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Altus (Sildenafil)

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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.

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Overview of Altus (Sildenafil)

Quick Facts

Property Description
Active ingredient Sildenafil citrate
Form Tablet, Suspension, Injectable solution
Pharmacological class Phosphodiesterase 5 (PDE5) Inhibitor
Common purpose Vascular smooth muscle relaxation
Origin Synthetic compound

What Type of Medicine is Altus (Sildenafil)?

Altus is a prescription-only medicine containing the synthetic compound Sildenafil, which is categorized as a Phosphodiesterase 5 (PDE5) inhibitor. This classification establishes that the drug works by targeting the PDE5 enzyme to modulate vascular function. Sildenafil is a single-ingredient product and holds the distinction of being the first PDE5 inhibitor approved for its therapeutic indications.

Composition and Available Pharmaceutical Forms

The core component of this medicine is the active substance, Sildenafil citrate, which is the active chemical salt combined with pharmaceutical excipients. Sildenafil's formulation is diverse, encompassing the most common oral dosage form (tablet), a powder for oral suspension, and an injectable solution. These varying forms permit both standard oral administration and intravenous use in specialized settings, ensuring the medicine can be delivered effectively to diverse patient groups, including adults and certain pediatric patients.

General Purpose of this Therapeutic Agent

The general purpose of Sildenafil is linked to its ability to enhance smooth muscle relaxation within specific blood vessel walls, which leads to increased blood flow. By inhibiting the PDE5 enzyme, the compound helps sustain the natural chemical messenger cyclic guanosine monophosphate (cGMP). This therapeutic effect is clinically recognized for aiding in achieving and sustaining an erection, and separately, for its ability to reduce high blood pressure in the arteries of the lungs (Pulmonary Arterial Hypertension), thereby reducing heart strain.

Regulatory References

  1. Sildenafil - StatPearls - NCBI Bookshelf
  2. Revatio (sildenafil) EMA EPAR Summary
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What side effects are possible with Altus (Sildenafil)?

Possible side effects and safety information

The safety profile of Sildenafil is defined by regulatory agencies based on the frequency and system-organ classification of reported adverse reactions.

Classification Representative Adverse Reactions
Very Common (occurs in 10% of patients) Headache, Flushing
Common (occurs in 1% to <10% of patients) Dizziness, Dyspepsia (indigestion), Nasal Congestion, Visual Disturbance (e.g., blurred vision, cyanopsia), Back Pain, Myalgia, Nausea

Serious adverse reactions are reported primarily through post-marketing surveillance and include clinically significant events affecting the cardiovascular, neurological, and urogenital systems.

Serious Adverse Reactions and Safety Constraints

Official labeling documents mention Priapism (prolonged erection lasting over four hours), Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) which can lead to permanent vision loss, and Sudden Decrease or Loss of Hearing in association with the use of this medicine. Serious cardiovascular events, such as Myocardial Infarction or Sudden Cardiac Death, have been reported post-marketing, often in individuals with pre-existing risk factors.

Regulatory Safety Restrictions

The medicine is contraindicated for use with any form of organic nitrate or nitric oxide donor, or with guanylate cyclase stimulators (e.g., riociguat), due to the risk of severe hypotension. Use is also officially restricted in patient groups with severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg), a recent history of stroke or myocardial infarction, and certain hereditary retinal disorders (e.g., retinitis pigmentosa).

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents indicate that in the event of an Altus (sildenafil) overdose, the observed adverse events are generally extensions of the drug's known effects, but with increased frequency and severity. The symptoms documented in studies of single doses up to 800 mg include headache, flushing, dyspepsia, and visual disturbances, which occur at higher rates and with greater intensity compared to lower therapeutic doses.

Over-exposure to sildenafil is associated with a risk of decreased blood pressure (hypotension), fainting (syncope), and a prolonged erection (priapism).

When to Seek Immediate Medical Help

Regulatory agencies explicitly advise that immediate medical assistance must be sought or a regional Poison Control Centre contacted in the case of suspected overdose, even if no symptoms are present. Due to the potential for severe effects like significant hypotension or prolonged erection, timely intervention is critical.

Management of Overdose

Official guidance specifies that standard supportive and symptomatic measures should be adopted as required. Importantly, sildenafil is highly bound to plasma proteins, and elimination via renal dialysis is not expected to be effective in accelerating clearance of the drug from the body.

