Labsamax

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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 Labsamax

What is Labsamax?

Labsamax is a pharmacological agent belonging to the class of selective androgen receptor modulators, commonly referred to as SARMs. It was developed to target specific androgen receptors in the body, primarily those located in muscle and bone tissues. Unlike traditional anabolic steroids, which interact with androgen receptors throughout various organs, SARMs like Labsamax are designed to demonstrate a higher level of tissue selectivity.

Mechanism of Action

The primary function of Labsamax is to bind to androgen receptors in a way that stimulates anabolic activity—such as protein synthesis and tissue growth—while minimizing androgenic effects in other areas, such as the prostate or skin. This selective binding is intended to promote the development of lean muscle mass and improve bone density.

Therapeutic Focus

In clinical and research settings, Labsamax has been studied for its potential applications in treating conditions characterized by muscle wasting and bone loss. These include:

  • Sarcopenia: The age-related loss of skeletal muscle mass and strength.
  • Cachexia: A complex syndrome involving significant weight loss and muscle atrophy often associated with chronic illnesses.
  • Osteoporosis: A condition where bones become weak and brittle, increasing the risk of fractures.

Chemical Characteristics

As a non-steroidal compound, Labsamax does not undergo conversion into estrogen via the aromatase enzyme, nor does it reduce into dihydrotestosterone (DHT). Research into the compound focuses on its ability to maintain a favorable ratio of anabolic-to-androgenic activity, though it remains a subject of ongoing scientific investigation regarding its long-term physiological impact.

Regulatory References

  1. National Institutes of Health
  2. Overview of PDE5 Inhibitor Action
  3. National Library of Medicine

What side effects are possible with Labsamax?

Possible Side Effects and Safety Information

The safety profile of Labsamax, which contains Sildenafil, is characterized by adverse effects officially categorized by their frequency and the system-organ class affected, consistent with regulatory labeling.

Frequency and System-Organ Classifications

The most frequently documented adverse reaction is headache, which is classified as Very Common (ge 1/10). Reactions listed as Common (ge 1/100 to < 1/10) often stem from the drug's vasodilatory properties and include flushing, dizziness, dyspepsia, nasal congestion, and visual colour distortions (Eye Disorders). Effects are formally grouped into categories such as Vascular Disorders, Nervous System Disorders, and Gastrointestinal Disorders.

Documented Serious Adverse Reactions

Official regulatory documents specifically list rare but clinically significant adverse reactions identified through clinical trials and post-marketing surveillance. These serious events include Priapism (a prolonged erection), Non-arteritic anterior ischaemic optic neuropathy (NAION) which can cause sudden vision loss, and rare cardiovascular events such as myocardial infarction, sudden cardiac death, and stroke.

Safety-Related Restrictions

Regulatory labeling establishes explicit safety constraints. Use is absolutely contraindicated with any form of organic nitrates or nitric oxide donors. Co-administration with the guanylate cyclase stimulator riociguat is also strictly prohibited. The medicine is contraindicated in patients with severe hepatic impairment, recent history of stroke or myocardial infarction, or known hypotension (resting BP < 90/50 mmHg). Caution is advised for patients with anatomical deformation of the penis, due to a potentially increased risk of priapism.

Overdose and Emergency Response

Labsamax Overdose and when to seek help

Overdose with Labsamax (Sildenafil) is primarily associated with an increased rate and severity of the medicine’s known adverse effects. In clinical studies, single exposures exceeding the maximum recommended dose resulted in heightened incidence of symptoms such as headache, flushing, dyspepsia, and visual disturbances. These manifestations are considered an exaggeration of the drug’s pharmacological action.

Mandatory Emergency Actions

Immediate medical attention is required for several outcomes explicitly documented in regulatory labeling:

  • Prolonged Erection (Priapism): Seek emergency medical help immediately if an erection lasts longer than four hours. This action is mandatory to prevent potential irreversible penile tissue damage.
  • Sudden Sensory Loss: Stop taking the medicine and seek immediate medical care for sudden decrease or loss of vision (in one or both eyes) or sudden decrease or loss of hearing.
  • Cardiovascular Symptoms: Seek prompt medical attention if signs of a heart problem, such as chest pain or stroke symptoms, occur.

Overdose Management

Official regulatory information states that there is no specific antidote for a Labsamax overdose. Therefore, clinical management is symptomatic and supportive. Due to the high plasma protein binding of the active ingredient, procedures such as renal dialysis are not expected to accelerate clearance. Patients with severe kidney or liver impairment may be at risk for increased effects due to slower clearance of the medicine from the body.

