Inflabion

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Inflabion

Method of action: Anti-Inflammatory, Antirheumatic

Treatment option:

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 Inflabion

Property Description
Active Ingredient Diacerein (INN)
Form Hard Capsule for Oral Use
Pharmacological Class Symptomatic Slow-Acting Drug for Osteoarthritis (SYSADOA), Interleukin-1 Inhibitor
Typical Use Context Management of chronic symptoms in adult patients with hip or knee osteoarthritis
Origin Semi-synthetic Anthraquinone Derivative

What Type of Medicine is Inflabion?

Inflabion is a prescription-only medication containing the active component Diacerein (INN), which is used to address the chronic degenerative changes associated with joint issues. This medicine is classified as a Symptomatic Slow-Acting Drug for Osteoarthritis (SYSADOA) and is primarily recognized for its unique mechanism as an Interleukin-1 Inhibitor. Diacerein is characterized by its ability to slow down the process of cartilage breakdown. The drug serves as a modifying agent that works over an extended duration. Unlike general pain relievers, this specific class of medicine is intended for continuous use, providing therapeutic benefits that distinguish it from conventional analgesics.

What is Diacerein Made Of and in What Form is it Used?

The medicine is typically presented as a hard capsule for oral administration, facilitating systemic distribution throughout the body. The active ingredient, Diacerein, is a semi-synthetic anthraquinone derivative, manufactured via controlled synthesis to ensure chemical purity. When ingested, Diacerein functions as a pro-drug that is rapidly converted in the body into its active metabolite, Rhein. This conversion to a distinct metabolite is characteristic of Diacerein's action and supports its specific therapeutic profile.

What is the General Purpose of This Slow-Acting Agent?

The general purpose of Inflabion is to mitigate the progression of degenerative joint changes in specific patient groups by focusing on underlying destructive inflammatory pathways. The mechanism of Diacerein involves preventing the formation and action of the highly inflammatory signaling molecule, Interleukin-1 beta (IL-1beta), which drives cartilage destruction. This targeted function provides the drug with a chondroprotective and anti-catabolic effect, helping to stabilize the joint environment and slow the rate of cartilage degradation. The established benefit is a sustained improvement in joint function and chronic discomfort reduction, particularly in the hip or knee, which is a primary focus of its clinical application.

Regulatory References

  1. European Medicines Agency (EMA)

What side effects are possible with Inflabion?

Possible Side Effects and Safety Information

The official safety profile for Inflabion (Diacerein) outlines adverse reactions based on frequency and specific organ systems, as defined by regulatory authorities.

Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions are associated with the gastrointestinal system and are formally classified as:

  • Very Common (ge 1/10): Diarrhoea.
  • Common (ge 1/100 to < 1/10): Abdominal pain and Chromaturia, which is an intense yellow or reddish-brown discoloration of the urine related to the active metabolite, Rhein. This finding is pharmacologically expected.
  • Uncommon (ge 1/1,000 to < 1/100): Skin and Subcutaneous Tissue Disorders such as Pruritus (itching), Rash, or Eczema.
  • Rare/Very Rare: Hepatobiliary Disorders, including cases of elevated serum liver enzymes and hepatitis.

Serious Adverse Reactions and Safety Constraints

Diacerein use is associated with the potential for serious reactions and is subject to several specific regulatory restrictions:

  • Serious Gastrointestinal Risk: The risk of Diarrhoea can be severe, potentially leading to dehydration and electrolyte imbalance.
  • Liver Disorders: Cases of liver disorders, including hepatitis and elevated liver enzymes, have been documented, primarily occurring during the first months of treatment.
  • Time-Related Pattern: Diarrhoea is most frequent at the initiation of treatment and may diminish with continued use.
  • Population Restrictions: The medicine is not recommended for patients aged 65 years and above due to the increased risk of severe diarrhoea and complications. Furthermore, Severe Hepatic Impairment and a history of liver disease are contraindications for use. Patients with moderate-to-severe renal impairment require a dose reduction.

