tadalafil

Contraindicated in:

Hypersensitivity;
Concurrent use of nitrates or riociguat;
Unstable angina, recent history of stroke, life-threatening HF within 6 mo, uncontrolled hypertension, arrhythmias, stroke within 6 mo, or MI within 90 days;
Any other cardiovascular pathology precluding sexual activity;
Known hereditary degenerative retinal disorders;
Severe hepatic impairment;
Severe renal impairment (Adcirca, Alyq, and Tadliq);
Severe renal impairment (Cialis once-daily dosing);
Pedi: Children or newborns.

Use Cautiously in:

Left ventricular outflow obstruction;
Penile deformity;
Renal impairment;
Underlying conditions predisposing to priapism, including sickle cell anemia, multiple myeloma, or leukemia;
Bleeding disorders or active peptic ulcer disease;
History of sudden severe vision loss or nonarteritic ischemic optic neuropathy; may ↑ risk of recurrence;
Low cup-to-disk ratio, age >50 yr, diabetes, hypertension, coronary artery disease, hyperlipidemia, or smoking (↑ risk of nonarteritic ischemic optic neuropathy);
Geri: ↑risk of diarrhea in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension, peripheral edema

Derm: flushing

EENT: hearing loss, nasal congestion, vision loss

GI: diarrhea, dyspepsia

GU: ↓fertility, priapism

MS: back pain, limb pain, myalgia

Neuro: headache

Interactions ⬆ ⬇

Drug-drug:

Concurrent use of nitrates may cause serious, life-threatening hypotension and is contraindicated.
Concurrent use of riociguat may result in severe hypotension; concurrent use contraindicated.
↑risk of hypotension with alpha-adrenergic blockers and acute ingestion of alcohol; discontinue alpha-adrenergic blocker therapy ≥1 day before starting Cialis for BPH.
Strong CYP3A4 inhibitors, including ritonavir, ketoconazole, and itraconazole, may ↑ levels and the risk of toxicity (dose adjustments recommended with Cialis; avoid concurrent use with Adcirca, Alyq, and Tadliq).
CYP3A4 inducers may ↓ levels and its effectiveness; avoid concurrent use with Adcirca, Alyq, or Tadliq.

Availability ⬆ ⬇

(Generic available)

Tablets (Cialis): 2.5 mg; 5 mg; 10 mg; 20 mg
Tablets (Adcirca or Alyq): 20 mg
Oral suspension (Tadliq) peppermint flavor: 20 mg/5 mL
In combination with: finasteride (Entadfi); macitentan (Opsynvi). See Appendix [not included in this PDA edition].

Route/Dosage ⬆ ⬇

Cialis (for ED)

PO (Adults ): 10 mg prior to sexual activity (range 5–20 mg; not to exceed one dose/24 hr) or 2.5 mg once daily (max: 5 mg/day); Concurrent use of strong CYP3A4 inhibitors: Single dose should not exceed 10 mg in any 72-hr period; for once-daily dose regimen, should not exceed 2.5 mg/day.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min (as-needed dosing): Initial dose should not exceed 5 mg/day; maximum dose should not exceed 10 mg in 48 hr; CCr <30 mL/min (as-needed dosing): Maximum dose should not exceed 5 mg in 72 hr; CCr <30 mL/min (once-daily dosing): Not recommended for use.

Hepatic Impairment

PO (Adults ): Mild or moderate hepatic impairment: Daily dose should not exceed 10 mg (once-daily dose regimen not recommended); Severe hepatic impairment: Not recommended for use.

Cialis (for BPH or ED/BPH)

PO (Adults ): 5 mg once daily; use for up to 26 wk when used concurrently with finasteride; Concurrent use of strong CYP3A4 inhibitors: Should not exceed 2.5 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: Initial dose should not exceed 2.5 mg/day; maximum dose should not exceed 5 mg/day; CCr <30 mL/min: Not recommended for use.

Hepatic Impairment

PO (Adults ): Not recommended for use.

Adcirca, Alyq, and Tadliq (for PAH)

PO (Adults ): 40 mg once daily; If receiving ritonavir for ≥1 wk: start 20 mg once daily; may then ↑ to 40 mg once daily based on tolerability; If initiating ritonavir while on Adcirca, Alyq, or Tadliq: Stop Adcirca, Alyq, or Tadliq ≥24 hr before starting ritonavir; may reinitiate Adcirca, Alyq, or Tadliq at 20 mg once daily after ≥1 wk of therapy with ritonavir; may then ↑ to 40 mg once daily based on tolerability.

Renal Impairment

PO (Adults ): CCr 31–80 mL/min: Start 20 mg once daily; may then ↑ to 40 mg once daily based on tolerability.

Hepatic Impairment

PO (Adults ): Mild or moderate hepatic impairment: Start with 20 mg once daily.

US Brand Names ⬆ ⬇

Adcirca, Alyq, Cialis, Tadliq

Action ⬆ ⬇

Increases cyclic guanosine monophosphate (cGMP) levels by inhibiting phosphodiesterase type 5, an enzyme responsible for the breakdown of cGMP. cGMP produces smooth muscle relaxation of the corpus cavernosum, which in turn promotes increased blood flow and subsequent erection. cGMP also leads to vasodilation of the pulmonary vasculature.

Therapeutic effects:

Cialis: Enhanced blood flow to the corpus cavernosum and erection sufficient to allow sexual intercourse.
Improved signs and symptoms of BPH.
Adcirca, Alyq, and Tadliq: Improved exercise tolerance in PAH.

Classifications ⬆ ⬇

Therapeutic Classification: erectile dysfunction agents, vasodilators

Pharmacologic Classification: phosphodiesterase type 5 inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration.

Distribution: Extensive tissue distribution; penetrates semen.

Protein Binding: 94%.

Metabolism/Excretion: Mostly metabolized by the liver via the CYP3A4 isoenzyme system; metabolites are excreted in feces (61%) and urine (36%).

Half-Life: 17.5 hr.

Time/Action Profile ⬆ ⬇

(vasodilation, improved erectile function)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	0.5–6 hr	36

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient to take as needed for ED >30 min before sexual activity and not more than once per day. Inform patient that sexual stimulation is required for an erection to occur after taking tadalafil. Instruct patient to take for PAH as directed.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient that tadalafil is not indicated for use in women.
Caution patient not to take tadalafil concurrently with alpha-adrenergic blockers (unless on a stable dose) or nitrates. If chest pain occurs after taking tadalafil, instruct patient to seek immediate medical attention.
Advise patient to avoid excess alcohol intake in combination with tadalafil; may ↑ risk of orthostatic hypotension, ↑ HR, ↓ standing BP, dizziness, and headache.
Instruct patient to notify health care professional promptly if erection lasts >4 hr, they are not satisfied with their sexual performance, they develop unwanted side effects, or they experience sudden or ↓ vision loss in one or both eyes, ↓or loss in hearing, ringing in the ears, or dizziness.
Inform patient that tadalafil offers no protection against sexually transmitted diseases. Counsel patient that protection against sexually transmitted diseases and HIV infection should be considered.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Pill Image