VIAGRA 100/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile dysfunction in adult men (Viagra). Pulmonary arterial hypertension is an indication for sildenafil under different products/strengths (e.g., Revatio), not for Viagra 100 mg tablets.

Off-Label Uses

Raynaud’s phenomenon and high‑altitude pulmonary edema/altitude-related pulmonary hypertension (evidence varies); other proposed uses (e.g., female sexual dysfunction) have limited/inconsistent evidence and are not routinely recommended.

Dosage & Administration

Dosing by Condition

Erectile dysfunction (Viagra): 50 mg PO as needed about 1 hour before sexual activity; adjust to 25-100 mg based on response/tolerability; maximum 100 mg per dose and maximum once daily. (PAH dosing is not applicable to Viagra 100 mg; PAH regimens use different sildenafil products/doses.)

Initial Dose

50mg as needed, approximately 1 hour before sexual activity.

Maintenance Dose

25mg to 100mg as needed, approximately 30 minutes to 4 hours before sexual activity.

Maximum Dose

100mg per dose, once per 24 hours

Children's Dosage

Not approved for children for erectile dysfunction. Revatio (sildenafil 20mg) is approved for PAH in pediatric patients ≥1 year under separate dosing guidelines.

Dose Adjustment Notes

Consider a 25 mg starting dose in adults ≥65 years, in severe renal impairment (CrCl <30 mL/min), or hepatic impairment; use caution with CYP3A4 inhibitors-avoid strong inhibitors when possible, and if used (e.g., ritonavir) limit to 25 mg no more frequently than every 48 hours; titrate to effect/tolerability (max 100 mg once daily).

How to Take

Oral use: swallow the film‑coated tablet whole with water, taken as needed about 30-60 minutes before sexual activity (can be taken up to ~4 hours before); sexual stimulation is required. Do not take more than 1 dose in 24 hours; do not crush/chew unless specifically advised.

Side Effects

Common Side Effects

Headache, flushing, dyspepsia, abnormal vision (including color tinge, blurred vision, and light sensitivity), nasal congestion, back pain, myalgia, nausea, dizziness, rash.

Side Effect Frequency

Very common (≥10%): Headache, flushing. Common (1-10%): Dyspepsia, nasal congestion, dizziness, visual disturbances (e.g., color tinge/blurred vision), nausea. Uncommon/rare: priapism; hypotension/syncope (especially with nitrates/alpha-blockers); rash; sudden hearing loss; NAION (sudden vision loss).

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant organic nitrates in any form and nitric oxide donors; (2) concomitant guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to sildenafil or any excipient.

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status and avoid use when sexual activity is inadvisable; risk of hypotension (especially with alpha-blockers/antihypertensives); discontinue and seek care for priapism, sudden vision loss (NAION), or sudden hearing loss; use caution with anatomical penile deformity or conditions predisposing to priapism; avoid in severe hepatic impairment and use lower starting dose in hepatic/renal impairment; not indicated for women.

Age Restriction

Not approved/indicated for erectile dysfunction in patients <18 years; use is for adults only.

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; riociguat. Clinically significant: alpha-blockers (risk symptomatic hypotension-ensure stable alpha-blocker therapy and start sildenafil at lowest dose), strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin/erythromycin-↑ sildenafil exposure; dose reduction/avoid highest doses), CYP3A4 inducers (e.g., rifampin-↓ effect), other antihypertensives including amlodipine (additive BP lowering).

Interaction Severity

MAJOR/Contraindicated: all nitrates (e.g., nitroglycerin, isosorbide) and riociguat (risk of profound hypotension). MODERATE/Use caution: alpha‑blockers and other antihypertensives (additive BP lowering), strong/moderate CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin/erythromycin) increase sildenafil levels; CYP3A4 inducers (e.g., rifampin) may reduce effect.

Food Interaction

May be taken with or without food; a high‑fat meal can delay onset and reduce peak effect-empty stomach gives faster onset. Avoid grapefruit/grapefruit juice (can increase sildenafil exposure via CYP3A4 inhibition).

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children for erectile dysfunction. Revatio (sildenafil 20mg) is approved for PAH in pediatric patients ≥1 year under separate dosing guidelines.

Elderly

Start at 25mg dose in patients ≥65 years due to reduced clearance and higher plasma levels; titrate based on response and tolerability

Kidney Impairment

CrCl 30-80 mL/min: no adjustment. CrCl <30 mL/min (severe renal impairment): consider starting at 25 mg and titrate based on response/tolerability.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A/B): consider starting at 25 mg and titrate. Severe hepatic impairment (Child-Pugh C): not recommended/insufficient data-avoid use.

Storage & Patient Advice

Missed Dose

For erectile dysfunction, it is taken as needed, so a missed dose is not applicable; do not take more than 1 dose in 24 hours.

Stopping the Medicine

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

Overdose

Overdose may cause exaggerated adverse effects (e.g., headache, flushing, dizziness, hypotension, visual disturbances; rarely priapism). Management is supportive (vital signs, fluids/vasopressors as needed); consider activated charcoal if recent ingestion; hemodialysis is unlikely to help due to high protein binding.

Patient Counseling

Take as needed about 30-60 minutes before sex (can be 30 minutes to ~4 hours before); sexual stimulation is required. Do not take more than once daily. Do not use with nitrates or riociguat; use caution with alpha‑blockers/antihypertensives and with strong CYP3A4 inhibitors; avoid grapefruit. High‑fat meals may delay effect; limit excessive alcohol. Seek urgent care for chest pain after dosing (do not take nitrates), sudden vision/hearing loss, or an erection lasting >4 hours.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Inhibits PDE5, enhancing nitric‑oxide-mediated increases in cGMP in the corpus cavernosum, leading to smooth‑muscle relaxation and increased penile blood flow during sexual stimulation.

Onset of Action

Typically 30-60 minutes; some patients may respond as early as ~15-30 minutes, and onset may be delayed by a high‑fat meal.

Duration of Effect

4-6 hours.

Half-Life

3-5 hours.

Metabolism

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

Excretion

Primarily fecal (~80%) and to a lesser extent urinary (~13%), mainly as metabolites

Protein Binding

Approximately 96%

Product Information

Available Dosage Forms

For this product: film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 100mg sildenafil as sildenafil citrate (equivalent to 140mg sildenafil citrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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