Индометацин

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Индометацин

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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 Индометацин

What is Индометацин?

This overview defines Индометацин (Indometacin), detailing its pharmaceutical identity, classification, and general function, highlighting its position as a recognized anti-inflammatory agent.

Property Description
Active Ingredient Indometacin (Indomethacin)
Form Capsules, Suppositories, Oral Suspension, Intravenous
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common Use Reducing pain, inflammation, and fever
Origin Synthetic (Indole-acetic acid derivative)

What Type of Medicine is Индометацин?

Индометацин is a potent, synthetic Nonsteroidal Anti-Inflammatory Drug (NSAID) that is widely used to reduce inflammation, pain, and fever. It is formally classified as an NSAID and is considered an essential medicine. The drug is often noted for its potency compared to other common NSAIDs.

The medication's active compound is Indometacin, a synthetic chemical entity derived from indole-acetic acid. This classification places it in the acetic acid derivative group, a distinctive feature that contributes to its powerful anti-inflammatory profile. It is typically manufactured as a single-ingredient product, focusing its entire action on the core effects of Indometacin.

What Does Индометацин Do in General?

The general purpose of Индометацин is to provide comprehensive symptomatic relief by inhibiting the production of inflammatory mediators called prostaglandins. As an established non-selective cyclooxygenase (COX) inhibitor, it effectively reduces symptoms associated with inflammation, such as the pain and swelling typical of chronic inflammatory conditions.

This action enables the reduction of primary symptoms like localized swelling, joint stiffness, and general aches. Its application is appropriate where a strong anti-inflammatory effect is required, providing targeted relief for intense inflammatory symptoms.

What Forms of Индометацин are Available?

Индометацин is available in several dosage forms, including oral capsules (both standard and extended-release), rectal suppositories, and liquid oral suspension. These preparations are designed for systemic action, meaning the active ingredient is absorbed for distribution throughout the entire body. The inclusion of forms like the rectal suppository offers a differentiated route of administration, providing a therapeutic option when oral intake is difficult.

What side effects are possible with Индометацин?

Possible Side Effects and Safety Information

The safety profile for Indometacin is established through official regulatory documents, classifying potential adverse reactions by frequency and the body system affected. These classifications ensure full disclosure of both common and serious possible effects.

System-Organ Classes and Common Adverse Reactions

Adverse effects are categorized by the official System-Organ Classes (SOC), frequently involving the Gastrointestinal Disorders and Nervous System Disorders. Officially classified as Common (affecting 1 to 10 users in 100), reactions may include headache, dizziness, dyspepsia, nausea, and abdominal pain. Less common reactions may affect the skin (e.g., rash, pruritus) and cardiovascular system (e.g., edema).

Classification Examples of Reactions
Common Headache, Dizziness, Dyspepsia, Nausea, Abdominal Pain
Uncommon Confusion, Insomnia, Hypertension, Acute Anaphylaxis

Serious Adverse Reactions and Safety Constraints

The official labeling highlights the risk of serious adverse reactions, which may occur without warning. These include the potential for life-threatening gastrointestinal bleeding, ulceration, and perforation, which can be fatal. Furthermore, there is a documented risk of serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke, which may increase with the duration of use.

Usage is subject to several high-level regulatory constraints. It is contraindicated for pain management following Coronary Artery Bypass Graft (CABG) surgery, and during the third trimester of pregnancy. Older adults are formally recognized as being at an increased risk for these serious gastrointestinal and cardiovascular events, necessitating particular caution.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with indomethacin, an NSAID, can lead to a range of symptoms, though they are often classified as generally reversible. The most common presentations following an acute overdose include central nervous system effects such as drowsiness, lethargy, confusion, or severe headache, and gastrointestinal symptoms like nausea, vomiting (sometimes with blood), epigastric pain, and potential gastrointestinal bleeding.

In rare but severe cases, an overdose may affect other physiological systems, potentially leading to acute renal failure, hypertension, respiratory depression, or even coma or seizures. The risk of serious gastrointestinal events, including bleeding or ulceration, is a critical concern in overdose situations.

There is no specific antidote for indomethacin overdose. Management is focused on symptomatic and supportive care. If the ingestion was recent and potentially toxic, measures such as administering activated charcoal may be considered by medical professionals.

