Rheosolon

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Rheosolon

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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

Overview of Rheosolon

Property Description
Active Ingredients Phenylbutazone, Prednisolone Acetate
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID) / Glucocorticoid (corticosteroid) combination
Origin Synthetic
Combination Type Fixed-dose combination product
General Purpose Control of intense inflammation and pain

What Type of Medicine is Rheosolon?

Rheosolon is a synthetic, fixed-dose combination product classified broadly as an Antirheumatic agent, designed for managing significant inflammatory symptoms. This medicine is structurally distinct because it combines two powerful, distinct pharmacological classes in one formulation: a Nonsteroidal Anti-inflammatory Drug (NSAID) and a potent Glucocorticoid (corticosteroid). This strategic dual composition is clinically recognized for providing a comprehensive approach to anti-inflammatory control. The Phenylbutazone component is a member of the pyrazolidine class, known for its anti-inflammatory action.


Composition and Available Forms of Rheosolon

The active ingredients in Rheosolon are Phenylbutazone and Prednisolone Acetate, both of which are synthetic in origin. The Phenylbutazone contributes an analgesic and anti-inflammatory effect, while the Prednisolone Acetate provides the broad Glucocorticoid activity, commonly used for its potent immunosuppressive properties. Rheosolon may be prepared in various dosage forms, including a tablet for systemic use or an ointment for topical administration, depending on the specific application intended. This versatility allows for different administration routes to address localized or systemic inflammatory needs.


What is the General Purpose of Rheosolon?

The general purpose of Rheosolon is to secure comprehensive control over intense pathological inflammation and the resulting pain and swelling. The complementary action of the NSAID and Glucocorticoid components enables the medicine to target the inflammatory process from multiple sides. This dual mechanism aims to alleviate severe physical discomfort, stiffness, and tenderness associated with various inflammatory and rheumatic conditions by addressing both the immediate chemical signals of pain and the underlying immune-mediated components of inflammation.

What side effects are possible with Rheosolon?

Possible Side Effects and Safety Information

Rheosolon is a fixed-dose combination product containing a Nonsteroidal Anti-inflammatory Drug (NSAID) and a Glucocorticoid (Prednisolone Acetate). The safety profile reflects documented risks from both pharmacological classes, as specified in regulatory documents.

Serious Adverse Reactions

The official labeling documents the potential for serious, sometimes fatal, adverse reactions. These include severe Blood and Lymphatic System Disorders, notably aplastic anemia and agranulocytosis. The NSAID component carries the risk of serious Gastrointestinal Events, such as ulceration, perforation, and severe bleeding. Additionally, an increased risk of serious Cardiovascular Thrombotic Events (e.g., myocardial infarction and stroke) is documented, particularly with higher doses or long-term use. Severe hepatic reactions, including fatal hepatitis, have also been cited.

System-Organ Class Effects

Adverse effects are documented across multiple physiological systems. Common effects related to the Glucocorticoid component involve Endocrine and Metabolism Disorders, leading to changes like fluid retention, hyperglycemia, and adrenal suppression. Eye Disorders, such as glaucoma (increased intraocular pressure) and cataracts, are officially noted consequences of prolonged systemic or ocular exposure. Psychiatric disturbances, including mood swings and insomnia, are also commonly documented.

Safety Patterns and Restrictions

Certain risks are officially associated with the duration or timing of exposure. The risk of bone density loss and ocular damage is primarily linked to prolonged use. Specific safety constraints mandate that the medicine is contraindicated in individuals with a history of blood dyscrasias, active peptic ulcers, or severe hepatic, renal, or cardiac dysfunction. Older adults are also specifically documented as having a heightened susceptibility to severe gastrointestinal and renal adverse reactions.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory information defines an overdose of Rheosolon's components as a medical emergency requiring immediate attention due to the severe systemic toxicity of the Phenylbutazone component.


Documented Manifestations and Risks

Domain Official Regulatory Statements
Manifestations & Systems Symptoms of overdose include severe Central Nervous System (CNS) effects such as dizziness, drowsiness, convulsions, and potentially coma. Further documented manifestations are Gastrointestinal disturbances (e.g., nausea, vomiting, epigastric distress). Documented severe outcomes include acute renal failure, hepatotoxicity, and severe Gastrointestinal bleeding along with hematological effects.
Severity & Specific Risk Overdose of the Phenylbutazone component is officially documented as potentially deadly in small children. Increased risk for severe toxicity is also noted in patients with known impaired hepatic function or impaired renal function. Chronic high-dose exposure to the Prednisolone component may result in HPA axis suppression.

