PENETRO 20/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile dysfunction in adult men.

Dosage & Administration

Dosing by Condition

Erectile dysfunction (adult men): 10 mg orally as needed about 25-60 minutes before sexual activity; adjust to 5 mg or 20 mg based on efficacy/tolerability; maximum 20 mg once daily (no more than 1 dose/24 h). For this 20 mg tablet: 1 tablet as needed only if prescribed/tolerated; do not exceed 1 tablet in 24 hours.

Initial Dose

10 mg as a single dose, no more than once per day, approximately 1 hour before sexual activity (up to 20 mg if needed

Maintenance Dose

5mg to 20mg as needed, not more than once daily

Maximum Dose

20mg per day.

Children's Dosage

Not approved for children or adolescents under 18 years

Dose Adjustment Notes

Elderly (≥65 years): consider starting at 5 mg. Moderate hepatic impairment (Child‑Pugh B): start 5 mg; maximum 10 mg. Severe hepatic impairment (Child‑Pugh C): not recommended. With moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin): maximum 5 mg once daily. With strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir): avoid or use only with strict low-dose limits per labeling (e.g., ritonavir: max 2.5 mg every 72 hours).

How to Take

Take 1 tablet (20 mg) by mouth with water as needed about 25-60 minutes before sexual activity; swallow whole. May be taken with or without food, but a high‑fat meal can delay onset/reduce peak effect. Sexual stimulation is required. Do not take more than 1 dose in 24 hours.

Side Effects

Common Side Effects

Headache, flushing, nasal congestion/rhinitis, dyspepsia, dizziness, nausea.

Side Effect Frequency

Very common (≥10%): headache, flushing. Common (1-10%): nasal congestion/rhinitis, dyspepsia, dizziness; nausea is generally reported as common/uncommon depending on dataset but is not typically among the highest-frequency events.

Safety & Warnings

Contraindications

Hypersensitivity to vardenafil; concomitant nitrates or nitric oxide donors; concomitant guanylate cyclase stimulators (e.g., riociguat); concomitant potent CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole/itraconazole at systemic doses); severe hepatic impairment (Child-Pugh C); hereditary degenerative retinal disorders (e.g., retinitis pigmentosa); patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina, severe heart failure); concomitant class IA/III antiarrhythmics or congenital QT prolongation (avoid/contraindicated per labeling).

Warnings & Precautions

Assess cardiovascular fitness before prescribing; avoid if sexual activity is inadvisable; counsel on priapism risk and predisposing conditions (sickle cell disease, leukemia, myeloma) and penile deformity; caution with alpha-blockers and other BP-lowering agents; avoid/use caution in QT prolongation risk (including class IA/III antiarrhythmics); stop and seek care for sudden vision/hearing loss; not indicated for women.

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Major interactions: nitrates/NO donors (contraindicated-profound hypotension); guanylate cyclase stimulators like riociguat (contraindicated); alpha-blockers (hypotension-use caution and stable dosing; separate administration); potent/moderate CYP3A4 inhibitors (e.g., ritonavir, ketoconazole/itraconazole, clarithromycin/erythromycin-↑ vardenafil exposure; dose limits/avoid); other PDE5 inhibitors (avoid duplication); antihypertensives and alcohol (additive hypotension); QT-prolonging drugs esp. class IA/III antiarrhythmics (avoid due to QT risk).

Interaction Severity

MAJOR/Contraindicated: nitrates (any form) and riociguat; avoid with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole/itraconazole) or use only with strict dose limits; avoid in patients taking class IA/III antiarrhythmics or with congenital QT prolongation (QT risk). MODERATE: alpha‑blockers and other antihypertensives (additive hypotension), moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin), grapefruit juice (CYP3A4 inhibition). MINOR: antacids (Al/Mg hydroxide) may slightly reduce absorption.

Food Interaction

May be taken with or without food; high‑fat meals can delay absorption/onset and lower peak concentrations, so a light meal/empty stomach may provide faster effect.

Special Populations

Breastfeeding

Consult Doctor

Children

Not approved for children or adolescents under 18 years

Elderly

Patients ≥65 years: consider starting at 5mg due to increased plasma levels; titrate based on response and tolerability

Storage & Patient Advice

Missed Dose

Not applicable (taken as needed for erectile dysfunction); if a dose is missed, do not double-take the next dose as needed, not more than once in 24 hours.

Stopping the Medicine

Safe to stop anytime; no taper required (typically used as needed).

Patient Counseling

Take as needed about 25-60 minutes before sex; sexual stimulation is required. Do not take more than 1 dose in 24 hours. Avoid nitrates and riociguat; tell your prescriber about alpha‑blockers, antihypertensives, and CYP3A4 inhibitors (including grapefruit). High‑fat meals may delay effect; limit alcohol. Seek urgent care for chest pain after dosing (do not use nitrates), sudden vision/hearing loss, or an erection lasting >4 hours. Prescription-only for adult men.

Monitoring Requirements

No routine laboratory monitoring is required; assess cardiovascular fitness/risk before initiation and monitor blood pressure/symptoms in patients on antihypertensives or alpha‑blockers and for adverse effects (e.g., vision/hearing changes, priapism).

Pharmacology

Mechanism of Action

Selective PDE5 inhibition increases cGMP in the corpus cavernosum during sexual stimulation, leading to smooth muscle relaxation, increased penile blood flow, and improved erection.

Onset of Action

25-60 minutes.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 20mg vardenafil (as vardenafil hydrochloride trihydrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Mechanism

PDE5 Inhibitor

Onset Time

25-60 minutes

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