Immediate medical attention is required if a severe overdose is suspected or if symptoms involve any signs of major systemic complications, such as a decreased level of consciousness (coma), difficulty breathing, persistent vomiting with or without blood, severe abdominal pain, or a severe headache. Prompt medical evaluation is essential to monitor vital signs and manage any potential serious complications.

Therapeutic Uses of Индометацин

What Индометацин Treats: Main Uses and Benefits

The primary therapeutic role of Индометацин (Indometacin) is to provide supportive symptomatic relief by targeting symptoms related to inflammatory or irritative states. It is commonly used across conditions presenting with acute or chronic episodes, including Rheumatoid Arthritis, Ankylosing Spondylitis, Osteoarthritis, acute gouty arthritis, bursitis, and tendinitis. It is generally applied in contexts where pronounced symptoms create noticeable interference with daily stability, and contributes to improved day-to-day comfort during symptomatic periods.

The medication assists with managing symptom clusters that may intensify over time, such as debilitating morning stiffness, joint swelling, and continuing musculoskeletal pain. This short-term supportive relief contributes to easing the overall symptom load during acute flares and may assist with maintaining functional stability in long-term management.

“The ability to manage heightened symptoms may help patients cope more steadily with difficult episodes and supports general well-being during symptomatic phases.”

The specialized uses cover the reduction of fever and the management of neurological disorders known as indomethacin-responsive headaches. It is also utilized in a specialized pediatric context for Patent Ductus Arteriosus application in premature infants.


Quick Fact: Relief for Inflammation and Stiffness

Индометацин is commonly used to help with the acute onset of pain and tenderness related to inflammatory or irritative states.

Eligibility and Restrictions for Use

Who Can and Cannot Use Индометацин (Indometacin)

The eligibility for Индометацин is strictly defined by regulatory documents, emphasizing absolute prohibitions and conditional use based on patient status.

Populations Allowed Under Standard Labeling

Use is generally established for adults diagnosed with inflammatory conditions such as Rheumatoid Arthritis, Ankylosing Spondylitis, Osteoarthritis, acute gouty arthritis, and acute painful shoulder. Limited use is established for children aged 2 years and older for Juvenile Rheumatoid Arthritis (JRA); general use for other indications is not established for those under 14 years old.


Absolute Contraindications (Must Not Use)

Category Non-Eligibility Criteria
Allergy Known hypersensitivity to Indometacin or cross-sensitivity to other NSAIDs (e.g., aspirin-induced asthma).
Gastrointestinal Active gastrointestinal ulceration, recurrent ulceration, or chronic bleeding.
Organ Function Severe renal impairment or severe hepatic impairment.
Surgical Use in the setting of coronary artery bypass graft (CABG) surgery.
Pregnancy Patients in the third trimester of pregnancy.

Restricted and Conditional Use

Older adults require caution and close monitoring due to increased sensitivity. Use is not recommended for breastfeeding women and is generally restricted during the first and second trimesters of pregnancy. Patients with mild to moderate renal or hepatic impairment require dose adjustment and functional monitoring. The medicine is also restricted for patients with a history of epilepsy, Parkinsonism, or psychiatric disturbance, as it may aggravate these conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products — Official Regulatory Information

The interaction profile of Индометацин is characterized by documented effects on renal drug clearance and additive pharmacodynamic risks, as established in government regulatory labels.

Interaction Scope Documented Details (Based on Regulatory Labels)
Medicinal Product Categories Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), Anticoagulants, Antiplatelet Agents, SSRIs, Diuretics, Antihypertensives (e.g., ACE Inhibitors, ARBs), and Probenecid-like Uricosurics.
Specific Interacting Agents Lithium, Methotrexate, Digoxin, Probenecid, Warfarin, and other NSAIDs are explicitly listed as having clinically significant interactions.
Mechanistic Basis Renal clearance inhibition reduces the excretion of drugs such as Lithium and Methotrexate, increasing their plasma concentrations. Additive effects increase the risk of serious bleeding with anticoagulants.
Population Notes The risk of adverse outcomes from interactions, particularly gastrointestinal bleeding and renal toxicity, is elevated in elderly patients.

