Viavag

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Medically reviewed

Marina Burgos

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 Viavag

Property Description
Active ingredient Sildenafil citrate (Sildenafil)
Form Film-coated tablets
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor
Origin Synthetic pyrazolo[4,3-d]pyrimidin-7-one derivative

What Type of Medicine is Viavag (Sildenafil)?

Viavag is a single-ingredient, synthetic prescription medicine containing the active substance Sildenafil, which is classified as a Phosphodiesterase type 5 (PDE5) inhibitor. Sildenafil is a pyrazolo[4,3-d]pyrimidin-7-one derivative, confirming its synthetic chemical origin. This pharmacological class is highly specific, meaning the drug’s mechanism is targeted at modulating the PDE5 enzyme. Sildenafil belongs to this group of PDE5 inhibitors. The use of Sildenafil as an orally administered agent is recognized for supporting circulatory function.

The drug's single active component is Sildenafil citrate. As a selective inhibitor, Viavag operates via a distinct mechanism compared to many older, non-selective vasodilator agents. The medicine is clinically recognized for its selective action, ensuring the drug targets the specific enzyme responsible for the breakdown of a key signaling molecule, defining its capacity for a controlled physiological response.

Composition and General Function of Viavag Tablets

The medicine is formulated as film-coated tablets for oral therapy, designed to deliver the Sildenafil citrate active ingredient efficiently throughout the body. The choice of a solid, oral dosage form combined with pharmaceutical excipients is standard for systemic medications, ensuring stability and a reliable route of administration. Viavag is consistently presented as a single-ingredient product, offering a focused formulation.

Functionally, Viavag is categorized as a vasodilator agent because its core mechanism promotes smooth muscle relaxation within the walls of specific blood vessels. By inhibiting the PDE5 enzyme, the drug prevents the breakdown of cyclic guanosine monophosphate (cGMP), facilitating vasodilation. This increase in cGMP is responsible for the smooth muscle relaxation that, in turn, supports increased blood flow, which is the fundamental physiological purpose of the medicine.

Regulatory References

  1. Sildenafil Actavis | European Medicines Agency (EMA)

What side effects are possible with Viavag?

The possible side effects and safety information for Sildenafil (the active ingredient in Viavag) are formally classified by regulatory authorities based on their reported frequency and the body system affected.

Adverse Reaction Categories

The most common adverse reactions reported in regulatory sources include System-Organ-Class effects such as Nervous System disorders (e.g., headache, dizziness) and Vascular disorders (e.g., flushing, hot flush). Other frequently reported effects involve Gastrointestinal disorders (dyspepsia, nausea) and Eye disorders (visual colour distortions, blurred vision).

Frequency Classification Examples of Adverse Reactions (Regulatory Basis)
Very Common ( ge 1/10 ) Headache
Common ( ge 1/100 to <1/10 ) Flushing, Dyspepsia, Nasal congestion, Visual colour distortions
Rare ( ge 1/10,000 to <1/1,000 ) Priapism, Sudden cardiac death, Non-arteritic anterior ischaemic optic neuropathy (NAION)
Not Known Sudden decrease or loss of hearing

Serious Adverse Reactions and Safety Constraints

Official labeling documents identify several rare but clinically significant adverse events. These serious adverse reactions include Priapism (a prolonged erection lasting over 4 hours), NAION (a cause of sudden, permanent vision loss), and certain serious cardiovascular events (e.g., myocardial infarction, stroke) reported in association with use, particularly in patients with pre-existing risk factors.

High-level Safety Restrictions

The medicine is strictly contraindicated for use with nitrate or nitric oxide donor medicines in any form, due to the potential for severe, life-threatening drops in blood pressure. Co-administration with guanylate cyclase stimulators is also restricted. Furthermore, specific safety considerations apply to patients with severe hepatic impairment, a history of NAION, or those whose conditions (such as severe hypotension or recent cardiac events) could be worsened by Sildenafil's systemic vasodilatory effects. Safety notes also exist for use in patients with conditions predisposing them to priapism (e.g., sickle cell anaemia).

