Idarac

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Idarac

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Medically reviewed

Rosario Oropesa

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 Idarac

Property Description
Active ingredient Floctafenine
Form Oral tablet
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General use Relief of acute pain and inflammation
Origin Synthetic (Anthranilic Acid Derivative)

The Identity of Idarac: Classification and Composition

Idarac is the trade name for a medicinal preparation whose active component is the synthetic compound floctafenine. This substance is an NSAID (Non-Steroidal Anti-Inflammatory Drug) belonging to the fenamate subgroup, which are chemical derivatives of anthranilic acid. The product is a single-ingredient product, typically administered through the oral route as a tablet. Floctafenine's classification reflects a defined pharmacological action, and its use as a prescription-only medication (Rx-only) in many jurisdictions reflects a medically supervised approach to pain management.


What is Idarac Used for Generally?

The general purpose of Idarac is to provide relief from acute pain and associated inflammatory symptoms. As both an analgesic (pain-relieving) and anti-inflammatory agent, floctafenine is designed to manage symptomatic discomfort. Its core action involves functioning as a cyclooxygenase inhibitor, which limits the biosynthesis of prostaglandins—chemical messengers that mediate pain and inflammation.

The main therapeutic purpose of this medication is due to this prostaglandin synthesis inhibition, directly addressing the source of the pain signals rather than acting on the central nervous system. The medicine is commonly used for short-term relief of, for example, post-operative discomfort or other acute painful episodes.


Summary of Core Entities and Purpose

In summary, Idarac is a synthetic, single-ingredient NSAID containing floctafenine as its active component, formulated as an oral tablet. This compound is utilized for its ability to relieve acute pain and reduce inflammation through the mechanism of inhibiting prostaglandin synthesis, distinguishing it as a specific fenamate derivative within the analgesic landscape.

What side effects are possible with Idarac?

Possible Side Effects and Safety Information for Idarac (Floctafenine)

Idarac (Floctafenine) belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, and its safety profile includes serious warnings and precautions associated with this class of medicines, primarily concerning the cardiovascular and gastrointestinal systems.

Serious and Clinically Significant Adverse Reactions

System-Organ Class Serious Adverse Reactions (Official Documentation)
Cardiovascular Increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. Risk is greater with higher doses and longer duration of use.
Gastrointestinal Serious GI adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Risk increases with dose and duration.
Hypersensitivity Severe allergic reactions, including anaphylaxis.
Hepatobiliary Liver problems, including elevated liver enzymes and, rarely, severe liver dysfunction.

General Adverse Reactions

Commonly reported side effects often involve the gastrointestinal system and may include nausea, vomiting, abdominal pain, heartburn, and diarrhea. Central nervous system effects such as headache, dizziness, and drowsiness have also been reported.

Contraindications and Safety Limitations

Floctafenine is typically contraindicated in patients with a known hypersensitivity to the drug, aspirin, or other NSAIDs, or in those with active gastrointestinal bleeding or ulceration. Use in the peri-operative setting of coronary artery bypass graft (CABG) surgery is also restricted. To minimize potential risks, the lowest effective dose should be used for the shortest possible duration. Safety and effectiveness have not been established in pediatric patients, and caution is advised when used in the elderly and in patients with pre-existing cardiovascular, renal, or hepatic impairment.

Overdose and Emergency Response

The official regulatory information for Floctafenine (Idarac) overdose is strictly based on documented cases and mandated management procedures, requiring immediate expert consultation.

Regulatory Guidance on Clinical Presentation and Action

Regulatory documentation confirms that in reported cases of Idarac overdose, no common symptoms or specific clinical signs could be reliably identified or distinguished. Despite the absence of a defined clinical syndrome in these instances, the overall prognosis in documented scenarios has been officially classified as favourable, with patients recovering well after clinical management.

The critical action mandated by regulatory authorities in the event of a suspected overdose is to immediately contact your regional poison control centre for guidance. This step is required to initiate prompt and necessary clinical procedures.

Officially Documented Supportive Measures

The official prescribing information outlines specific supportive interventions that must be employed. These standard procedures are intended to mitigate potential systemic exposure, and include efforts to help evacuate gastric contents, actively maintain urinary output, and provide general supportive care throughout the required observation period. No specific antidote is officially documented for Floctafenine overdose management. No population-specific monitoring or special considerations for the elderly or those with underlying conditions are explicitly detailed in the regulatory overdose section.