Interaction-Related Restrictions

  • Contraindication: Concomitant use with other NSAIDs is formally restricted or prohibited due to the cumulative risk of severe gastrointestinal toxicity and hemorrhage.
  • Exposure Modification: Co-administration with Probenecid reduces the clearance of Индометацин, leading to increased plasma exposure of Indometacin.
  • Efficacy Blunting: The antihypertensive effect of Diuretics (e.g., Furosemide) and certain Antihypertensives is officially documented as being diminished or reduced.
  • Substance Interaction: The official risk of gastrointestinal bleeding is documented as being increased with the concomitant consumption of Alcohol.

Regulatory documents define the product's interaction structure primarily through two major pathways: pharmacodynamic interference, which involves the blunting of antihypertensive efficacy and the additive risk of bleeding, and pharmacokinetic inhibition of renal clearance, which dictates the accumulation and increased exposure of several co-administered medicines.

Mechanism of Action

Inhibition of Cyclooxygenase (COX) Enzymes

Индометацин primarily works by acting as a non-selective, reversible inhibitor of the Cyclooxygenase (COX-1 and COX-2) enzymes. . This molecular interaction blocks the initial step in the arachidonic acid cascade, thereby preventing the synthesis of prostaglandins (PGE2) and other key inflammatory mediators. This mechanistic domain is responsible for modulating the heightened signaling of inflammatory and pyretic mediators at the tissue level.


Central Pathway Modulation and Thermoregulation

Due to its high lipid solubility, the compound readily crosses the blood-brain barrier to exert a central effect. By inhibiting COX within the hypothalamus, it adjusts the body’s thermoregulatory set point, contributing to a shift in the hypothalamic set point for temperature. This domain engages mechanisms that regulate overactive processes within the central nervous system that drive the pyretic response.


Secondary Receptor and Enzyme Targeting

The drug also engages secondary mechanisms, including a weak inhibition of Phospholipase A2 (PLA2) and the positive allosteric modulation of the Type 1 Cannabinoid Receptor (CB1R). This secondary domain affects distinct signaling patterns, providing an additional pathway for modulating nociceptive signaling and CNS function.

Dosage and Administration Information

Indomethacin administration is based on specific protocols that detail the appropriate route, frequency, and conditions of intake. The medicine is available for systemic administration via the oral route (capsules and suspension), the rectal route (suppositories), and as an intravenous (IV) preparation.

Official Dosing and Frequency Patterns

Treatment for chronic conditions typically begins with a low initial daily dose, such as 25 mg taken two or three times daily, which may be gradually increased in 25 mg increments at weekly intervals. Standard capsules are administered in divided doses throughout the day, while the 75 mg extended-release form is usually taken once or twice daily. The total adult daily intake typically does not exceed 200 mg for most chronic uses. Use is categorized as short-term for acute episodes, such as gout, or as part of a long-term plan at the lowest effective dose for chronic conditions.

Administration Conditions and Handling

Oral dosage forms are typically administered immediately after meals or with food, milk, or antacids to enhance gastrointestinal tolerability. Extended-release capsules are designed to be swallowed whole and are not crushed, chewed, or opened. The intravenous preparation requires precise reconstitution and dilution and is reserved for specialist use in a hospital setting. In the event of a missed dose, the protocol generally involves taking it as soon as possible, unless it is close to the time for the next scheduled dose, in which case the missed dose is skipped.

Recent Clinical Evidence

Research Evidence / Overview of studies for Индометацин

The available scientific evidence for Indometacin is primarily derived from controlled clinical trials and observational data gathered over many years of research. This overview outlines the types of studies that have been conducted, the outcomes measured by researchers, and the areas where information remains limited or uncertain. Findings describe group patterns observed in studies and do not provide individual predictions.

Evidence for Chronic Inflammatory Conditions

This section will summarize the structure of Controlled Clinical Trials, comparative studies, and long-term observational analyses used to examine its use in chronic conditions such as Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis, focusing on the symptomatic outcomes measured by researchers.

Research has explored the compound in conditions characterized by fluctuating or episodic manifestations, specifically targeting outcomes linked to inflammatory or irritative states. Studies conducted in adult populations included individuals with forms of active inflammatory disease and utilized different research designs, including short-term comparisons and longer retrospective analyses. Trials monitored patient-reported outcomes describing perceived discomfort and outcomes reflecting daily functioning or activity level.