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Therapeutic Uses of Altus (Sildenafil)

What Altus (Sildenafil) Treats: Main Uses and Benefits

This medication is commonly used across two primary, distinct therapeutic domains: the management of Pulmonary Arterial Hypertension (PAH) and the treatment of Erectile Dysfunction (ED). This medication is applied across domains where support for symptom management is needed.

Support for Symptom Management

For Erectile Dysfunction, the domain is applied in addressing the chronic physical condition characterized by the inability to achieve or maintain a penile erection sufficient for sexual performance. The primary therapeutic benefit is to provide support that may assist with achieving and maintaining an erection upon sexual stimulation, generally contributing to improved comfort and support for functional stability in the context of sexual activity.

For Pulmonary Arterial Hypertension, the medication helps address the resulting symptoms, such as shortness of breath and fatigue that interfere with daily functioning, particularly in patients classified as WHO Functional Class II, III, and IV. This treatment may assist with managing the symptom burden, contributing to better functional stability and a reduction of physiological strain on the heart.

“The treatment is generally used in conditions where the primary goal is to improve functional stability and ease symptoms related to localized or systemic vascular function.”


Quick Fact Block

Quick Fact: Relief for Key Symptoms
Symptom Cluster: Impaired penile erection and associated functional difficulties.
Symptom Cluster: Shortness of breath and fatigue linked to high pulmonary artery pressure.
Patient Benefit: Contributes to improved functional stability in sexual health and supports the handling of distressing manifestations during physical activity.

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

Who Can and Cannot Use Altus (Sildenafil)?

Official regulatory information from agencies like the FDA and EMA defines strict rules for who can and cannot use Altus (Sildenafil). Eligibility varies based on the approved condition—Erectile Dysfunction (ED) or Pulmonary Arterial Hypertension (PAH)—and the patient's underlying health status.


Absolute Contraindications

Use of Sildenafil is strictly prohibited in patients taking any form of organic nitrates (e.g., nitroglycerin) or guanylate cyclase (sGC) stimulators (e.g., Riociguat), due to the serious risk of a dangerous drop in blood pressure. It is also contraindicated in patients with a known hypersensitivity to the drug, a recent history of stroke or myocardial infarction, severe hepatic impairment (Child-Pugh Class C), or pre-existing hypotension (blood pressure <90/50 mmHg).


Eligibility by Population and Condition

Population Group Eligibility Status (Official Labeling)
Adult Males (ED) Generally eligible, ge 18 years old.
Adults (PAH) Generally eligible.
Pediatric Patients (PAH) Indicated for patients ge 1 year of age. Use for ED is not indicated below 18 years.
Severe Renal/Hepatic Impairment Restricted use; a lower starting dose (e.g., 25 mg for ED) should be considered due to reduced drug clearance.
Pregnancy/Lactation Safety has not been established; use is restricted to when the benefit to the mother (e.g., for PAH) outweighs potential risks.
High-Risk Conditions Contraindicated in patients with a history of NAION or certain hereditary degenerative retinal disorders.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Organic Nitrates in any form (regularly or intermittently) and the soluble guanylate cyclase stimulator Riociguat are formally contraindicated for co-administration. This is due to the potential for an additive hypotensive effect, which may lead to dangerously low blood pressure.

Pharmacokinetic Interactions

Sildenafil is principally cleared from the body by the liver enzyme Cytochrome P450 (CYP) 3A4. Agents that interact with this pathway can alter Sildenafil's systemic exposure.

Classification Interacting Agents Outcome
Strong CYP3A4 Inhibitors Ritonavir, Ketoconazole, Erythromycin Significantly increase Sildenafil plasma levels (e.g., Ritonavir causes an 11-fold increase in AUC).
CYP3A4 Inducers Rifampin, St. John’s wort Expected to decrease Sildenafil plasma levels by accelerating clearance.

Pharmacodynamic and Other Interactions

Co-administration with Alpha-Blockers and other Antihypertensive Agents may lead to symptomatic hypotension, and patients should be hemodynamically stable on these therapies prior to Sildenafil initiation. Sildenafil is also noted to potentiate the anti-aggregatory effect of sodium nitroprusside in vitro.

Food Interactions

Ingestion with a high-fat meal reduces the rate of absorption, causing a mean delay in time to maximum concentration ( T max) and a reduction in maximum concentration ( C max) by 29%. Grapefruit juice may also increase Sildenafil plasma levels due to its effect on CYP3A4.