Overdose and Emergency Response

Overexposure to Viavag (Sildenafil) is formally documented in regulatory labeling to result in an increased frequency and greater severity of adverse reactions typically known for the medicine. These exaggerated effects may include pronounced hypotension (decreased blood pressure), severe headache, facial flushing, and intensified visual color distortions or blurred vision.

When Immediate Medical Help is Required

Certain overdose manifestations necessitate immediate medical assistance as mandated by regulatory authorities, due to the risk of severe or permanent complications:

  • Prolonged Erection: Seek immediate medical help if an erection persists longer than four hours (priapism). Delayed treatment may result in irreversible penile tissue damage and permanent loss of potency.
  • Sensory Loss: Urgent medical attention is required for the acute onset of sudden loss of vision in one or both eyes or a sudden decrease or loss of hearing.

Supportive Management and Risk Considerations

The official prescribing information states that the management of Sildenafil overexposure is symptomatic and supportive. Due to the high protein-binding of the active substance, procedural interventions like renal dialysis are not expected to accelerate the clearance of the drug from the body. Clearance is known to be reduced in patients with severe hepatic or renal impairment, which may lead to higher systemic drug exposure.

Therapeutic Uses of Viavag

Quick Facts

  • Therapeutic Domain 1: Management of Erectile Dysfunction
  • Therapeutic Domain 2: Administration for Pulmonary Arterial Hypertension (PAH)

Viavag is a prescription medication utilized to support adult patients facing specific health challenges. Its therapeutic actions are primarily directed toward two distinct conditions.

First, Viavag is indicated for the management of erectile dysfunction (ED) in men. This use is intended to assist in achieving or maintaining an erection sufficient for satisfactory sexual activity. To achieve the intended effect, appropriate sexual stimulation is necessary.

Second, Viavag is also administered to adults and children over one year of age for the treatment of pulmonary arterial hypertension (PAH). This condition involves abnormally high blood pressure in the arteries of the lungs. In this context, the medication is used to help improve exercise capacity and manage symptoms associated with the condition.

Any decision regarding the use of Viavag must be made in consultation with a qualified healthcare provider.

Eligibility and Restrictions for Use

Who Can and Cannot Use Viavag (Sildenafil)

The eligibility for Viavag is defined by specific exclusions, restrictions, and age requirements documented by regulatory authorities (such as the FDA and EMA) for its licensed uses (Erectile Dysfunction and Pulmonary Arterial Hypertension).

Absolute Contraindications (Must Not Use)

Contraindicated Group Restriction Basis
Patients using Nitrates/NO Donors Concomitant use with organic nitrates or nitric oxide donors is strictly prohibited due to the risk of severe hypotension.
Patients with Severe Cardiovascular Events Contraindicated in those with a recent history of stroke, myocardial infarction, or severe hypotension (lt 90/50 mmHg).
Patients with Severe Liver Impairment Contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).
Patients with Specific Ocular Conditions Contraindicated in those with known hereditary retinal disorders or a history of Non-Arteritic Anterior Ischaemic Optic Neuropathy (NAION).

Age- and Condition-Based Restrictions

  • Adults (ED Indication): Only adults (18+ years) are eligible for the Erectile Dysfunction indication. Use in the pediatric population is not indicated.
  • Pediatrics (PAH Indication): Approved for use in children over one year for Pulmonary Arterial Hypertension (PAH), but major regulatory warnings exist regarding chronic use in this age group.
  • Older Adults & Organ Impairment: Patients ge 65 years and those with severe renal impairment (creatinine clearance lt 30 mL/min) often require special consideration.
  • Pregnancy/Lactation: The official labeling indicates that there are no adequate and well-controlled human studies regarding use during pregnancy or lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Viavag (Sildenafil) describes specific interactions based on pharmacokinetic and pharmacodynamic mechanisms that result in required restrictions on co-administration.

