Индоцид

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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 Индоцид

Quick Facts

Property Description
Active ingredient Indometacin (Indomethacin)
Form Capsules, Suppositories, Powder for injection
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Relief of pain, inflammation, and fever
Origin Synthetic compound

Что такое Индоцид (Индометацин)?

Индоцид (Indometacin): Identity and Pharmacological Class

Индоцид is a prescription-only, synthetic, single-ingredient medication containing Indometacin (or Indomethacin) as its sole active ingredient. The compound is chemically recognized as an Indole-acetic acid derivative, which places the medicine within the Non-Steroidal Anti-Inflammatory Drug (NSAID) pharmacological class. This classification is based on its specific mechanism in targeting inflammatory pathways. Indometacin is clinically recognized for being a particularly potent agent within the NSAID group, often utilized when significant anti-inflammatory action is required in addition to its analgesic and antipyretic effects. The drug is primarily designated for adult patients and is typically reserved for conditions that necessitate powerful symptomatic control of inflammation.

Composition, Forms, and Primary Symptomatic Purpose

The formulation of Индоцид utilizes Indometacin combined with appropriate pharmaceutical excipients, resulting in several core dosage forms, notably oral capsules, rectal suppositories, and powder for intravenous injection. The availability of both standard and specialized preparations is a differentiating factor, offering flexibility in administration. The primary symptomatic purpose of Индоцид is to provide comprehensive relief from the physical manifestations of inflammatory processes. Indometacin functions by inhibiting the synthesis of prostaglandins. This means the medication helps to alleviate associated symptoms such as moderate to severe pain, persistent fever, swelling, and joint stiffness by addressing a primary chemical mediator of these symptoms.

Regulatory References

  1. Indomethacin - StatPearls - NCBI Bookshelf - NIH

What side effects are possible with Индоцид?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and safety constraints of Indocin (Indomethacin) as documented in official government regulatory labeling (e.g., FDA, EMA/SmPC).

Serious Documented Adverse Reactions

The official labeling includes a Boxed Warning highlighting two critical risks:

  • Serious Cardiovascular Thrombotic Events: The risk of myocardial infarction and stroke is documented and may occur early in treatment, increasing with duration of use.
  • Serious Gastrointestinal (GI) Events: Risks include bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during treatment, with or without warning symptoms.

Other serious events documented in regulatory information include severe cutaneous adverse reactions (SJS, TEN, DRESS), renal toxicity (acute renal failure), hepatic toxicity, and anaphylaxis.

Common Adverse Reactions and Organ Systems

The most Common adverse reactions (occurring in ge 3% of patients) cited in official labeling are:

System-Organ Class Common Adverse Reactions (mathbfge 3% Frequency)
Nervous System Headache, Dizziness
Gastrointestinal Dyspepsia (Indigestion), Nausea

The drug is associated with effects across multiple systems, including the Cardiovascular, Renal/Urinary, and Nervous Systems. CNS effects, such as headache and dizziness, are often noted to be dose-related.

Safety Considerations for Specific Populations

  • Elderly Patients: Official labeling indicates a higher risk of serious GI and renal adverse reactions, as well as an increased susceptibility to CNS effects.
  • Pregnancy: Indomethacin is contraindicated from 30 weeks of gestation due to the risk of premature closure of the fetal ductus arteriosus. Use is restricted between 20 and 30 weeks due to the potential for fetal renal dysfunction.

Key Restrictions

Indomethacin is contraindicated in patients with a history of asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs, and for pain management following coronary artery bypass graft (CABG) surgery. Regulatory guidance also recommends periodic monitoring of renal and hepatic function during treatment.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information is derived exclusively from official government regulatory documents detailing the presentation and management of Indometacin overdose.

Documented Overdose Manifestations and Severe Outcomes

Symptoms of an Indometacin overdose, as listed in prescribing information, frequently involve the gastrointestinal and central nervous systems.