Emergency Action Requirements

The official requirement is to seek immediate medical attention or contact emergency services immediately upon suspected overdose. While acute overdosage of the corticosteroid component is generally not expected to produce life-threatening symptoms, medical assessment is always mandatory.

Management and Monitoring:

Management is defined as symptomatic and supportive treatment. No specific antidote is known. Procedures like gastric lavage and administration of activated charcoal are officially described for acute ingestion. Hospital monitoring of vital signs, renal function, and liver enzymes is required to manage the documented toxicity.

Therapeutic Uses of Rheosolon

What Rheosolon Treats: Main Uses and Benefits

Rheosolon is generally applied in contexts where severe rheumatic or autoimmune conditions, such as Rheumatoid Arthritis or Ankylosing Spondylitis, present with heightened symptoms. These agents are used to address conditions affecting the joints and may assist with symptoms related to inflammatory states. The medication thus helps address symptom clusters that may become intense, specifically symptoms related to physical discomfort, noticeable swelling, and stiffness that interfere with daily functioning.

The medication is commonly used during phases when symptoms become more noticeable due to a sudden escalation of inflammation, which includes acute episodes of gouty arthritis, post-traumatic inflammation, dermatologic conditions (like intense eczema flares), and certain inflammatory eye conditions (e.g., uveitis). It is applied in clinical settings where acute manifestations create noticeable interference with comfort.

“It is relevant in contexts marked by increased discomfort to offer supportive symptomatic relief during episodes of heightened symptoms.”

Applied in these scenarios, the combination supports the patient during difficult episodes by easing symptoms related to physical discomfort, which supports general well-being during symptomatic phases.


Quick Fact: Support for Symptoms that Escalate Rheosolon is relevant when supportive symptom management is appropriate for conditions characterized by periods of heightened symptoms, helping to ease the overall symptom load.


Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Absolute Contraindications

The eligibility profile for Rheosolon, defined by its combined NSAID and Glucocorticoid components, establishes strict absolute contraindications. The medicine must not be used by patients with a known hypersensitivity or allergy to Phenylbutazone, Prednisolone Acetate, or any component. Use is prohibited for individuals with an existing or history of blood dyscrasia or Active Systemic Fungal Infections.

Furthermore, Rheosolon is contraindicated in patients with serious, pre-existing pathology affecting hepatic (liver), renal (kidney), or cardiac (heart) function. Patients with an active peptic ulcer or inflammatory disease of the gastrointestinal system are also formally prohibited from use.

Age and Physiological Restrictions

Use is contraindicated in children fourteen years of age or less, and the overall safety and efficacy in the pediatric population are generally not established by regulatory authorities. Use during pregnancy is restricted and permitted only if the potential benefit justifies the potential risk to the fetus. The medicine is formally not recommended for women who are breastfeeding due to the potential for adverse effects in the infant.

What should I know about interactions with other medicines?

Rheosolon is a fixed-dose combination containing a Glucocorticoid and an NSAID. The officially documented interaction profile is defined by the properties of both active ingredients and includes constraints related to metabolic clearance, additive risks, and formal prohibitions.


Interactions with other medicines and products

Interaction Category Specific Regulatory Information
Formal Prohibition Co-administration with Mifepristone is a formal contraindication documented for the glucocorticoid component.
Exposure Alteration (PK) CYP 3A4 Inducers (e.g., Phenytoin, Rifampin) are documented to increase the clearance of the glucocorticoid component, potentially reducing its systemic plasma exposure. Conversely, CYP 3A4 Inhibitors (e.g., Ketoconazole) may decrease clearance, which can increase exposure and the risk of adverse effects.
Risk Amplification (PD) The NSAID component is documented to amplify the effect of Vitamin K antagonists (e.g., Warfarin), leading to a heightened official risk of hemorrhage. The glucocorticoid component may elevate blood glucose levels, interacting with the required dosage of Antidiabetic Agents.
Substance/PD Risk Combined use with other NSAIDs or Alcohol is documented to increase the risk of serious gastrointestinal side effects. Co-administration with Fluoroquinolones carries an increased risk of tendon injury.
Population Note The clearance of the glucocorticoid component is documented as potentially impaired in elderly patients and those with renal impairment, which may result in higher systemic plasma concentrations.

This interaction profile is officially structured around Pharmacodynamic Risk Amplification, which governs combination restrictions (NSAIDs, Alcohol), and Pharmacokinetic Modification, detailing the impact of CYP 3A4 modifiers on clearance. These domains establish the necessary constraints based strictly on documented regulatory data.

