ERECTA 100/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile dysfunction in adult men

Off-Label Uses

Raynaud’s phenomenon/digital ischemia; prevention/treatment of high-altitude pulmonary edema (HAPE) in select situations. (Female sexual dysfunction is not an established, guideline-supported routine use.)

Dosage & Administration

Dosing by Condition

Erectile dysfunction: Initial 50 mg taken approximately 1 hour before sexual activity; may adjust to 25 mg or 100 mg based on response and tolerability; max 100 mg per dose, once daily. Pulmonary arterial hypertension: 20 mg three times daily (not this formulation/strength).

Initial Dose

50 mg approximately 1 hour before sexual activity (25 mg in elderly or those with hepatic/renal impairment)

Maintenance Dose

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

Maximum Dose

100 mg per day for erectile dysfunction.

Children's Dosage

Not approved for children for erectile dysfunction.

Dose Adjustment Notes

Consider a lower starting dose (25 mg) in older adults (≥65 years), severe renal impairment (CrCl <30 mL/min), or hepatic impairment; use caution and lower starting dose with concomitant potent CYP3A4 inhibitors. With ritonavir: maximum 25 mg and do not repeat more often than every 48 hours.

How to Take

Swallow the film-coated tablet whole with water, taken as needed about 30-60 minutes (up to 4 hours) before sexual activity; sexual stimulation is required. Do not take more than 1 dose in 24 hours.

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 (≥10%): headache, flushing. Common (1-10%): dyspepsia, nasal congestion, dizziness, visual disturbances (e.g., color tinge/blurred vision), nausea. Also reported: back pain/myalgia (more prominent with PDE5 inhibitors, especially at higher doses). Rare/serious: priapism, severe hypotension (especially with contraindicated drugs), sudden vision loss (NAION), sudden hearing loss.

Safety & Warnings

Contraindications

Concomitant use with nitrates/nitrites or nitric oxide donors; concomitant use with guanylate cyclase stimulators (e.g., riociguat); hypersensitivity to sildenafil or excipients.

Warnings & Precautions

Assess cardiovascular status before prescribing; caution with alpha-blockers/other antihypertensives (symptomatic hypotension); caution in anatomical penile deformity or conditions predisposing to priapism (e.g., sickle cell disease, leukemia, myeloma); counsel to stop and seek care for sudden vision/hearing loss; avoid use in patients for whom sexual activity is inadvisable; caution with bleeding disorders/active peptic ulcer; not indicated for women for ED.

Age Restriction

Not indicated for erectile dysfunction in patients <18 years; pediatric use may exist only for specific sildenafil products/indications (e.g., PAH) and is not applicable to this ED product.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major/contraindicated: nitrates/NO donors; riociguat. Clinically significant: alpha-blockers and other antihypertensives (additive hypotension); strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, ketoconazole/itraconazole, clarithromycin) increase exposure-use lower starting dose/avoid highest doses; CYP3A4 inducers (e.g., rifampin) decrease effect; cimetidine increases exposure.

Interaction Severity

MAJOR/Contraindicated: nitrates (including nitroglycerin/isosorbide) and riociguat due to profound hypotension. MAJOR (avoid/strict limits): potent CYP3A4 inhibitors-especially ritonavir/cobicistat (large exposure increase; dose limits). MODERATE: alpha-blockers and other antihypertensives (additive BP lowering), moderate CYP3A4 inhibitors (e.g., erythromycin/clarithromycin, ketoconazole) increase levels; excessive alcohol may worsen hypotension/dizziness. MINOR: strong CYP 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 levels), so for faster onset take on an empty stomach.

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 mL/min: no adjustment; severe renal impairment (CrCl <30 mL/min) or ESRD: start 25 mg and titrate based on response/tolerability.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A/B): start 25 mg and titrate; severe hepatic impairment: avoid/not recommended (often treated as contraindicated in practice).

Storage & Patient Advice

Missed Dose

For erectile dysfunction, it is taken as needed (not scheduled), so there is no missed dose; do not take more than once in 24 hours.

Stopping the Medicine

Safe to stop anytime; no tapering required

Overdose

Symptoms: headache, flushing, dizziness, hypotension/syncope, visual disturbances, tachycardia, and priapism. Management: supportive care with vital-sign monitoring; consider activated charcoal if recent ingestion; hemodialysis is unlikely to help due to high protein binding; urgent evaluation for priapism or severe hypotension.

Patient Counseling

Take 30-60 minutes before sexual activity (up to 4 hours); sexual stimulation is required; do not exceed 1 dose/24 hours. Do not use with nitrates or riociguat; use caution with alpha-blockers/antihypertensives and limit 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 monitoring required for erectile dysfunction; monitor blood pressure when initiating therapy in patients on antihypertensives or alpha-blockers

Pharmacology

Mechanism of Action

Selective inhibition of cGMP-specific phosphodiesterase type 5 (PDE5) enhances nitric oxide-mediated increases in cGMP in the corpus cavernosum, causing smooth muscle relaxation and increased penile blood flow to facilitate erection with sexual stimulation.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Half-Life

3-5 hours.

Bioavailability

Approximately 41% (range about 25-63%).

Metabolism

Hepatic metabolism mainly via CYP3A4 (major) and CYP2C9 (minor) to an active metabolite (N-desmethyl sildenafil) with ~40% of parent potency.

Excretion

Primarily as metabolites in feces (~80%) and to a lesser extent in urine (~13%).

Protein Binding

Approximately 96%.

Product Information

Available Dosage Forms

For this SFDA product (ERECTA): film-coated tablet for oral use (100 mg). In general, sildenafil is also available in other markets as oral tablets, oral suspension/powder for suspension, and injection (IV) for pulmonary arterial hypertension.

Composition per Dose

Each film-coated tablet: Sildenafil 100 mg (as sildenafil citrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

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