System Documented Manifestations Severe Outcomes
Gastrointestinal Nausea, Vomiting, Epigastric Pain, Diarrhea Significant Gastrointestinal Bleeding
Central Nervous System Severe Headache, Dizziness, Drowsiness, Confusion Seizures, Coma
Other Systems Tinnitus, Blurred Vision, Edema Acute Renal Failure, Liver Damage, Cardiac Effects

Immediate Required Actions

Seeking Urgent Medical Attention:

Official regulatory information mandates that you seek immediate medical attention and contact a poison control center or emergency room at once if an overdose is suspected or confirmed. Urgent help is required immediately if the person has collapsed, experienced a seizure, or has difficulty breathing.

Official Management and Antidote Status

No specific antidote is documented for Indometacin overdose in official labeling; therefore, management is strictly supportive and symptomatic. Procedural measures, such as the use of activated charcoal and, in life-threatening adult cases, gastric lavage, may be considered within one hour of ingestion. Hospital monitoring of vital signs, blood work, and ECG are typically required for assessment and continuous observation. Elderly patients are noted to have an increased risk of serious adverse effects during an overdose.

Therapeutic Uses of Индоцид

The medication is used to provide supportive symptomatic relief for conditions driven by inflammatory states, focusing on easing discomfort and improving daily function. It is relevant in clinical settings marked by heightened symptoms across several musculoskeletal and joint domains.

This medicine is commonly used in various conditions where symptoms are related to inflammatory or irritative states, including the management of symptoms in conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gouty arthritis, bursitis, and tendinitis. It helps address symptom clusters that include persistent pain, swelling, and stiffness.

“It is applied in clinical settings that involve acute or unstable symptom patterns, offering support when symptoms become temporarily overwhelming.”

In scenarios such as chronic joint disorders or acute flares, the medication provides support that helps ease the overall symptom burden. It assists with maintaining functional stability and may help patients cope more steadily with symptom fluctuations, contributing to improved day-to-day comfort.


Quick Fact: Relief for Inflammation and Pain

Eligibility and Restrictions for Use

Who Can and Cannot Use Индоцид (Indometacin)

Official regulatory labeling strictly defines the population eligible to use Индоцид (Indometacin), primarily restricting its use to adult patients for oral and rectal formulations. Use in children under 14 years for these forms is generally not established.

Absolute Contraindications

Indometacin must not be used by individuals with a known hypersensitivity to the drug, aspirin, or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), specifically those with aspirin-sensitive asthma. It is also contraindicated for treating peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Contraindications related to patient health status include active peptic ulceration or a history of recurrent gastrointestinal bleeding, as well as severe heart failure, severe hepatic failure, or severe renal failure.

Pregnancy and Conditional Use

Indometacin is contraindicated during the third trimester of pregnancy (starting at approx 30 weeks gestation). Use in the second trimester is limited to the lowest effective dose for the shortest duration. The medicine is not recommended for women attempting to conceive or for nursing mothers. Patients with advanced renal disease or severe heart failure should generally avoid use unless the benefit outweighs the risk.

What should I know about interactions with other medicines?

Indocid (Indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) and can interact with numerous other medications and substances, potentially altering their effects or increasing the risk of adverse reactions. It is crucial to inform a healthcare provider of all prescription drugs, over-the-counter medicines, vitamins, and herbal supplements being taken.

Key Drug Interactions

Drug Class Examples Potential Interaction and Risk
Other NSAIDs/Aspirin Ibuprofen, naproxen, celecoxib Greatly increased risk of serious gastrointestinal bleeding, ulcers, and perforation. Concomitant use is generally avoided.
Anticoagulants/Antiplatelets Warfarin, apixaban, clopidogrel Increased risk of bleeding. Close monitoring is required.
Corticosteroids Prednisone, methylprednisolone Increased risk of gastrointestinal side effects.
Blood Pressure Medications ACE inhibitors (e.g., lisinopril), ARBs (e.g., losartan), Diuretics (e.g., furosemide) May reduce the effectiveness of these medications and increase the risk of kidney problems, including acute kidney failure.
Lithium Indocid can increase lithium blood levels, leading to toxicity.
Methotrexate Indocid may increase methotrexate levels, raising the risk of toxicity.

