XYRIO 20/MG TAB 4/TAB

Indications

Approved Uses

Erectile dysfunction, Benign prostatic hyperplasia (BPH

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as needed): 10 mg prior to sexual activity; adjust to 5-20 mg; max 20 mg once daily. Erectile dysfunction (once daily): 2.5 mg daily; may increase to 5 mg daily. BPH (with or without ED): 5 mg once daily. PAH: 40 mg once daily (two 20 mg tablets) using the PAH-specific tadalafil product.

Initial Dose

10 mg taken prior to anticipated sexual activity (on-demand); 2.5 mg once daily for daily dosing regimen

Maintenance Dose

Erectile Dysfunction (as-needed): 5-20mg. Erectile Dysfunction (daily): 2.5-5mg. BPH: 5mg daily. PAH: 40mg daily.

Maximum Dose

Erectile Dysfunction (as-needed): 20mg not more than once per day. Erectile Dysfunction (daily): 5mg per day. BPH: 5mg per day. PAH: Not indicated in this label

Children's Dosage

Not approved for children under 18 years.

Dose Adjustment Notes

Renal impairment (ED as-needed): CrCl 30-50 mL/min: max 10 mg every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg every 72 hours. Hepatic impairment (ED): Child-Pugh A/B: max 10 mg once daily (as-needed); Child-Pugh C: not recommended. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): for ED as-needed, max 10 mg every 72 hours; for once-daily use, avoid or limit to 2.5 mg daily per labeling.

How to Take

Swallow tablet whole with water; may be taken with or without food. For erectile dysfunction (as needed), take prior to anticipated sexual activity (onset can be ~30 minutes); do not take more than one dose in 24 hours.

Side Effects

Common Side Effects

Headache, dyspepsia, back pain, myalgia, flushing, nasopharyngitis, nasal congestion, pain in extremity.

Side Effect Frequency

Very common (≥10%): Headache. Common (1-10%): Flushing, Dyspepsia, Nasal congestion, Back pain, Myalgia, Pain in extremity. Uncommon (0.1-1%): Dizziness. Rare/very rare (≤0.1%) or frequency not known: Priapism, Non-arteritic anterior ischemic optic neuropathy (NAION)/sudden vision loss, Sudden hearing loss, Hypersensitivity reactions.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any organic nitrate or nitric oxide donor (acute or chronic), (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat), and (3) known hypersensitivity to tadalafil or any excipients. Use is generally not recommended/avoid in patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina, uncontrolled arrhythmias, severe hypotension), but these are typically warnings/precautions rather than absolute labeled contraindications.

Warnings & Precautions

Assess cardiovascular status before prescribing and avoid use when sexual activity is inadvisable; caution with alpha-blockers/other antihypertensives and substantial alcohol due to hypotension; counsel to seek urgent care for priapism (>4 hours) and to stop the drug and seek care for sudden vision or hearing changes; use caution in patients with penile anatomical deformity or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma).

Age Restriction

Not approved under 18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; guanylate cyclase stimulators (riociguat). Clinically significant: potent CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir/cobicistat, clarithromycin) increase tadalafil exposure; CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) decrease exposure; alpha-blockers and other antihypertensives can add hypotension (separate dosing/titrate); substantial alcohol increases orthostatic symptoms/hypotension.

Interaction Severity

MAJOR/Contraindicated: Nitrates; riociguat. MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) require strict dose limitation/avoid daily regimens. MODERATE: Alpha-blockers and other antihypertensives (additive hypotension); substantial alcohol intake (orthostatic hypotension). MINOR: CYP3A4 inducers (reduced efficacy); antacids may slightly delay absorption.

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children under 18 years.

Elderly

Standard adult dosing. No adjustment is required based on age alone, but greater sensitivity in some older individuals should be considered.

Kidney Impairment

Erectile dysfunction (as-needed): CrCl 30-50 mL/min: 5 mg initially; maximum 10 mg not more frequently than every 48 hours. CrCl <30 mL/min or on hemodialysis: maximum 5 mg not more frequently than every 72 hours. Once-daily use: CrCl 30-50 mL/min: 2.5 mg once daily, may increase to 5 mg based on response; CrCl <30 mL/min or hemodialysis: once-daily use not recommended.

Liver Impairment

Child-Pugh A or B: use with caution; for erectile dysfunction as-needed dosing, maximum 10 mg once daily (do not exceed 10 mg per dose). Child-Pugh C: use is not recommended (avoid).

Storage & Patient Advice

Missed Dose

As-needed ED: no missed dose concept-take only when needed. Once-daily regimens (ED/BPH/PAH): take as soon as remembered the same day; if close to the next dose, skip and resume regular schedule; do not double doses.

Stopping the Medicine

Safe to stop anytime

Overdose

Expected findings: exaggerated adverse effects (e.g., headache, flushing, dizziness, hypotension, tachycardia, dyspepsia, back pain/myalgia; rarely priapism). Management: supportive care with vital-sign/hemodynamic monitoring; treat hypotension as needed; hemodialysis is unlikely to be useful because tadalafil is highly protein bound.

Patient Counseling

For ED as needed, take before sexual activity; sexual stimulation is required. Do not take more than one dose in 24 hours. Do not use with nitrates or riociguat; caution with alpha-blockers/antihypertensives and alcohol. Seek urgent care for chest pain, sudden vision/hearing loss, or erection >4 hours; report severe dizziness/syncope.

Monitoring Requirements

Assess cardiovascular status and contraindications before initiation; monitor blood pressure and symptoms of hypotension as clinically indicated, especially with antihypertensives/alpha-blockers or alcohol use.

Pharmacology

Mechanism of Action

Inhibits phosphodiesterase type 5 (PDE5), increasing cGMP and promoting nitric-oxide-mediated smooth muscle relaxation in the corpus cavernosum (and pulmonary/prostatic vasculature), enhancing blood flow in response to sexual stimulation.

Duration of Effect

Up to 36 hours.

Half-Life

Terminal half-life ~17.5 hours (may be modestly prolonged in older adults).

Bioavailability

Absolute bioavailability is not established; food does not have a clinically meaningful effect on exposure.

Metabolism

Hepatic metabolism predominantly via CYP3A4 to metabolites (largely inactive).

Excretion

Fecal (approximately 61%) and renal (approximately 36%).

Protein Binding

94%.

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: 20 mg tadalafil

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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