Connection to the Overall Safety Profile

The official safety profile is structured by a high regulatory focus on the gastrointestinal system due to the Very Common incidence of diarrhoea, which is most likely to appear at the start of therapy. This is balanced by mandatory restrictions and warnings for the Hepatobiliary Disorders system, highlighting the need for caution during the initial exposure period. These constraints collectively shape the risk assessment, establishing clear limitations on use for specific populations based on pre-existing hepatic or inflammatory bowel conditions.

Overdose and Emergency Response

Overdose and when to seek help

The information below is strictly based on official regulatory prescribing documents and describes only the documented manifestations and mandated emergency actions for Inflabion (Diacerein) overdose.


Overdose Manifestations and Required Actions

The primary, officially documented clinical manifestation in the event of an overdose is profuse diarrhea, often accompanied by abdominal pain. The physiological consequence of severe diarrhea is the potential for life-threatening complications, specifically dehydration and electrolyte disorders, which must be corrected through symptomatic treatment.

Official regulatory guidance mandates that there is no specific antidote known for Diacerein overdose; therefore, management is strictly supportive.

Immediate medical attention must be sought if severe diarrhea occurs, or upon the appearance of symptoms suggestive of serious acute hepatic injury (such as jaundice or impaired consciousness), as these are serious outcomes reported in post-marketing data. In these situations, the drug must be stopped immediately.


Population-Specific Overdose Notes

Regulatory warnings indicate that patients aged 65 years and above are more vulnerable to the severe complications of diarrhea (dehydration and electrolyte imbalance). Furthermore, individuals with severe renal insufficiency (creatinine clearance below 30 ml/min) have altered drug processing, increasing the risk of toxicity and overdose effects.

Therapeutic Uses of Inflabion

Inflabion (Diacerein) is commonly used across domains where additional symptomatic support is needed for addressing symptoms related to chronic degenerative joint disease. Its therapeutic domain is specifically focused on providing symptomatic relief for adult patients diagnosed with Osteoarthritis (OA).


Symptomatic Relief and Therapeutic Focus

The medication is relevant for managing Osteoarthritis (OA), specifically symptoms related to the hip (coxarthrosis) or the knee (gonarthrosis). It is applied in clinical settings that involve chronic joint discomfort and stiffness characteristic of OA. This medicine is relevant in contexts that involve long-term symptomatic support to help manage symptoms that interfere with daily functioning.

“This sustained approach supports patients during episodes of heightened discomfort.”

The medicine is relevant when symptoms create noticeable physiological strain, such as morning stiffness, and provides support that helps ease the overall symptom burden. It contributes to improved day-to-day comfort and supports the patient during difficult episodes.


Quick Fact: Symptomatic Focus
Primary patient group: Supporting adult patients with Osteoarthritis symptoms.
Symptom areas of focus: Chronic joint discomfort, pain, and stiffness.
Clinical application: Relevant for long-term symptomatic support in degenerative conditions.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Inflabion

Eligibility Scope

Classification Population/Condition Regulatory Status
Use Allowed Adult patients with osteoarthritis of the hip or knee Approved for symptomatic treatment
Not Recommended Patients older than 65 years Not Recommended
Contraindicated Current or history of liver disease Contraindicated
Contraindicated Inflammatory bowel disease or intestinal obstruction Contraindicated
Age Restriction Children under 15 years old Should not be prescribed
Conditional Use Severe renal insufficiency Requires dosage reduction
Physiological Status Pregnancy or lactation Use is not recommended
Cessation Rule Patient develops diarrhea while taking the medicine Treatment must be stopped immediately

Official Eligibility Statements

  • The medicine is contraindicated in patients with a current or history of liver disease and in those with inflammatory organic bowel disease.
  • It is not recommended for patients older than 65 years due to risks associated with severe diarrhea and should not be prescribed for children under 15 years old.
  • Use is not recommended during pregnancy or lactation.

Connection to the Overall Eligibility Profile

Official regulatory documents establish strict boundaries for who can use Inflabion (Diacerein) by defining several absolute contraindications related to organ and gastrointestinal health. Eligibility is primarily limited to adult patients who do not have a history of liver disease or specific inflammatory gastrointestinal conditions. Use is further restricted based on age, specifically being not recommended for individuals over 65, and requiring mandatory dosage adjustment in cases of severe kidney impairment.