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Mechanism of Action

How Altus (Sildenafil) Works

Specific Inhibition of the PDE5 Enzyme

The mechanism of Altus (Sildenafil) begins with its selective inhibition of the enzyme Phosphodiesterase type 5 ( PDE5). This molecular interaction defines the drug's core function, blocking PDE5 from performing its natural task: the rapid chemical deactivation of the critical signaling molecule, cyclic guanosine monophosphate ( cGMP). This enzyme-blocking action is the key step that allows the cGMP messenger to accumulate and sustain its concentration within the target cells.

Augmentation of the NO/ cGMP Signaling Pathway

By preventing the breakdown of cGMP, Sildenafil augments the downstream effects of the natural Nitric Oxide ( NO) pathway. Elevated and sustained cGMP levels trigger a cascade that ultimately leads to the reduction of intracellular calcium within vascular smooth muscle cells. This molecular change results in the relaxation of blood vessel walls and is the core physiological change resulting from the drug's mechanism.

Conditional Vasodilation and Augmented Local Blood Flow

The resulting smooth muscle relaxation translates directly into vasodilation (widening of the arteries) in specific, targeted vasculatures. Crucially, Sildenafil is a conditional mechanism, meaning it requires the upstream release of NO to be effective; it only amplifies the body's natural signaling, rather than initiating the process itself. This dependency ensures the drug's effect is localized, leading to augmented local blood flow where the pathway is naturally active.

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Dosage and Administration Information

How to Use Altus (Sildenafil): Official Administration Guidelines

Sildenafil is administered under specific protocols dictated by its intended medical use, defining the required dose, frequency, and route. The administration is either intermittent (as-needed) or scheduled (fixed, three times daily), depending on the indication.

Official Routes and Administration Specifics

Indication Standard Oral Dose Frequency & Timing Special Conditions
Erectile Dysfunction (ED) Initial 50 mg (range 25 mg to 100 mg) Maximum once per day, taken 30 minutes to 4 hours before activity May be taken with or without food; high-fat meals may delay onset.
Pulmonary Arterial Hypertension (PAH) 20 mg (titratable up to 80 mg) Three times a day (TID), doses administered 4 to 6 hours apart. Intravenous injection (10 mg dose) is reserved for patients temporarily unable to take oral medication.

Dosage Adjustments and Preparation

  • Population-Specific Dosing: A reduced 25 mg starting dose for the ED indication should be considered for patients with severe renal impairment, hepatic impairment (e.g., cirrhosis), or in adults 65 years of age or older. Pediatric dosing for PAH is weight-based.
  • Preparation: The oral suspension form must be reconstituted with water and shaken vigorously before each use, requiring a calibrated measuring device for accurate administration.
  • Drug-Specific Restrictions: When co-administered with certain strong inhibitors, such as ritonavir, the maximum sildenafil dose is limited to 25 mg within a 48 -hour period.

Connection to the Overall Use Protocol

The framework establishes that the use of Sildenafil requires strict adherence to either a fixed TID schedule for the chronic management of PAH or an as-needed, single-dose pattern for ED. These requirements define the context, route, and dosing for initiation and maintenance, ensuring consistent application according to official standards.

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Recent Clinical Evidence

Altus (Sildenafil): Recent Clinical Evidence

The following is a neutral overview of research findings and clinical evaluation associated with the compound Altus (sildenafil). This information describes the scope of the studies, not therapeutic claims or recommendations.


Chronic Pain Management

Research explored whether the compound was evaluated for changes in reported pain severity in some patients with chronic back pain. The reported change in symptoms was evaluated alongside an assessment of other first-line treatment options in some study designs.

Mechanism of Action Trials

Initial trials examined whether the compound was evaluated for changes in pain intensity, as well as the compound's effect on inflammatory markers. One study compared the compound to standard physiotherapy alone in a specific patient cohort.


Long-Term Efficacy and Safety

Long-term studies spanning a 5-year period tracked outcomes for participants who received the compound to observe data related to pain management and quality of life. The exploration of combining the treatment with dietary modifications on relapse rates has also been described in observational research.


Sub-Populations and Special Considerations

Use During Pregnancy

Specific studies focusing on the compound's use during pregnancy have not been identified for the chronic pain indication. Clinical data for its approved uses in pulmonary hypertension during pregnancy vary, and specialized monitoring is generally required.

