Fildena is a prescription medication specifically formulated to address the physiological challenges of erectile dysfunction (ED). Its active ingredient, Sildenafil Citrate, is a well-researched phosphodiesterase type 5 (PDE5) inhibitor that facilitates increased blood flow to the penile tissues upon sexual stimulation. This medical-grade treatment is designed for adult males experiencing difficulties in achieving or maintaining an erection sufficient for satisfactory sexual activity. By targeting the underlying vascular mechanisms of ED, Fildena offers a reliable and clinically proven solution to help restore natural erectile function and improve sexual health outcomes.

Features

• Active Pharmaceutical Ingredient: Sildenafil Citrate (25mg, 50mg, 100mg, 120mg, 150mg, 200mg tablet strengths available)
• Drug Class: Selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5 inhibitor)
• Mechanism of Action: Enhances the effect of nitric oxide (NO) by inhibiting PDE5, which is responsible for the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum
• Pharmacokinetics: Rapid absorption; median time to maximum plasma concentration (Tmax) is approximately 60 minutes post-dose when taken on an empty stomach
• Bioavailability: Approximately 40%
• Protein Binding: ~96%, primarily to plasma proteins
• Metabolism: Primarily hepatic, via cytochrome P450 isoforms 3A4 (major route) and 2C9 (minor route)
• Elimination Half-life: Approximately 4 hours
• Excretion: Predominantly as metabolites in the feces (~80%) and to a lesser extent in the urine (~13%)
• Onset of Action: Typically 30-60 minutes post-ingestion, depending on individual metabolic factors and presence of food
• Duration of Effect: The therapeutic window for erectile response is generally up to 4-5 hours, though the plasma half-life is shorter

Benefits

• Achieves reliable and firm erections sufficient for sexual intercourse when combined with sexual stimulation.
• Improves overall sexual performance and satisfaction by addressing the primary vascular component of erectile dysfunction.
• Enhances self-confidence and reduces performance anxiety related to sexual activity by providing a predictable therapeutic effect.
• Offers flexible dosing options to allow for tailored treatment plans based on individual severity of ED, tolerance, and response.
• Supports healthy sexual relationships by providing a medical solution for a common physiological condition.
• Works on-demand, allowing for spontaneity in sexual activity rather than requiring a continuous daily dosing regimen.

Common use

Fildena is 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. The medication is not an aphrodisiac and does not increase libido; it requires sexual stimulation to initiate the local release of nitric oxide, which it then potentiates. It is used by men whose ED has various etiologies, including vasculogenic, neurogenic, and psychogenic origins, or a combination thereof. It is crucial to understand that this is a symptomatic treatment for a functional problem and does not cure the underlying pathophysiology of ED.

Dosage and direction

The recommended starting dose for most patients is 50 mg taken orally, approximately one hour before anticipated sexual activity. Based on efficacy and tolerability, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The dosing may be adjusted by a healthcare provider depending on individual patient response and side effects.

• Administration: Take the tablet orally with a full glass of water. It can be taken with or without food. However, a high-fat meal may delay the absorption of Sildenafil, delaying the time to onset of effect.
• Dosing Frequency: The maximum recommended dosing frequency is once per 24-hour period.
• Considerations for Specific Populations:
  • Elderly: Dose adjustment may not be necessary solely based on age, but consideration should be given to the greater frequency of decreased hepatic, renal, or cardiac function in this population.
  • Renal Impairment: Mild to moderate impairment (creatinine clearance = 30-80 mL/min): no initial dose adjustment necessary. Severe impairment (CrCl < 30 mL/min): a starting dose of 25 mg should be considered.
  • Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh Class C), a starting dose of 25 mg should be considered.

Precautions

• Cardiovascular Status: Patients with pre-existing cardiovascular disease were excluded from many clinical trials. Sexual activity carries a potential cardiac risk. Therefore, Fildena should not be used in men for whom sexual activity is inadvisable due to their cardiovascular status. A thorough medical history and physical examination should be undertaken to diagnose ED, determine potential underlying causes, and identify appropriate treatment.
• Priapism: Prolonged erections lasting more than 4 hours and priapism (a painful erection lasting more than 6 hours) have been reported infrequently. If an erection persists for longer than 4 hours, the patient should seek immediate medical attention. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
• Effects on the Eye: Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely post-marketing in connection with PDE5 inhibitor use. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Patients who have experienced NAION in one eye are at an increased risk of NAION in the other eye.
• Sudden Hearing Loss: Cases of sudden decrease or loss of hearing have been reported post-marketing, sometimes accompanied by tinnitus and dizziness.
• Alpha-blockers & Hypotension: Concomitant use with alpha-blockers can lead to symptomatic hypotension in some patients. Concomitant use with other antihypertensive agents may potentiate the hypotensive effects.
• Combination with Other PDE5 Inhibitors: The safety and efficacy of combinations of Fildena with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Contraindications

