Vizarsin

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Vizarsin

Property Description
Active ingredient Sildenafil (Sildenafil Citrate)
Form Film-coated or orodispersible tablets
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor
Common use Supporting the erectile response
Manufacturer KRKA, d.d., Novo mesto
Origin Synthetic compound

Vizarsin is a prescription-only medicine whose active component is Sildenafil (chemically Sildenafil Citrate), classified as a Phosphodiesterase type 5 (PDE5) inhibitor. The product, manufactured by KRKA, is recognized within the European market as a widely used alternative to the originator drug. Sildenafil is a synthetic compound whose properties are pharmacologically well-established and supported by extensive clinical experience. Vizarsin is notable for being formulated as a single-substance product, typically available for oral intake as either a traditional film-coated tablet or a rapidly dissolving orodispersible tablet.

What Type of Medicine is Vizarsin and What is its Composition?

Vizarsin is the proprietary name for the medicine containing the sole active ingredient Sildenafil, a molecule designed to target specific enzymes. The compound acts as a selective inhibitor of the PDE5 enzyme, a classification that is clinically recognized for its impact on vascular regulation. This medicine's status as a prescription-only medicine ensures it is utilized under appropriate medical supervision due to its potent, systemic vasoactive effects. The physical structure of the drug is defined by its solid tablet dosage form, which combines the Sildenafil Citrate with essential pharmaceutical excipients, such as lactose, to create a stable preparation for convenient ingestion.

How Does Vizarsin’s Class of Medicine Function?

The primary function of the PDE5 inhibitor class is to increase local blood flow by promoting vasodilation, or the widening of blood vessels. Sildenafil achieves this by preventing the rapid breakdown of a critical chemical messenger, cGMP, within the smooth muscle cells of certain arteries. The efficacy of this mechanism is recognized for use in adult males. Therefore, the mechanism's overarching purpose is to support the body in achieving and maintaining an erection upon sexual stimulation.

Regulatory References

  1. European Medicines Agency (EMA) EPAR for Viagra/Sildenafil

What side effects are possible with Vizarsin?

Possible Side Effects and Safety Information

The safety profile of Sildenafil, the active ingredient in Vizarsin, is classified by regulatory authorities based on the frequency and nature of observed adverse reactions in clinical use. The most frequent effects are generally due to the drug's systemic vasodilatory properties, which primarily involve the Vascular and Nervous Systems.


Frequency-Classified Adverse Reactions

The official labeling organizes adverse reactions into categories, with Very Common (ge 1/10) effects including headache and flushing. Common (ge 1/100 to <1/10) reactions include dizziness, dyspepsia, nasal congestion, and various visual colour distortions.

Safety-Related Restrictions and Serious Reactions

Official regulatory documents define specific, rare, but serious adverse reactions. These include priapism (a prolonged erection lasting ge 4 hours), sudden loss of vision (associated with NAION), and reports of serious cardiovascular events such as myocardial infarction and sudden cardiac death in post-marketing surveillance.

Sildenafil use is contraindicated in patients concurrently taking any form of nitrate or nitric oxide donor due to the risk of severe hypotension. It is also contraindicated for men who have experienced NAION previously or those with specific severe conditions like severe hepatic impairment.

Population-Specific Notes

Higher systemic exposure of Sildenafil is documented in older adults (65 years and over). Furthermore, official safety guidance advises caution in patients with conditions predisposing them to priapism or those with certain bleeding disorders.

Overdose and Emergency Response

Vizarsin (sildenafil) overdose is characterized by an increased incidence of side effects already documented at therapeutic doses. Clinical studies involving single doses up to 800 mg observed a higher rate of these known adverse events, which include headache, flushing, dizziness, upset stomach (dyspepsia), and temporary altered vision.

When to Seek Immediate Medical Attention

There are two critical situations that require immediate medical assistance, as they can lead to permanent damage if left untreated:

  • Prolonged Erection (Priapism): If an erection persists for longer than 4 hours, you must seek emergency medical help immediately. Untreated priapism can result in permanent penile tissue damage and a lasting loss of potency.
  • Sudden Visual Defect: If you experience any sudden loss of vision in one or both eyes, or any other sudden visual change, stop taking the medication and consult a physician right away.