Therapeutic Uses of Idarac

What Idarac Treats: Main Uses and Benefits

Idarac is used for the short-term symptomatic relief of mild to moderate acute pain and associated inflammatory manifestations. It is applicable across therapeutic domains that involve heightened discomfort or tension. This supportive use may assist in managing symptoms that appear suddenly or fluctuate, which contributes to improved comfort and supports the maintenance of functional stability during periods where pain or inflammation creates noticeable interference with daily stability.

This medication is used for conditions marked by symptoms that interfere with daily functioning, such as acute musculoskeletal pain, symptoms related to physical discomfort in the joints, and pain following localized injuries. It is commonly applied during acute episodes, including the management of postoperative discomfort following dental or minor surgical procedures.

“It is commonly used when short-term symptomatic assistance is needed.”

The symptomatic relief provided can assist in coping more steadily with episodes of sudden symptom escalation and contributes to easing day-to-day comfort during symptomatic periods.

Quick Fact: Used for managing Mild to Moderate Acute Pain

Regulatory References

  1. Health Canada-approved Product Monograph

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility for Idarac

Idarac (floctafenine) is regulated for short-term use in patients requiring symptomatic relief from mild to moderate acute pain. Official regulatory documents strictly define the populations that may and may not use this medicine.

Populations Contraindicated (Must Not Use)

Category Non-Eligibility Condition
Hypersensitivity Known or suspected allergy to floctafenine or any other NSAID, including ASA-sensitive asthma or nasal polyps.
Organ Dysfunction Severely impaired renal function (e.g., CrCl < 30 mL/min), significant hepatic impairment, severe cardiac insufficiency, or ischemic cardiomyopathy.
Gastrointestinal Active peptic ulcer, history of recurrent ulceration, or active inflammatory disease of the gastrointestinal system.
Surgery Patients in the peri-operative setting of CABG surgery.

Age and Condition-Based Restrictions

Population Group Regulatory Status
Children Not recommended; safety and efficacy have not been established.
Older Adults Use requires caution; patients over 65 years are documented as most susceptible to adverse effects.
Pregnancy Not recommended from 20 weeks gestation onward (standard NSAID guidance).
Lactation Not recommended as the active metabolite is slightly secreted into breast milk.
Comorbidities Patients with lesser degrees of renal impairment or GI risk factors require close medical supervision and monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Idarac (floctafenine) interaction data is structured based on official regulatory classifications, emphasizing potential additive risks when co-administered with certain medications. The use of other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) is formally not recommended due to the lack of synergistic benefit and the potential for increased adverse effects.

Documented Pharmacodynamic Risks

Official labeling documents two key areas of increased risk:

  • Hemorrhagic Risk: Co-administration with Anticoagulants and Oral Corticosteroids is associated with an increased likelihood of serious gastrointestinal events, including ulceration and bleeding.
  • Renal/Electrolyte Risk: Combining Idarac with medicines such as Diuretics or ACE Inhibitors (Angiotensin-Converting Enzyme Inhibitors) carries a documented risk of compromising renal function, potentially leading to renal decompensation or hyperkalemia (high blood potassium).

Administration and Substance Restrictions

Regulatory documents identify a heightened risk for these interactions in specific groups, including elderly patients and those with impaired renal function. Furthermore, consumption of alcohol is documented to increase the risk of gastrointestinal irritation. The use of herbal products or supplements with antiplatelet or anticoagulant properties is also noted due to the documented potential for increased bleeding risk.

Mechanism of Action

Molecular Inhibition of Cyclooxygenase (COX) Enzymes

Floctafenine acts as a pro-drug, rapidly converting to its active metabolite, floctafenic acid, which functions as an inhibitor of the Cyclooxygenase (COX-1 and COX-2) enzymes. By blocking the activity of these enzymes, the drug interrupts the arachidonic acid cascade, reducing the biosynthesis of pro-inflammatory prostaglandins in the body.


Peripheral Modulation of Nociceptive Signaling

This mechanism is primarily peripheral, with the effect concentrated outside of the Central Nervous System. The suppressed synthesis of prostaglandins directly leads to a reduction in the sensitization of peripheral nociceptors (pain-sensing nerve endings) at the site of tissue injury. This results in reduced signaling and altered local inflammation-related physiological processes such as vasodilation.

Dosage and Administration Information

How to Use Idarac

Idarac, containing the active ingredient floctafenine, is administered as an oral tablet for short-term use.