Mechanism of Action

Dual-Point Blockade of Inflammation's Chemical Signals

This combination medicine engages the Arachidonic Acid Cascade at two critical points: the Nonsteroidal component, Phenylbutazone, directly inhibits COX enzymes, and the Glucocorticoid, Prednisolone Acetate, indirectly modulates Phospholipase A2 ( PLA2) via GR agonism. This dual molecular targeting effectively reduces the synthesis of Prostaglandins, chemical mediators that increase nociceptor sensitivity and regulate local vascular changes.


Suppression of Immune Cell Function and Gene Transcription

The Glucocorticoid Receptor (GR) agonism by Prednisolone Acetate initiates a deep, genomic-level suppression of inflammation by modulating gene expression. This process involves switching off (transrepression) the transcription factors that drive the production of numerous pro-inflammatory cytokines ( IL-1, TNF-alpha) and simultaneously inhibits the functional activity and migration of key immune cells like lymphocytes and macrophages.


Coordinated Systemic and Peripheral Action

The two mechanisms work synergistically: Phenylbutazone provides a rapid-onset blockade of peripheral Prostaglandin action, which causes a rapid reduction in nociceptive signaling. Prednisolone Acetate's GR-mediated effects provide a more sustained and systemic cellular suppression, systemically modulates the underlying cellular dynamics of the inflammatory response. This coordinated action helps limit the cascade of events that escalate local tissue responses and contributes to the resulting modulation of inflammatory pathways.

Dosage and Administration Information

Rheosolon is a combination medication whose usage is governed by the official administration protocols for its two active components, Phenylbutazone and Prednisolone Acetate. These protocols define its high-level use patterns for both systemic and localized therapeutic approaches.

Official Administration Scope

Usage Parameter Regulatory Principle
Routes Oral for systemic therapy (tablets, suspension); Topical/Ophthalmic for localized treatment.
Systemic Dosing Glucocorticoid component starts between 5 mg and 60 mg per day, reducing to the lowest effective maintenance dose. Acute courses may be limited by the NSAID component.
Frequency Systemic use is prescribed once daily (often in the morning) or in divided doses. Topical application is typically multiple times per day.
Intake Timing Oral forms must be administered with food or milk to limit gastrointestinal irritation.

Procedural Use and Duration

The systemic use of Rheosolon is often directed toward short courses or acute phases, but the duration is constrained by the labeled instructions. Pediatric dosing is determined primarily by the severity of the disease and the patient's response, not standardized weight-based formulas.

A mandatory procedural instruction requires that the medicine must not be stopped abruptly following prolonged systemic administration. Instead, therapy must be concluded with a gradual dose tapering schedule prescribed by a healthcare provider, a protocol explicitly mandated by regulatory documentation to standardize discontinuation.

Recent Clinical Evidence

Research evidence / Overview of studies for Rheosolon

Research exploring the use of this medicine was studied in the context of conditions involving periods of heightened symptoms, such as active Rheumatoid Arthritis (RA) and acute gouty arthritis flares. The evidence base includes formal Randomized Controlled Trials (RCTs) conducted on the medicine’s individual components—specifically the glucocorticoid part—and systematic reviews that summarize findings from these studies. Studies examined outcomes related to physical discomfort, disease activity scores, and patient-reported outcomes in adult patients.

For RA, findings describe patterns observed in the studies where changes were measured in metrics like pain reports and measures of overall disease activity following administration of the component medicines. Research focused on episodes where symptoms become more noticeable, exploring short-term symptom changes over defined time intervals.

For acute gout, the research base includes a broad set of studies for both components. Data show patterns related to how symptoms evolved, with studies measuring the time required for symptom characteristics to change. Research describes that the component classes were observed in some studies to reach clinical equivalence when compared to other standard treatments.

Evidence for use in Ankylosing Spondylitis (AS) primarily examined the NSAID component, exploring outcomes reflecting daily functioning and stiffness. However, the evidence for the specific fixed-dose combination product in AS is limited, and comparative evidence is lacking against continuous single-agent NSAID therapy.

The primary research uncertainty relates to the lack of comparative evidence from modern RCTs that test the fixed combination against single-agent therapies. Limited information for long-term outcomes is a recognized gap for the specific formulation. Furthermore, the results apply only to the populations studied, and research does not determine whether an individual will respond similarly outside the specific conditions under which the studies were conducted.

Key Studies & References

  1. Prednisone - NIH MedlinePlus Drug Information
  2. Pharmacologic Management of Acute Gout: A Systematic Review and Meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Rheosolon (FAQ)


Q: What is the main condition Rheosolon is approved to treat?

