Monograph Details
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Urogenital System
> Erectile dysfunction
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CIALIS |
| Manufacturer |
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Lilly/ICOS LLC |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Phosphodiesterase type 5 inhibitor (cGMP-specific). |
| Generic Name |
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Tadalafil 2.5mg, 5mg, 10mg, 20mg; tabs. |
| Indications |
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Erectile dysfunction. |
| Children |
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Not recommended. |
| Adults |
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Use as needed: Initially 10mg (taken before sexual activity), range: 5–20mg. Max dosing: once daily; effect may last ≤36hrs. Renal impairment: CrCl 31–50mL/min: initially 5mg; max 10mg per 48 hours; CrCl <30mL/min and hemodialysis: max 5mg per 72 hours. Mild to moderate hepatic impairment: max 10mg. Concomitant potent CYP3A4 inhibitors (See Interactions): max 10mg per 72 hours. Once-Daily Use: Initially 2.5mg (taken at same time each day); may increase to 5mg/day. Concomitant potent CYP3A4 inhibitors (See Interactions): max 2.5mg. CrCl<30mL/min and hemodialysis: not recommended. Both: Concomitant α-blockers: use lowest recommended dose (see literature). |
| Contraindications |
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Concomitant nitrates, or nitric oxide donors (eg, sodium nitroprusside). |
| Precautions |
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Confirm diagnosis. Cardiovascular disease (eg, MI within 90 days, unstable angina or angina during intercourse, severe heart failure or stroke within 6 months; BP <90/50 or BP>170/100, uncontrolled arrhythmias, severely impaired autonomic BP regulation, LV outflow obstruction), severe hepatic impairment, retinitis pigmentosa and related retinal disorders: not recommended. Anatomical penile deformation. Predisposition to priapism. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Hypotension with nitrates, α-blockers, other antihypertensives, alcohol. Plasma levels increased by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, protease inhibitors, erythromycin, grapefruit juice) and decreased by CYP3A4 inducers (eg, rifampin). Concomitant other erectile dysfunction treatments: not recommended. |
| Adverse Reactions |
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Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain, sudden vision or hearing loss (discontinue if occurs), cardiovascular effects (eg, hypotension, tachycardia); rare: priapism. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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