Silda

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Silda

What is Silda? A Foundational Overview

Property Description
Active ingredient Sildenafil (as Sildenafil citrate)
Form Film-coated tablets (Oral preparation)
Pharmacological class Selective Phosphodiesterase type 5 (PDE5) inhibitor
General purpose Enhancing localized blood flow (Vasodilation)
Origin Synthetic compound (piperazine derivative)

What Type of Medicine is Silda, and What is its Core Identity?

Silda is the pharmaceutical designation for a product containing the active compound Sildenafil, which is classified as a highly selective Phosphodiesterase type 5 (PDE5) inhibitor. This categorization defines Silda as an agent designed to selectively block the PDE5 enzyme within the body, a mechanism that is clinically recognized for its efficacy in promoting targeted vascular responses. The Sildenafil active ingredient is distinguished by its focused therapeutic influence, allowing for targeted modulation of specific physiological processes.

Composition, Origin, and Physical Form

Silda's core therapeutic action is derived from the active ingredient, Sildenafil, typically formulated as Sildenafil citrate. Sildenafil is a synthetic compound, specifically a synthetic piperazine derivative created through defined chemical processes. It is primarily designed for peroral administration as film-coated tablets, serving as a convenient solid preparation for oral therapy. The formulation is a single product, consisting only of Sildenafil combined with necessary pharmaceutical excipients required for the product's effective systemic delivery, and is typically available as a prescription-only medication (POM).

General Purpose: How Sildenafil Modulates Blood Flow

The general therapeutic purpose of Sildenafil is to enhance local blood flow by promoting targeted vasodilation, which is the widening of blood vessels. This effect is achieved because the drug prevents the rapid breakdown of a natural signaling molecule, cyclic Guanosine Monophosphate (cGMP). By allowing cGMP to persist, Sildenafil enables prolonged smooth muscle relaxation in specific vascular tissues. The ability of Sildenafil to restore vascular reactivity is affirmed through extensive clinical evidence, providing fundamental physiological support necessary to improve localized circulation, for example, in the context of treating pulmonary hypertension.

Regulatory References

  1. PDE5 Inhibitors - StatPearls - NIH

What side effects are possible with Silda?

Official Adverse Reactions and Safety Profile

The safety profile for Silda (Sildenafil) is classified by regulatory authorities based on observed incidence rates from clinical studies and post-marketing surveillance. Adverse reactions are grouped by frequency and the body's physiological system or organ affected.

Frequency-Classified Adverse Reactions

Adverse effects are categorized using standard regulatory terminology:

  • Very Common (Affects 1 in 10 or more): Headache.
  • Common (Affects 1 to 10 in 100): Flushing (hot flush), Dyspepsia (indigestion), Nasal congestion, Dizziness, and Visual disturbances such as chromatopsia (tinted vision) or blurred vision.
  • Uncommon (Affects 1 to 10 in 1,000): Palpitations, Tachycardia, Vomiting, Hypotension, Hypertension, and Hypersensitivity reactions.

Serious Adverse Reactions and Safety Constraints

The regulatory label documents rare but serious adverse reactions and critical limitations on use:

Serious Adverse Reactions: These include Priapism (a prolonged erection lasting over four hours), Non-arteritic anterior ischaemic optic neuropathy (NAION) leading to potential permanent loss of vision, and serious cardiovascular events such as Myocardial Infarction or Sudden Cardiac Death, which have been reported in temporal association with use.

Safety Restrictions: Silda is contraindicated (should not be used) with any form of organic nitrates or nitric oxide donors due to the risk of severe hypotension. Use is also restricted in patients with pre-existing conditions such as severe hepatic impairment, recent stroke or myocardial infarction, or known hypotension (blood pressure < 90/50 mmHg). Caution is advised for patients with anatomical penile deformation or a predisposition to Priapism.

Overdose and Emergency Response

Overdose and when to seek help

Overdosage with Silda (Sildenafil) is documented to result in an increase in the incidence and severity of known adverse reactions. Manifestations observed are typically an exaggeration of the drug's pharmacological effects, often noted in studies involving higher-than-recommended doses.