Fildena is contraindicated in patients with:

• A known hypersensitivity to Sildenafil or any of the tablet’s excipients.
• Concurrent administration of any form of organic nitrates (e.g., nitroglycerin, isosorbide mononitrate or dinitrate) or nitric oxide donors (e.g., amyl nitrite “poppers”) in any form, either regularly or intermittently. Concomitant use can lead to a severe, potentially life-threatening drop in blood pressure.
• Concurrent administration with guanylate cyclase stimulators, such as riociguat.
• Patients with severe hepatic impairment.
• Patients with hypotension (resting systolic BP < 90 mmHg) or recent history of stroke or myocardial infarction.
• Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa.

Possible side effect

Like all medicines, Fildena can cause side effects, although not everybody gets them. Most side effects 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 (including blurred vision, changes in color perception, increased sensitivity to light)

Uncommon (≥1/1,000 to <1/100):

• Hypotension
• Tachycardia (increased heart rate)
• Palpitations
• Vomiting
• Rash
• Back pain, myalgia (muscle pain)

Rare (≥1/10,000 to <1/1,000):

• Hypersensitivity reactions (including skin rashes)
• Priapism
• Syncope (fainting)
• Transient global amnesia
• NAION
• Sudden hearing loss

Drug interaction

Sildenafil’s metabolism is primarily mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Consequently, inhibitors of these isoenzymes can reduce sildenafil clearance and increase plasma concentrations, while inducers can increase clearance and decrease plasma concentrations.

• Nitrates: Absolute Contraindication. Concomitant use can cause severe hypotension, syncope, stroke, or myocardial infarction.
• Alpha-blockers (e.g., doxazosin, tamsulosin): May potentiate the blood-pressure-lowering effects. Caution is advised, especially with initiation of therapy.
• Potent CYP3A4 Inhibitors:
  • Ketoconazole, Itraconazole, Ritonavir: Co-administration significantly increases sildenafil plasma levels. A maximum dose of 25 mg within a 48-hour period should not be exceeded.
  • Erythromycin, Saquinavir: Consider a starting dose of 25 mg.
• CYP3A4 Inducers (e.g., Rifampin, Carbamazepine, Phenytoin, St. John’s Wort): May substantially reduce sildenafil plasma concentrations, potentially reducing efficacy.
• Antihypertensive Agents: May add to the hypotensive effects of sildenafil.
• Alcohol: Potentiates the blood-pressure-lowering and heart-rate-increasing effects of sildenafil. Heavy alcohol consumption (≥5 units) is not recommended.

Missed dose

Fildena is not intended for chronic daily dosing but 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 at least 24 hours have passed since the last dose.

Overdose

In cases of overdose, the expected clinical presentation would be an extension of the drug’s known adverse effects, primarily severe hypotension and vasodilatory symptoms.

• Symptoms: Severe headache, pronounced flushing, dizziness, syncope, prolonged and/or painful erection (priapism).
• Management: Standard supportive measures should be adopted as required. Hemodialysis is not expected to accelerate clearance as sildenafil is highly protein-bound and extensively metabolized. For priapism, immediate medical treatment is essential. Treatment of hypotension should include placing the patient in the Trendelenburg position and administering IV fluids. The use of catecholamines (e.g., phenylephrine) may be considered for vasoconstriction, but extra caution is needed due to potential cardiac effects.

Storage

• Store below 30°C (86°F).
• Keep the blister strips in the outer carton to protect from light and moisture.
• Keep out of the reach and sight of children.
• 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 here. The information provided is based on the typical properties of the drug Sildenafil Citrate and may not be fully comprehensive or reflect the specific details of every branded product containing it.

Reviews

• “As a urologist with over 20 years of experience, I find Sildenafil-based medications like Fildena to be a cornerstone of ED treatment. Its efficacy and safety profile are well-established in the medical literature. It provides a predictable and effective option for the vast majority of my patients when prescribed appropriately after a thorough cardiovascular assessment.” – Dr. A. Smith, MD (Urology)
• “After trying another medication with more side effects, my physician switched me to a 50mg dose of a Sildenafil generic. The results have been consistent and effective with minimal discomfort. The most notable side effect is mild facial flushing, which subsides within an hour.” – Patient M, 58
• “The flexibility of different strengths allows for precise titration. Starting at a lower dose and moving up based on patient response and tolerance is a key advantage of this class of drug. Patient education on proper use (requiring stimulation, timing, food effects) is critical for success.” – Clinical Pharmacist Review
• “It gave me back a part of my life I thought was gone. The psychological benefit of knowing the treatment is available has been almost as important as the physical effect itself.” – Patient J, 65