Interaction Classifications and Restrictions

The following high-level interaction classifications are defined in regulatory documents:

Classification Interacting Agents Basis of Restriction (Regulatory)
Contraindicated Nitrates and Nitric Oxide Donors, Guanylate Cyclase (GC) Stimulators (e.g., Riociguat). Potentiation of Hypotensive Effects
Clinically Significant Strong CYP3A4 Inhibitors (e.g., Ritonavir, Ketoconazole, Erythromycin), Alpha-Blockers (e.g., Doxazosin, Terazosin). Reduced Clearance / Additive Vasodilation

Pharmacokinetic and Administration Constraints

Sildenafil clearance is primarily mediated by the CYP3A4 isoenzyme. Co-administration with strong inhibitors of this enzyme, such as Ritonavir, results in a major increase in Sildenafil systemic exposure (AUC). Due to this effect, regulatory documents stipulate that when combined with Ritonavir, the maximum Sildenafil dose must not exceed 25 mg within a 48-hour period.

The official profile notes that co-administration with alpha-blockers may lead to an additive hypotensive effect, with the greatest risk of symptomatic low blood pressure documented within four hours of Sildenafil dosing. Furthermore, a high-fat meal is documented to reduce the rate of absorption and decrease peak plasma concentration (Cmax) of Sildenafil. Individuals with severe hepatic or severe renal impairment are noted in labeling as having reduced Sildenafil clearance, an effect that must be considered alongside other drug interactions.

Mechanism of Action

Selective Enzyme Inhibition and Second Messenger Preservation

Viavag's mechanism is defined by its action as a selective competitive inhibitor of the Phosphodiesterase type 5 (PDE5) enzyme . This molecular interaction prevents the breakdown of the signaling molecule cyclic Guanosine Monophosphate (cGMP), resulting in the accumulation of cGMP within the vascular smooth muscle cells.


Modulation of the NO-cGMP Pathway

The preservation of cGMP sustains the signal cascade initiated by the natural release of Nitric Oxide (NO), a regulator of vascular tone. Elevated cGMP activates Protein Kinase G (PKG), which leads to a reduction in the intracellular concentration of calcium ions ( Ca^2+). This sequence influences the physiological process of muscle contraction and relaxation.


Resulting Physiological Consequence: Targeted Vasodilation

The lowered calcium concentration facilitates the relaxation of vascular smooth muscle cells, resulting in vasodilation (widening of the blood vessels) in the areas where the PDE5 enzyme is most prevalent. This physiological change is the direct consequence of vasodilation and results in an increase in localized blood flow, which is contingent upon active NO signaling.

Dosage and Administration Information

How Viavag is Used: Administration Guidelines

Viavag (Sildenafil) administration follows specific protocols for the two approved indications: Erectile Dysfunction (ED) and Pulmonary Arterial Hypertension (PAH).

Administration Pathways and Dosing

The medicine is primarily administered via the oral route as tablets or a reconstituted suspension. An intravenous (IV) injection is also approved for temporary use in PAH patients unable to take the oral form.

Indication Standard Dosing and Frequency Administration Constraint
Erectile Dysfunction (ED) 50 mg starting dose (range 25 mg to 100 mg). Maximum once per day. Must be taken 30 minutes to 4 hours before sexual activity.
Pulmonary Arterial Hypertension (PAH) Recommended oral dose of 20 mg three times a day (TID), titratable up to 80 mg TID. Doses must be separated by approximately 4 to 6 hours.

Contextual Use and Adjustments

Administration can occur with or without food; however, a high-fat meal may lead to a delay in the onset of action. The use pattern for ED is acute and intermittent (as needed), while for PAH, the medicine is utilized as part of a long-term, chronic treatment protocol.

Specific starting dose adjustments are outlined for certain patient populations. A starting oral dose of 25 mg for ED should be considered for older adults (over 65 years), and for those with severe renal or hepatic impairment. The oral suspension form for PAH requires a specific reconstitution process with water prior to administration.

Recent Clinical Evidence

Viavag: Recent Clinical Evidence

Studies on Clinical Outcomes

Research on Pain Management

Clinical research has evaluated the potential to affect pain scores across various chronic conditions. Initial randomized controlled trials (RCTs) examined the compound as a potential analgesic. These studies explored whether the compound affects the need for rescue medication or changes in patient-reported pain scales over short-term observation periods. Findings across several trials were mixed, with some reports showing statistically significant differences in outcomes compared to placebo and others showing no significant difference in primary endpoints.

