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CIALIS
Benign prostatic hyperplasia/urinary retention
Erectile dysfunction
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Drug Name:

CIALIS Rx

Generic Name and Formulations:
Tadalafil 2.5mg, 5mg, 10mg, 20mg; tabs.

Company:
Lilly, Eli and Company

Therapeutic Use:

Indications for CIALIS:

Benign prostatic hyperplasia (BPH). Limitations of use: if concomitant with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.

Adult:

≥18yrs: 5mg once daily (taken at same time each day). Concomitant finasteride: 5mg once daily for up to 26 weeks. Renal impairment: CrCl 30–50mL/min: initially 2.5mg; may increase to 5mg/day. CrCl <30mL/min or hemodialysis: not recommended. Concomitant potent CYP3A4 inhibitors (See Interactions): max 2.5mg/day. Concomitant α-blockers: not recommended.

Children:

<18yrs: not established.

Contraindications:

Concomitant nitrates. Concomitant guanylate cyclase (GC) stimulators (eg, riociguat).

Warnings/Precautions:

Not for use in women. Confirm diagnosis before therapy. Cardiovascular disease (eg, MI within 90 days, unstable angina or angina during intercourse, NYHA Class 2 or greater HF or stroke within 6 months; hypotension [<90/50mmHg], uncontrolled hypertension or arrhythmias, severely impaired autonomic BP regulation, LV outflow obstruction), severe hepatic impairment, hereditary degenerative retinal disorders including retinitis pigmentosa: not recommended. Anatomical penile deformation. Predisposition to priapism. Underlying non-arteritic anterior ischemic optic neuropathy risk factors. "Crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. Patients for whom sexual activity is inadvisable or contraindicated. Renal impairment. Mild or moderate hepatic impairment. Bleeding disorders. Active peptic ulcer. Pregnancy (Cat.B).

Interactions:

See Contraindications. Hypotension with nitrates, GC stimulators, other antihypertensives, alcohol (≥5 units). Potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, protease inhibitors, erythromycin, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin). Concomitant α-blockers: not recommended; discontinue at least 1 day prior to therapy. Concomitant other erectile dysfunction treatments: not recommended.

Pharmacological Class:

Phosphodiesterase type 5 inhibitor (cGMP-specific).

Adverse Reactions:

Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain; sudden vision or hearing loss, cardiovascular effects; rare: priapism, prolonged erection.

Generic Availability:

NO

How Supplied:

Tabs 2.5mg—2 x 15 (blisters); 5mg—30, 2 x 15 (blisters); 10mg, 20mg—30

Indications for CIALIS:

Erectile dysfunction (ED). Treatment of ED and signs/symptoms of benign prostatic hyperplasia (BPH). Limitations of use: if concomitant with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.

Adult:

≥18yrs: ED: As Needed Use: Initially 10mg (taken before sexual activity), range: 5–20mg. Max dosing: once daily; effect may last ≤36hrs. Renal impairment: CrCl 30–50mL/min: initially 5mg/day; max 10mg per 48hrs; CrCl <30mL/min or hemodialysis: max 5mg per 72hrs. Mild-to-moderate hepatic impairment: max 10mg/day. Concomitant potent CYP3A4 inhibitors (See Interactions): max 10mg per 72hrs. 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 or hemodialysis: not recommended. Both ED Uses: Concomitant α-blockers: use lowest recommended dose (see full labeling). ED/BPH: 5mg once daily (taken at same time each day). Renal impairment: CrCl 30–50mL/min: initially 2.5mg; may increase to 5mg/day; CrCl <30mL/min or hemodialysis: not recommended. For BPH: concomitant α-blockers: not recommended.

Children:

<18yrs: not established.

Contraindications:

Concomitant nitrates. Concomitant guanylate cyclase (GC) stimulators (eg, riociguat).

Warnings/Precautions:

Not for use in women. Confirm diagnosis before therapy. Cardiovascular disease (eg, MI within 90 days, unstable angina or angina during intercourse, NYHA Class 2 or greater HF or stroke within 6 months; hypotension [<90/50mmHg], uncontrolled hypertension or arrhythmias, severely impaired autonomic BP regulation, LV outflow obstruction), severe hepatic impairment, hereditary degenerative retinal disorders including retinitis pigmentosa: not recommended. Anatomical penile deformation. Predisposition to priapism. Underlying non-arteritic anterior ischemic optic neuropathy risk factors. "Crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. Patients for whom sexual activity is inadvisable or contraindicated. Renal impairment. Mild or moderate hepatic impairment. Bleeding disorders. Active peptic ulcer. Pregnancy (Cat.B).

Interactions:

See Contraindications. Hypotension with nitrates, GC stimulators, other antihypertensives, alcohol (≥5 units). Potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, protease inhibitors, erythromycin, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin). Concomitant α-blockers: not recommended; discontinue at least 1 day prior to therapy. Concomitant other erectile dysfunction treatments: not recommended.

Pharmacological Class:

Phosphodiesterase type 5 inhibitor (cGMP-specific).

Adverse Reactions:

Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain; sudden vision or hearing loss, cardiovascular effects; rare: priapism, prolonged erection.

Generic Availability:

NO

How Supplied:

Tabs 2.5mg—2 x 15 (blisters); 5mg—30, 2 x 15 (blisters); 10mg, 20mg—30

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