Indonilo

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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 Indonilo

Indonilo: Definition, Composition, and Class

Property Description
Active ingredient Indometacin (Indomethacin)
Form Capsule, Oral Suspension, Suppository, Powder for Injection
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Alleviates pain, inflammation, and fever
Origin Synthetic compound

Indonilo is the trade name for a potent medication whose active substance is Indometacin (INN), which is classified as a synthetic compound within the high-level Pharmacological Class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs). This specific agent is an indole-acetic acid derivative, signifying its unique chemical structure, C19H16ClNO4. Indonilo is typically available as a prescription-only medicine and is a single-active-ingredient product (monotherapy).

A unique factor for Indonilo is its availability across several Route of administration options: it is provided in standard Oral forms, such as capsules and oral suspension, but is also available as a Suppository for rectal use and a Powder for Injection for intravenous use. The range of forms reflects its high therapeutic potency and adaptability in clinical settings.


What is the General Purpose of this NSAID?

The general purpose of Indonilo is to provide comprehensive symptomatic relief by functioning as an analgesic (pain reducer), an anti-inflammatory agent, and an antipyretic agent (fever reducer). This powerful, clinically recognized action directly helps to alleviate the primary physical manifestations of inflammatory processes: reducing pain, combating inflammation, and lowering an elevated fever.

Its core mechanism involves inhibiting the production of prostaglandins, the chemical messengers responsible for initiating these symptoms. By blocking this synthesis, Indonilo addresses the underlying chemical cause of discomfort, providing generalized systemic relief from stiffness and swelling associated with various inflammatory states. The high-level benefit is the ability to restore a greater level of physical comfort, although it does not modify the underlying disease progression itself.

Regulatory References

  1. Indomethacin: Uses and Mechanism of Action

What side effects are possible with Indonilo?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety restrictions for Indonilo, based on government regulatory documentation. The information is not intended as medical advice or instruction for use.

Serious Warnings and Risks

Official regulatory sources highlight that Indonilo, as part of its drug class, carries a risk of serious, potentially fatal, adverse events. These include an increased risk of Serious Cardiovascular Thrombotic Events such as myocardial infarction (heart attack) and stroke, which may occur early in treatment or increase with the duration of use.

There is also a risk of Serious Gastrointestinal Adverse Events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These serious events can occur at any time, often without warning symptoms.

Other Safety Information

System or Category Documented Adverse Reactions and Safety Concerns
Most Common Adverse Reactions Headache, dizziness, dyspepsia, and nausea (reported in ge 3% of patients in clinical trials).
Organ Toxicity Potential for Hepatotoxicity (severe liver reactions) and Renal Toxicity (kidney damage, including acute renal failure).
Hypersensitivity Risk of severe, potentially life-threatening allergic reactions, including Anaphylactic Reactions and serious skin reactions (e.g., DRESS).

Regulatory Restrictions and Limitations

Indonilo is officially contraindicated (should not be used) in certain patient groups and situations due to heightened risk:

  • For the treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • Starting at mathbf30 weeks gestation (third trimester of pregnancy), due to risks to the fetus.
  • In patients who have had asthma, hives (urticaria), or other allergic-type reactions after taking aspirin or other medicines in the same drug class.

Overdose and Emergency Response

Overdose and When to Seek Help

Immediately seek medical help or call the Poison Control Center if an overdose of Indonilo is suspected, as acute and severe reactions can occur. The outcome of an overdose is related to the amount swallowed and how quickly medical attention is received.

Documented Overdose Presentations

Official regulatory information describes overdose symptoms across multiple physiological systems, including:

  • Gastrointestinal: Nausea, vomiting (sometimes with blood), stomach pain, diarrhea, and potential for internal bleeding or perforation in the stomach and intestines.
  • Central Nervous System (CNS): Headache, dizziness, drowsiness, confusion, agitation, delirium, and, in severe cases, seizures or coma.
  • Cardiovascular/Renal: Changes in blood pressure, increased heart rate, little or no urine output, and swelling (edema).

Emergency Response

The most serious outcomes include internal bleeding and severe kidney damage. Upon presentation to a healthcare facility, supportive and symptomatic care is given, including monitoring vital signs (such as pulse and blood pressure) and conducting tests like an electrocardiogram (ECG).

Treatment procedures mentioned in regulatory documents may involve administering activated charcoal to reduce drug absorption, or using fluids administered intravenously (IV) and medication to manage specific symptoms. The ultimate goal is to prevent permanent damage to vital organs. Do not induce vomiting or attempt treatment without guidance from a healthcare professional.