Targeted Delivery Methods

Research has explored whether the compound affects local pain when administered via topical formulations, driven by concerns regarding systemic exposure. Studies typically involved the use of the lowest possible dose to minimize systemic absorption while examining local effect. This approach was investigated in the context of reducing overall systemic exposure. Research specifically examined the use of patches versus creams, evaluating absorption rates and local tolerability.

Cardiovascular Safety Context

A meta-analysis of short-term RCTs examined the potential for changes in the incidence of adverse cardiovascular events, such as myocardial infarction and stroke, when comparing the compound to placebo. Overall, the evidence base remains limited, and long-term observational studies are necessary to provide a more complete assessment of the compound's cardiovascular safety.

Preclinical and Mechanistic Context

Preclinical research suggests that the compound may affect certain biological processes, such as the modulation of specific neural pathways involved in nociception (the processing of painful stimuli). In vitro (cell culture) and animal studies have investigated various molecular targets, including ion channels and neurotransmitter receptors, to better understand potential pathways of action.

Important Context and Safety Notes

This information is a summary of research findings and does not constitute a recommendation or advice. The available research is descriptive of study design and observed changes in outcomes, not an endorsement of therapeutic use.

Frequently Asked Questions (FAQ)

Common questions about Viavag (FAQ)

Q: How quickly does Viavag typically start working?

Official administration guidelines state that the medicine is typically taken between 30 minutes and 4 hours before planned activity for the ED indication. The exact time it begins to work can vary from person to person, as it depends on how quickly your body absorbs the medicine. Taking it with a high-fat meal may lead to a delay in the onset of action.

Q: Is it safe to drink alcohol while taking Viavag?

Regulatory documents caution that drinking alcohol while taking this medicine can increase the likelihood of side effects like dizziness and headache. This is because alcohol, like Viavag, can lead to a drop in blood pressure. Caution is noted in official safety information.

Q: Are there any specific foods, like grapefruit, that should be avoided when taking Viavag?

Official safety information indicates that consuming grapefruit juice may lead to an increase in the amount of medicine circulating in the body. This interaction occurs because grapefruit can affect the way the liver breaks down the drug. Due to the potential for increased side effects, avoidance of grapefruit products is generally noted.

Q: Can Viavag be taken alongside daily vitamins or herbal supplements?

Regulatory guidance emphasizes the importance of informing your healthcare provider about all vitamins and herbal supplements you are taking. Some supplements, such as St. John's wort, may interact with the medicine's metabolism, which is managed by a liver enzyme called CYP3A4.

Q: Does Viavag affect the ability to drive or operate machinery?

Official product labeling warns that Viavag may cause certain side effects, including dizziness and changes in vision. If these effects are experienced, regulatory labeling contains a caution against driving or operating heavy machinery.

Q: Does Viavag have a potential for dependence or addiction?

Regulatory documents and clinical safety summaries indicate that Viavag is not known to carry a potential for physical dependence or addiction.

Q: Will stopping Viavag suddenly cause any withdrawal-like symptoms?

According to official regulatory safety data, patients do not typically experience physical withdrawal symptoms when they stop taking the medicine abruptly.

Q: Is it normal to feel a mild headache or nausea when first starting Viavag?

Headache is listed as a very common side effect, and nausea is listed as a common side effect in official documents. It is recognized that side effects may occur, particularly when a patient first begins taking the medication.

Q: Does Viavag come with a patient information or medication guide?

Yes, as required by regulatory agencies like the FDA and EMA, all prescription medicines are dispensed with specific patient materials. This material usually takes the form of a Patient Information Leaflet or Medication Guide, which provides essential usage and safety details.

Q: What is the procedure for reporting a side effect experienced with Viavag?

Official regulatory agencies maintain specific voluntary reporting systems to collect information on suspected side effects once a medicine is on the market. Patients can find details on how to submit a report directly on the websites of bodies like the FDA or the EMA.