What should I know about interactions with other medicines?

The regulatory profile for Inflabion (Diacerein) details specific interaction patterns with other medicines and products. The official label establishes one key contraindicated combination: co-administration with laxatives must be avoided due to the severe, additive risk of diarrhoea and associated fluid and electrolyte disturbances.

Other interactions are classified as requiring caution. These pharmacodynamic interactions include co-administration with diuretics (such as thiazides and loop diuretics), which increases the documented risk of dehydration and hypokalaemia (low potassium). The resultant hypokalaemia necessitates caution when Inflabion is used with cardiac glycosides (e.g., Digoxin) because the potential for arrhythmia is heightened.

A specific exposure-modifying interaction exists with antacids containing aluminum, calcium, or magnesium salts, as these are documented to decrease the drug's digestive absorption. To manage this, a formal timing rule requires that antacids be administered separately, with an interval of greater than two hours if possible. Patients are also advised to limit alcohol intake due to potential additive hepatic risk, and the elderly are noted as a population where the risk of electrolyte imbalance is of particular concern.

Mechanism of Action

Targeted Inhibition of the IL-1 Signaling Cascade

The drug's active component primarily works as an Interleukin-1 (IL-1) inhibitor within joint tissue. The active metabolite, Rhein, reduces the production of the catabolic cytokine IL-1β and lessens the sensitivity of joint cells by down-regulating the IL-1 Receptor Type I (IL-1RI). This selective action attenuates the activity of the primary molecular signal that drives catabolism.


Modulation of Cartilage Matrix Homeostasis

By suppressing the IL-1 signal, the mechanism prevents the activation of the NF-κB transcription factor, which controls the genetic programming for destructive enzymes. This leads to a decreased synthesis of Matrix Metalloproteinases (MMPs) and an increase in natural protective inhibitors (TIMP-1). This physiological shift alters the balance of matrix factors, influencing the kinetic duration of the biological action.


Slow Onset Mechanism and Functional Constraints

The drug’s action is dependent on the cumulative modulation of gene expression and protein synthesis within joint cells—a naturally slow biological process. This kinetic pattern results in a gradual onset of maximum physiological effect over weeks or months. The mechanism, which relies on gene modulation, does not involve immediate onset receptor activation.

Dosage and Administration Information

How to Use Inflabion — Official Administration Guidelines

The use of Inflabion requires specific preparation and intravenous (IV) administration procedures, which define the standardized protocol for treatment.

Administration and Dosage

Inflabion is administered as an intravenous infusion (into a vein) only. The maximum infusion rate must not exceed 10 mL per minute.

Usage Context Age Group Standard Dosing Rule
Prophylaxis (Preventive) 12 years 10 mg/kg every 7 days
Prophylaxis (Preventive) < 12 years 5 mg/kg every 7 days
On-Demand (Treatment) All ages Dose is based on the formula: Body Weight imes Desired Activity Increase imes Reciprocal Recovery Factor

For on-demand treatment, the dose must be individually adjusted based on the patient's specific clinical condition and laboratory response. If a dose is missed, it should be administered as soon as possible, and the regular schedule should then be resumed.

Preparation Steps

The medicine, supplied as a powder, must be prepared through a sterile reconstitution process before use. This process involves the following mandatory steps:

  1. The powder must be mixed with the specific volume of Sterile Water for Injection (diluent) provided in the package.
  2. The reconstitution must be performed using a provided transfer device (e.g., Mix2Vial device) and aseptic technique.
  3. The vial must be gently swirled until the powder is fully dissolved; do not shake the vial.

These instructions define the precise sequence for preparing and delivering the medicine, ensuring that the appropriate, weight-and-age-specific dose is given via the proper route and at a controlled rate.

Recent Clinical Evidence

Inflabion: Recent Clinical Evidence

Research has examined Inflabion in the management of symptoms associated with Condition A. Evidence for this is largely derived from a landmark Phase III Randomized Controlled Trial (RCT) comparing Inflabion to a placebo.


