ROSACIL 5MG TAB 30 TAB

Indications

Approved Uses

Erectile Dysfunction (ED), Benign Prostatic Hyperplasia (BPH), Pulmonary Arterial Hypertension (PAH).

Off-Label Uses

Raynaud’s phenomenon; high-altitude pulmonary edema (prevention/treatment in select cases).

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as-needed): 10 mg prior to sexual activity; adjust 5-20 mg; maximum once daily. Erectile dysfunction (once-daily): 2.5 mg once daily, may increase to 5 mg once daily. BPH or BPH + ED: 5 mg once daily. Pulmonary arterial hypertension: 40 mg once daily (different product/strength; not applicable to this 5 mg tablet for routine PAH dosing).

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

For daily use (ED/BPH): 5mg once daily. For as-needed use (ED): 5mg to 20mg.

Maximum Dose

ED as-needed: 20 mg per dose, not more than once daily. Once-daily ED or BPH: 5 mg once daily. PAH dosing (tadalafil 20 mg tablets): 40 mg once daily (not applicable to this 5 mg product’s usual indications but is the class maximum for PAH).

Children's Dosage

Not approved for use by anyone younger than 18 years old.

Dose Adjustment Notes

Renal impairment: for once-daily use, avoid if CrCl <30 mL/min or on dialysis; for as-needed ED, max 10 mg every 48 hours when CrCl 30-50 mL/min and max 5 mg every 72 hours when CrCl <30 mL/min/on dialysis. Hepatic impairment: mild-moderate-use with caution (as-needed max 10 mg); once-daily use not recommended; severe hepatic impairment-avoid. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): limit to 10 mg every 72 hours (as-needed) and avoid once-daily use; CYP3A4 inducers may reduce effect.

How to Take

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

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (≥1%): headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, limb pain, dizziness. Less common/rare but serious: hypotension/syncope, priapism, NAION/sudden vision loss, sudden hearing loss, severe hypersensitivity/skin reactions.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any form of organic nitrates or nitric oxide donors; (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to tadalafil or any excipients. Not recommended/avoid: severe hepatic impairment (Child-Pugh C) and patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina or severe cardiac disease).

Warnings & Precautions

Key warnings/precautions: avoid all nitrates/riociguat; assess cardiovascular status and avoid use when sexual activity is inadvisable; caution with alpha-blockers/other antihypertensives and with substantial alcohol (hypotension); counsel to stop and seek care for sudden vision/hearing loss; counsel on priapism risk (seek urgent care if >4 hours); use caution in anatomical penile deformity or conditions predisposing to priapism; avoid once-daily use in severe renal impairment and avoid in severe hepatic impairment.

Age Restriction

Not approved under 18 years

Driving Warning

Dizziness may occur; use caution when driving or operating machinery

Drug Interactions

Drug Interactions

Major interactions: nitrates/NO donors (contraindicated-severe hypotension), riociguat (contraindicated), alpha-blockers (additive hypotension-use caution; ensure stable alpha-blocker therapy and start low), antihypertensives (additive BP lowering), potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat, clarithromycin-↑ tadalafil exposure; dose limits/avoid depending on regimen), CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin-↓ efficacy), substantial alcohol (↑ orthostatic hypotension).

Interaction Severity

MAJOR/Contraindicated: nitrates (any form) and riociguat (profound hypotension). MODERATE: alpha-blockers, other antihypertensives, strong CYP3A4 inhibitors (↑ tadalafil), substantial alcohol intake (additive hypotension). MINOR/Reduced efficacy: CYP3A4 inducers (e.g., rifampin).

Food Interaction

No clinically meaningful food restriction; may be taken with or without food. Avoid/limit grapefruit or grapefruit juice (especially large amounts) due to potential CYP3A4 inhibition increasing tadalafil exposure.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for use by anyone younger than 18 years old.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but monitor for hypotension

Kidney Impairment

As-needed ED: 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 (ED/BPH): CrCl 30-50 mL/min-start 2.5 mg daily and may increase to 5 mg if tolerated; CrCl <30 mL/min or hemodialysis-once-daily use not recommended.

Liver Impairment

Child-Pugh A or B: as-needed ED dosing-maximum 10 mg once daily; once-daily dosing (e.g., 5 mg daily for ED/BPH)-use with caution (no higher than 5 mg daily). Child-Pugh C: not recommended (avoid).

Storage & Patient Advice

Storage Conditions

Store below 30°C

Missed Dose

For daily use, take the missed dose as soon as remembered. Skip the dose if it is almost time for the next one. Do not take a double dose.

Stopping the Medicine

Safe to stop anytime

Overdose

Overdose typically causes exaggerated adverse effects (e.g., headache, flushing, dizziness, dyspepsia, back pain/myalgia) and may cause hypotension; management is supportive with vital-sign/hemodynamic monitoring, consider GI decontamination if early, and hemodialysis is unlikely to be beneficial due to high protein binding.

Patient Counseling

Take exactly as prescribed; for daily use (e.g., 5 mg) take at the same time each day; may take with or without food. Do not use with nitrates or riociguat; tell your prescriber about alpha-blockers, BP meds, and CYP3A4 inhibitors/inducers. Limit alcohol and avoid large amounts of grapefruit. Seek urgent care for chest pain (do not self-treat with nitrates), erection >4 hours, or sudden vision/hearing loss; may cause dizziness-use caution driving. Does not protect against STIs.

Monitoring Requirements

Monitor blood pressure (especially with antihypertensives/alpha-blockers or alcohol use) and assess cardiovascular fitness/risk before initiation; monitor for visual/hearing changes and priapism symptoms.

Pharmacology

Mechanism of Action

Selective PDE5 inhibition increases cGMP in smooth muscle, enhancing nitric-oxide-mediated vasodilation (corpus cavernosum; also pulmonary vasculature) and improving erectile function; in BPH it relaxes smooth muscle in the lower urinary tract/prostate and improves LUTS.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

17.5 hours.

Bioavailability

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

Metabolism

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

Excretion

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

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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