Overdose Manifestations Severe Outcomes
Headache, flushing, dizziness, dyspepsia, nasal congestion, and intensified visual disturbances are commonly documented. The primary severe risk is severe, sustained hypotension (dangerously low blood pressure) due to exaggerated vasodilation. A prolonged erection lasting more than four hours (priapism) also requires immediate medical attention.

Emergency Action and Management

Official regulatory guidance mandates that patients seek immediate medical attention for any suspected overdose. Urgent help is explicitly required if a prolonged erection (priapism) occurs or if there is sudden decrease or loss of vision.

Overdose management is constrained by the drug's clearance profile. Sildenafil is highly protein-bound, and renal dialysis is not expected to accelerate clearance. Consequently, regulatory documents state that no specific antidote is known. Treatment must therefore consist solely of symptomatic and supportive measures, along with necessary clinical monitoring and observation, which is particularly relevant for patients with severe renal or hepatic impairment due to reduced drug clearance.

Therapeutic Uses of Silda

What Silda Treats: Main Uses and Benefits

Silda is applied across two distinct therapeutic domains, both related to the symptoms of compromised blood flow dynamics.

The primary therapeutic use is in adult men for managing Erectile Dysfunction (ED), a condition where symptoms related to physical discomfort include the inability to achieve or maintain an erection suitable for sexual activity. It is also used as a chronic therapy relevant in conditions characterized by periods of heightened symptoms, specifically the management of Pulmonary Arterial Hypertension (PAH).

Silda is commonly used in clinical settings that involve acute or unstable symptom patterns, such as providing short-term symptomatic assistance for erectile impairment, and in chronic contexts for supporting exercise tolerance. It is relevant for easing symptoms that interfere with daily comfort. This medication is generally considered relevant for conditions presenting with disruptive symptom manifestations, including ED, PAH, and PAH associated with conditions like diabetes mellitus or connective tissue disease.

“The primary benefit is in supporting functional stability and assisting patients with managing the burden of symptoms in both cardiovascular and sexual health contexts.”

Supportive Therapeutic Benefit
Silda helps manage the physical limitations associated with high pressure in the lung arteries and assists in addressing symptoms of functional erectile impairment, contributing to improved day-to-day comfort.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Silda?

Eligibility for Silda (Sildenafil) is strictly governed by population criteria established in official regulatory documents, primarily outlining groups for whom the medication is contraindicated.

Use is absolutely prohibited for patients concurrently receiving any form of organic nitrates or nitric oxide donors, as well as those taking guanylate cyclase stimulators (e.g., riociguat). Exclusionary conditions also include a recent history of stroke or myocardial infarction (MI within the last six months), severe hypotension (BP <90/50 mmHg), or a history of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). For the ED indication, severe hepatic impairment is a contraindication.

The medicine is not indicated for individuals under the age of 18 for its approved uses. Furthermore, chronic use in pediatric patients with Pulmonary Arterial Hypertension (PAH) is not recommended due to specific mortality warnings. Geriatric patients (age ge 65) and patients with severe renal impairment typically require special consideration for use due to altered drug clearance, which may necessitate an adjustment to the initial dose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Silda's (Sildenafil) interaction profile is defined by specific pharmacokinetic and pharmacodynamic restrictions detailed in regulatory documents. The most critical restriction is the absolute contraindication for co-administration with organic nitrates in any form, due to the severe, life-threatening risk of excessive blood pressure lowering. Co-administration with the guanylate cyclase stimulator Riociguat is also strictly prohibited.

Pharmacokinetic Interactions

Silda's clearance is significantly affected by inhibitors of the CYP3A4 metabolic enzyme, which is the primary route of elimination. Co-administration with strong CYP3A4 inhibitors, such as Ritonavir or Ketoconazole, substantially increases Sildenafil systemic exposure, requiring a restriction on the maximum dose allowed within a 48-hour period. Conversely, CYP3A4 inducers like Bosentan may reduce Silda plasma levels.

Pharmacodynamic and Substance Interactions

Co-administration with alpha-blockers or other anti-hypertensive agents may result in an additive hypotensive effect, which may lead to symptomatic low blood pressure. The drug's rate and extent of absorption are reduced when taken with a high-fat meal. Furthermore, substances like Grapefruit Juice may increase systemic exposure, while alcohol (ethanol) can augment the hypotensive effects.