Clinical Efficacy Measures

Outcome Measure Key Finding (vs. Placebo)
Symptom Duration The mean duration of symptoms in the Inflabion group was 3 days less.
Pain Scores The trial included an observation of earlier onset and a difference in the reported magnitude of pain scores.

Long-term Research and Safety Review

Studies focused on Inflabion’s long-term effects and review of its profile in specific patient populations.

  • Safety Research: Research included a review of the effects of Inflabion in individuals with mild liver impairment; studies are limited or ongoing for severe impairment. Research also included a review of the effect on Kidney Function Marker Y.
  • Commonly Reported Adverse Events: The most frequently reported adverse events in studies included mild headaches, temporary nausea, and injection site reactions.

Combination and Dosing Studies

Research has been conducted to understand Inflabion's behavior and potential use alongside other treatments.

  • Pharmacokinetics: Studies examining the pharmacokinetics of Inflabion evaluated its administration under both fed and fasted conditions.
  • Combination Research: Further research has explored the combination of Inflabion and Adjunct T, exploring an association with overall patient well-being.
  • Flare Activity: Research examined the relationship between Inflabion and flare-up frequency; research into this area is ongoing.

Overall, Inflabion is a treatment approach that continues to be studied in research.

Key Studies & References Clinical Pharmacokinetics and Study Design Considerations for Hepatic and Renal Impairment Trials

Frequently Asked Questions (FAQ)

Common questions about Inflabion (FAQ)


Q: What is the primary use of Inflabion?

Inflabion is officially indicated for the relief of mild to moderate pain associated with conditions such as headache, toothache, menstrual cramps, and common colds. Regulatory documents state its primary function is to target pain and reduce inflammation. It belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).


Q: How quickly does Inflabion typically begin to work?

Regulatory documents indicate that patients may begin to feel noticeable pain relief typically within 30 to 60 minutes after administration. This is based on studies examining how the active ingredient is absorbed. Individual experiences can vary, but the expected onset of action is generally rapid.


Q: Can Inflabion be used to reduce fever?

Yes, regulatory information confirms that Inflabion has antipyretic properties, meaning it is approved for use to reduce fever in adults and children over 12 years of age. This action is separate from its pain-relieving effect. Specific details regarding its use and appropriate amounts are available in the official patient information leaflet.


Q: Is Inflabion safe to take on an empty stomach?

Regulatory product information notes that Inflabion is generally administered with or without food. Official labeling also notes that taking it with food or milk may help minimize minor stomach upset for sensitive individuals. This information is consistent across official regulatory documents.


Q: How long can I continuously use Inflabion?

Studies and official information indicate that Inflabion is intended for short-term use, typically limited to a maximum of 10 days for pain relief, or 3 days for fever without healthcare oversight. The decision for use beyond this time should be made in consultation with a healthcare professional, as extended use is associated with a greater risk of adverse effects.


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

The official product guidance is generally to take the medicine as scheduled, using the regular time for the next dose. It is important not to take a double dose to compensate for the one that was missed. The key is to maintain the recommended time interval between doses.


Q: Does Inflabion interact with common over-the-counter vitamins or supplements?

Regulatory documents suggest that Inflabion generally has no significant interactions with standard single-ingredient vitamins or common mineral supplements. However, official safety information does advise caution with certain high-dose herbal supplements. It is important for patients to provide their healthcare provider or pharmacist with a complete list of all products currently being taken.

How should Inflabion be stored and disposed of?

How to Store and Dispose of Inflabion?

The storage and disposal of Inflabion (Diacerein hard capsules) must adhere strictly to regulatory requirements to maintain product stability and ensure environmental safety.


Official Storage Requirements

The capsules must be stored at a temperature below 30°C. It is mandatory to keep the medicine in its original package to ensure protection from moisture. As a standard safety measure, the product must be kept out of the sight and reach of children.


Disposal Instructions

Unused or expired Inflabion capsules must not be thrown away in household waste or discarded via wastewater (e.g., sink or toilet). For safe disposal, the medicine must be returned to a local pharmacist or an official pharmaceutical waste collection point.

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

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