Sildigra Softgel represents a significant advancement in the oral pharmacotherapy of erectile dysfunction (ED), combining the proven efficacy of sildenafil citrate with an innovative softgel delivery system. This formulation is engineered to bypass the first-pass metabolism and dissolve rapidly in the gastrointestinal tract, facilitating a quicker onset of action and more predictable absorption compared to traditional tablet forms. It is specifically indicated for the treatment of erectile dysfunction in adult males, operating through selective inhibition of phosphodiesterase type 5 (PDE5), resulting in increased blood flow to the corpus cavernosum upon sexual stimulation. The softgel technology ensures that the active pharmaceutical ingredient is in a solubilized state, enhancing bioavailability and reducing the impact of dietary factors, making it a superior choice for patients seeking reliability and speed.

Features

• Active Pharmaceutical Ingredient: Sildenafil Citrate, USP (equivalent to 25mg, 50mg, or 100mg Sildenafil).
• Dosage Form: Oral softgel capsule.
• Delivery Technology: Advanced lipid-based solubilization system.
• Excipients: Includes solubilizers like Polyoxyl 40 Hydrogenated Castor Oil, Propylene Glycol, and softgel shell components (Gelatin, Glycerin, Sorbitol, Titanium Dioxide).
• Pharmacokinetic Profile: Designed for rapid disintegration and absorption.
• Packaging: Blister packs (ALU/ALU) for optimal stability and protection from moisture and light.

Benefits

• Accelerated Onset of Action: The pre-dissolved, solubilized formulation allows the active ingredient to be absorbed more quickly, potentially reducing the time to onset compared to standard tablets.
• Enhanced Bioavailability: The lipid-based system improves the solubility of sildenafil, leading to more consistent and reliable absorption into the bloodstream, which can translate to more predictable therapeutic effects.
• Reduced Food Interference: The absorption of the medication is less affected by a high-fat meal, offering greater dosing flexibility and convenience for the patient.
• Ease of Administration: The smooth, gelatin-coated softgel is often easier to swallow than a compressed tablet for some individuals.
• Effective PDE5 Inhibition: Provides robust and reliable erectile response when combined with sexual stimulation, helping to restore natural sexual function.
• Improved Patient Confidence: The combination of rapid action and reliable performance can significantly reduce performance anxiety associated with erectile dysfunction.

Common use

Sildigra Softgel is prescribed for the management of erectile dysfunction (ED), a condition characterized by the consistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. It is used on an as-needed basis to facilitate erections. It is crucial for patients and prescribers to understand that Sildigra Softgel is not an aphrodisiac; it does not increase libido. Its mechanism of action is entirely dependent on sexual stimulation. The drug will not cause an erection in the absence of psychological or physical sexual arousal.

Dosage and direction

The recommended starting dose for most patients is 50 mg, taken approximately 30-60 minutes prior to 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. Dosing should be limited to a maximum of once per 24-hour period.

Directions for Use:

1. Take one softgel capsule by mouth with a full glass of water.
2. Do not crush, chew, or break the softgel. It must be swallowed whole.
3. The medication can be taken with or without food; however, a very high-fat meal may delay the time of onset slightly.
4. Sexual stimulation is required for the medication to be effective.

Precautions

• Cardiovascular Status: Patients with underlying cardiovascular disease should undergo a thorough medical risk-benefit assessment before initiating treatment for ED, as sexual activity carries a potential cardiac risk. Sildigra Softgel is not recommended for use in men for whom sexual activity is inadvisable due to their cardiovascular status.
• Priapism: Prolonged erections lasting more than 4 hours and priapism (a painful erection lasting more than 6 hours) have been reported infrequently. This condition requires immediate medical attention to prevent long-term damage to the penile tissues and potential permanent impotence.
• Effects on the Eye: Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision or permanent vision loss, has been reported rarely in connection with PDE5 inhibitor use. Patients who have experienced NAION in one eye are at increased risk of developing it in the other. Advise patients to stop use and seek immediate medical attention for sudden vision loss in one or both eyes.
• Sudden Hearing Loss: Cases of sudden decrease or loss of hearing, sometimes accompanied by tinnitus and dizziness, have been reported. Patients should discontinue use and seek prompt medical attention if such symptoms occur.
• Alpha-blockers & Blood Pressure: Concomitant use with alpha-blockers can lead to symptomatic hypotension in some patients. A time interval between dosing should be considered.
• Use in Specific Populations: The safety and efficacy of Sildigra Softgel have not been studied in pediatric patients or women. It is not indicated for use by these populations.

