FALLAH 100/MG FC TAB 4/FC TAB

Indications

Approved Uses

Erectile dysfunction in adult men

Dosage & Administration

Dosing by Condition

Erectile dysfunction: Initial 50 mg approximately 1 hour before sexual activity; may adjust to 25 mg or 100 mg based on response; max 100 mg per dose, once daily

Initial Dose

50 mg approximately 30-60 minutes before sexual activity (for erectile dysfunction)

Maintenance Dose

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

Maximum Dose

100 mg per dose, once daily

Children's Dosage

Not approved for children

Dose Adjustment Notes

Reduce initial dose to 25 mg in elderly (>65 years), hepatic impairment, severe renal impairment (CrCl <30 mL/min), or concurrent use of CYP3A4 inhibitors

How to Take

Swallow tablet whole with water approximately 30-60 minutes before sexual activity. Can be taken with or without food, but avoid high-fat meals as they delay onset.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Concurrent use of nitrates or nitric oxide donors, Concurrent use of guanylate cyclase stimulators (e.g., riociguat), Severe hepatic impairment, Recent stroke or myocardial infarction (within 6 months), Severe hypotension (BP <90/50 mmHg), Hereditary degenerative retinal disorders (e.g., retinitis pigmentosa), Hypersensitivity to sildenafil

Warnings & Precautions

Use with caution in patients with cardiovascular disease; assess cardiac risk before prescribing. Avoid in patients with anatomical penile deformity (Peyronie's disease) or conditions predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia). Discontinue immediately if sudden vision or hearing loss occurs. Not indicated for use in women (except PAH indication). Avoid recreational use or use without medical supervision.

Age Restriction

Not approved under 18 years

Drug Interactions

Drug Interactions

Nitrates (absolute contraindication - severe hypotension), Riociguat (absolute contraindication), Alpha-blockers (additive hypotension), CYP3A4 inhibitors - ketoconazole, itraconazole, ritonavir, erythromycin (increased sildenafil levels), CYP3A4 inducers - rifampicin (decreased sildenafil levels), Antihypertensives (additive hypotension), Cimetidine (increased sildenafil exposure)

Interaction Severity

MAJOR: Nitrates (severe life-threatening hypotension), Riociguat (severe hypotension - absolute contraindication), Ritonavir and strong CYP3A4 inhibitors (markedly increased sildenafil exposure). MODERATE: Alpha-blockers (additive hypotension), Antihypertensives (additive hypotension), Erythromycin/ketoconazole (increased sildenafil levels). MINOR: Cimetidine (modest increase in sildenafil exposure), Rifampicin (reduced sildenafil efficacy)

Food Interaction

Take on empty stomach or with a light meal; high-fat meals delay absorption and reduce peak plasma concentration

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children

Elderly

Start with 25 mg initial dose due to reduced clearance; titrate based on response and tolerability

Kidney Impairment

CrCl ≥30 mL/min: No adjustment needed. CrCl <30 mL/min or end-stage renal disease: Start with 25 mg initial dose

Liver Impairment

Mild-to-moderate (Child-Pugh A or B): Start with 25 mg initial dose. Severe (Child-Pugh C): Contraindicated

Storage & Patient Advice

Missed Dose

Used on an as-needed basis; take approximately 30-60 minutes before sexual activity. Do not take more than one dose in 24 hours.

Stopping the Medicine

Safe to stop anytime; no tapering required

Patient Counseling

Take this tablet 30 to 60 minutes before sexual activity. Sexual stimulation is required for the medication to work. Do not take more than one tablet in 24 hours. Avoid grapefruit juice and high-fat meals before taking this medication. Never take this medication with nitrate drugs (e.g., nitroglycerin) as this can cause a dangerous drop in blood pressure. Stop the medication and seek immediate medical attention if you experience sudden vision loss, sudden hearing loss, or an erection lasting more than 4 hours. Inform your doctor of all medications you are taking, especially blood pressure medications.

Monitoring Requirements

No routine monitoring required for erectile dysfunction use; monitor blood pressure in patients on antihypertensives or alpha-blockers

Pharmacology

Mechanism of Action

Selectively inhibits phosphodiesterase type 5 (PDE5), preventing degradation of cyclic GMP (cGMP) in corpus cavernosum smooth muscle, leading to smooth muscle relaxation, increased blood flow, and penile erection in response to sexual stimulation

Onset of Action

30-60 minutes

Metabolism

Hepatic via CYP3A4 (major) and CYP2C9 (minor); active metabolite N-desmethylsildenafil

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 100 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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