Other Important Considerations

  • Alcohol and Tobacco: Daily use of alcohol, especially when combined with Indocid, significantly increases the risk of stomach bleeding. Smoking also contributes to this risk.
  • Herbal Supplements: Certain supplements, such as those that affect blood clotting (e.g., garlic, ginger, ginkgo), may also increase the risk of bleeding.

Mechanism of Action

️ How Индоцид Works: Mechanism of Action

Primary Mechanism: Inhibition of Prostaglandin Synthesis

The primary mechanism involves the direct, non-selective inhibition of Cyclooxygenase ( COX) enzymes ( COX-1 and COX-2), which are responsible for converting arachidonic acid into pro-inflammatory prostaglandins. This molecular action directly modifies the early steps in the lipid signaling cascade, which leads to a reduction in inflammatory mediators and lowered sensitivity of peripheral pain nerve endings.


Central and Specialized Physiological Modulation

The mechanism extends beyond the periphery to include a specialized central action on the brain's hypothalamic thermoregulatory center, where COX inhibition suppresses PGE2 production, allowing for the normalization of the hypothalamic temperature set-point. Furthermore, secondary, non-COX mechanisms, such as the stabilization of cellular components and PPARgamma receptor activity, contribute to the modulation of cellular inflammatory signaling and regulatory systems.


Mechanistic Constraints and Specificity

The non-selective nature of the inhibition results in a specific mechanistic profile characterized by tight, sustained binding to the COX enzymes. This action results in significant reduction in PGE2 synthesis but concurrently limits the synthesis of constitutive prostaglandins and thromboxane A2, which represents an inherent functional constraint on the mechanism.

Dosage and Administration Information

Official Administration Guidelines for Индоцид (Indometacin)

The following details describe the standard administration protocol for indometacin.

Administration Scope Details
Available Routes Oral (capsule, extended-release, suspension), Rectal (suppository), Intravenous (IV solution).
General Dosing Rule Use the lowest effective dosage for the shortest duration consistent with the treatment goals. The total daily dose generally should not exceed 200 mg.
Oral Dosing The initial dose for the standard-release capsule is typically 25 mg two or three times a day (BID or TID). The dose may be gradually increased by 25 mg or 50 mg at weekly intervals.
Rectal Dosing Typically 50 mg to 100 mg per dose, often administered once at bedtime. Rectal administration may supplement oral therapy, but the combined total daily dose must not exceed the maximum limit.
Administration Timing Oral forms must be taken with food, milk, or an antacid to minimize gastrointestinal discomfort. Extended-release capsules should be swallowed whole; they must not be opened, crushed, or chewed.
Missed Dose If a dose is missed, take it as soon as remembered. If it is almost time for the next scheduled dose, skip the missed dose and resume the regular schedule. Do not double the dose to make up for the missed one.
Special Populations Elderly patients must use the lowest effective dose due to an increased risk of reactions. Pediatric use (under 14 years old) for non-IV forms is generally not recommended, except for specified juvenile conditions.

Recent Clinical Evidence

Overview of Indomethacin Research

Indomethacin (marketed as Индоцид) is a nonsteroidal anti-inflammatory drug (NSAID) that has been studied across multiple conditions since its introduction. Its primary clinical applications are in the symptomatic management of inflammation, swelling, and pain associated with chronic conditions, including rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Clinical evidence also documents the use of indomethacin for acute painful shoulder (bursitis/tendinitis) and acute gouty arthritis. Studies conducted for acute gout have reported the observation of pain relief within 2 to 4 hours of administration.


Efficacy and Safety Profile

Indomethacin's effect is achieved through the nonselective inhibition of cyclooxygenase (COX) enzymes, which modulate the production of prostaglandins—compounds involved in mediating pain, fever, and inflammation.

Clinical Area Study Findings Safety Note
Gouty Arthritis Clinical trials have shown a reduction in pain, tenderness, and swelling during acute attacks. Gastrointestinal (GI) adverse events, including bleeding and ulceration, are a known class risk for NSAIDs.
Rheumatoid Arthritis Research has documented relief of pain and a reduction in fever, swelling, and tenderness associated with the disease. The risk of serious cardiovascular thrombotic events (e.g., heart attack, stroke) is associated with NSAID use and may increase with the duration of use.