Contraindications

Sildigra Softgel is strictly contraindicated in the following patient populations:

• Patients using any form of organic nitrates (e.g., nitroglycerin, isosorbide mononitrate or dinitrate) or nitric oxide donors (e.g., amyl nitrite “poppers”) in any dosage form (regular, intermittent, or topical). Concomitant use can cause a severe, life-threatening drop in blood pressure.
• Patients with a known hypersensitivity to sildenafil citrate or any of the inactive ingredients in the softgel formulation.
• Patients with severe hepatic impairment (Child-Pugh class C).
• Patients with severe hypotension (blood pressure <90/50 mmHg).
• Patients with recent stroke, myocardial infarction, or life-threatening arrhythmia within the last 6 months.
• Patients with known hereditary degenerative retinal disorders (e.g., retinitis pigmentosa).

Possible side effect

Sildenafil citrate is a vasodilator, and its side effects are often related to this physiological effect. 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, color tinge to vision, increased sensitivity to light)

Uncommon (≥1/1,000 to <1/100):

• Back pain
• Myalgia (muscle pain)
• Nausea
• Rash

Rare (≥1/10,000 to <1/1,000):

• Priapism
• Hypotension
• Syncope (fainting)
• Sudden hearing loss
• NAION (non-arteritic anterior ischemic optic neuropathy)

Drug interaction

The most critical interaction is with NITRATES, which is an absolute contraindication. Other significant interactions include:

• Alpha-adrenergic blocking agents (e.g., doxazosin, tamsulosin): Potentiates the blood-pressure-lowering effects. Concomitant use requires caution and should only be initiated under close medical supervision, potentially with a lower starting dose of Sildigra (25 mg).
• Potent CYP3A4 Inhibitors:
  • Strong inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): Can significantly increase sildenafil plasma concentrations. A maximum dose of 25 mg within a 48-hour period is recommended.
  • Moderate inhibitors (e.g., erythromycin, saquinavir, amlodipine): May increase sildenafil concentrations. Consider a starting dose of 25 mg.
• Other Antihypertensive Agents: May potentiate the hypotensive effect.
• Alcohol: Excessive consumption can increase the risk of orthostatic hypotension, dizziness, and increased heart rate.

Missed dose

Sildigra Softgel is not intended for chronic, scheduled dosing. It is taken on an as-needed basis. Therefore, the concept of a “missed dose” does not apply. Do not take an extra dose to make up for a missed one. Simply take the next dose when planned prior to sexual activity, ensuring at least 24 hours have passed since the last dose.

Overdose

In cases of overdose, the expected clinical presentation would be an exaggeration of the known dose-dependent adverse effects, including severe headache, profound flushing, visual disturbances, hypotension, and potentially syncope.

Management:

1. Standard supportive measures should be employed.
2. The patient should be placed in a supine position with the legs elevated to manage hypotension and help restore blood pressure.
3. Hemodialysis is not expected to accelerate clearance, as sildenafil is highly protein-bound and extensively metabolized.
4. Cardiovascular monitoring is advised until the patient’s vital signs stabilize.

Storage

• Store below 30°C (86°F).
• Keep the blister strips in the outer carton 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 product information is intended for educational and informational purposes only and does not constitute medical advice. This document 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 the typical properties of the drug sildenafil citrate and may not be fully inclusive of all possible data specific to the Sildigra Softgel brand. Always refer to the official prescribing information provided with the medication.

Reviews

• David R., 54: “After struggling with standard tablets and their inconsistent results, my urologist suggested trying the softgel form. The difference is noticeable. It seems to work faster, and I don’t have to worry as much about timing my meal. A significant improvement in reliability.”
• Michael T., 61: “The 50mg softgel has been a game-changer for me. The onset is definitely quicker than the pill I used to take. I experience the common side effect of flushing, but it’s a mild trade-off for the effectiveness. Much easier to swallow as well.”
• John K., 58: “I have a sensitive stomach and often found that the tablets caused some indigestion. Switching to the Sildigra Softgel has virtually eliminated that issue for me. The efficacy is excellent, and the reduction in GI discomfort is a major benefit.”
• Anonymous, 49: “Extremely effective. Works within 30-40 minutes for me consistently. The headache can be strong, so I make sure to be well-hydrated. Would not go back to the tablet form.”
• Robert L., 66: “My cardiologist approved this for me after a full work-up. I take the 25mg dose and it’s perfectly sufficient. I appreciate that the absorption is less affected by food, giving me more flexibility. A well-designed product.”