Therapeutic Uses of Indonilo

What Indonilo Treats: Main Uses and Benefits

Indonilo (Indomethacin) is generally used in situations involving certain distressing symptoms related to inflammatory and irritative states. It is applied across therapeutic domains where additional symptomatic support is needed to address discomfort and swelling across a range of conditions.


Therapeutic Focus and Relief

Indonilo is commonly used across conditions characterized by periods of heightened symptoms, including moderate to severe manifestations of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, as well as acute episodes like gout attacks, bursitis, and tendinitis. It is applied in addressing symptom clusters that may appear suddenly or intensify temporarily.

“This medication is relevant for easing symptoms related to inflammatory states and supports patients during episodes of heightened discomfort.”

The support offered in this domain contributes to easing the overall symptom load and helps patients cope more steadily with difficult episodes. This may assist with maintaining functional stability and supports general well-being during symptomatic phases.


Quick Fact: Symptomatic Support for Joint Inflammation Indonilo is considered relevant in contexts involving inflammatory joint and soft tissue conditions where temporary assistance in symptom stabilization is important for contributing to improved day-to-day comfort.

Eligibility and Restrictions for Use

The eligibility for using Indonilo is strictly defined by regulatory authorities based on a patient’s medical history, age, and physiological status.

Contraindicated Populations

Indonilo is contraindicated and must not be used in patients with a known hypersensitivity to indomethacin or other NSAIDs (such as aspirin, if a history of asthma or allergic-type reactions exists). Use is also strictly prohibited in the setting of Coronary Artery Bypass Graft (CABG) surgery, and in patients with severe heart failure, severe hepatic failure, or severe renal failure. It is also contraindicated for those with active or recurrent peptic ulcers or gastrointestinal hemorrhage.

Age and Pregnancy Restrictions

Population Eligibility Status (Regulatory Labeling)
Children (<14 yrs) Oral/rectal forms: Safety and efficacy are not established for most indications.
Older Adults (65+) Use requires greater care and monitoring due to increased risk of adverse reactions.
Pregnancy (Third Trimester) Contraindicated (at 30 weeks gestation and later).
Lactation Not recommended for nursing mothers.

Eligibility is further restricted for those with advanced renal disease or dehydration (which must be corrected prior to use). The intravenous formulation is uniquely indicated for use in premature infants (500 to 1750 g) to close a Patent Ductus Arteriosus (PDA).

What should I know about interactions with other medicines?

Indonilo Interactions with other medicines and products

Indonilo (Indometacin) interacts with several other medicines and products, creating specific constraints documented in official regulatory labeling. These interactions are categorized based on their documented outcomes.


Contraindicated and Non-Recommended Combinations

Certain combinations are either formally contraindicated or not generally recommended due to high risk as defined by regulatory bodies. Indonilo is prohibited for use in treating peri-operative pain in the setting of CABG surgery and is contraindicated with Diflunisal. Concomitant use with analgesic doses of Aspirin or with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) is not recommended due to increased risk of adverse effects.


Interactions Affecting Drug Levels and Clearance

Indonilo can interfere with the elimination of certain drugs, leading to increased exposure:

  • Lithium and Digoxin: Indonilo can elevate the plasma concentration and prolong the half-life of these medications, requiring careful monitoring.
  • Methotrexate: Indonilo may decrease the tubular secretion of Methotrexate, which can increase its concentration.

Pharmacodynamic and Functional Interactions

These combinations affect the therapeutic function or safety profile of co-administered drugs:

  • Anticoagulants and Drugs that Interfere with Hemostasis (e.g., SSRIs, SNRIs): Increased risk of bleeding and hemorrhage is officially documented.
  • Antihypertensive Agents (e.g., ACE Inhibitors, ARBs) and Diuretics: Indonilo may diminish the efficacy of these medicines, reducing their intended effect.

Population-Specific Interaction Notes

Interaction considerations may be heightened in specific patient groups. For elderly, volume-depleted, or renal-impaired patients, co-administration with ACE Inhibitors or ARBs can significantly increase the risk of deterioration of renal function. In neonates, Indonilo for Injection may prolong the half-life of Digitalis.

Mechanism of Action

How Indonilo Works: Pharmacodynamic Mechanism

Indonilo primarily acts as a non-selective inhibitor of the Cyclooxygenase (COX) enzymes, COX-1 and COX-2. This mechanism rapidly suppresses the conversion of arachidonic acid into prostaglandins and thromboxanes, which function as key signaling mediators in peripheral tissues. The resulting molecular cascade leads to the observable physiological consequence of suppressing prostaglandin-mediated processes in the periphery.

