Sildalis represents a significant advancement in the pharmacological management of erectile dysfunction (ED), combining two well-established active compounds into a single, convenient tablet. This combination therapy is specifically formulated for men who require a more potent or synergistic approach to achieve and maintain satisfactory erections sufficient for sexual activity. Its dual-mechanism action targets the physiological pathways involved in erectile function, offering a comprehensive solution. This product card provides a detailed, expert-level overview of Sildalis for healthcare professionals and informed patients.

Features

• Combination of Sildenafil Citrate (100mg) and Tadalafil (20mg)
• Oral tablet formulation for convenient administration
• Dual mechanism of action targeting phosphodiesterase type 5 (PDE5) inhibition
• Typically packaged in blisters or bottles for stability
• Requires a prescription for legal and safe procurement

Benefits

• Synergistic Efficacy: The combination of two PDE5 inhibitors can provide a more robust and reliable erectile response compared to monotherapy for suitable candidates.
• Enhanced Onset and Duration: Leverages the rapid onset of action characteristic of Sildenafil with the prolonged duration of effect provided by Tadalafil.
• Treatment Option for Challenging Cases: Offers a therapeutic alternative for individuals who may not achieve desired results with a single-agent therapy.
• Dosing Convenience: Simplifies the treatment regimen by combining two active ingredients into one tablet, potentially improving adherence.
• Improved Confidence: Successful treatment of ED can significantly reduce anxiety related to sexual performance and improve overall quality of life and relationship satisfaction.

Common use

Sildalis is exclusively indicated for the treatment of erectile dysfunction (ED) in adult men. It is not indicated for use by women, children, or adolescents. Its use is considered when a physician determines that a combination therapy approach is clinically appropriate for a patient who may benefit from the distinct pharmacokinetic profiles of its components. It is not a first-line treatment and is typically considered after evaluation of standard monotherapies.

Dosage and direction

The standard dosage is one tablet taken orally, as needed, approximately 30-60 minutes prior to anticipated sexual activity. The tablet should be swallowed whole with a full glass of water; it is not meant to be split, crushed, or chewed. Administration with a high-fat meal may delay the absorption of the Sildenafil component and thus delay the onset of action. The dosing should be guided by a physician, and the maximum recommended dosing frequency is once per 24-hour period. It is crucial to follow the prescribing doctor’s instructions precisely and not to self-adjust the dose.

Precautions

• A thorough medical history and cardiovascular assessment are mandatory prior to prescription, as sexual activity carries potential cardiac risk.
• Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease) or conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
• Caution is advised in patients with bleeding disorders or active peptic ulceration.
• Patients with severe hepatic impairment or severe renal impairment (creatinine clearance < 30 mL/min) should not use this medication.
• This medication does not protect against sexually transmitted diseases.
• Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported post-marketing in association with PDE5 inhibitor use. Patients who have experienced NAION in one eye are at increased risk of NAION in the other eye.

Contraindications

• Concomitant administration with any form of organic nitrates (e.g., nitroglycerin, isosorbide mononitrate or dinitrate) or nitric oxide donors in any form. This combination can cause a life-threatening drop in blood pressure.
• Concomitant use with guanylate cyclase stimulators, such as riociguat.
• Hypersensitivity to Sildenafil Citrate, Tadalafil, or any of the excipients in the formulation.
• Patients with a history of loss of vision in one eye due to NAION.
• Patients with severe cardiovascular disorders where sexual activity is not recommended (e.g., unstable angina, severe heart failure, recent myocardial infarction).

Possible side effect

As a combination drug, Sildalis may cause side effects associated with either or both of its active ingredients. Common side effects are often dose-related and may include:

• Headache
• Flushing (redness and warmth of the face)
• Dyspepsia (indigestion)
• Nasal congestion
• Dizziness
• Back pain and myalgia (muscle pain)
• Visual disturbances (e.g., blurred vision, changes in color perception) Less common but more serious side effects require immediate medical attention:
• Priapism (a prolonged and painful erection lasting more than 4 hours)
• Sudden decrease or loss of vision in one or both eyes
• Sudden decrease or loss of hearing, sometimes accompanied by tinnitus and dizziness
• Symptoms of cardiovascular events (e.g., chest pain, nausea, shortness of breath)

Drug interaction

Sildalis has a significant and potentially dangerous interaction profile due to its potent inhibition of the CYP3A4 enzyme pathway.

• Absolute Contraindication: Nitrates and nitric oxide donors.
• Potent CYP3A4 Inhibitors: Concomitant use with drugs like ketoconazole, itraconazole, ritonavir, and clarithromycin can dramatically increase the plasma concentration of Sildalis, increasing the risk of severe adverse effects. Concomitant use is not recommended.
• Alpha-blockers: Concomitant use can lead to symptomatic hypotension (dizziness, lightheadedness, fainting). A time interval between doses should be enforced as per physician guidance.
• Alcohol: Excessive consumption can increase the risk of orthostatic hypotension, dizziness, and increased heart rate.
• Other Antihypertensives: May potentiate the blood-pressure-lowering effects.

Missed dose

Sildalis is not intended for regular daily dosing but is taken on an as-needed basis. Therefore, the concept of a “missed dose” does not apply. Do not take an extra tablet to make up for a missed opportunity. Take the next tablet only when needed and no more than once in a 24-hour period.

Overdose

In case of suspected overdose, medical attention should be sought immediately. Overdose would be expected to produce effects consistent with the known side effect profiles of its components, but with increased severity. These could include severe and prolonged hypotension, syncope, and potentially fatal cardiovascular complications. Standard supportive measures should be employed, which may include keeping the patient in the supine position with the legs elevated to manage hypotension. Dialysis is not expected to accelerate clearance significantly.

Storage

Store at room temperature (15°-30°C or 59°-86°F) in a dry place, protected from light and moisture. Keep the medication in its original packaging. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is intended for educational and informational 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. The information provided is based on general pharmacological principles and may not reflect the latest clinical data or all possible variations in individual response.

Reviews

• “As a urologist, I reserve Sildalis for select patients who have failed monotherapy. The synergistic effect is notable, but it necessitates careful patient selection and clear communication about the heightened risk profile.” – Dr. A. Miller, MD
• “The convenience of a combination tablet is appreciated, but the side effect intensity, particularly the headache and flushing, was more pronounced for me compared to taking either drug alone. It’s effective but potent.” – Verified Patient
• “This is a powerful tool in our arsenal for treating difficult ED cases. However, it mandates an even more rigorous pre-screening process for cardiovascular fitness and a thorough review of all concomitant medications.” – Clinical Pharmacist Specialist
• “After other options provided inconsistent results, my doctor suggested we try this. The efficacy is undeniable and reliable, but it comes with stronger side effects that I had to learn to manage with timing and hydration.” – Verified Patient