The medicine is approved for conditions that require therapeutic action from both a glucocorticoid (steroid) and an anti-inflammatory agent. According to official documents, this includes various endocrine, allergic, and rheumatic disorders, particularly those involving intense inflammation.


Q: What are the most common side effects listed for Rheosolon?

Regulatory documents state that common adverse reactions associated with the glucocorticoid component may include fluid retention, increased appetite, and weight gain. Official product information also notes possible alterations in mood or behavior.


Q: Is it true that Rheosolon can cause weight changes?

Regulatory documents indicate the glucocorticoid component is associated with side effects such as increased appetite and weight gain. It may also cause fluid retention, which can be a contributing factor to a change in weight.


Q: Does Rheosolon commonly cause stomach issues or nausea?

Nausea is listed in the official safety profile as a reported adverse reaction for the components of Rheosolon. Furthermore, the NSAID component carries a documented risk of serious gastrointestinal issues, such as ulcers and bleeding.


Q: What signs of an allergic reaction to Rheosolon should a person be aware of?

According to regulatory patient materials, signs of a serious allergic reaction may include hives, skin rash, and swelling of the face, tongue, or throat. If these signs occur, regulatory guidance emphasizes seeking prompt medical attention.


Q: Can Rheosolon be taken with common over-the-counter pain relievers?

Official documents strictly prohibit taking Rheosolon with other nonsteroidal anti-inflammatory drugs (NSAIDs), as this significantly increases the risk of severe gastrointestinal side effects. It is important to clarify with a healthcare provider whether an over-the-counter pain reliever is an NSAID.


Q: Is Rheosolon considered appropriate for older adults (seniors)?

Official label information suggests that the clearance of the glucocorticoid component may be less efficient in older patients. This may result in higher amounts of the medicine remaining in the body; therefore, its use in this population is approached with caution.


Q: Does Rheosolon interact with common blood pressure medications?

Yes, the medicine is associated with elevated blood pressure and fluid retention. Individuals taking medication for high blood pressure should be aware that the need to adjust antihypertensive dosage may arise during treatment with Rheosolon.


Q: How can I find a complete, official list of drug interactions for Rheosolon?

A complete, official list of all known interactions is published within the full prescribing information for the medicine. This document can be located using the regulatory authority's drug database, such as the FDA's DailyMed or the European Medicines Agency's SmPC.


Q: Is Rheosolon classified as a controlled substance?

Based on official drug classification data, the active components of Rheosolon are generally not listed as controlled substances in many major regulatory jurisdictions.


Q: What is the informational guidance on handling a missed dose of Rheosolon?

Patient guidance states that if a dose is missed, it may be taken as soon as it is remembered on the same day. However, regulatory instructions advise against taking a double dose to make up for the missed one or taking it too close to the time for the next day's dose.


Q: What stage of clinical trials did Rheosolon complete before approval?

Before regulatory approval, new drug products must typically complete three distinct phases of clinical trials: Phase I (safety and dosing), Phase II (efficacy), and Phase III (large-scale confirmation of safety and efficacy).


Q: Where is the official prescribing information for Rheosolon published?

The official prescribing information is published by the primary regulatory authority in each region, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These documents are often searchable on their respective public websites.


Q: Are there ongoing studies or research examining new uses for Rheosolon?

Information about whether there are ongoing clinical trials, including those investigating new uses for Rheosolon, is generally registered in official government-run registries. An example of such a resource is the NIH's ClinicalTrials.gov.


Q: Is Rheosolon typically considered a first-line or second-line therapy for the main condition it treats?

The placement of a treatment as first-line, second-line, or later is determined by established professional medical guidelines, not by the drug label itself. These guidelines weigh the medicine's risk-benefit profile against other available therapies for the specific condition.

How should Rheosolon be stored and disposed of?

How to Store and Dispose of Rheosolon

Official regulatory documents define strict conditions for the storage and disposal of Rheosolon (prednisone delayed-release tablets).

Storage Requirements

The medicine must be stored at controlled room temperature, specifically between 20°C and 25°C (68°F and 77°F). It is mandatory to keep the product out of the reach of children.

To ensure product stability, the tablets must be protected from both freezing and excessive heat. The container should be kept tightly closed to protect the medicine from moisture and must be stored away from direct light.

Disposal Instructions

Disposal of unused or expired Rheosolon must follow official pharmaceutical waste procedures. Regulators recommend using a formal drug take-back program when available. It is required that the medicine is not disposed of by flushing or pouring into any drain or wastewater system.

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

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