Ongoing research continues to investigate other potential applications, including its use in certain headache disorders and its potential antiviral properties, though these areas require further large-scale clinical confirmation.

Frequently Asked Questions (FAQ)

Common questions about Индоцид (FAQ)


Q: Может ли Индоцид повлиять на желудок, и как это описывается в документах?

A: Official labeling states that the medicine carries a Boxed Warning—the FDA's most serious safety alert—regarding the risk of serious gastrointestinal (GI) events. These documented risks include inflammation, bleeding, ulceration, and perforation of the stomach or intestines. Common GI adverse reactions documented are indigestion (dyspepsia) and nausea.

Q: Индоцид вызывает сонливость или усталость?

A: Official regulatory documents list side effects affecting the nervous system, such as headache and dizziness, as common adverse reactions. Other Central Nervous System (CNS) effects, such as drowsiness or fatigue, are described in association with its use.

Q: Какие общие побочные эффекты Индоцида встречаются чаще всего?

A: According to the official product information, the most common adverse reactions reported (occurring in three percent or more of patients) involve the nervous system and the gastrointestinal tract. These typically include headache, dizziness, indigestion, and nausea.

Q: Есть ли в официальных источниках информация о приеме Индоцида во время беременности?

A: Official information indicates the drug is generally restricted from approximately 30 weeks of gestation due to potential risks to the fetus. Use is limited between about 20 and 30 weeks due to the potential for fetal kidney dysfunction.

Q: Почему некоторые люди используют Индоцид для лечения подагры?

A: Official indications state that the medicine is approved for the symptomatic treatment of acute gouty arthritis. This use is based on its mechanism as an anti-inflammatory agent and is recognized for having potent anti-inflammatory properties that help relieve the severe pain, tenderness, and swelling associated with acute gout attacks.

Q: Что официальные документы говорят о передозировке Индоцидом?

A: Regulatory documents describe potential signs of an overdose, which may include symptoms like nausea, vomiting, confusion, severe headache, and dizziness. Management for overdose is generally described as supportive and involves monitoring the patient's condition.

Q: Что означает 'черный ящик' (Boxed Warning) для Индоцида, если он есть?

A: The Boxed Warning is the most serious safety alert required by the FDA to call attention to severe risks. For this medicine, it highlights two critical risks: the potential for serious cardiovascular thrombotic events (such as heart attack or stroke) and the risk of serious gastrointestinal events (such as bleeding or ulceration).

Q: Есть ли различия в действии Индоцида у пожилых людей?

A: Official labeling indicates that elderly patients are at greater risk for serious side effects, particularly gastrointestinal and kidney adverse reactions, and are more susceptible to CNS effects. For this reason, official guidance recommends the use of the lowest effective dose for this population.

Q: Индоцид это то же самое, что ибупрофен или напроксен?

A: The active ingredient in this medicine is Indometacin. While it belongs to the same general class of drugs (Non-Steroidal Anti-Inflammatory Drugs, or NSAIDs) as ibuprofen and naproxen, it is a chemically distinct compound. It is generally reserved for prescription use.

Q: Сколько времени нужно, чтобы почувствовать действие Индоцида?

A: Studies and official information indicate that the drug is absorbed rapidly into the bloodstream after taking it. Depending on the condition being treated, relief of pain and swelling may begin to be noticed within a few hours after administration, according to clinical observations.

Q: Опишите, как Индоцид может влиять на почки, согласно официальной информации.

A: Regulatory documents state that this medicine, like other NSAIDs, can cause renal toxicity (kidney damage), including the risk of acute kidney failure. It can also cause the body to retain fluid, and its use requires caution in patients with pre-existing kidney conditions.

Q: Можно ли принимать Индоцид, если у меня повышенное давление?

A: Official labeling includes a warning that NSAIDs can lead to the onset of new high blood pressure or worsen pre-existing high blood pressure. Official guidance indicates that use requires caution in patients with this condition, and regulatory documents describe the need for close blood pressure monitoring.

