AVIALIS 20 MG 1 TAB

Indications

Approved Uses

Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability

Dosage & Administration

Dosing by Condition

Pulmonary arterial hypertension: 20 mg once daily; may increase to 40 mg once daily

Maintenance Dose

20 mg once daily for PAH; increase to 40 mg once daily based on individual tolerability

Maximum Dose

Erectile Dysfunction/BPH: 20 mg as needed or 5 mg daily. Pulmonary Arterial Hypertension: 40 mg daily.

Dose Adjustment Notes

Renal impairment: for ED on‑demand, consider lower starting dose in CrCl 30-50 mL/min and limit frequency; in CrCl <30 mL/min or on dialysis, use lower dose and do not exceed 5 mg with extended dosing interval (e.g., not more often than every 72 hours). Once‑daily tadalafil is not recommended in severe renal impairment. Hepatic impairment: mild-moderate-use lower dose/caution; severe hepatic impairment-avoid. Drug interactions: with potent CYP3A4 inhibitors (e.g., ritonavir/ketoconazole/itraconazole/clarithromycin), reduce dose and/or extend interval (e.g., max 10 mg every 72 hours with ritonavir for ED on‑demand); avoid with strong CYP3A4 inducers (e.g., rifampin) due to reduced efficacy.

How to Take

Swallow the 20 mg film‑coated tablet whole with water; may be taken with or without food. For erectile dysfunction (on‑demand), take prior to anticipated sexual activity (commonly at least 30 minutes before); do not take more than one dose in 24 hours.

Side Effects

Common Side Effects

Headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, nasopharyngitis, limb pain

Side Effect Frequency

Common: headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, limb pain, dizziness. Less common/rare but serious: hypotension/syncope, priapism, non‑arteritic anterior ischemic optic neuropathy (sudden vision loss), sudden hearing loss, severe cutaneous reactions (e.g., SJS/TEN).

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any organic nitrates or nitric oxide donors; (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to tadalafil or excipients. Additionally, tadalafil should not be used in patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina or severe cardiac disease), and is generally avoided in severe hepatic impairment (Child-Pugh C) per labeling/guidelines.

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status and ensure sexual activity is safe; avoid/stop and seek urgent care for chest pain during sexual activity; caution with alpha-blockers/other antihypertensives and with substantial alcohol; 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 deformity or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma); caution in severe renal/hepatic impairment; not indicated for use in women for ED.

Drug Interactions

Drug Interactions

Clinically significant interactions include: nitrates/NO donors (contraindicated-profound hypotension), riociguat/guanylate cyclase stimulators (contraindicated-hypotension), history of serious hypersensitivity (contraindicated). Assess cardiovascular status; caution with vasodilatory effects in patients with underlying cardiovascular disease

Interaction Severity

MAJOR/CONTRAINDICATED: nitrates (including recreational nitrites) and guanylate cyclase stimulators (e.g., riociguat) (risk of profound hypotension

Food Interaction

No clinically meaningful food effect; may be taken with or without food.

Special Populations

Kidney Impairment

Mild (CrCl 51-80 mL/min) or moderate (CrCl 31-50 mL/min): Start 20 mg once daily; may increase to 40 mg once daily. Severe (CrCl <30 mL/min or hemodialysis): Avoid use

Liver Impairment

Mild-to-moderate hepatic impairment (Child-Pugh A or B): for erectile dysfunction on-demand use, maximum 10 mg once daily; use with caution. Severe hepatic impairment (Child-Pugh C): use is not recommended (avoid).

Storage & Patient Advice

Monitoring Requirements

No routine laboratory monitoring is required; clinically monitor blood pressure and symptoms of hypotension (especially with antihypertensives/alpha‑blockers), and counsel to seek urgent care for priapism, sudden vision loss (NAION), or sudden hearing loss.

Pharmacology

Mechanism of Action

Selective phosphodiesterase type 5 (PDE5) inhibition increases cGMP in the corpus cavernosum and pulmonary/vascular smooth muscle, enhancing nitric‑oxide-mediated smooth muscle relaxation and blood flow; erectile response requires sexual stimulation.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: Tadalafil 20 mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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