SNAFI 20/MG FC TAB 6/FC TAB

Indications

Approved Uses

Erectile dysfunction, Pulmonary arterial hypertension (PAH), Benign prostatic hyperplasia (BPH), BPH with erectile dysfunction

Dosage & Administration

Dosing by Condition

Erectile dysfunction (on‑demand): 10 mg prior to sexual activity; may adjust to 5-20 mg based on efficacy/tolerability; maximum once daily (this product strength is 20 mg). Erectile dysfunction (once daily): 2.5 mg once daily, may increase to 5 mg once daily. BPH or BPH with ED: 5 mg once daily. Pulmonary arterial hypertension: 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 dose once daily for erectile dysfunction; 40mg once daily for pulmonary arterial hypertension (Adcirca formulation

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 hours; CrCl <30 mL/min or hemodialysis: max 5 mg every 72 hours. Renal impairment (once‑daily use for ED/BPH): not recommended if CrCl <30 mL/min; if CrCl 30-50 mL/min, start 2.5 mg once daily and may increase to 5 mg based on response/tolerability. Hepatic impairment: mild-moderate (Child‑Pugh A/B) use with caution; for ED as‑needed, max 10 mg once daily; once‑daily use not recommended; severe hepatic impairment (Child‑Pugh C) not recommended. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): max 10 mg every 72 hours (as‑needed) or 2.5 mg once daily (daily regimen).

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food. For erectile dysfunction (on‑demand), take 20 mg at least 30 minutes before sexual activity; do not take more than once in 24 hours. Do not crush/chew; splitting is generally not recommended for film‑coated tablets unless a score line and prescriber direction exist.

Side Effects

Common Side Effects

Headache, Flushing, Dyspepsia, Back pain, Myalgia, Nasal congestion, Nasopharyngitis, Limb pain, Dizziness

Side Effect Frequency

Very common (≥10%): headache. Common (1-10%): dyspepsia, back pain, myalgia, flushing, nasal congestion. Uncommon/rare: dizziness, hypotension, visual disturbances/NAION, sudden hearing loss, priapism, hypersensitivity.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant organic nitrates in any form (including nitric oxide donors), (2) concomitant guanylate cyclase stimulators (e.g., riociguat), and (3) hypersensitivity to tadalafil or excipients. Also do NOT use in men for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina, recent MI/stroke, uncontrolled arrhythmias/hypotension) per PDE5 inhibitor labeling precautions.

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status before prescribing and avoid use if sexual activity is inadvisable; caution in patients predisposed to priapism (sickle cell disease, leukemia, multiple myeloma) or with penile anatomical deformity; caution with alpha-blockers/other antihypertensives and with substantial alcohol due to hypotension; discontinue and seek urgent care for sudden vision or hearing loss; caution in bleeding disorders/active peptic ulcer; not indicated for women/children.

Age Restriction

Not approved under 18 years

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major/contraindicated: organic nitrates/NO donors; guanylate cyclase stimulators (riociguat). Clinically significant: alpha-blockers (additive hypotension-ensure stable alpha-blocker therapy and start low), antihypertensives (additive BP lowering), substantial alcohol (additive hypotension), strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole/ritonavir/cobicistat/clarithromycin-↑ tadalafil exposure; consider dose reduction/avoid high doses), CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin-↓ exposure/efficacy).

Interaction Severity

MAJOR/Contraindicated: nitrates (e.g., nitroglycerin/isosorbide) and riociguat (profound hypotension). MODERATE: strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) requiring dose limitation; alpha‑blockers and other antihypertensives (additive hypotension); substantial alcohol intake (increased risk of symptomatic hypotension). MINOR: CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) may reduce efficacy.

Food Interaction

May be taken with or without food; high‑fat meals do not meaningfully affect tadalafil exposure. Avoid/limit grapefruit or grapefruit juice (may increase tadalafil levels via CYP3A4 inhibition).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children.

Elderly

Standard adult dosing. No dose adjustment is 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: 5 mg initially; maximum 10 mg no more frequently than every 48 hours. CrCl <30 mL/min or on hemodialysis: maximum 5 mg no more frequently than every 72 hours. Once-daily ED dosing: not recommended when CrCl <30 mL/min or on hemodialysis.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A or B): for erectile dysfunction as-needed use, maximum 10 mg once daily; once-daily use should be used cautiously (limited data). Severe hepatic impairment (Child-Pugh C): use is not recommended (avoid).

Storage & Patient Advice

Missed Dose

On‑demand use: skip the missed dose (take only when needed); do not take extra to make up. 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 overdose effects: exaggerated tadalafil adverse effects (e.g., headache, flushing, dizziness, hypotension/syncope, tachycardia) and risk of prolonged erection/priapism. Management: supportive care with vital-sign monitoring; treat hypotension as needed; urgent evaluation for priapism; hemodialysis is unlikely to be helpful due to high protein binding.

Patient Counseling

Take by mouth with water, with or without food; for ED on‑demand take at least 30 minutes before sexual activity and no more than once in 24 hours; sexual stimulation is required. Do not use with nitrates or riociguat; tell clinicians you take tadalafil. Limit alcohol and use caution with blood‑pressure medicines/alpha‑blockers. Seek urgent care for chest pain after dosing (do not take nitrates), erection >4 hours, sudden vision loss, or sudden hearing loss.

Monitoring Requirements

No routine laboratory monitoring is required; assess cardiovascular status and baseline blood pressure before initiation and monitor blood pressure/symptoms as clinically indicated, especially with antihypertensives/alpha‑blockers or dose changes.

Pharmacology

Mechanism of Action

Selectively inhibits PDE5, increasing cGMP in corpus cavernosum/pulmonary vascular smooth muscle, leading to smooth‑muscle relaxation and increased blood flow; erectile response requires sexual stimulation.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

Terminal half‑life ~17.5 hours (healthy subjects).

Bioavailability

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

Metabolism

Hepatic metabolism predominantly via CYP3A4 to metabolites (largely inactive), followed by conjugation (e.g., glucuronidation).

Excretion

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

Protein Binding

94%.

Product Information

Available Dosage Forms

Film-coated tablet

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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