Q: Does Viavag carry a specific Black Box Warning from the FDA?

The FDA label for the medicine's Erectile Dysfunction indication does not include a Black Box Warning. This is a specific, high-level alert that the FDA reserves for certain serious safety concerns.

Q: Are there any known allergens or inactive ingredients in Viavag that commonly cause issues?

Official regulatory documents, such as the FDA Prescribing Information, contain a full list of all inactive ingredients and excipients used in the medicine's formulation. These details are provided so that individuals with known allergies can check the list.

Q: What should I do if I accidentally take two doses of Viavag close together?

Taking more than the prescribed amount is associated with an increased risk and severity of known side effects. Official guidance states that a healthcare professional or poison control center should be contacted in the event of an accidental overdose.

Q: Are there long-term side effects that have been studied for Viavag?

While many of the initial clinical trials for the medicine were short-term, the overall safety profile, including rare and serious events, is continually monitored. This is achieved through regulatory post-marketing surveillance, which collects long-term data on the drug’s use in the general population.

Q: Does Viavag cause any mental or mood changes, such as anxiety or insomnia?

Studies and official adverse reaction tables indicate that certain changes in mood and mental status have been reported. Specifically, insomnia (difficulty sleeping) and anxiety are listed among the common adverse reactions documented in clinical trials.

Q: What is the risk classification of Viavag during pregnancy, such as Category B or C?

The medicine has historically been classified in some regulatory documents as Pregnancy Category B, though current labels often use the newer Pregnancy and Lactation Labeling Rule (PLR) format. It is important to note that the official label consistently states there are no adequate and well-controlled human studies on its use during pregnancy.

Q: Where can I find the official regulatory document (like the FDA label or SmPC) for Viavag online?

Official regulatory documents, such as the FDA Prescribing Information or the EMA Summary of Product Characteristics (SmPC), are made publicly available. These documents can typically be found by searching government resources like the FDA's DailyMed database or the European Medicines Agency website.

Q: Does Viavag affect fertility in men or women?

Non-clinical research, primarily studies conducted in animals, indicated no observed effect on fertility at prescribed dose levels. However, the official prescribing information notes that the effects on human fertility have not been fully evaluated in dedicated studies.

Q: Is it necessary to complete the entire course of Viavag even if symptoms improve quickly?

The required duration of use depends entirely on the condition being addressed. For the ED indication, the use is acute and intermittent (as needed), while for the PAH indication, it is part of a long-term, chronic protocol. Official information states that the use should align with the specific regimen defined by the prescribing physician.

Q: How does Viavag affect the body's metabolism?

Official pharmacokinetic information states that the medicine is primarily broken down and cleared from the body by the liver. Specifically, it uses a major enzyme system in the liver known as CYP3A4 for its metabolism.

Q: Is it possible to develop a tolerance to the effects of Viavag over time?

While some patients may require a higher dose over time, regulatory documents suggest this often reflects the natural progression of the underlying medical condition rather than the body developing a tolerance to the drug itself.

Q: What should I do if I miss a dose of Viavag?

The procedure for a missed dose depends on the reason you are taking the medicine. For the 'as-needed' ED use, a dose cannot technically be missed. For the regularly scheduled PAH indication, official patient instructions usually state that the next dose should be taken as scheduled and not doubled.

How should Viavag be stored and disposed of?

Storage and Protection Requirements

Viavag tablets must be stored at a Controlled Room Temperature to maintain stability. The required range is 20 C to 25 C (68 F to 77 F), with temporary excursions permitted from 15 C to 30 C (59 F to 86 F); storage must not exceed 30 C.

The medicine must be kept in the original package and tightly closed to ensure it is protected from moisture. For safety, the product is required to be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Viavag tablets must be disposed of according to local regulations. General regulatory guidance prohibits discarding the medicine via wastewater or mixing it with household trash, as Sildenafil is not on the list of medicines recommended for flushing. No special requirements for handling this solid dosage form are specified in official labeling.

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

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