What remains uncertain is the limited information for long-term outcomes versus newer anti-inflammatory therapies. While some retrospective data exists, contemporary comparative evidence focusing on durability of response and extended-duration functional change is lacking. Scientific literature notes that the results apply only to the populations studied in the research settings.

Evidence for Acute Inflammatory Episodes

This part will focus on the Randomized Controlled Trials (RCTs) and short-term controlled studies that examined its use in the rapid, limited duration of conditions like acute gouty arthritis, bursitis, and tendinitis, detailing the time-bound endpoints that were reported by the researchers.

Research examined the compound in acute conditions involving periods of heightened symptoms. The research explored short-term symptom changes over a limited follow-up duration, often spanning just a few days to two weeks, which is relevant in trials assessing short-term or episodic symptom patterns. Measured outcomes typically included the rate of change in pain, tenderness, and swelling in the affected joint.

The research provides insight into short-term changes, with studies reporting how symptoms evolved quickly in the observed populations during the defined time window. Data show patterns related to a consistent focus on the initial days of symptom activity, which is the primary scope of this research.

Evidence in Specialized and Neonatal Contexts

This subsection will outline the design of Multicenter Placebo-Controlled Trials conducted in premature infants to assess rates of Patent Ductus Arteriosus (PDA) closure. It will also briefly summarize the research base for the specialized management of fever and Indomethacin-responsive headaches.

Evidence for Patent Ductus Arteriosus (PDA)

The compound was studied in the context of its use in premature infants diagnosed with Patent Ductus Arteriosus. This involved controlled trials that monitored the rate of ductal closure and the need for surgical intervention. Research is ongoing to characterize long-term outcomes on neurodevelopmental outcomes in this population.

Evidence for Other Specialized Uses

Research examined the use of the compound in specific neurological conditions known as Indometacin-responsive headaches. Similarly, the compound was observed in research exploring its effect on systemic temperature to address outcomes related to systemic or functional imbalance, such as fever. The evidence quality varies across studies for these specialized uses, and large-scale comparative evidence is lacking compared to other primary conditions studied.

What is Still Uncertain About the Research for Индометацин

Research highlights that comparative evidence is lacking against the full range of newer anti-inflammatory agents now available, particularly in the chronic arthritis setting. For many uses, follow-up durations were limited, focusing heavily on acute or short-term symptomatic change. This means that long-term functional outcomes are not fully established by prospective trials. Furthermore, evidence quality varies across studies, and data for certain groups remain insufficient, especially for specific pediatric populations outside of the neonatal intensive care setting.

Frequently Asked Questions (FAQ)

Common questions about Индометацин (FAQ)


Q: Is Indomethacin a steroid medication?

The official classification of this medication is a Nonsteroidal Anti-Inflammatory Drug (NSAID). This means that it is not a type of hormonal medication known as a steroid. It is chemically defined as an indole-acetic acid derivative.

Q: How does Indomethacin differ from common painkillers?

Regulatory information indicates that Indomethacin provides symptomatic relief by targeting Cyclooxygenase (COX) enzymes, which stops the production of inflammatory mediators. It is noted for a mechanism that also involves a weak inhibition of Phospholipase A₂, which may contribute to its effective anti-inflammatory activity compared to some simpler pain relievers.

Q: What are the less common side effects?

Official product information categorizes possible effects by frequency. Less common, or 'uncommon,' reactions reported in the nervous and cardiovascular systems may include confusion, insomnia (trouble sleeping), high blood pressure, and acute allergic reactions like anaphylaxis.

Q: How quickly does Indomethacin begin to work?

Studies reported in official documents indicate that initial pain relief has been been reported within 2 to 4 hours after the medication is administered. It is important to remember that the timeline for observing effects may vary among different individuals.

Q: How long does Indomethacin stay in the body?

According to clinical pharmacology data, the average elimination half-life of Indomethacin is approximately 4.5 hours. The half-life is the time it takes for the concentration of the medication in the bloodstream to decrease by half.

Q: Is Indomethacin allowed for people with diabetes?