Q: В чем основное отличие Индоцида от других нестероидных противовоспалительных средств?

A: The medicine is chemically categorized as an indole-acetic acid derivative. It is recognized as a potent NSAID and is generally reserved for prescription use in moderate to severe inflammatory conditions, based on its official indications.

Q: Может ли Индоцид влиять на результаты анализа крови?

A: Regulatory guidance recommends periodic monitoring of blood tests related to kidney and liver function during treatment. Mild and transient elevations in liver enzymes, which are measured in blood tests, have been documented in some patients.

Q: Что известно о безопасности Индоцида при длительном применении?

A: Official labeling advises using the lowest effective dosage for the shortest duration possible. Official labeling indicates that the risk of serious adverse events—specifically cardiovascular and gastrointestinal risks—is documented to increase with the duration of use.

Q: Как Индоцид описывается в разделе о безопасности для печени?

A: The drug carries a documented warning regarding hepatotoxicity (liver damage). Official guidance requires discontinuing the drug if abnormal liver tests persist or worsen, or if clinical signs of liver disease develop.

Q: Может ли Индоцид взаимодействовать с травяными добавками?

A: Regulatory labeling states that certain herbal supplements, particularly those that are known to affect blood clotting (such as garlic, ginger, or ginkgo), are documented to potentially increase the risk of bleeding when used concurrently.

Q: Каковы данные исследований о применении Индоцида у детей?

A: The oral and rectal forms are generally not established for use in children under 14 years old. However, the intravenous form has an established, specific use in premature infants for a certain heart condition, based on regulatory approval.

Q: Можно ли принимать Индоцид, если я принимаю антикоагулянты (препараты для разжижения крови)?

A: Official regulatory guidance warns that concomitant use with anticoagulants (such as warfarin) or antiplatelet drugs is known to increase the risk of bleeding. Regulatory guidance indicates that patients require close monitoring for signs of bleeding if these drugs are taken together.

Q: Что значит 'повышенный риск сердечно-сосудистых событий' при использовании Индоцида?

A: The official Boxed Warning means there is an increased risk of serious, sometimes fatal, cardiovascular events, specifically myocardial infarction (heart attack) and stroke. This risk may begin early in treatment and may increase with the duration of use.

Q: Есть ли информация о том, как Индоцид влияет на способность управлять автомобилем?

A: Because some patients have reported side effects such as headache and dizziness, the official patient information indicates caution is needed. If these or other nervous system effects occur, the ability to drive or operate machinery may be affected.

Q: Что официальные источники говорят о взаимодействии Индоцида с алкоголем?

A: Official warnings state that daily use of alcohol, particularly when combined with this medicine, significantly increases the risk of serious gastrointestinal bleeding and ulcers. Official warnings advise patients to generally avoid consuming alcohol while using this medication.

Q: Может ли Индоцид вызывать аллергические реакции? Как их распознать?

A: Official labeling documents the risk of serious allergic-type reactions (hypersensitivity), including anaphylaxis. Signs of a serious reaction are described to include difficulty breathing, swelling of the face or throat, hives, or a severe skin rash.

Q: Описаны ли случаи привыкания к Индоциду?

A: Official regulatory information does not classify this medicine as a controlled substance. As an NSAID, it does not document a potential for physical dependence or abuse.

Q: Как долго Индоцид остается в организме после приема?

A: Pharmacokinetic studies in adults show that the medicine has a plasma half-life that typically ranges from approximately 2.6 to 11.2 hours. This is the time it takes for half the drug to be eliminated from the bloodstream.

Q: Есть ли в исследованиях данные о влиянии Индоцида на фертильность?

A: Official regulatory labeling suggests that, similar to other NSAIDs, this medicine may delay or prevent ovulation, which has been reported to be reversible upon stopping treatment. Official guidance indicates that use is generally not recommended for women who are actively attempting to conceive.

Q: Что известно об эффективности Индоцида в сравнении с плацебо?

