AVIALIS 5/MG FC TAB 28/FC TAB

Indications

Approved Uses

Erectile dysfunction (ED); benign prostatic hyperplasia (BPH), including ED with BPH

Dosage & Administration

Dosing by Condition

ED (once daily): 2.5 mg once daily, may increase to 5 mg once daily. ED (on-demand): 10 mg prior to sexual activity, adjust 5-20 mg based on response/tolerability. BPH or ED+BPH: 5 mg once daily. (PAH: 40 mg/day is a separate indication/product and not applicable to this 5 mg AVIALIS listing.)

Initial Dose

5 mg once daily (for daily dosing regimen for ED or BPH)

Maintenance Dose

5 mg once daily

Maximum Dose

5 mg once daily

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment: for once-daily use, limit to 5 mg/day in moderate impairment and avoid once-daily use in severe impairment (CrCl <30 mL/min) or dialysis; for on-demand use, lower starting dose and extend dosing interval in severe impairment. Hepatic impairment: use caution and lower doses in mild-moderate impairment; avoid in severe hepatic impairment.

How to Take

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

Side Effects

Common Side Effects

Headache, dyspepsia (indigestion), back pain, myalgia (muscle pain), flushing, and nasal congestion.

Side Effect Frequency

Common (1-10%): headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, pain in extremity. Uncommon (0.1-1%): dizziness. Rare/very rare (<0.1%): priapism, non-arteritic anterior ischemic optic neuropathy (NAION)/sudden vision loss, sudden hearing loss. Frequency not known/rare: hypotension (more likely with concomitant nitrates/alpha-blockers).

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any organic nitrates (regular or intermittent) or nitric oxide donors; (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat); (3) hypersensitivity to tadalafil or any excipients. Not absolute contraindications but generally avoid/use only with specialist assessment: patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina, uncontrolled arrhythmias, severe heart failure, recent MI/stroke per product labeling).

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status before prescribing and avoid use when sexual activity is inadvisable; risk of hypotension (caution with alpha-blockers/antihypertensives and with alcohol); priapism risk-use caution in predisposed patients (e.g., sickle cell disease, leukemia, multiple myeloma) or penile anatomical deformity; discontinue and seek urgent care for sudden vision or hearing changes; use caution in hepatic/renal impairment and with strong CYP3A4 inhibitors/inducers.

Age Restriction

Not approved under 18 years

Driving Warning

Caution advised due to potential dizziness or hypotension

Drug Interactions

Drug Interactions

Major interactions: nitrates/NO donors (contraindicated-severe hypotension); riociguat/GC stimulators (contraindicated-hypotension); alpha-blockers (additive BP lowering-start stable on one agent and use lowest doses); antihypertensives (additive hypotension possible); potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat, clarithromycin-↑ tadalafil exposure; dose limitation/avoid depending on regimen); potent CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s wort-↓ exposure/efficacy); alcohol (additive hypotension/dizziness).

Interaction Severity

MAJOR/Contraindicated: nitrates (including recreational nitrites) and riociguat. MODERATE: alpha-blockers and other antihypertensives (additive hypotension), potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) (↑ exposure), substantial alcohol (↑ orthostasis). MINOR/Reduced effect: CYP3A4 inducers (e.g., rifampin) (↓ exposure/efficacy).

Food Interaction

May be taken with or without food; avoid/limit grapefruit or grapefruit juice (especially large amounts) due to potential CYP3A4-mediated increase in tadalafil exposure.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children.

Elderly

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

Kidney Impairment

For once-daily use (ED/BPH): CrCl 30-50 mL/min start 2.5 mg once daily, may increase to 5 mg based on response/tolerability; CrCl <30 mL/min or on hemodialysis: once-daily use not recommended. For as-needed ED: CrCl 30-50 mL/min max 10 mg no more frequently than every 48 hours; CrCl <30 mL/min or on hemodialysis max 5 mg no more frequently than every 72 hours.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A or B): use with caution; for ED as-needed dosing do not exceed 10 mg once daily; once-daily (5 mg) use has limited data and should be used cautiously. Severe hepatic impairment (Child-Pugh C): not recommended (effectively avoid).

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Safe to stop anytime

Overdose

Overdose: expected to produce exaggerated tadalafil adverse effects (e.g., headache, flushing, dizziness, hypotension/syncope, tachycardia; rarely priapism). Management is supportive/symptomatic with monitoring of vital signs and cardiovascular status; consider GI decontamination if very recent ingestion per standard toxicology practice; hemodialysis is unlikely to be beneficial due to high protein binding.

Patient Counseling

Take exactly as prescribed; for daily therapy take at the same time each day. Do not use with nitrates or riociguat; tell clinicians you take tadalafil before any emergency chest-pain treatment. Use caution with alcohol and with alpha-blockers/antihypertensives due to dizziness/low BP. Seek urgent care for chest pain, sudden vision/hearing loss, or erection >4 hours. Does not protect against STIs.

Monitoring Requirements

No routine laboratory monitoring required; monitor blood pressure and symptoms of hypotension, especially when used with antihypertensives/alpha-blockers or in patients with cardiovascular disease.

Pharmacology

Mechanism of Action

Selective PDE5 inhibition increases cGMP in smooth muscle, enhancing nitric-oxide-mediated relaxation; this improves penile blood flow for erection with sexual stimulation and relaxes lower urinary tract/prostatic smooth muscle to improve BPH symptoms.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

17.5 hours.

Bioavailability

Absolute bioavailability: not established (unknown); food does not produce a clinically meaningful effect on exposure.

Metabolism

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

Excretion

Excreted mainly as metabolites: ~61% in feces and ~36% in urine.

Protein Binding

94%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: Tadalafil 5 mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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