Regulatory documents suggest caution is needed when Indomethacin is used by patients with diabetes. The medication may impact glucose levels and carries an increased risk of kidney-related complications. This risk is especially relevant if the patient is taking certain diabetes medications, such as Metformin.

Q: Are there new studies on the use of Indomethacin?

Official reviews acknowledge that Indomethacin has a long history of use and research. However, regulatory summaries indicate there are limited comparative data against newer anti-inflammatory therapies and that the evidence for long-term functional outcomes is not fully established by contemporary prospective trials.

Q: What is the place of Indomethacin in modern treatment guidelines?

Official guidance notes that Indomethacin is established for the treatment of acute conditions, notably acute gouty arthritis. However, regulatory overviews often highlight a lack of contemporary data for comparing its long-term efficacy with the newest anti-inflammatory agents now available.

Q: Is it true that Indomethacin can cause drowsiness?

Yes, the official list of possible adverse reactions includes effects on the central nervous system. These documented effects may include confusion, dizziness, and lethargy, which can sometimes be experienced as sleepiness or drowsiness.

Q: Why is Indomethacin sometimes recommended to be taken on a strict schedule?

Taking this medication on a regular schedule is often advised to achieve stable concentrations of the drug in the blood. This steady presence is important for ensuring the medication can maintain its therapeutic effect over time.

Q: Can I drive a car while taking Indomethacin?

Because Indomethacin can cause side effects like dizziness, confusion, and other central nervous system disturbances, official warnings state that caution is warranted due to the risk of impairment when operating machinery or driving a vehicle.

Q: Does Indomethacin affect blood test results?

The documented risk of hematological toxicity means that monitoring of certain blood parameters may be required during treatment. This is due to the documented risk affecting hemoglobin, hematocrit, white blood cell count, and platelet count.

Q: Do I need to follow a specific diet when taking Indomethacin?

Regulatory documents state that this medication should be taken with food, milk, or antacids to help minimize the risk of gastrointestinal irritation. Generally, there are no specific, strict dietary restrictions beyond this administration condition.

Q: What is the specific feature of using Indomethacin in the form of suppositories?

The rectal suppository form is designed for systemic absorption throughout the body. Official product information notes that suppositories have a contraindication for use if the patient has any recent bleeding or inflammation of the rectum or anus.

Q: What is the specific feature of using Indomethacin in the form of an ointment or gel?

The gel and ointment forms are intended for external (topical) application to the skin for local symptoms in muscles and joints. Regulatory labels state that these forms are contraindicated for use on damaged skin or in children under the age of 14 years.

Q: Can Indomethacin cause mood changes?

The official adverse reaction profile includes reports of psychiatric disturbances and changes in the central nervous system. These documented effects may involve confusion, depression, or other changes to mental status or mood.

Q: Can Indomethacin affect the ability to conceive a child?

Regulatory documents indicate that NSAIDs, including Indomethacin, are associated with a potential risk of reversible infertility. Official guidance documents state that withdrawal of the drug is generally considered for women who are having difficulties conceiving.

Q: How can Indomethacin affect vision?

The official product labeling specifies that possible adverse reactions include the occurrence of blurred vision or any other changes in vision. Changes in vision are often noted as requiring attention.

Q: What is the difference between Indomethacin tablets and capsules?

Official documents primarily distinguish between standard capsules and extended-release capsules. A key difference in administration is that extended-release capsules have the requirement that they be swallowed whole and not be crushed, chewed, or opened.

How should Индометацин be stored and disposed of?

Storage and Disposal of Indomethacin

Storage instructions for Indomethacin are defined by the specific dosage form to maintain product quality, as required by regulatory labeling.

Required Storage Conditions

Indomethacin oral forms and the powder for injection must be stored at Controlled Room Temperature, which is 20 to 25 C (68 to 77 F). Excursions between 15 and 30 C are permitted.

Protection and Handling

Dosage Form Required Protection
Extended-Release Capsules Must be protected from moisture
Injection (Powder) Must be protected from light and stored in its carton

The reconstituted solution for injection must be discarded immediately after use as it does not contain a preservative. All forms must be stored out of the sight and reach of children.

Disposal

Unused or expired product should be disposed of according to local regulations.

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

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