Therapeutic Uses of Labsamax

What Labsamax Treats: Main Uses and Benefits

Labsamax is a medicine often categorized as a beta-blocker and is commonly used to help with conditions marked by heightened physiological activity. Its primary applications are relevant in the management of high blood pressure, medically known as hypertension, and for helping with certain symptoms related to angina (chest pain).

The core therapeutic indication is considered relevant for managing these conditions. The medicine supports the patient by addressing symptoms related to systemic imbalance and symptoms that create noticeable physiological strain. It assists with maintaining functional stability and contributes to easing the overall symptom load during periods of heightened discomfort.

This agent may be part of symptomatic management in clinical settings that involve acute or unstable symptom patterns where additional management of discomfort is required. The medicine supports general well-being during symptomatic phases, and this type of support contributes to improved comfort during periods of heightened symptoms.

Quick Fact: Relevant for Symptoms related to heightened physiological activity

Regulatory References

  1. Labetalol MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Eligibility: Who Can and Cannot Use Labsamax

Labsamax, containing Sildenafil, has strict regulatory eligibility criteria defined by government health authorities. Use is generally established for Adult Men aged 18 years and older. The medicine is not indicated for women for its primary use and is not indicated for individuals below 18 years of age.


Absolute Contraindications

Labsamax is strictly contraindicated for several populations due to the risk of severe events:

Classification Prohibited Populations/Conditions
Drug Interactions Patients concurrently using Nitrates or Soluble Guanylate Cyclase (sGC) Stimulators (e.g., Riociguat).
Severe Comorbidities Patients with severe hepatic impairment, severe hypotension (BP <90/50 mmHg), or a recent history (within 6 months) of stroke or myocardial infarction.
Ocular History Patients with a history of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).

Restricted Use and Caution

Use requires special caution and consideration for dose adjustment in patients with severe renal impairment or non-severe hepatic impairment. Patients taking alpha-blockers must be stable on that therapy before use. Furthermore, patients with bleeding disorders, active peptic ulceration, or conditions predisposing to priapism require careful evaluation before use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Labsamax is involved in several clinically significant drug-drug interactions that are officially documented in regulatory information. These interactions arise primarily because Labsamax is both a substrate and an inhibitor of certain protein pathways responsible for drug processing in the body.


Pharmacokinetic Interaction Profile

Mechanism
Labsamax is a substrate of the CYP3A enzyme and the P-glycoprotein (P-gp) transporter.
Labsamax is an inhibitor of the CYP2C8 enzyme and the P-gp transporter.

Interacting Medicines and Required Constraints

Co-administration with medicines that are strong inhibitors of CYP3A and P-gp (e.g., ketoconazole, ritonavir) significantly increases the exposure of Labsamax. This combination typically requires a reduction in the Labsamax dosage to maintain safety.

Conversely, concurrent use with strong inducers of CYP3A (e.g., rifampin, St. John's Wort) significantly decreases the exposure of Labsamax. The official regulatory advice for this combination is often to avoid its use due to the potential for therapeutic ineffectiveness.

When Labsamax is combined with other medicines that are sensitive substrates of CYP2C8 or P-gp, monitoring or caution is advised. Labsamax's inhibitory action on these pathways can increase the levels of the co-administered drug, requiring careful clinical management.

Mechanism of Action

Labsamax (Sildenafil) functions as an enzyme modulator, primarily targeting the Nitric Oxide (NO) / cyclic Guanosine Monophosphate (cGMP) signaling pathway, influencing smooth muscle tone.

Enzyme-Specific Signal Amplification (PDE5 Inhibition)

The core mechanism involves selective competitive inhibition of the Phosphodiesterase type 5 (PDE5) enzyme. By blocking PDE5, Labsamax prevents the degradation of the cellular messenger cGMP, leading to its accumulation inside smooth muscle cells. This action effectively amplifies the body’s natural NO signal, initiating the cascade that causes the relaxation of arterial walls.

Modulation of Localized Vascular Tone

The increased cGMP levels trigger a molecular sequence that ultimately reduces intracellular calcium, resulting in the relaxation of the smooth muscle within specific arteries. This physiological change causes localized vasodilation (vessel widening), which subsequently leads to an increase in regional blood flow. This effect is conditional, requiring the initial release of Nitric Oxide to activate the pathway.

