SNAFI 20 MG 12 TAB

Indications

Approved Uses

Erectile dysfunction, Benign prostatic hyperplasia (BPH) symptoms

Dosage & Administration

Dosing by Condition

ED (as-needed): 10 mg prior to sexual activity; adjust to 5-20 mg; max 20 mg per 24 hours. ED (once daily): 2.5 mg daily, may increase to 5 mg daily. BPH (once daily): 5 mg daily (with or without ED). PAH: 40 mg once daily (two 20 mg tablets).

Initial Dose

10mg taken approximately 30 minutes before anticipated sexual activity (on-demand dosing)

Maintenance Dose

10-20mg as needed (on-demand); 2.5-5mg once daily (daily dosing)

Maximum Dose

20mg per 24 hours for erectile dysfunction; 40mg per day (two 20mg tablets) for pulmonary arterial hypertension

Children's Dosage

Not approved for children for ED or BPH. Use and dose for Pulmonary Arterial Hypertension must be determined by a doctor.

Dose Adjustment Notes

Renal impairment (ED/BPH 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; once-daily use is not recommended when CrCl <30 mL/min. 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 (e.g., ketoconazole, ritonavir): for ED as-needed max 10 mg every 72 hours; for once-daily ED/BPH max 2.5 mg daily; avoid with tadalafil 40 mg/day for PAH.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food. For erectile dysfunction (ED) as-needed use, take prior to anticipated sexual activity (commonly at least 30 minutes before); do not take more than 1 dose in 24 hours.

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): Headache. Common (1-10%): Dyspepsia, Back pain, Myalgia, Flushing, Nasal congestion. Uncommon (0.1-1%): Dizziness, Rash. Rare/very rare (post-marketing): NAION, Priapism, Sudden hearing loss, Hypersensitivity reactions, Hypotension.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any organic nitrates or nitric oxide donors (acute or chronic), (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat), (3) known hypersensitivity to tadalafil or any excipients. Also do NOT use in patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina, uncontrolled arrhythmias, severe hypotension, recent MI/stroke per labeling).

Warnings & Precautions

Avoid all nitrates/NO donors and riociguat; assess cardiovascular status and avoid use when sexual activity is inadvisable; caution with alpha-blockers/other antihypertensives (ensure stable therapy, start low); counsel to seek urgent care for priapism, sudden vision loss, or sudden hearing loss; use caution in anatomical penile deformity or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, multiple myeloma); caution in severe hepatic/renal impairment and with substantial alcohol; not indicated for women/children for ED indication.

Age Restriction

Not approved under 18 years for ED or BPH.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; riociguat. Clinically significant: alpha-blockers and other antihypertensives (additive BP lowering-separate dosing/ensure stability), potent CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir/cobicistat, clarithromycin) increase tadalafil exposure-dose limitation/avoid high doses; CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) decrease exposure-reduced efficacy; substantial alcohol intake increases orthostatic hypotension risk.

Interaction Severity

CONTRAINDICATED/MAJOR: Any nitrates (acute or chronic) and riociguat (risk of profound hypotension). MAJOR: Strong CYP3A4 inhibitors markedly increase exposure-require dose reduction for ED/BPH and avoidance with PAH dosing. MODERATE: Alpha-blockers and other antihypertensives (additive hypotension), substantial alcohol (hypotension). MINOR: CYP3A4 inducers (reduced effect).

Food Interaction

No clinically significant food interaction; may be taken with or without food (including high-fat meals).

Alcohol Interaction

Use caution with alcohol

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children for ED or BPH. Use and dose for Pulmonary Arterial Hypertension must be determined by a doctor.

Elderly

Standard adult dosing. Dose adjustment is not required based on age alone, but greater sensitivity in some older individuals cannot be ruled out.

Kidney Impairment

Erectile dysfunction (as-needed): CrCl 30-50 mL/min: start 5 mg, max 10 mg no more than every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg no more than every 72 hours. Once-daily tadalafil (ED/BPH): CrCl 30-50 mL/min: start 2.5 mg daily, may increase to 5 mg; CrCl <30 mL/min or on hemodialysis: not recommended.

Liver Impairment

Child-Pugh A or B: limit to 10 mg as needed (avoid/very cautious with daily use). Child-Pugh C: use not recommended (generally avoid).

Storage & Patient Advice

Missed Dose

As-needed ED use: skip the missed dose (take only when needed); do not double. 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.

Stopping the Medicine

May be stopped at any time; no taper is required.

Overdose

Expected findings: exaggerated adverse effects (e.g., headache, flushing, dizziness, hypotension, tachycardia, dyspepsia, back pain; priapism possible). Management: supportive/symptomatic care with vital-sign and ECG monitoring; consider activated charcoal if early after ingestion; hemodialysis is unlikely to help due to high protein binding-seek urgent medical care/poison center guidance.

Patient Counseling

Take exactly as prescribed (either once daily at the same time or as-needed before sexual activity); sexual stimulation is required for ED effect. Do not exceed 1 dose/day for ED/BPH regimens. Avoid all nitrates and riociguat; tell clinicians you use tadalafil. Use caution with alcohol and blood-pressure medicines due to dizziness/low BP. Seek urgent care for chest pain after dosing (do not take nitrates), erection >4 hours, or sudden vision/hearing loss. Store below 30°C (per SFDA).

Monitoring Requirements

No routine laboratory monitoring is required; clinically monitor blood pressure (especially with antihypertensives/alpha-blockers), efficacy and adverse effects, and counsel to seek urgent care for priapism (>4 hours) or sudden vision/hearing changes.

Pharmacology

Mechanism of Action

Selective PDE5 inhibition increases cGMP in smooth muscle (corpus cavernosum and pulmonary vasculature; also lower urinary tract), enhancing nitric-oxide-mediated smooth muscle relaxation and vasodilation-facilitating erection with sexual stimulation, improving BPH symptoms, and lowering pulmonary arterial pressure.

Onset of Action

Typically ~30-60 minutes; some patients may require up to ~2 hours for maximal effect.

Duration of Effect

Up to 36 hours.

Half-Life

Approximately 17.5 hours (mean terminal half-life in healthy adults); may be prolonged in older adults (reported ~21-22 hours).

Bioavailability

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

Metabolism

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

Excretion

Eliminated 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 20mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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