Administration Scope

Instruction Category Guideline
Route of Administration Oral (as a tablet)
Standard Adult Dosing Single doses range from 200 mg to 400 mg.
Maximum Daily Dose The total daily dose must not exceed 1,200 mg.
Frequency Doses are taken every 6 to 8 hours and used as needed for pain relief.
Course Duration Use must be limited to the shortest possible duration of treatment.

Procedural Instructions and Constraints

Proper administration involves specific steps to ensure correct use. Tablets are consumed after a meal or food and should be swallowed with a glass of water.

For a missed dose, the standard procedure is to take the dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose is skipped and the regular schedule is resumed, ensuring the 1,200 mg daily maximum is not exceeded.

Population Use Rules

Pediatric Patients (under 18 years of age): The safety and efficacy of floctafenine have not been established, and the medication is not authorized for use in this population. Use in older adults is associated with noted differences in safety or effectiveness, which are considerations for this demographic.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Idarac


Evidence for Use in Acute Pain and Postoperative Discomfort

Research on Idarac has centered on research exploring how symptoms change over time related to sharp, sudden pain, including discomfort that occurs after minor medical or dental procedures. This area has been studied for many years through short-term, randomized controlled trials (RCTs). These studies typically compare Idarac against an inactive substance, known as a placebo, and sometimes against other commonly used pain relievers. The research examined outcomes related to physical discomfort and outcomes describing episodic or acute changes.

Researchers designed the trials to measure changes in patient-reported outcomes describing perceived discomfort using standardized scales. Studies monitored the total duration of the measured change in discomfort and the recording of the use of rescue medication—a secondary pain treatment—shortly after taking the study dose. Findings describe patterns observed in the studies over the immediate post-dosing phase, indicating that research has explored episodes where symptoms become more noticeable related to acute symptom patterns.


Evidence for Use in Musculoskeletal and Joint Pain

Idarac was also evaluated in the context of conditions marked by functional limitations related to the muscles and joints, such as those that characterize conditions involving periods of heightened symptoms, like osteoarthrosis. Research here also relied on short-term randomized controlled trials where the medicine was compared against a placebo or other active anti-inflammatory agents.

Research examined changes in outcomes reflecting daily functioning or activity level in patients receiving Idarac. Researchers monitored patient reports on measures such as pain experienced during walking and joint stiffness after periods of rest. Studies reported data show patterns related to measured changes between the groups over the short duration of the studies.


What is Still Uncertain About the Research for Idarac

The available evidence primarily reflects short treatment durations; consequently, the follow-up durations were limited. There is limited information for long-term outcomes or the durability of observed symptom changes beyond the immediate period of study. Furthermore, the reliance on older trial designs means that some data may lack the standardization of contemporary studies, and comparative evidence is lacking against newer treatment options.

For children and adolescents and older adults, the data available for specific patient groups remain insufficient. The evidence highlights what is known — and what is still uncertain regarding sustained effects and specific findings across diverse, unstudied patient populations.

Key Studies & References Health Canada Product Monograph: IDARAC (Floctafenine) Tablets

Frequently Asked Questions (FAQ)

Common questions about Idarac (FAQ)

Q: Is Idarac considered a strong pain reliever?

According to official product information, Idarac (floctafenine) is generally described as having analgesic activity that addresses mild to moderate acute pain. The drug is indicated for the short-term relief of these painful episodes.

Q: How quickly should I expect Idarac to start working?

Official information indicates that the onset of pain relief is typically observed within 1 hour of administration. The active component reaches its peak levels in the body approximately 1 to 2 hours after administration.

Q: Does Idarac build up in your system, or does it leave quickly?

Regulatory studies state that floctafenine and its active components do not accumulate in the body following repeated administration of the recommended doses. This regulatory information indicates that no accumulation of the drug is expected with repeated, appropriate dosing.

Q: Can I take Idarac if I have to drive or operate machinery?

Official patient warnings note that this medication may cause side effects such as drowsiness or dizziness. Because of these reported effects, it is generally recommended to exercise caution if engaging in activities that require full mental alertness, such as driving or operating machinery.

Q: What is the difference between Idarac and generic anti-inflammatory drugs?

Idarac is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), just like ibuprofen or naproxen. Its specific classification is as an anthranilic acid derivative, a unique type of NSAID.

Q: Can Idarac be taken with common cold and flu medicines?