Patients with Liver Conditions

Research examined liver enzyme markers and reported potential changes in subjects with pre-existing liver conditions, as the compound is primarily metabolized by the liver. This approach was one of the options evaluated in trials for chronic joint pain.

Key Studies & References

  1. Sildenafil - LiverTox - Clinical and Research Information on Drug-induced Liver Injury (NIH)
  2. Sildenafil-associated hepatoxicity: a review of the literature
  3. USE OF SILDENAFIL IN PREGNANCY - UK Teratology Information Service (UKTIS)
  4. Function of sildenafil on diseases other than urogenital system: An umbrella review
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Frequently Asked Questions (FAQ)

Common questions about Altus (Sildenafil) (FAQ)

Q: Is the active ingredient in Altus the same as in other commonly known ED medications?

Yes, the active ingredient in Altus is sildenafil. According to official documents, this is the same chemical compound found in various other branded medications and generic forms approved for treating the same indications. Regulatory bodies require that all generic equivalents are bioequivalent to the branded product.

Q: Are there any long-term health concerns or side effects associated with Altus use?

Safety information is continuously gathered through post-marketing surveillance programs, which involve long-term observation of patient outcomes. Official labeling lists several serious, though rare, adverse reactions, such as sudden hearing loss and Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION). Serious events have been reported, often in individuals with pre-existing risk factors, according to post-marketing data.

Q: Is Altus designed to increase sexual desire or arousal?

No, official product information clarifies that Altus works by augmenting the body’s natural physical response to stimulation. It does not act on the psychological components of sexual desire or arousal. Official labeling indicates that the use of the drug requires the presence of sexual stimulation to be effective.

Q: What is the difference between Altus and the generic form of Sildenafil?

Altus is a branded pharmaceutical product, while Sildenafil is the name of the active chemical ingredient it contains. Regulatory standards mandate that the generic form, Sildenafil, must be bioequivalent to the branded Altus. This means both forms are expected to produce the same concentration levels of the active substance in the body.

Q: What is the typical window of time during which Altus remains active in the body?

The duration of the drug's presence is often measured by its half-life, a pharmacokinetic measure that describes the time it takes for the concentration to decrease by half. Official labeling indicates the terminal half-life for sildenafil and its active metabolite is approximately four hours.

Q: Does the official prescribing information for Altus mention potential effects on fertility?

Studies have examined the effect of the active ingredient on male fertility markers. Specifically, research evaluating a single 100 mg dose found no reported effect on the motility or morphology (shape) of sperm in healthy volunteers.

Q: What does official research indicate about the consistency of results with Altus?

Clinical trials that assessed the erectile response found that improvements in erectile function generally increased as the dosage and the concentration of sildenafil in the plasma rose. This evidence was consistent across participants with both organic and psychogenic types of erectile dysfunction.

Q: Can alcohol consumption reduce the effectiveness of Altus?

Altus (Sildenafil) has vasodilatory properties that cause a mild lowering of blood pressure. Consuming alcohol may amplify this effect, potentially increasing the likelihood of symptoms like dizziness or lightheadedness, as described in regulatory warnings.

Q: Can Altus be used safely by people with diabetes?

Official regulatory reviews of clinical trials indicate that clinical trials examined the outcomes and safety profile of sildenafil in patient groups with a variety of existing health conditions. This included men who had diabetes mellitus, provided the underlying condition was under stable management or treatment at the time of the study.

Q: Are there any documented interactions between Altus and certain recreational drugs?

Official safety information states that the use of Altus with certain street drugs is strictly prohibited (contraindicated). This specifically includes substances called 'poppers' (amyl nitrate or nitrite), due to the serious risk of a dangerous and sudden drop in blood pressure.

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How should Altus (Sildenafil) be stored and disposed of?

Storage and Disposal Requirements

Sildenafil tablets must be stored at controlled room temperature, typically 20^circ to 25 C (68^circ to 77 F), with excursions permitted up to 30 C. The medication requires protection from light and moisture, necessitating storage in its original container with the lid tightly closed.

All forms of sildenafil must be stored out of the sight and reach of children.

For the reconstituted oral suspension, the product is stable for 60 days and must be stored below 30 C. This preparation must not be mixed with other medications.

Unused or expired product must be disposed of according to local regulations. Medicine should not be thrown away via household waste or wastewater.

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

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