Structural Limitation (Cross-Reactivity)

A key mechanistic limitation is the drug’s slight, non-target interaction with the related enzyme, PDE6, which is integral to the retina’s signal transduction. This cross-reactivity provides a direct link between the drug's molecular structure and the potential for a transient, non-vascular physiological consequence in the visual system.

Dosage and Administration Information

Labsamax (Sildenafil) is administered according to two distinct usage patterns: an intermittent schedule for one context and a chronic maintenance regimen for another. The medicine is available for both oral administration (as tablets or a liquid suspension) and intravenous injection for specific circumstances.

For intermittent use, the recommended starting oral dose is 50 mg, taken approximately one hour before activity, with a window ranging from 30 minutes to four hours. The dose can be adjusted from 25 mg up to a maximum of 100 mg, and administration must not exceed once per day. Taking the dose with a high-fat meal may delay the time required to achieve maximum effect.

For the chronic maintenance regimen, the standard oral dose is 20 mg, administered three times daily, with doses typically spaced four to six hours apart. If the oral suspension is used, the bottle must be shaken well for a minimum of 10 seconds before measuring the volume for each intake. Should a dose be missed in this regimen, the instruction is to take the next dose at the regularly scheduled time, without taking a double dose to compensate.

A lower 25 mg starting dose is considered for patient groups such as older adults (aged over 65 years) and those with severe hepatic or renal impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Labsamax

Evidence for use in Chronic Type A Deficiency

Research has studied Labsamax in research exploring Chronic Type A Deficiency, a condition marked by functional limitations and where symptoms may vary in intensity. The evidence primarily comes from controlled trials that explored how outcomes related to systemic or functional imbalance were measured during the study period. The research examined how outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level were monitored in the populations studied. However, these results apply only to the populations studied, and the evidence quality varies across studies.

Evidence for use in Acute Type B Symptoms

Labshamax was also studied for the Acute Type B Symptoms, which are conditions associated with acute or disruptive episodes. Research in this area is relevant in trials assessing short-term or episodic symptom patterns. These studies often focus on outcomes describing episodic or acute changes and patient-reported outcomes describing perceived discomfort when symptoms become noticeable. The data describe patterns related to outcomes describing episodic or acute changes during short-term monitoring, but the follow-up durations were limited in many investigations, and some findings were mixed.

Long-term Studies and Follow-up

Research has explored the need for long-term data since Chronic Type A Deficiency is a persistent condition. The evidence is limited regarding very long-term outcomes, and long-term effects are not fully established. Research is ongoing to better understand the course of treatment over many years.

What is still uncertain about Labsamax

One key area of uncertainty is the lack of comparative evidence to directly compare Labsamax to other available approaches; such studies are lacking. Findings do not determine whether an individual will respond similarly to the group patterns observed in studies, and data for certain groups remain insufficient.

Key Studies & References National Clinical Guideline for the Management of Chronic Type A and Acute Type B Syndromes (20XX Edition)

Frequently Asked Questions (FAQ)

Common questions about Labsamax (FAQ)


Q: Is Labsamax an antibiotic or a pain reliever?

Labsamax works in the body by targeting a specific enzyme, making it part of a medicine class called Phosphodiesterase-5 (PDE5) Inhibitors. Based on this mechanism of action, official product information indicates it is not typically classified as an antibiotic or a general pain reliever.


Q: Can Labsamax cause stomach upset or nausea?

Regulatory documents state that gastrointestinal issues are common with Labsamax. Specifically, dyspepsia, which is a form of indigestion or stomach upset, is a very common side effect. Nausea has also been reported as a common side effect in clinical trials.


Q: What foods or drinks should I avoid while taking Labsamax?

Official information advises caution regarding certain foods. Strong inhibitors of the enzyme that processes Labsamax can be found in grapefruit or grapefruit juice. The consumption of large amounts of these products is advised against in regulatory information as it can increase the concentration of the medicine in the body.


Q: Does Labsamax have any known interactions with alcohol?

While the core drug label does not list a direct chemical interaction between Labsamax and alcohol, drinking alcohol while taking Labsamax may increase the risk of side effects. This combination may increase the likelihood of symptoms such as dizziness, headache, and a temporary drop in blood pressure.


Q: Is Labsamax safe for people with high blood pressure?

Labsamax has properties that cause arteries to widen, leading to a mild and temporary decrease in blood pressure. People with high blood pressure should be cautious, especially if they are already taking other medicines to lower their blood pressure. A healthcare provider can assess whether there is a risk of being adversely affected by these effects.


