ERECTA 50/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile dysfunction in adult men

Off-Label Uses

Raynaud’s phenomenon and prevention/treatment of high-altitude pulmonary edema (HAPE) are recognized off-label uses; evidence for female sexual arousal disorder is inconsistent and not routinely recommended.

Dosage & Administration

Dosing by Condition

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

Initial Dose

50 mg taken approximately 1 hour before sexual activity

Maintenance Dose

25-100 mg as needed, not more than once per day

Maximum Dose

100 mg per dose; maximum once daily

Children's Dosage

Not approved for children for erectile dysfunction.

Dose Adjustment Notes

Consider a 25 mg starting dose for erectile dysfunction in patients ≥65 years, with severe renal impairment (CrCl <30 mL/min), or hepatic impairment; also consider 25 mg when used with CYP3A4 inhibitors, and avoid/strictly limit use with ritonavir per labeling.

How to Take

Swallow tablet whole with water. Take approximately 30-60 minutes before sexual activity. Sexual stimulation is required for the drug to be effective.

Side Effects

Common Side Effects

Headache, Flushing, Dyspepsia, Nasal congestion, Dizziness, Visual disturbances (color tinge, blurred vision), Back pain, Myalgia

Side Effect Frequency

Very common: headache, flushing. Common: dyspepsia, nasal congestion, dizziness, nausea, visual disturbances (e.g., color tinge/blurred vision). Uncommon/rare but serious: hypotension/syncope, priapism, sudden hearing loss, NAION/vision loss, tachycardia/palpitations, rash.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant organic nitrates or nitric oxide donors (any form), (2) concomitant guanylate cyclase stimulators (e.g., riociguat), (3) hypersensitivity to sildenafil or excipients; additionally, do not use in patients for whom sexual activity is inadvisable due to cardiovascular status (per labeling warnings/contraindication language in many references).

Warnings & Precautions

Key precautions: assess cardiovascular fitness for sexual activity; avoid/use extreme caution in unstable cardiovascular disease; risk of hypotension (especially with alpha-blockers/antihypertensives and alcohol); priapism risk (penile deformity or predisposition such as sickle cell disease, leukemia, myeloma); visual/hearing warning signs (stop and seek care); caution with bleeding disorders/active peptic ulcer; not indicated for women for this ED product.

Age Restriction

Adults ≥18 years for erectile dysfunction; not indicated for ED in patients <18 years.

Driving Warning

May cause dizziness or visual disturbances; use caution when driving or operating machinery

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; riociguat. Clinically significant: potent CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole/itraconazole, clarithromycin) increase sildenafil exposure-use lowest starting dose and/or avoid with strong inhibitors; CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) may reduce effect; alpha-blockers and other antihypertensives can cause additive hypotension (separate dosing and start low). Food interactions: grapefruit can increase levels; alcohol may worsen hypotension/dizziness.

Interaction Severity

MAJOR/Contraindicated: nitrates; riociguat. MODERATE: alpha-blockers (additive hypotension), strong/moderate CYP3A4 inhibitors (increase sildenafil exposure; ritonavir is especially significant). MINOR: CYP3A4 inducers (reduced effect); grapefruit/alcohol may increase adverse effects or alter exposure but are generally managed with counseling rather than being major interactions.

Food Interaction

High-fat meals can delay the onset of action; may be taken with or without food. Avoid grapefruit juice.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children for erectile dysfunction.

Elderly

Start at 25 mg due to reduced clearance; titrate based on response and tolerability

Kidney Impairment

CrCl 30-80 mL/min: no adjustment; CrCl <30 mL/min (severe impairment) or ESRD: consider starting at 25 mg.

Liver Impairment

Hepatic impairment: consider a starting dose of 25 mg in cirrhosis/Child-Pugh A or B; in severe hepatic impairment (Child-Pugh C), use is not recommended/avoid due to limited data and increased exposure.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep in original blister packaging. Keep out of reach of children.

Missed Dose

For erectile dysfunction PRN use: no missed-dose instructions apply; do not take more than one dose in 24 hours.

Stopping the Medicine

May be stopped at any time; no taper is required.

Overdose

Symptoms may include headache, flushing, dizziness, hypotension/syncope, visual disturbances, tachycardia, and priapism; management is supportive (vital signs, treat hypotension, evaluate priapism/vision/hearing symptoms urgently), consider activated charcoal if recent ingestion; hemodialysis is unlikely to help due to high protein binding.

Patient Counseling

Take 30-60 minutes (up to ~1 hour) before sexual activity; sexual stimulation is required; do not exceed one dose in 24 hours; avoid nitrates and riociguat; use caution with alpha-blockers/antihypertensives and excess alcohol; high-fat meals may delay onset; seek urgent care for erection >4 hours or sudden vision/hearing loss.

Monitoring Requirements

No routine laboratory monitoring is required for ED use; clinically monitor blood pressure/symptoms in patients on antihypertensives or alpha-blockers and counsel to seek urgent care for priapism or sudden vision/hearing changes.

Pharmacology

Mechanism of Action

Selective PDE5 inhibition increases cGMP in the corpus cavernosum, enhancing nitric-oxide-mediated smooth muscle relaxation and penile blood inflow in response to sexual stimulation.

Onset of Action

30-60 minutes.

Duration of Effect

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) to an active N-desmethyl metabolite (about 50% potency of parent).

Excretion

Excreted mainly as metabolites in feces (~80%) and urine (~13%).

Protein Binding

Approximately 96%.

Product Information

Available Dosage Forms

Film-coated tablet (oral use) for this product (ERECTA 50 mg); sildenafil also exists in other dosage forms (oral suspension and injection) in other products/indications.

Composition per Dose

Each film-coated 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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