Official product information advises that floctafenine may interact with non-prescription medications. Due to the variety of ingredients in common cold and flu medicines, professional consultation is required regarding any concurrent use to avoid potential negative interactions.

Q: Is Idarac considered an opioid or a habit-forming drug?

Idarac (floctafenine) is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and an analgesic. It is not designated as an opioid or narcotic.

Q: What medical conditions is Idarac officially approved to treat?

Regulatory documents state that Idarac is formally indicated for the short-term use in acute pain of mild and moderate severity. Its purpose is to provide symptomatic relief for these painful episodes.

Q: How does Idarac fit into treatment plans for rheumatoid arthritis?

As a member of the NSAID class of medicines, it may be used for the symptomatic relief of pain and inflammation associated with conditions such as rheumatoid arthritis. Its use is limited to short-term relief.

Q: Are there specific symptoms that mean I should stop taking Idarac immediately?

Stopping the medication and seeking immediate professional advice is warranted if you notice signs of a severe allergic reaction (such as a sudden rash or swelling). It is also warranted if you notice persistent gastrointestinal upset, including unusual stomach pain or vomiting.

Q: Why is Idarac sometimes prescribed when other NSAIDs haven't worked?

Clinical literature reviewed by regulatory bodies suggests that floctafenine may be utilized as an alternative NSAID treatment. This approach may be considered for patients who have had specific adverse reactions to other types of NSAIDs.

Q: Does Idarac change the way other medications are absorbed in the body?

Floctafenine is associated with various drug interactions, primarily through its effects on blood components and the kidneys. The official documents highlight potential interactions with the action of other drugs, such as blood thinners and Aspirin.

Q: Do official documents mention anything about Idarac use and fertility?

Official information notes that the drug belongs to the NSAID class, which has been associated in some studies with reversible female infertility by potentially interfering with ovulation. This information is relevant for patients who are discussing conception or fertility with their healthcare provider.

Q: What does the research say about Idarac and headaches?

Headache is listed as a potential side effect in official product information for floctafenine. Generally, NSAIDs are utilized for the symptomatic relief of acute pain, which can include certain types of headaches.

Q: What does the term 'non-steroidal anti-inflammatory' mean in simple language?

The term means that the drug acts to relieve pain and swelling (anti-inflammatory) but does not contain corticosteroids (it is non-steroidal). It achieves this effect by reducing the body’s production of substances called prostaglandins.

Q: Are there any specific laboratory tests required before starting Idarac?

For patients with pre-existing conditions (such as impaired kidney or liver function) or those on extended treatment, a doctor may require monitoring of blood or urine abnormalities. The necessity of these tests is determined on a case-by-case basis by the prescribing physician.

Q: What is the official purpose of the black box warnings (if any) on Idarac?

Like other NSAIDs, the official warnings highlight the potential increased risk of serious cardiovascular (CV) thrombotic events (such as heart attack or stroke) and serious gastrointestinal (GI) events (such as bleeding or ulceration). This serves as mandatory communication of the most serious risks associated with the drug class.

Q: What should I do if I notice a change in my urine color while on Idarac?

Changes in urine output or color may be related to potential renal (kidney) issues. As kidney problems are a documented serious risk with NSAIDs, this symptom should be promptly reported to a doctor for assessment.

Q: Does Idarac affect blood sugar levels for people with diabetes?

Official warnings advise that patients with chronic conditions like diabetes or those following a special diet should consult with a healthcare professional before starting the medication. This ensures appropriate oversight and management of the pre-existing condition.

Q: Is it okay to crush or chew Idarac tablets if I have trouble swallowing?

According to the regulatory administration instructions, the tablets must be swallowed whole with a glass of water. They should not be crushed or chewed.

How should Idarac be stored and disposed of?

Official Storage and Disposal Requirements

Storage & Disposal Scope Requirement
Temperature Requirement Store at room temperature between 15 C and 30 C.
Protection Requirements Protect the tablets from light, moisture, and excessive heat.
Child Safety Must be kept out of the sight and reach of children.
Disposal Method Return unused or expired medication to a pharmacy for proper disposal; do not discard in household trash or down the drain.

Regulatory documentation mandates that Idarac (floctafenine) tablets be maintained within a specific room temperature range to preserve product stability. The required storage environment must provide protection from external factors, specifically light and moisture. The official labeled disposal method requires that unused product be returned to an authorized drug collection point, and strictly prohibits primary disposal into wastewater or household waste streams. The safety profile includes the mandatory handling constraint to keep the medication away from children.

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

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