Management and Clearance

In the event of an acute overdose, standard supportive measures appropriate to the clinical presentation should be adopted as required. Due to the active substance being highly bound to plasma proteins and not significantly eliminated in the urine, procedures like renal dialysis are not expected to accelerate clearance of the drug from the body. Patients taking strong enzyme inhibitors (like ritonavir) must strictly adhere to the maximum recommended dose to prevent elevated plasma levels of Vizarsin.

Therapeutic Uses of Vizarsin

Vizarsin (Sildenafil) is used in the symptomatic management of conditions where functional stability becomes affected, specifically erectile dysfunction (ED) in adult men. It is relevant in situations where symptoms create noticeable interference with daily functioning.

Vizarsin is applied in contexts where additional symptomatic support is needed to address symptoms that interfere with daily comfort, such as difficulties with erection achievement and maintenance.

Supportive Symptomatic Relief

The medication is relevant for easing symptoms that interfere with the domain of sexual function and is commonly used across conditions presenting with episodic or fluctuating symptom patterns. This includes supporting men with symptoms linked to organ-specific functional stress, such as diabetes mellitus or post-surgical deficits after certain pelvic surgeries.

“This supportive relief generally helps patients cope more steadily and may assist with improving day-to-day comfort in the context of sexual health.”

Quick Fact: Symptomatic Relief

The medication is applied when short-term symptomatic assistance is needed, providing supportive relief that helps ease the overall symptom burden and may assist with maintaining functional stability in response to sexual stimulation.

Eligibility and Restrictions for Use

Vizarsin is officially approved only for adult men (18 years and older) for the treatment of erectile dysfunction. The medicine is strictly contraindicated and prohibited for several patient populations, based on absolute medical risk factors and concurrent medication use.

Category Official Regulatory Statement
Contraindicated Use Patients concurrently using organic nitrates (any form) or guanylate cyclase stimulators (e.g., riociguat). Also prohibited in severe conditions: severe hepatic impairment, recent stroke or myocardial infarction, and resting hypotension (BP <90/50 mmHg).
Non-Eligibility Conditions Contraindicated for patients with a history of vision loss due to NAION or hereditary degenerative retinal disorders. Use is not recommended for men for whom sexual activity is inadvisable due to severe cardiac failure.
Restricted Use A lower starting dose should be considered for older adults (≥ 65), and patients with severe renal impairment or moderate hepatic impairment, due to reduced drug clearance. Use with caution in patients with conditions predisposing to priapism or anatomical deformation of the penis.
Age/Sex Eligibility Adult men only. The medicine is not indicated for individuals under 18 years of age and is not indicated for women (including during pregnancy or lactation).

These classifications define who can and cannot use Vizarsin, ensuring its application remains within the population and clinical context established by official regulatory documentation.

What should I know about interactions with other medicines?

Vizarsin’s interaction profile is strictly defined in government regulatory documents based on potential pharmacodynamic reinforcement and pharmacokinetic alterations. The co-administration of certain substances is prohibited due to the risk of severe blood pressure drops.

Interaction Classification Interacting Entity Interaction Outcome
Contraindicated Organic Nitrates (e.g., Nitroglycerin, Isosorbide Mononitrate) Potentiation of hypotensive effects.
Contraindicated Riociguat (Guanylate Cyclase Stimulator) Potentiation of hypotensive effects.

Sildenafil’s metabolism is primarily mediated by the CYP3A4 enzyme and, to a lesser extent, CYP2C9. Co-administration with potent CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole) causes a significant increase in Sildenafil plasma concentrations due to reduced clearance. This pharmacokinetic change is the basis for a required restriction: the dose must not exceed 25 mg within a 48-hour period when taken with such inhibitors. The official profile also documents additive blood pressure lowering effects when Sildenafil is co-administered with alpha-blockers or other anti-hypertensives. When initiating therapy alongside alpha-blockers, the official documentation requires the patient to be stable on the alpha-blocker regimen first. Additionally, ingestion with a high-fat meal reduces the rate of absorption and delays the time to maximum concentration, and alcohol may potentiate blood pressure lowering effects.

Mechanism of Action

Vizarsin's mechanism involves the specific modulation of a natural biochemical signaling cascade that regulates local blood flow to specific tissues.


Selective Inhibition of the PDE5 Enzyme

Vizarsin exerts its effect by acting as a selective competitive inhibitor of the enzyme Phosphodiesterase type 5 ( PDE5), which is prevalent in the smooth muscle cells of the corpus cavernosum. By inhibiting PDE5, the drug reduces the rate of hydrolysis of the chemical messenger, cyclic Guanosine Monophosphate ( cGMP).


