XYRIO 5/MG TAB 30/TAB

Indications

Approved Uses

Erectile Dysfunction (ED), Benign Prostatic Hyperplasia (BPH), Pulmonary Arterial Hypertension (PAH).

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as needed): 10 mg prior to sexual activity; adjust to 5-20 mg; max 20 mg/day. Erectile dysfunction (once daily): 2.5 mg once daily; may increase to 5 mg once daily. Benign prostatic hyperplasia (BPH): 5 mg once daily. Pulmonary arterial hypertension (PAH): 40 mg once daily (not applicable to this 5 mg tablet strength/product use unless specifically prescribed off-strength).

Initial Dose

For ED (as needed): 10mg prior to sexual activity. For BPH/ED (daily): 5mg once daily.

Maintenance Dose

2.5-5mg once daily for daily use; 5-20mg for as-needed use.

Maximum Dose

For ED as-needed: 20 mg; For once-daily ED/BPH: 5 mg; For PAH: 40 mg

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment: ED as-needed-CrCl 30-50 mL/min max 10 mg every 48 h; CrCl <30 mL/min max 5 mg every 72 h; avoid once-daily use if CrCl <30 mL/min. BPH/ED once-daily-CrCl 30-50 mL/min start 2.5 mg daily (may increase to 5 mg if tolerated); CrCl <30 mL/min or on hemodialysis: not recommended. Hepatic impairment: mild-moderate (Child-Pugh A/B) use with caution (as-needed max 10 mg); severe (Child-Pugh C) not recommended. Strong CYP3A4 inhibitors: reduce/limit tadalafil exposure (avoid daily use with strong inhibitors; for as-needed dosing do not exceed 10 mg every 72 h).

How to Take

Swallow tablet whole with water; may be taken with or without food. For once-daily regimens (e.g., 5 mg daily), take at approximately the same time each day.

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (≥10%): headache, dyspepsia. Common (1-10%): back pain, myalgia, flushing, nasal congestion, limb pain. Less common/rare but serious: hypotension/syncope, priapism, non-arteritic anterior ischemic optic neuropathy (NAION) and sudden hearing loss.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any form of organic nitrates or nitric oxide donors; (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to tadalafil or any excipients. Also contraindicated in patients for whom sexual activity is inadvisable due to cardiovascular status (per PDE5 inhibitor labeling).

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status and avoid use when sexual activity is inadvisable; do not use with nitrates/riociguat; caution with alpha-blockers and other antihypertensives due to hypotension (ensure stable alpha-blocker therapy and start low); counsel to seek urgent care for priapism (>4 hours); discontinue and seek care for sudden vision loss (NAION risk) or sudden hearing loss; use caution in patients with anatomical penile deformation or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma); caution in patients with severe renal/hepatic impairment and in those with bleeding disorders/active peptic ulcer (per PDE5 class labeling).

Age Restriction

Not approved under 18 years

Drug Interactions

Drug Interactions

Major interactions: (1) Nitrates/NO donors (contraindicated-profound hypotension); (2) Riociguat/GC stimulators (contraindicated-hypotension); (3) Alpha-blockers (additive BP lowering-separate dosing and ensure stable alpha-blocker therapy; avoid with doxazosin in some labeling); (4) Antihypertensives (additive BP lowering); (5) Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat, clarithromycin-↑ tadalafil exposure; dose limitation/avoid daily regimen depending on indication); (6) Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin-↓ exposure/efficacy); (7) Alcohol (substantial intake increases risk of symptomatic hypotension).

Interaction Severity

MAJOR/Contraindicated: nitrates (e.g., nitroglycerin) and riociguat (profound hypotension). MODERATE: alpha-blockers and other antihypertensives (additive BP lowering), strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) increase tadalafil exposure; substantial alcohol intake can increase orthostatic symptoms. MINOR/Reduced efficacy: CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) decrease tadalafil levels.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Children

Not approved for children.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but consider renal and hepatic function

Storage & Patient Advice

Missed Dose

For once-daily use: take the missed dose as soon as remembered the same day; if close to the next dose, skip and resume the regular schedule; do not double doses.

Stopping the Medicine

Safe to stop anytime

Overdose

Overdose: adverse reactions are expected to be similar to those at recommended doses but may be more severe (e.g., headache, flushing, dizziness, hypotension, dyspepsia, back pain/myalgia, priapism). Management: supportive care with vital sign/hemodynamic monitoring; consider evaluation for prolonged erection/ischemic events; hemodialysis is unlikely to be helpful due to high protein binding.

Patient Counseling

Take exactly as prescribed (daily at the same time for once-daily regimens, or prior to sexual activity for as-needed use). Do not use with nitrates or riociguat due to dangerous hypotension; use caution with alpha-blockers/antihypertensives and limit excessive alcohol. Seek urgent care for chest pain after dosing (do not self-treat with nitrates), an erection lasting >4 hours, or sudden vision/hearing loss; do not share this prescription medicine.

Monitoring Requirements

No routine laboratory monitoring is required; monitor blood pressure and symptoms of hypotension when used with antihypertensives/alpha-blockers or with alcohol, and counsel to seek urgent care for priapism or sudden vision/hearing changes.

Pharmacology

Mechanism of Action

Selectively inhibits phosphodiesterase type 5 (PDE5), an enzyme that degrades cyclic guanosine monophosphate (cGMP). By increasing cGMP levels, it promotes smooth muscle relaxation and vasodilation in the corpus cavernosum and pulmonary vasculature.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

Terminal half-life: ~17.5 hours.

Bioavailability

Absolute oral bioavailability: not determined; food does not produce a clinically meaningful effect on absorption.

Metabolism

Hepatic metabolism primarily via CYP3A4 to inactive metabolites.

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: 5 mg tadalafil

Generic Availability

Yes

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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