EREVARD 20/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile dysfunction in adult men.

Dosage & Administration

Dosing by Condition

Erectile dysfunction: 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.

Initial Dose

Erectile dysfunction: 10mg taken approximately 60 minutes before sexual activity

Maintenance Dose

Erectile dysfunction: 5-20mg as needed, not more than once daily

Maximum Dose

Erectile dysfunction: 20mg per dose, once daily

Children's Dosage

Not approved for children or adolescents under 18 years

Dose Adjustment Notes

Elderly (≥65 years): consider starting 5 mg. Moderate hepatic impairment (Child‑Pugh B): start 5 mg; max 10 mg. Severe hepatic impairment (Child‑Pugh C): contraindicated/not recommended. Severe renal impairment (including CrCl <30 mL/min): no routine adjustment, but consider lower starting dose (e.g., 5 mg) based on tolerability. With moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin): reduce dose (often max 5 mg/day). With potent CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir/indinavir): avoid or use very low/extended‑interval dosing per labeling.

How to Take

Oral use: swallow the 20 mg film‑coated tablet whole with water, with or without food; take as needed for erectile dysfunction about 25-60 minutes before sexual activity (do not exceed once daily). Avoid grapefruit juice; high‑fat meals may delay onset.

Side Effects

Common Side Effects

Headache, flushing, nasal congestion, dyspepsia (indigestion), dizziness, nausea, back pain.

Side Effect Frequency

Very common (≥10%): Headache, flushing. Common (1-10%): Nasal congestion/rhinitis, dyspepsia, dizziness, nausea.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant nitrates or nitric oxide donors in any form; (2) concomitant soluble guanylate cyclase stimulators (e.g., riociguat); (3) hypersensitivity to vardenafil or excipients; (4) patients in whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina or severe cardiac failure); (5) concomitant potent CYP3A4 inhibitors (e.g., ritonavir/other HIV protease inhibitors, ketoconazole/itraconazole at systemic doses); (6) severe hepatic impairment (Child-Pugh C); (7) pregnancy (not indicated for use in women).

Warnings & Precautions

Key warnings/precautions: assess cardiovascular fitness before prescribing (sexual activity risk); avoid/withhold in unstable cardiovascular disease or recent serious events per guidance; risk of symptomatic hypotension with alpha-blockers/other antihypertensives (start low, separate dosing); QT prolongation-avoid in congenital long-QT and with class IA/III antiarrhythmics; priapism risk (penile deformity; sickle cell disease, leukemia, multiple myeloma)-seek urgent care if >4 hours; discontinue and seek care for sudden vision (NAION) or hearing loss; not indicated for women/children.

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Clinically important interactions: (1) nitrates/NO donors-contraindicated (severe hypotension); (2) riociguat-contraindicated (severe hypotension); (3) alpha-blockers-additive hypotension (separate dosing and start low); (4) strong CYP3A4 inhibitors (e.g., ritonavir/other protease inhibitors, ketoconazole, itraconazole)-avoid/contraindicated or require major dose limitation; (5) moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, fluconazole)-increase exposure (dose reduction/limit max dose); (6) CYP3A4 inducers (e.g., rifampicin)-reduced efficacy; (7) other QT-prolonging drugs, especially class IA/III antiarrhythmics (e.g., quinidine, procainamide, amiodarone, sotalol)-avoid due to QT prolongation risk; (8) antihypertensives/alcohol-additive BP lowering.

Interaction Severity

MAJOR/contraindicated: nitrates (any form) and riociguat; potent CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole/itraconazole) due to large exposure increases. MODERATE: alpha‑blockers/other antihypertensives (additive hypotension), moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin/fluconazole), and QT‑prolonging antiarrhythmics (class IA/III) due to QT risk.

Food Interaction

Can be taken with or without food; a high‑fat meal may delay onset and reduce peak concentration. Avoid grapefruit/grapefruit juice.

Special Populations

Pregnancy

Contraindicated

Children

Not approved for children or adolescents under 18 years

Elderly

Start at 5mg for ED; titrate based on response and tolerability; maximum 20mg once daily

Kidney Impairment

CrCl >80 mL/min: no adjustment. CrCl 30-80 mL/min (mild-moderate): no adjustment. CrCl <30 mL/min (severe): use with caution, maximum 10 mg. End-stage renal disease on dialysis: not evaluated

Liver Impairment

Child-Pugh A (mild): no adjustment. Child-Pugh B (moderate): start 5 mg; maximum 10 mg. Child-Pugh C (severe): contraindicated/avoid use.

Storage & Patient Advice

Missed Dose

For erectile dysfunction (as‑needed use): not applicable; take only when needed and do not take more than one dose in 24 hours.

Stopping the Medicine

Safe to stop anytime; no tapering required

Overdose

Overdose may cause exaggerated adverse effects (e.g., headache, flushing, dizziness, hypotension/syncope, visual disturbances, back pain) and can precipitate priapism; management is supportive (monitor vitals/ECG, treat hypotension with fluids/vasopressors as needed, manage priapism urgently), consider activated charcoal if early, avoid nitrates, and dialysis is unlikely to help due to high protein binding.

Patient Counseling

Take 1 tablet as needed about 25-60 minutes before sexual activity; sexual stimulation is required; do not take more than once daily. Do not use with nitrates or riociguat; tell your clinician about alpha‑blockers/antihypertensives and CYP3A4 inhibitors. Avoid grapefruit; limit alcohol. Seek urgent care for chest pain after dosing (do not take nitrates), erection >4 hours, or sudden vision/hearing loss.

Monitoring Requirements

No routine laboratory monitoring; assess cardiovascular fitness for sexual activity and monitor blood pressure/symptoms in patients on antihypertensives or alpha‑blockers, and counsel to seek urgent care for priapism or sudden vision/hearing loss.

Pharmacology

Mechanism of Action

Selective phosphodiesterase‑5 (PDE5) inhibition increases cGMP in the corpus cavernosum during sexual stimulation, causing smooth‑muscle relaxation and increased penile blood flow to facilitate erection.

Onset of Action

25-60 minutes.

Duration of Effect

Approximately 4-5 hours (up to ~6 hours in some patients).

Half-Life

4-5 hours.

Bioavailability

Approximately 15%.

Metabolism

Hepatic metabolism primarily via CYP3A4; minor contributions from CYP3A5 and CYP2C9; major circulating metabolite is N-desethylvardenafil (M1), which has PDE5 inhibitory activity and contributes ~7% of total PDE5 inhibitory activity (exposure) compared with parent.

Product Information

Available Dosage Forms

Film‑coated tablet (this product).

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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