye pain, increased lacrimation, eyelid swelling, epistaxis, nasal congestion, pharyngitis
GI: nausea, vomiting, diarrhea, dyspepsia, esophagitis, gastroesophageal reflux, gastritis, upper abdominal pain, dysphagia, dry mouth
GU: increased or spontaneous erection
Musculoskeletal: myalgia; back, neck, limb, and joint pain
Skin: pruritus, rash, sweating
Other: facial edema, pain
Drug-drug. Alpha-adrenergic blockers (except tamsulosin 0.4 mg/day): marked blood pressure decrease
Angiotensin receptor blockers, enalapril, metoprolol: decreased blood pressure
CYP450-3A4 inducers (such as carbamazepine, phenobarbital, phenytoin, rifampin): decreased tadalafil blood level
CYP450-3A4 inhibitors (such as erythromycin, itraconazole, ketoconazole, ritonavir): increased tadalafil blood level
Theophylline: slight increase in heart rate
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, uric acid: increased levels
Drug-food. Grapefruit juice: increased drug blood level
Drug-behaviors. Alcohol use: decreased blood pressure
• Monitor for drug efficacy.
• Advise patient taking Cialis for erectile dysfunction on an as-needed basis to take before anticipated sexual activity.
• Instruct patient that when taking Cialis on a daily basis he should take tablet at approximately the same time every day, without regard to sexual activity.
• Instruct patient to take Adcirca tablets one after the other every day and not to split the dose.
Caution patient never to take concurrently with nitrates.
Instruct patient to stop sexual activity and contact prescriber immediately if chest pain, dizziness, or nausea occurs.
Advise patient to seek immediate medical attention if sudden loss of vision or sudden decrease in or loss of hearing occurs.
• Instruct patient not to take other PDE5 inhibitors.
• Instruct patient to contact prescriber if erection lasts more than 4 hours.
• Tell patient drug can cause serious interactions with many common drugs. Instruct him to tell all prescribers he is taking it.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Inform patient that drug may cause temporary blood pressure drop, leading to light-headedness if he stands up suddenly. Advise him to rise slowly and carefully.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.