SNAFI 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

Erectile Dysfunction (ED), Benign Prostatic Hyperplasia (BPH), ED and the signs and symptoms of BPH (ED/BPH

Dosage & Administration

Dosing by Condition

This 5 mg tadalafil product is used for: (1) ED once-daily: 2.5 mg once daily, may increase to 5 mg once daily; (2) BPH (with or without ED): 5 mg once daily. ED on-demand dosing (10-20 mg) and PAH dosing (40 mg) are tadalafil indications but are not achievable with this 5 mg-only strength without multiple tablets and are typically supplied as different strengths/products.

Initial Dose

For daily use (ED/BPH): 2.5mg to 5mg once daily. For as-needed use (ED): 10mg prior to sexual activity.

Maintenance Dose

ED (daily): 2.5-5mg once daily. BPH (daily): 5mg once daily. ED (as needed): 5-20mg as needed.

Maximum Dose

ED as-needed: 20 mg per dose (no more than once daily). ED/BPH once-daily: 5 mg daily. PAH dosing (40 mg/day) is not applicable to this 5 mg product’s typical ED/BPH use context

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment (once-daily 5 mg use): 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. Hepatic impairment: mild-moderate (Child‑Pugh A/B)-use with caution; once-daily use generally not recommended; severe (Child‑Pugh C)-avoid. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): avoid once-daily tadalafil; if used on-demand, reduce frequency/dose per labeling; CYP3A4 inducers may reduce effect.

How to Take

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

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common: headache. Common: dyspepsia, back pain, myalgia, flushing, nasal congestion, dizziness (and may include nasopharyngitis/URI). Rare but serious: priapism, sudden vision loss (NAION), sudden hearing loss, hypersensitivity.

Safety & Warnings

Contraindications

Hypersensitivity to tadalafil; concomitant use with any form of organic nitrates or nitric oxide donors; concomitant use with guanylate cyclase stimulators (e.g., riociguat)

Warnings & Precautions

Assess cardiovascular status before use and avoid when sexual activity is inadvisable; caution with alpha-blockers/other antihypertensives (risk of symptomatic hypotension); counsel to stop and seek care for vision/hearing changes; warn about priapism risk and use caution in predisposition (e.g., sickle cell disease, leukemia, myeloma) or penile deformity; not indicated for women

Age Restriction

Not approved under 18 years

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

MAJOR/contraindicated: nitrates/NO donors; riociguat. Clinically significant: alpha-blockers (additive hypotension), antihypertensives (additive BP lowering), potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat-↑ tadalafil exposure), CYP3A4 inducers (e.g., rifampin-↓ exposure), substantial alcohol (additive hypotension)

Interaction Severity

MAJOR/Contraindicated: nitrates (including recreational nitrites) and riociguat (profound hypotension). MODERATE: alpha-blockers and other antihypertensives (additive BP lowering), strong CYP3A4 inhibitors (↑ tadalafil exposure), substantial alcohol intake (↑ orthostatic symptoms/hypotension). MINOR/Reduced efficacy: CYP3A4 inducers (e.g., rifampin).

Food Interaction

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

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 increased sensitivity to hypotensive effects warrants caution

Kidney Impairment

Once-daily (ED/BPH): CrCl ≥50 mL/min: 5 mg daily; CrCl 30-50 mL/min: start 2.5 mg daily, may increase to 5 mg based on response/tolerability; CrCl <30 mL/min or on hemodialysis: once-daily use not recommended. As-needed ED: CrCl 30-50 mL/min: max 10 mg every 48 h; CrCl <30 mL/min or on hemodialysis: max 5 mg every 72 h

Liver Impairment

Child-Pugh A or B: use with caution; for ED as-needed max 10 mg once daily; once-daily use has limited data-use cautiously. Child-Pugh C: not recommended (avoid)

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime

Overdose

Symptoms: exaggerated adverse effects (e.g., headache, flushing, dizziness) and potentially marked hypotension/syncope; management: supportive care with hemodynamic monitoring-dialysis is unlikely to be helpful due to high protein binding; seek urgent medical attention

Patient Counseling

Take by mouth once daily at about the same time each day (for daily therapy), with or without food; swallow whole. Sexual stimulation is required for ED benefit. Do not use with nitrates or riociguat; tell clinicians about all BP medicines/alpha-blockers. Limit excessive alcohol to reduce dizziness/low BP. Seek urgent care for chest pain after dosing (do not take nitrates), sudden vision/hearing loss, or erection lasting >4 hours.

Monitoring Requirements

No routine laboratory monitoring required; monitor blood pressure and symptoms of hypotension when used with antihypertensives/alpha-blockers or in patients with cardiovascular risk, and monitor for vision/hearing changes and priapism symptoms clinically.

Pharmacology

Mechanism of Action

Selective phosphodiesterase type 5 (PDE5) inhibitor that increases cGMP by preventing its breakdown, enhancing NO-mediated smooth muscle relaxation and blood flow (penile erection with sexual stimulation; also relaxes smooth muscle in prostate/bladder vasculature for BPH symptom improvement).

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Bioavailability

Absolute oral bioavailability: not established/unknown; food does not produce a clinically meaningful effect on the extent or rate of absorption.

Metabolism

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

Excretion

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

Protein Binding

94%.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 5 mg tadalafil

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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