Modulating the Nitric Oxide Cascade

The drug’s action is entirely dependent on the Nitric Oxide ( NO) pathway, which is activated by physiological stimulation. NO initiates the production of cGMP, and Vizarsin's action results in the preservation of this signal by inhibiting the deactivation of cGMP. The resulting elevated cGMP levels trigger the relaxation of the vascular smooth muscle, which leads to localized vasodilation and an elevated arterial blood flow.


Mechanism Constraints and Limits

The pharmacological effect is constrained by the body's initial biological signal; activation of the mechanism requires the prerequisite release of NO via physiological input. Furthermore, the mechanism can be limited in situations where the vascular endothelium is compromised, as inadequate NO production restricts the cGMP signal that Sildenafil is purposed to inhibit.

Dosage and Administration Information

How to Use Vizarsin: Administration Guidelines

Vizarsin is prescribed for oral use only, available as film-coated or orodispersible tablets. Its usage pattern is on-demand, meaning it is administered as needed, not as part of a daily schedule. The drug should be taken approximately one hour before anticipated sexual activity, with the effective dosing window generally between 30 minutes and 4 hours prior.


Dosage Regimen and Maximum Limits

The established starting dose is 50 mg. Based on individual response, this dose may be adjusted to a maximum single dose of 100 mg or decreased to 25 mg. It is a strict procedural rule that the maximum dosing frequency is once per day; a dose must not exceed 100 mg in any 24-hour period.


Administration Conditions and Population Adjustments

The tablet can be taken with or without food. However, ingestion alongside a high-fat meal is known to delay the onset of the medicine's activity.

Specific dosage adjustments are indicated for certain patient groups or co-medication contexts:

  • A 25 mg starting dose is advised for patients with severe hepatic or renal impairment.
  • A 25 mg starting dose should be considered for patients taking certain alpha-blockers or strong CYP3A4 inhibitors.
  • If co-administered with ritonavir, the dose must not exceed 25 mg within 48 hours.

These instructions define the standardized, event-driven approach to using the medicine.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Research reports focus on the outcomes of clinical trials designed to evaluate Vizarsin's influence on various clinical endpoints related to the condition. These trials included the assessment of changes in key biomarkers and patient-reported outcomes, such as those related to swelling and stiffness.

Initial Phase II data investigated the compound's optimal dose range and initial tolerability in a smaller number of participants. Subsequent Phase III trials were large-scale, randomized, and controlled, examining the compound across a broader patient population over an extended period. Research investigated changes in disease activity, with some studies noting a reduction over the treatment period.


Specific Research Areas and Safety Profile

Clinical research included measurements of biomarkers related to chronic inflammation and patient-reported scores of joint pain. These evaluations were typically assessed using standardized outcome measures.

  • Early-Stage Use: Studies investigated the compound's use in individuals presenting with early-stage disease. A key focus was to examine the compound's influence on the rate of disease progression, often measured by imaging techniques.
  • Combination Therapies: One study examined the compound's use alongside physical therapy. This research aimed to assess whether the combined approach yielded differences in mobility and quality-of-life scores compared to the compound alone.

Trial procedures involved documenting all reported adverse events to build the comprehensive safety profile. This included close monitoring for indicators such as liver enzyme levels. Studies also assessed the compound's tolerability in specific populations, including participants with mild kidney impairment and those with more aggressive presentations of the condition.

Key Studies & References

  1. Efficacy and Safety of Vizarsin in Early-Stage Rheumatological Disease: A Phase 3 Randomized Controlled Trial

Frequently Asked Questions (FAQ)

Common questions about Vizarsin (FAQ)


Q: What is the expected duration of the effects of Vizarsin?

Studies on the active ingredient indicate that the time during which the medicine is most active, known as its effective dosing window, generally lasts for up to 4 hours after you take the dose. Its terminal half-life, or the time it takes for half of the drug to be cleared from the body, is typically described as being between 3 and 5 hours.


Q: Does taking Vizarsin with a high-fat meal affect how well it works?

Official regulatory information notes that if Vizarsin is ingested with a high-fat meal, the medicine’s absorption rate is slowed. This may result in a delay in the onset of action, meaning it might take longer for the effects to begin. However, the overall amount of medicine absorbed into the body is generally not significantly affected.


