Names and pronunciation
(tah-dal′a-fil) Adcirca, Cialis, Alyq
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Individual generic drug information
Extracted information for tadalafil only.
(tah-dal′a-fil) Adcirca, Cialis, Alyq
Source page 1250
Func. class.: Impotence agent
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Chem. class.: Phosphodiesterase type 5 inhibitor
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ACTION: Inhibits phosphodiesterase type 5 (PDE5); enhances erectile function by increasing the amount of cGMP, which causes smooth muscle relaxation and increased blood flow into the corpus cavernosum; improves erectile function for up to 36 hr
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USES: Treatment of erectile dysfunction (Cialis), benign prostatic hyperplasia (BPH) with or without erectile dysfunction, pulmonary arterial hypertension (PAH) (Adcirca only)
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Extracted information for tadalafil only.
CONTRAINDICATIONS: New- borns, children, women, hypersensitivity, patients taking organic nitrates either regularly and/or intermittently, patients taking any α-adrenergic antagonist other than 0.4 mg once-daily tamsulosin Precautions: Pregnancy, anatomic penile deformities, sickle cell anemia, leukemia, multiple myeloma, CV/renal/hepatic dis- ease, bleeding disorders, active peptic ulcer, prolonged erection
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SIDE EFFECTS CNS: Headache, flushing, dizziness, seizures, transient global amnesia CV: Hypotension, QT prolongation INTEG: Stevens-Johnson syndrome, exfoliative dermatitis, urticaria MISC: Back pain/myalgia, dyspepsia, nasal congestion, UTI, blurred vision, changes in color vision, diarrhea, pruri- tus, priapism, nonarteritic ischemic optic neuropathy (NAION), hearing loss
Source page 1251
INTERACTIONS Do not use with nitrates because of unsafe drop in B/P, which could result in MI or stroke Increase: tadalafil levels—itraconazole, ketoconazole, ritonavir (although not studied, may also include other HIV pro- tease inhibitors) Decrease: B/P—alcohol, α-blockers, amLODIPine, angiotensin II receptor blockers, enalapril Decrease: effects of tadalafil—bosentan, antacids Drug/Food T Increase: tadalafil effect—grapefruit
Source page 1251
Extracted information for tadalafil only.
DOSAGE AND ROUTES Erectile dysfunction • Adult: PO (Cialis) 10 mg taken be- fore sexual activity; dose may be reduced to 5 mg or increased to max 20 mg; usual max dosing frequency is 1×/day; once- daily dosing 2.5 mg/day at same time each day BPH • Adult: PO 5 mg daily at the same time every day Pulmonary hypertension (Adcirca, Alyq) • Adult: PO 40 mg (two 20-mg tablets) daily with or without food Concomitant use with ketoconazole, itraconazole, ritonavir • Adult: PO max 10 mg q72hr Renal dose (Adcirca) • Adult: PO CCr 51-80 mL/min: no adjustment for erectile dysfunction, 20 mg/day initially for pulmonary hyper tension; CCr 31-50 mL/min, 5 mg/day, max 10 mg q48hr; CCr <30 mL/min, max 5 mg q72hr Hepatic dose (Adcirca) • Adult: PO (Child-Pugh A, B) max 10 mg/day or 20 mg/day (pulmonary hyper tension) max 40 mg/day; (Child-Pugh C) not recommended
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Available forms: Tabs (Cialis) 2.5, 5, 10, 20 mg; tabs (Adcirca Alyq) 20 mg
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Administer: • Product should not be used with ni trates in any form • Erectile dysfunction: give before sexual activity; do not use more than 1×/day • Pulmonary hypertension: give Adcirca, Alyq with/without meals
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Extracted information for tadalafil only.
Assess: • Cialis: underlying cause of erectile dys- function before treatment; use of organic nitrates that should not be used with this product; any severe loss of vision while taking this or any similar products • BPH: urinary hesitancy, poor stream, dribbling baseline and periodically • Adcirca, Alyq: hemodynamic param- eters to exercise tolerance at baseline and periodically • Respiratory changes: dyspnea, wheezing • CV status: B/P, angina, palpitation, HR, edema, dizziness • Pregnancy/breastfeeding: use only if clearly needed (Adcirca only); Cialis is not indicated for women; not used in breastfeeding • Beers: use with caution in older adults; may exacerbate syncope; monitor frequently for syncope
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Evaluate: • Therapeutic response: ability to en- gage in sexual intercourse, improvement in exercise ability in pulmonary hyper- tension
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To take 1 hr before sexual activity • Not to drink large amounts of alcohol • To discuss with provider all OTC, Rx, herbals, supplements taken • That product does not protect against sexually transmitted diseases, including HIV • That product has no effect in the ab- sence of sexual stimulation; to seek medical help if erection lasts >4 hr • To notify physician about all medicines, vitamins, herbs being taken, especially rito- navir, indinavir, ketoconazole, itraconazole, erythromycin, nitrates, α-blockers; that tadalafil is contraindicated for use with α- blockers except 0.4 mg/day tamsulosin • To notify prescriber immediately and to stop taking product if vision, hearing loss occurs or if erection lasts >4 hr or if chest pain occurs
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Extracted information for tadalafil only.
PHARMACOKINETICS Rapidly absorbed; metabolized by liver by CYP3A4; terminal half-life 17.5 hr; peak 1⁄2-6 hr; excreted primarily as metabolites in feces, urine; excreted 61% in feces, 36% in urine; 94% protein bound; rate and extent of absorption not influenced by food
Source page 1251
Filter the extracted dose blocks for this individual drug.
Erectile dysfunction
• Adult: PO (Cialis) 10 mg taken be- fore sexual activity; dose may be reduced to 5 mg or increased to max 20 mg; usual max dosing frequency is 1×/day; once- daily dosing 2.5 mg/day at same time each day BPH
Candidate age grouping · source page 1251
Erectile dysfunction
• Adult: PO 5 mg daily at the same time every day Pulmonary hypertension (Adcirca, Alyq)
Candidate age grouping · source page 1251
Erectile dysfunction
• Adult: PO 40 mg (two 20-mg tablets) daily with or without food Concomitant use with ketoconazole, itraconazole, ritonavir
Candidate age grouping · source page 1251
Erectile dysfunction
• Adult: PO max 10 mg q72hr Renal dose (Adcirca)
Candidate age grouping · source page 1251
Erectile dysfunction
• Adult: PO CCr 51-80 mL/min: no adjustment for erectile dysfunction, 20 mg/day initially for pulmonary hyper tension; CCr 31-50 mL/min, 5 mg/day, max 10 mg q48hr; CCr <30 mL/min, max 5 mg q72hr Hepatic dose (Adcirca)
Candidate age grouping · source page 1251
Erectile dysfunction
• Adult: PO (Child-Pugh A, B) max 10 mg/day or 20 mg/day (pulmonary hyper tension) max 40 mg/day; (Child-Pugh C) not recommended
Candidate age grouping · source page 1251