DEVARIN 20/MG TAB 4/TAB

Indications

Approved Uses

Erectile dysfunction in adult men

Dosage & Administration

Dosing by Condition

Erectile dysfunction: Initial dose 10 mg taken approximately 25-60 minutes before sexual activity; may be adjusted to 5 mg or 20 mg based on efficacy and tolerability; maximum one dose per day. The 20 mg dose is used when lower doses are insufficient.

Initial Dose

10 mg taken approximately 25-60 minutes before sexual activity (this product is 20 mg strength, used when 10 mg is insufficient)

Maintenance Dose

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

Maximum Dose

20 mg per day

Children's Dosage

Not approved for children or adolescents under 18 years

Dose Adjustment Notes

Elderly (≥65 years): consider starting 5 mg. Hepatic impairment: mild (Child‑Pugh A) start 5 mg; moderate (Child‑Pugh B) max 10 mg; severe (Child‑Pugh C) not recommended. Renal impairment: no adjustment generally required, but use caution in severe renal impairment. CYP3A4 interactions: reduce dose with moderate inhibitors (e.g., erythromycin); with strong inhibitors (e.g., ketoconazole/itraconazole, ritonavir) avoid or use very low/extended-interval dosing per labeling.

How to Take

Oral use (film‑coated tablet): swallow whole with water as needed about 25-60 minutes before sexual activity; may be taken with or without food, but a high‑fat meal can delay onset; sexual stimulation is required; do not take more than once in 24 hours.

Side Effects

Common Side Effects

Headache, flushing, nasal congestion/rhinitis, dyspepsia (indigestion), dizziness; nausea and back pain can also occur.

Side Effect Frequency

Very common: headache. Common: flushing, nasal congestion/rhinitis, dyspepsia, dizziness; sinusitis/flu-like symptoms, nausea, and back pain are also reported as common in some references.

Safety & Warnings

Contraindications

Concomitant nitrates or nitric oxide donors; concomitant guanylate cyclase stimulators (e.g., riociguat); hypersensitivity to vardenafil; severe hepatic impairment (Child-Pugh C); end-stage renal disease requiring dialysis; patients for whom sexual activity is inadvisable due to cardiovascular status (e.g., unstable angina/recent MI or stroke); concomitant class IA/III antiarrhythmics or congenital QT prolongation

Warnings & Precautions

Assess cardiovascular fitness before prescribing; avoid if sexual activity is inadvisable; caution with alpha-blockers and other BP-lowering drugs; caution in predisposition to priapism or penile deformity; caution with bleeding disorders/active peptic ulcer; counsel to seek urgent care for chest pain, vision/hearing loss, or erection >4 hours; avoid with QT-prolonging drugs/class IA/III antiarrhythmics

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Nitrates/NO donors (contraindicated); riociguat (contraindicated); alpha-blockers (additive hypotension-use caution and stable dosing); potent/moderate CYP3A4 inhibitors (e.g., ritonavir, ketoconazole/itraconazole, clarithromycin/erythromycin-raise vardenafil exposure, require dose limits/avoid); other antihypertensives and alcohol (additive BP lowering); QT-prolonging antiarrhythmics (class IA/III-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 label-based dose limits. MODERATE: alpha‑blockers (additive hypotension-ensure stable alpha‑blocker therapy and start low), other antihypertensives (additive BP lowering), moderate CYP3A4 inhibitors (dose reduction), and other QT‑prolonging drugs-particularly class IA/III antiarrhythmics (avoid due to QT risk). MINOR: alcohol (may worsen hypotension/dizziness).

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children or adolescents under 18 years

Elderly

Start at 5 mg; titrate based on response and tolerability; maximum 20 mg per day

Storage & Patient Advice

Missed Dose

Not applicable (taken as needed); if used, take a single dose before anticipated sexual activity and do not exceed one dose in 24 hours.

Stopping the Medicine

Safe to stop anytime - no tapering required as it is used on an as-needed basis

Pharmacology

Mechanism of Action

Inhibits phosphodiesterase type 5 (PDE5), an enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. This inhibition increases cGMP levels, leading to smooth muscle relaxation and increased blood flow to the penis during sexual stimulation, which facilitates an erection.

Onset of Action

25-60 minutes.

Product Information

Available Dosage Forms

Film‑coated tablet (this SFDA-registered product); vardenafil also exists in some markets as an orally disintegrating/orodispersible tablet, but that is a different product/formulation and not this SFDA listing.

Mechanism

PDE5 Inhibitor

Onset Time

25-60 minutes

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