A: Clinical studies supporting the drug's approval demonstrate that it provides significant improvement in symptoms of inflammation and pain compared to placebo. This evidence forms the basis for its approved uses in conditions like rheumatoid arthritis and gout.

Q: Как Индоцид классифицируется в отношении безопасности (например, категория)?

A: Under the FDA's current risk communication system, the medicine has a specific summary of risks for each trimester of pregnancy. The classification summarizes its use as an NSAID and the documented risks it poses to the fetus, especially in the third trimester.

Q: Можно ли принимать Индоцид во время грудного вскармливания?

A: Regulatory information from the NIH states that because low levels of the medicine are found in breastmilk, use is generally described as acceptable. However, other agents with more published information may be preferred, especially when nursing a newborn or premature infant.

Q: Описаны ли взаимодействия Индоцида с витаминами?

A: Official drug labeling generally advises patients to inform their healthcare provider of all prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. This general warning applies because all these products have the potential to interact with Indocid.

Q: Может ли Индоцид влиять на сон?

A: Side effects involving the nervous system, such as headache and dizziness, are commonly reported. While not specifically listed as a sleep medication effect, patients using the medicine for night pain may experience CNS effects that could potentially impact sleep patterns.

Q: Почему при приеме Индоцида иногда рекомендуют следить за функцией почек?

A: Official regulatory guidance recommends monitoring kidney function because all NSAIDs, including this medicine, carry a documented risk of causing renal toxicity. This toxicity is documented to potentially lead to acute kidney failure or the worsening of pre-existing kidney disease.

Q: Как Индоцид взаимодействует с лекарствами для лечения депрессии (СИОЗС)?

A: Official labeling warns that taking this medicine concurrently with selective serotonin reuptake inhibitors (SSRIs) may increase the risk of bleeding. Regulatory guidance indicates that patients require close monitoring for signs of bleeding if these drugs are taken together.

Q: Как Индоцид влияет на способность крови сворачиваться?

A: The medicine affects the ability of the blood to clot by reversibly inhibiting the function of platelets. This effect is why its use is associated with an increased risk of bleeding, particularly in the gastrointestinal tract.

Q: Можно ли прекратить прием Индоцида, как только симптомы исчезли?

A: The general dosing rule in the official labeling is to use the medicine for the shortest duration possible that is consistent with the patient's treatment goals. Regulatory documents describe the general dosing rule and indicate that any decision to stop or change treatment should be discussed with the prescribing physician.

Q: Какие симптомы указывают на возможное серьезное побочное действие Индоцида?

A: Regulatory information describes signs of a serious event, such as chest pain, shortness of breath, unexplained weakness, slurring of speech, or signs of gastrointestinal bleeding (e.g., bloody or black stools, or vomiting blood), which indicate the need for immediate medical attention.

Q: Какое исследование лежит в основе одобрения Индоцида?

A: The approval of the medicine by regulatory agencies, such as the FDA, is based on a New Drug Application (NDA) package. This package includes clinical studies and comprehensive data demonstrating the drug’s effectiveness and overall safety profile for its approved uses.

Q: Как Индоцид описывается в отношении риска кровотечений?

A: Official documents highlight the risk of serious gastrointestinal bleeding as part of the Boxed Warning. The risk of bleeding is also increased when taken with other medicines that affect blood clotting, such as anticoagulants.

How should Индоцид be stored and disposed of?

How to Store and Dispose of Indocin (Indomethacin)

The storage conditions for Indomethacin are form-dependent and must align with regulatory requirements.

Storage Requirements

Dosage Form Required Temperature Range Special Conditions
Capsules 20 C to 25 C (Controlled Room Temp) Store in a tightly closed container.
Suppositories 2 C to 8 C (Refrigerated) Do not freeze.
Powder for Injection 20 C to 25 C Store in original carton to protect from light.

All forms of Indomethacin must be stored out of the sight and reach of children. The solution prepared from the injectable powder does not contain a preservative and must be discarded if unused.

Disposal

Unused or expired product must be disposed of in accordance with local regulations for pharmaceutical waste. Unless directed otherwise by regulation, do not dispose of medication via wastewater systems.

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

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