VIAGRA 50/MG ODT TAB 8/TAB

Indications

Approved Uses

Erectile dysfunction in adult men.

Dosage & Administration

Dosing by Condition

Erectile dysfunction: 50 mg orally as needed about 1 hour before sexual activity; adjust to 25-100 mg based on response/tolerability; maximum once daily. (PAH dosing is different and applies to other sildenafil products, e.g., 20 mg three times daily.)

Initial Dose

50 mg taken approximately 30-60 minutes before sexual activity

Maintenance Dose

25mg to 100mg as needed before sexual activity.

Maximum Dose

100 mg per day (one dose per 24-hour period)

Children's Dosage

Not approved for children or adolescents under 18 years for erectile dysfunction

Dose Adjustment Notes

Consider a 25 mg starting dose in adults ≥65 years, in severe renal impairment (CrCl <30 mL/min), or in hepatic impairment; use lower starting doses and caution with CYP3A4 inhibitors (especially strong inhibitors), and titrate up to 100 mg only if needed and tolerated (max once daily).

How to Take

Place the orodispersible tablet on the tongue and allow it to dissolve, then swallow; water is not required but may be taken if desired. Take about 30-60 minutes before sexual activity; do not take more than once in 24 hours.

Side Effects

Common Side Effects

Headache, flushing, dyspepsia, nasal congestion, dizziness, and visual disturbances (e.g., color tinge/blurred vision); nausea and rash can occur but are less common.

Side Effect Frequency

Very common (≥10%): headache, flushing. Common (1-10%): dyspepsia, nasal congestion, dizziness, visual disturbances (e.g., color tinge/blurred vision/photophobia), nausea. Less common/rare but clinically important: hypotension/syncope (especially with interacting drugs), priapism, sudden hearing loss, and NAION (sudden vision loss).

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any nitrates/NO donors (e.g., nitroglycerin, isosorbide dinitrate/mononitrate, amyl nitrite/poppers); (2) concomitant use of soluble guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to sildenafil or any excipient. Not absolute contraindications (but require avoidance/caution or dose adjustment): severe hepatic impairment, recent MI/stroke/unstable angina, baseline hypotension, hereditary retinal disorders (e.g., retinitis pigmentosa), and strong CYP3A4 inhibitors.

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status before prescribing (sexual activity cardiac risk); do not use with nitrates/riociguat; risk of symptomatic hypotension (especially with alpha-blockers/antihypertensives/alcohol); priapism risk (higher in sickle cell disease, leukemia, multiple myeloma) and penile anatomical deformity; discontinue and seek care for sudden vision loss (NAION) or sudden hearing loss; caution in bleeding disorders/active peptic ulcer; caution in hereditary retinal disorders (e.g., retinitis pigmentosa); not indicated for use in women/children for ED.

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; riociguat. Clinically significant: alpha-blockers (risk of symptomatic hypotension-ensure stable alpha-blocker therapy and start sildenafil at lowest dose), other antihypertensives and alcohol (additive BP lowering), strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole/itraconazole, clarithromycin-markedly increase exposure; require dose limitation/avoidance per labeling), moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, cimetidine-may increase levels), CYP3A4 inducers (e.g., rifampin-may reduce efficacy).

Interaction Severity

MAJOR/CONTRAINDICATED: nitrates (any form) and riociguat (risk of profound hypotension). SIGNIFICANT: strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole/itraconazole, clarithromycin) increase exposure-dose reduction/avoid per labeling; alpha-blockers and other antihypertensives may cause additive hypotension (use caution and stable dosing).

Food Interaction

High-fat meals can delay absorption and onset; for fastest onset, take on an empty stomach or after a light meal.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children or adolescents under 18 years for erectile dysfunction

Elderly

Start at 25 mg due to reduced clearance in patients ≥65 years; titrate to 50 mg or 100 mg based on response and tolerability

Kidney Impairment

CrCl ≥30 mL/min: no initial dose adjustment; CrCl <30 mL/min (severe renal impairment): consider a starting dose of 25 mg and titrate based on efficacy/tolerability.

Liver Impairment

Hepatic impairment (e.g., cirrhosis/Child-Pugh A or B): consider a starting dose of 25 mg and titrate based on response/tolerability; severe hepatic impairment: use with caution (not an absolute contraindication) and generally start at 25 mg if used.

Storage & Patient Advice

Missed Dose

For erectile dysfunction, it is taken as needed-no missed dose concept; do not take more than one dose in 24 hours.

Stopping the Medicine

May be stopped at any time; no taper is required (typically used as needed).

Overdose

Overdose may cause exaggerated adverse effects (e.g., headache, flushing, dizziness, hypotension, visual disturbances) and priapism; management is supportive/symptomatic with urgent medical evaluation, consider activated charcoal if early after ingestion, and hemodialysis is unlikely to help due to high protein binding/no enhanced clearance.

Patient Counseling

Sildenafil (VIAGRA) 50 mg ODT: Take 1 tablet as needed about 30-60 minutes before sexual activity (may take up to 4 hours before); place on the tongue and allow to dissolve (water not required) and swallow; sexual stimulation is required. Do not take more than 1 dose in 24 hours

Monitoring Requirements

No routine laboratory monitoring is required; assess cardiovascular fitness for sexual activity and monitor for symptomatic hypotension, especially when used with antihypertensives/alpha-blockers or in patients with cardiovascular disease.

Pharmacology

Mechanism of Action

Selectively inhibits PDE5, increasing cGMP in the corpus cavernosum during sexual stimulation, leading to smooth muscle relaxation and increased penile blood flow to facilitate erection.

Onset of Action

30-60 minutes.

Duration of Effect

Approximately 4 hours (often cited range ~4-6 hours).

Half-Life

3-5 hours.

Bioavailability

Oral absolute bioavailability ~41% (reported range ~25-63%); the ODT/orodispersible formulation is intended for oral swallowing after disintegration and is generally considered comparable in systemic exposure to conventional oral tablets at the same dose.

Metabolism

Hepatic metabolism primarily via CYP3A4 (major) and CYP2C9 (minor); major active metabolite is N-desmethylsildenafil with ~50% of parent potency and contributes ~20% of overall pharmacologic effect.

Excretion

Primarily fecal (approximately 80%) and renal (approximately 13%).

Protein Binding

Approximately 96%.

Product Information

Available Dosage Forms

For sildenafil: film-coated oral tablet; orodispersible oral tablet; oral suspension (for PAH products); intravenous injection (for PAH products).

Composition per Dose

Each orodispersible tablet: 50 mg sildenafil (as sildenafil citrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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