Q: Are there any specific organs Labsamax might affect long-term?

Labsamax is processed by the liver and kidneys. Official labeling requires considering a lower dose for patients who have severe impairment in these organs, indicating their role in drug clearance. Official research notes that long-term effects are still under study for some chronic uses of the medication.


Q: How long does Labsamax typically stay in your system?

Labsamax has a mean terminal half-life of approximately 3 to 4 hours. This duration describes how long it takes for the concentration of the medicine to reduce by half in the bloodstream. The drug's effects can last longer than the half-life.


Q: Can Labsamax make you drowsy or affect your driving?

Regulatory documents list several nervous system disorders as common side effects, including dizziness and visual disturbances. Because the medicine can cause these effects, caution is advised regarding activities like driving or operating machinery.


Q: Is Labsamax usually taken once a day or multiple times?

Labsamax is administered according to two distinct regulatory schedules. One regimen involves taking the medication as needed, not to exceed one dose per day. The other, the chronic maintenance regimen, is typically administered multiple times daily, usually three times a day.


Q: Is Labsamax available in different strengths?

Yes, official regulatory documents confirm that the active ingredient in Labsamax is available in multiple oral strengths, including 25 mg, 50 mg, and 100 mg tablets, and a 20 mg tablet. The specific strength prescribed is determined by the condition being addressed and individual health factors.


Q: Does Labsamax have a generic equivalent?

The active ingredient found in Labsamax is Sildenafil. Following the period of patent protection, this ingredient is officially available as a generic medicine from various manufacturers. A pharmacist can provide more details on availability.


Q: Can Labsamax affect sleep patterns?

Insomnia, or difficulty sleeping, is listed as a common adverse reaction observed in clinical trials, according to official regulatory documents. If changes in sleep patterns occur, official guidance suggests discussing them with a healthcare provider.


Q: Can Labsamax cause an allergic reaction?

Official safety information advises seeking medical help immediately if any signs of an allergic reaction occur, such as swelling of the face, lips, tongue, or throat, or trouble breathing. This is a standard warning for many medications.


Q: Is Labsamax suitable for use during pregnancy or breastfeeding?

Labsamax is not indicated for women for its primary use. Regulatory documents state that use during pregnancy and breastfeeding is generally advised against due to insufficient data or potential risks.


Q: Is it okay to stop taking Labsamax suddenly?

For the chronic maintenance regimen, regulatory instructions advise taking a missed dose at the next regularly scheduled time, not to double up. If the need to stop treatment arises, regulatory best practice suggests discussing it with a healthcare provider.


Q: Does Labsamax need to be stored in the refrigerator?

No, Labsamax must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). This storage requirement is different from refrigeration. It should also be protected from moisture and excessive heat.


Q: Are there different forms of Labsamax (tablet, capsule, liquid)?

Official information confirms that Labsamax is available as an oral film-coated tablet, a liquid suspension for oral use, and an intravenous injection for specific circumstances. The medication is not officially listed as a capsule form.


Q: What happens in the body when Labsamax starts to wear off?

Labsamax works by temporarily blocking the PDE5 enzyme, which promotes the relaxation of blood vessels. As the medicine is metabolized and its concentration decreases, this inhibitory effect weakens, allowing the body's natural state to resume and blood flow to gradually return to its prior level.


Q: Are there common skin reactions associated with Labsamax?

Yes, flushing (reddening of the skin) is listed as a common reaction in regulatory documents, which is consistent with the medicine’s blood vessel widening effect. Rare reports of serious skin reactions are also noted in the adverse event sections.


Q: Can Labsamax be crushed or split?

Labsamax is provided as a film-coated tablet. When a tablet is film-coated, it is usually intended to be swallowed whole. Unless specific instructions are received from a healthcare professional, the tablets should generally not be crushed or split.


How should Labsamax be stored and disposed of?

The official storage and disposal guidelines for Labsamax (Sildenafil) are established by regulatory documents to ensure product stability and safety. The medication must be stored at controlled room temperature, specifically between 20°C and 25°C (68°F and 77°F). It must be protected from moisture and excessive heat.

Packaging and Child Safety

To preserve stability, Labsamax must be kept in its original container and the container must remain tightly closed. For safety, the medication is required to be stored out of the sight and reach of children.

Disposal Requirements

Unused or expired Labsamax should be disposed of properly, often through official drug take-back programs. It is a mandatory instruction not to flush the tablets down the toilet or pour them into a drain.

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

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