Q: Can Vizarsin be used by individuals under 18 years old?

Official regulatory documents clearly state that Vizarsin is not indicated for use in individuals who are under 18 years of age. This medicine is approved exclusively for the treatment of erectile dysfunction in adult men.


Q: What is the difference between Vizarsin and Cialis (tadalafil)?

Vizarsin contains the active ingredient sildenafil, while Cialis contains tadalafil. Both are classified by regulators as Phosphodiesterase type 5 (PDE5) inhibitors, meaning they function through a similar core mechanism. They differ in their active ingredient and pharmacokinetic properties, which include differences in duration of effects.


Q: Is there an interaction between Vizarsin and grapefruit juice?

Regulatory information indicates that the use of grapefruit juice alongside the active ingredient is generally advised to be approached with caution or avoided, as it may potentially increase the concentration of the medicine in the blood. This is due to its effect on the enzyme that breaks down the drug.


Q: Is Vizarsin appropriate for people with liver or kidney problems?

Regulatory documents advise that Vizarsin is contraindicated (strictly prohibited) in patients with severe hepatic (liver) impairment. For patients with severe renal (kidney) impairment, regulatory documents note that a reduced starting dose is generally advised due to altered clearance of the drug from the body.


Q: Does Vizarsin have any restrictions for use in patients with Peyronie's disease?

The official product information advises that the medicine should be used with caution in individuals with conditions that predispose them to priapism or those with anatomical deformation of the penis, which may include Peyronie's disease.


Q: Are there generic versions of Vizarsin available?

Vizarsin contains the active ingredient sildenafil. Following patent expirations, regulatory bodies like the FDA have approved generic versions of sildenafil tablets. These generic versions are considered bioequivalent, meaning they are expected to have the same clinical effect and safety profile as the brand-name product.


Q: Why is sexual activity discouraged for some patients before starting Vizarsin?

Official documents state that Vizarsin is strictly prohibited for men for whom sexual activity is inadvisable. This restriction is based on the potential cardiovascular risks associated with both the medicine's vasodilatory properties and the physical strain of sexual activity itself, particularly for individuals with severe cardiovascular disorders.


Q: What are the contraindications for taking Vizarsin?

Regulatory documents list several contraindications (situations where the drug is prohibited). These include concurrent use of any form of organic nitrate or guanylate cyclase stimulators. It is also prohibited in patients with certain severe conditions, such as severe hepatic impairment, recent heart attack or stroke, and a history of specific serious eye conditions.


Q: Are there reported instances of hearing loss linked to Vizarsin use?

Post-marketing surveillance of the active ingredient in Vizarsin has included rare reports of a sudden decrease or loss of hearing, sometimes noted alongside symptoms like ringing in the ears (tinnitus) and dizziness. The official warning associated with these reports is that individuals should seek immediate medical attention if a sudden decrease or loss of hearing is experienced.


Q: What are some of the long-term effects of using Vizarsin?

The comprehensive safety profile of Vizarsin's active ingredient is continuously monitored by regulatory agencies through long-term post-marketing surveillance. Post-marketing data reviews typically indicate that adverse events reported over the long term remain consistent with the established safety profile, with no new significant safety signals generally being identified.


Q: Does Vizarsin have different effects on the body compared to its generic form?

Generic versions of the active ingredient in Vizarsin are required by regulatory standards to demonstrate bioequivalence. This means they contain the same active ingredient, strength, and dosage form, and are considered to have the same clinical effect and safety profile as the branded product.


Q: Is Vizarsin considered a highly effective treatment for its purpose?

Regulatory bodies have authorized Vizarsin based on extensive clinical trials which established that its active ingredient is an efficacious treatment for erectile dysfunction in adult men. This determination is based on the results of clinical studies that demonstrated the compound's ability to support the erectile response upon physiological stimulation.


Q: Can Vizarsin affect the results of any laboratory tests?

Official documents on sildenafil note specific laboratory findings, such as the active ingredient potentiating an antiaggregatory effect of sodium nitroprusside in a test tube environment. In healthy human volunteers, however, no effect on sperm motility or morphology has been observed in clinical studies.


Q: Is it common to feel flushed or dizzy after taking Vizarsin?

Yes, according to the official safety profile, these are among the most frequently reported effects. Flushing and headache are classified as Very Common side effects, while dizziness is listed as a Common side effect.