Mechanism of Action

Selective PDE5 Enzyme Inhibition

Silda functions as a highly selective inhibitor of the cyclic guanosine monophosphate ( cGMP)-specific phosphodiesterase type 5 ( PDE5) enzyme. This molecular action prevents the breakdown of cGMP in specific vascular smooth muscle cells, resulting in elevated cGMP levels.


Modulating the NO/cGMP Signaling Cascade

The mechanism primarily acts to enhance the body's natural Nitric Oxide ( NO) / cGMP signaling cascade. By preventing cGMP degradation, Silda prolongs the duration of the existing NO signal; this mechanistic action is dependent upon Nitric Oxide release.


Altering Peripheral Vascular Tone

The accumulation of cGMP triggers downstream pathways that result in the relaxation of vascular smooth muscle in specific peripheral tissues, particularly the pulmonary circulation and the corpus cavernosum. This physiological change results in increased blood flow and a reduction in vascular resistance within PDE5-rich systems.

Dosage and Administration Information

How Silda is Used: Official Administration Guidelines

Silda, which contains sildenafil, is administered following two distinct protocols depending on the condition being addressed. The medicine is available for both oral administration (film-coated tablets or suspension) and, for certain chronic conditions, as an intravenous (IV) injection when oral intake is interrupted or unsuitable.


Official Dosing Regimens and Frequency

Indication Starting Dose Maximum Dose Frequency/Schedule
Erectile Dysfunction (ED) 50 mg (As Needed) 100 mg Maximum of once per day
Pulmonary Arterial Hypertension (PAH) 20 mg 80 mg Three times a day (TID)

Administration Context and Adjustments

Administration frequency and dose are strictly linked to the indication. For PAH, the dose is taken on a scheduled basis, typically spaced 4 to 8 hours apart, and the oral dose may be taken with or without food. For the ED indication, the dose is taken as needed and timing is critical, usually administered 30 minutes to 4 hours prior to activity.

Standard guidelines specify that a lower 25 mg starting dose for the ED indication should be considered for specific populations, including older adults (typically >65 years) and patients with severe hepatic or renal impairment. Furthermore, patients receiving the scheduled PAH regimen must not concurrently take any other forms of sildenafil, regardless of the strength.

Recent Clinical Evidence

Research evidence / Overview of studies for Silda

Evidence for use in Erectile Dysfunction (ED) in Adult Men

The research base for Silda's use in adult men with Erectile Dysfunction is composed primarily of short-term Randomized Controlled Trials (RCTs), supported by Systematic Reviews and Meta-analyses. These studies were used in research exploring how symptoms change over time and monitored patient groups who received Silda compared to those who received an inactive placebo. The studies examined outcomes related to physical discomfort and functional imbalance, using tools like the International Index of Erectile Function (IIEF) to measure changes in erectile function and patient-reported outcomes.

These clinical trials included adult men with varying causes of ED, including those where conditions like diabetes mellitus or cardiovascular disease were also present. Findings described patterns observed in the studies regarding the patient-reported metrics of sexual activity success rates and satisfaction.

What remains uncertain is that long-term outcomes are not well characterized from blinded, placebo-controlled data. Research has not uniformly assessed the medication's activity 24 hours after administration.


Evidence for use in Pulmonary Arterial Hypertension (PAH) in Adults

For adults with Pulmonary Arterial Hypertension (PAH), the evidence structure is built upon short-term, double-blind, placebo-controlled trials, later supported by observational registry data and mandated post-marketing studies. The research examined functional capacity using measures like the 6-minute walk distance (6MWD) and monitored the time until patients experienced a clinical worsening event.

Initial trials reported findings describing patterns observed in the studies, particularly measurements of change in 6MWD in the observed populations. Post-marketing data contributed to the observation of long-term survival patterns in this condition. Evidence regarding dosages above the standard range is limited; some studies observed that higher doses did not consistently correspond to greater changes in functional measures and was associated with increased occurrences of non-fatal adverse events.


