DEVARIN ODT 10/MG TAB 4/TAB

Indications

Approved Uses

Erectile dysfunction in adult men.

Dosage & Administration

Dosing by Condition

Erectile Dysfunction: 10mg taken as needed approximately 25-60 minutes before sexual activity. Dose may be adjusted to 5mg or 20mg based on efficacy and tolerability. Maximum frequency is once per day.

Initial Dose

10mg taken approximately 25-60 minutes before sexual activity

Maintenance Dose

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

Maximum Dose

20mg per day.

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Consider a lower starting dose (5 mg) in adults ≥65 years and in moderate hepatic impairment (Child‑Pugh B); avoid use in severe hepatic impairment (Child‑Pugh C). With moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin) do not exceed 5 mg in 24 hours; with potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole/itraconazole) avoid or use only with strict dose limitation per labeling (very low dose/extended interval). No routine renal dose adjustment is required, but use caution in severe renal impairment.

How to Take

This SFDA-registered product is vardenafil 10 mg film‑coated tablet (not ODT): swallow the tablet whole with water, with or without food; take about 25-60 minutes before anticipated sexual activity; sexual stimulation is required; avoid grapefruit juice and note that a high‑fat meal may delay onset.

Side Effects

Common Side Effects

Headache, flushing, nasal congestion/rhinitis, dyspepsia, dizziness (± nausea).

Safety & Warnings

Contraindications

Concomitant nitrates or nitric oxide donors; concomitant guanylate cyclase stimulators (e.g., riociguat); hypersensitivity to vardenafil; men for whom sexual activity is inadvisable due to cardiovascular status; congenital QT prolongation or use with Class IA/III antiarrhythmics; severe hepatic impairment (Child-Pugh C); end-stage renal disease on dialysis (not recommended/avoid); hereditary degenerative retinal disorders (e.g., retinitis pigmentosa) (avoid/contraindicated per labeling).

Warnings & Precautions

Assess cardiovascular status and avoid use when sexual activity is inadvisable; hypotension risk (especially with alpha-blockers/antihypertensives/alcohol); priapism risk (predisposing conditions) and penile anatomical deformation; QT prolongation-avoid congenital QT prolongation and Class IA/III antiarrhythmics; discontinue and seek care for sudden vision/hearing loss; caution with bleeding disorders/active peptic ulcer

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Major: nitrates/NO donors (contraindicated), guanylate cyclase stimulators (riociguat) (contraindicated); alpha-blockers (hypotension-separate dosing/start low); strong CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole, itraconazole, clarithromycin) increase exposure-avoid or use lowest dose per labeling; other antihypertensives/alcohol (additive hypotension); Class IA/III antiarrhythmics and other QT-prolonging drugs (avoid due to QT risk).

Interaction Severity

MAJOR/Contraindicated: nitrates (any form) and riociguat; potent CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole) require avoidance or strict dose limitation. MODERATE: alpha‑blockers (symptomatic hypotension risk), moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin/fluconazole), other antihypertensives and alcohol (additive hypotension), and drugs that prolong QT (e.g., class IA/III antiarrhythmics). MINOR: grapefruit juice is clinically relevant enough to generally avoid rather than classify as “minor.”

Food Interaction

Can be taken with or without food; high‑fat meals may delay absorption/onset and reduce peak concentration; avoid grapefruit/grapefruit juice.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children.

Elderly

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

Storage & Patient Advice

Missed Dose

Not applicable (PRN use): take a dose about 25-60 minutes before sexual activity as needed; do not take more than one dose in 24 hours.

Patient Counseling

Swallow one tablet with water about 25-60 minutes before sexual activity (do not exceed one dose in 24 hours); sexual stimulation is required. Do not use with nitrates or riociguat; tell your clinician about alpha‑blockers, antihypertensives, and strong CYP3A4 inhibitors. Avoid grapefruit and consider avoiding high‑fat meals near dosing; 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 is required; assess cardiovascular status and contraindications (especially nitrate/riociguat use and QT-risk) before initiation and monitor clinically for hypotension and serious adverse effects (priapism, vision/hearing changes).

Pharmacology

Mechanism of Action

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

Onset of Action

25-60 minutes.

Product Information

Available Dosage Forms

Film-coated tablet, Orodispersible tablet (ODT)

Composition per Dose

Each orodispersible tablet: 10mg vardenafil as vardenafil hydrochloride trihydrate.

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Mechanism

PDE5 Inhibitor

Onset Time

25-60 minutes

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.