VIAGRA 50/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile dysfunction (ED) in adult men (Viagra brand/formulation); pulmonary arterial hypertension is an approved indication for sildenafil under the Revatio formulation, not for Viagra 50 mg film‑coated tablets.

Off-Label Uses

Raynaud’s phenomenon (especially secondary), prevention/treatment of high-altitude pulmonary edema (HAPE) in select cases; female sexual arousal disorder has been studied but is not routinely recommended/approved.

Dosage & Administration

Dosing by Condition

Erectile dysfunction: 50 mg orally as needed about 1 hour (range ~30-60 minutes) before sexual activity; adjust to 25 mg or 100 mg based on response/tolerability; maximum 100 mg per dose and no more than once daily.

Initial Dose

50mg as a single dose approximately 1 hour before sexual activity.

Maintenance Dose

25mg to 100mg as needed before sexual activity, not more than once daily.

Maximum Dose

100mg per dose; maximum once daily

Children's Dosage

Not approved for erectile dysfunction in children. Use for pulmonary arterial hypertension in children is not recommended due to increased mortality risk at high doses and lack of efficacy at low doses.

Dose Adjustment Notes

Consider a 25 mg starting dose in patients >65 years, with severe renal impairment (CrCl <30 mL/min), hepatic impairment, or when used with strong CYP3A4 inhibitors; titrate to 50-100 mg based on efficacy/tolerability, not exceeding 100 mg once daily.

How to Take

Swallow tablet whole with water. Take approximately 30-60 minutes before sexual activity. May be taken with or without food. Do not take more than one tablet in 24 hours.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any nitrates/nitrites or nitric oxide donors (e.g., nitroglycerin, isosorbide, amyl nitrite), (2) concomitant use of guanylate cyclase stimulators (e.g., riociguat), and (3) known hypersensitivity to sildenafil or any excipient.

Warnings & Precautions

Assess cardiovascular status before prescribing (sexual activity risk); avoid/use extreme caution in patients for whom sexual activity is inadvisable and in those with significant hypotension; caution with left ventricular outflow obstruction; caution with anatomical penile deformity or conditions predisposing to priapism; counsel to stop and seek urgent care for sudden vision/hearing loss or priapism; does not protect against STIs; not indicated for women for ED.

Age Restriction

Not approved for erectile dysfunction in individuals <18 years; pediatric use is only for specific pulmonary arterial hypertension products/dosing and is not applicable to this Viagra ED product.

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; riociguat. Clinically significant: potent CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole/itraconazole, clarithromycin/erythromycin) increase exposure-use lower starting dose/avoid with strong inhibitors; CYP3A4 inducers (e.g., rifampin) may reduce effect; alpha-blockers and other antihypertensives can cause additive hypotension (separate dosing and start low).

Interaction Severity

MAJOR/Contraindicated: nitrates (all forms) and riociguat (risk of profound hypotension). MODERATE: alpha-blockers and other antihypertensives (additive hypotension); strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole/itraconazole, clarithromycin/erythromycin) increase sildenafil exposure-use lower starting dose/avoid certain combinations per labeling. MINOR: CYP3A4 inducers (e.g., rifampin) may reduce efficacy.

Food Interaction

May be taken with or without food; a high-fat meal can delay onset and reduce/slow peak effect, so taking on an empty stomach may produce a faster onset.

Special Populations

Children

Not approved for erectile dysfunction in children. Use for pulmonary arterial hypertension in children is not recommended due to increased mortality risk at high doses and lack of efficacy at low doses.

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep in original packaging. Keep out of reach of children.

Missed Dose

Not applicable for ED use because it is taken as needed; do not take more than one dose in 24 hours.

Stopping the Medicine

Safe to stop anytime; no tapering is required.

Patient Counseling

Take 50 mg about 30-60 minutes (up to ~4 hours) before sexual activity; sexual stimulation is required; do not use more than once daily; avoid/never combine with nitrates and do not use with riociguat; use caution with alpha-blockers/antihypertensives and limit alcohol; seek urgent care for chest pain after use (do not take nitrates), erection >4 hours, or sudden vision/hearing loss; caution with dizziness/visual changes when driving.

Pharmacology

Mechanism of Action

Selective inhibition of cGMP-specific phosphodiesterase type 5 (PDE5), increasing cGMP in the corpus cavernosum during sexual stimulation, leading to smooth muscle relaxation and increased penile blood flow.

Onset of Action

Typically 30-60 minutes (may be as early as ~15-30 minutes in some patients; delayed by high-fat meals).

Duration of Effect

Approximately 4-6 hours.

Half-Life

3-5 hours.

Bioavailability

Approximately 40% (reported range about 25-63%).

Metabolism

Hepatic metabolism primarily via CYP3A4 (major) and CYP2C9 (minor); main circulating active metabolite is N-desmethyl sildenafil with ~50% of parent PDE5 inhibitory potency.

Protein Binding

Approximately 96%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 50mg sildenafil as sildenafil citrate.

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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