Evidence for use in Pulmonary Arterial Hypertension (PAH) in Children

Research on Silda in children with PAH involved Randomized, placebo-controlled, dose-ranging trials, followed by a multi-year extension study focusing on long-term safety. This long-term reporting described a dose-dependent pattern of observed mortality in children receiving higher weight-adjusted doses, a finding that led to different regulatory decisions internationally.

Because of the need for long-term safety observation, the evidence quality varies across studies in this group. The pattern observed in the long-term data regarding higher doses and survival highlights an area where certainty remains low. Furthermore, data for certain groups remain insufficient due to modest sample sizes.

Frequently Asked Questions (FAQ)

Common questions about Silda (FAQ)

Q: What is Silda, and how does it work?

Silda is the brand name for the drug sildenafil, which is primarily used to treat erectile dysfunction (ED). It belongs to a class of medications called phosphodiesterase type 5 (PDE5) inhibitors. Sildenafil works by relaxing the muscles in the walls of blood vessels and increasing blood flow to specific areas of the body, such as the penis, during sexual stimulation. This increased blood flow helps to achieve and maintain an erection. It is also sometimes used to treat pulmonary arterial hypertension (PAH) under a different brand name (Revatio), but Silda is specifically for ED.

Q: How quickly does Silda start working?

Silda typically starts working within 30 to 60 minutes after taking a dose. However, the time may vary depending on the individual, the dose taken, and whether it is taken with food. Taking Silda with a high-fat meal may delay the onset of action, making it take longer to start working effectively. Sexual stimulation is required for Silda to produce an erection.

Q: What are the common side effects of Silda?

The most common side effects of Silda can include headache, flushing (warmth or redness in the face, neck, or chest), stomach upset, abnormal vision (such as a slight blue tint to vision or increased sensitivity to light), nasal congestion, back pain, and dizziness. Most of these side effects are mild and usually temporary. If side effects are severe or persistent, a patient should contact their healthcare provider.

Q: Can I take Silda if I have heart problems or take nitrates?

No, you must not take Silda if you are taking medications called nitrates. Nitrates are often prescribed for chest pain (angina). Taking Silda with nitrates can cause a sudden and serious drop in blood pressure, which could be fatal. Patients with certain heart problems or those who have had a recent stroke or heart attack should discuss their medical history thoroughly with their healthcare provider before taking Silda.

Q: Are there any foods or drinks I should avoid while taking Silda?

It is generally recommended to avoid drinking large amounts of alcohol while taking Silda, as alcohol can increase the risk of side effects like dizziness and headache, and may also impair the ability to get an erection. Additionally, grapefruit juice can interact with Silda, potentially increasing the amount of the drug in the body, which raises the risk of side effects. It is best to avoid consuming grapefruit and grapefruit juice while on this medication.

Q: Is Silda safe for long-term use?

Silda has been widely studied and used for years, and it is generally considered safe for long-term use when taken as prescribed by a healthcare provider. There is no evidence that the body becomes dependent on Silda for an erection, nor does it typically lose effectiveness over time. Regular monitoring by a healthcare provider is important to ensure the continued appropriateness and safety of the medication, especially in older patients or those with underlying health conditions.

How should Silda be stored and disposed of?

How to Store and Dispose of Silda?

Silda (sildenafil) storage and disposal instructions are defined by regulatory bodies to maintain the product's quality and ensure environmental safety.

Requirement Official Standard
Storage Conditions No special storage conditions are required for the film-coated tablets; it is stable at normal room temperature but should be protected from excessive heat and direct moisture.
Container Integrity The medicine must be kept in the original container, which should be tightly closed to preserve the shelf-life.
Child Protection A mandatory requirement is to keep the medication stored out of the sight and reach of children at all times.
Disposal Protocol The preferred method is returning unused or expired tablets via a community drug take-back program or an authorized mail-back envelope. Silda is not on the flush list and should not be poured down the sink or toilet.
Household Disposal If a take-back option is unavailable, discard the tablets by mixing them with an undesirable substance, such as coffee grounds or dirt, placing the mixture in a sealed bag or container, and throwing it into the household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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