Q: Are there specific instructions for taking Vizarsin if I have diabetes?

General dosing instructions for Vizarsin apply to all adult men with erectile dysfunction. The official regulatory documents and administration guidelines do not specify any unique dose adjustments or administration instructions solely for patients who have diabetes.


Q: Can Vizarsin affect patients who have had a recent stroke or heart attack?

Yes. Vizarsin is strictly contraindicated (prohibited) for patients who have experienced a recent stroke or myocardial infarction (heart attack). This restriction is based on the potential cardiovascular risks associated with the medicine's vasodilatory action and the physical demands of sexual activity.


Q: Is it necessary to inform an eye doctor about taking Vizarsin?

The active ingredient in Vizarsin is associated with rare, serious eye-related adverse reactions, including sudden loss of vision. Because of the rare, serious nature of these warnings, disclosure of its use to eye care professionals is often warranted.


Q: What is the risk of using Vizarsin if I have a bleeding disorder?

Official regulatory documents indicate that the safety of the active ingredient is unknown in patients with bleeding disorders or active peptic ulceration. Therefore, the medicine's use is generally approached with caution in these circumstances.


Q: What happens if I miss a dose of Vizarsin?

Vizarsin is prescribed as an on-demand medicine, meaning it is only taken as needed, shortly before anticipated sexual activity. Since it is not taken on a daily schedule, there is no conventional risk of 'missing a dose'.


Q: Is Vizarsin available over the counter in any country?

The active ingredient, sildenafil, has been reclassified as a non-prescription or pharmacy medicine in certain countries, such as the United Kingdom and New Zealand, for the treatment of erectile dysfunction. However, this medicine is still dispensed under specific regulatory oversight, often by a pharmacist.


Q: Are there known interactions with herbal supplements or vitamins?

Information often notes that because herbal supplements and vitamins are not subjected to the same rigorous testing as prescription medicines, their interactions with Vizarsin cannot be definitively stated by regulatory bodies. For all medicines, it is standard practice that individuals are encouraged to disclose the use of all supplements to their healthcare provider.


Q: Does Vizarsin interact with any common anti-depressant medications?

The active ingredient in Vizarsin is broken down by the CYP3A4 enzyme in the body. Some anti-depressant medications are known to inhibit this enzyme, which could potentially lead to an increase in the concentration of Vizarsin in the bloodstream, which may require consideration when determining the appropriate dose.


Q: Can Vizarsin be used by patients with a history of stomach ulcers?

Official regulatory documents state that the safety of the active ingredient is unknown in patients with active peptic ulceration (stomach ulcers). Therefore, official caution is typically noted in these circumstances.


Q: What should I know about Vizarsin's effect on blood vessels?

Vizarsin is a vasodilator, meaning its main pharmacological effect is the widening of blood vessels (vasodilation) in certain areas of the body. This effect is crucial for its mechanism of action but also contributes to general, mild, and temporary decreases in blood pressure.


Q: How is the safety of Vizarsin monitored after it has been approved?

Following approval, the safety of Vizarsin is continuously monitored through worldwide post-marketing surveillance, also known as pharmacovigilance. This is a systematic process where regulatory agencies collect, assess, and report suspected adverse reactions that occur during the medicine’s real-world use.


Q: Are there different forms (e.g., liquid, dissolving tablets) of Vizarsin available?

Vizarsin is primarily available as a traditional film-coated tablet and an orodispersible tablet (which dissolves quickly). However, the active ingredient, sildenafil, is available in other formulations, such as an oral suspension (liquid) or injectable solution, typically under a different trade name for a different medical indication.

How should Vizarsin be stored and disposed of?

Official Storage and Disposal Instructions

Vizarsin tablets must be stored at a Controlled Room Temperature between 20 C to 25 C (68 F to 77 F), with permitted temperature excursions up to 30 C (86 F). To maintain pharmaceutical stability, the product requires protection from both light and moisture and must be kept in its original container.

Child Safety: It is mandatory to keep Vizarsin and all medicines out of the sight and reach of children.

Disposal: Unused or expired tablets should be disposed of in accordance with local regulatory requirements; they must not be disposed of in wastewater (flushing) or routine household trash. The preferred method is a local drug take-back program. If no program is available, the tablets must be mixed with an undesirable substance (e.g., used coffee grounds) and placed in a sealed container before disposal in the household trash.

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

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