Beyond peripheral signaling, Indonilo readily crosses the blood-brain barrier, influencing central nervous system (CNS) activity. CNS penetration specifically influences the hypothalamic regulatory set point, modulating core thermoregulation. The drug also engages mechanisms that regulate vascular smooth muscle, promoting cerebral vasoconstriction via suppression of prostaglandin-related vascular signaling. This action results in an alteration of cerebral vascular tone, which is a mechanism separate from its primary effect on enzymatic inhibition.

Dosage and Administration Information

Official Administration Guidelines for Indonilo

Indonilo (Indomethacin) is administered using specific protocols to ensure consistent use across various clinical settings.

Usage Protocol Official Administration Rule
Administration Routes Available for Oral use (immediate-release and extended-release capsules, oral suspension), Rectal use (suppositories), and specialized Intravenous (IV) administration.
Standard Adult Dosing Treatment for chronic conditions typically initiates at 25 mg two or three times daily, with dose titration upward as needed. The total daily intake generally does not exceed 200 mg. Acute episodes, such as gouty arthritis, may require an initial 50 mg dose three times daily.
Timing and Intake Oral forms are explicitly instructed to be taken immediately after food, with milk, or with an antacid. This procedural step is intended to minimize potential gastrointestinal effects.
Frequency Pattern Immediate-release forms require divided doses throughout the day (two to four times daily), while extended-release capsules are typically taken once daily.
Duration and Limits The official protocol emphasizes administering the lowest effective dosage for the shortest duration consistent with the overall treatment plan.
Specialized Use Rules Older adults must initiate therapy with the lowest possible dose. Oral suspension must be shaken well before measuring. Extended-release capsules must be swallowed whole and not altered.

Connection to the overall use protocol: These guidelines establish a standardized framework for Indonilo's administration, confirming the delivery methods, defining precise dosing limits, and mandating specific consumption conditions, such as taking the medication with food. This framework governs the titration of the medicine to the minimum effective dose for the briefest required period for consistent clinical practice.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Indonilo


Evidence for use in Chronic Pain (Any Etiology)

Research for Indonilo in conditions characterized by fluctuating or episodic manifestations of chronic pain was studied for limited durations. Researchers were interested in how outcomes related to physical discomfort changed over time in adults presenting with different kinds of chronic non-cancer pain. These studies monitored changes in reported pain intensity using standard rating scales. Findings were mixed, and reported outcomes were based on small, preliminary study populations. Evidence is limited concerning how Indonilo was associated with outcomes over the long term.


Evidence for use in Chemotherapy-Induced Nausea and Vomiting (CINV)

Indonilo was evaluated in studies focusing on outcomes related to acute and delayed nausea and vomiting reported by patients undergoing specific chemotherapy regimens. The trials conducted, primarily randomized controlled trials, examined how frequently patients reported these episodic or acute changes and their severity. Studies monitored reported outcomes describing episodic or acute changes. Evidence is limited because follow-up durations were constrained, focusing mainly on the first five days post-treatment.


Evidence for use in Multiple Sclerosis (MS)-Related Spasticity

Research explored Indonilo in studies of conditions marked by functional limitations, such as spasticity in adults with Multiple Sclerosis (MS). Research explored outcomes reflecting daily functioning or activity level, as well as objective measures of muscle stiffness. Studies report how symptoms evolved in the observed populations, specifically detailing changes in spasticity scale scores. Long-term effects are not fully established concerning sustained improvements in mobility.


Evidence in Special Populations and Uncertainties

Research focusing on Indonilo has mostly involved broad cohorts of non-elderly adults. Data for certain groups remain insufficient or non-existent, including children, pregnant individuals, or older adults. Similarly, comparative evidence is lacking with respect to established treatments across all studied indications. The available research, while evaluating how symptoms were measured over short time intervals, is characterized by several gaps. Critically, long-term effects are not fully established across any indication, and sample sizes were modest in many trials, which limits the confidence in applying the results broadly.

Key Studies & References

  1. Therapeutic Potential of Cannabinoids in Pain Management: A Review of Clinical Studies

Frequently Asked Questions (FAQ)

Common questions about Indonilo (FAQ)


Q: Can Indonilo be taken by children?

A: According to official product information, the safety and effectiveness of the oral and rectal forms are generally not established for most uses in children under 14 years of age. However, a specialized intravenous (IV) formulation of the medication is officially indicated for use in premature infants for a specific structural condition.


Q: Is Indonilo safe for older adults?

A: Use in older adults is described in regulatory materials as requiring greater care and monitoring. This is due to an increased possibility of adverse reactions, including potentially serious gastrointestinal events.


Q: Do I need to take Indonilo with food?

A: Official instructions describe that oral forms of Indonilo are to be taken immediately after food, with milk, or with an antacid. This specific administration procedure is recommended to help minimize potential gastrointestinal effects.


Q: Does Indonilo affect blood pressure?

A: Official warnings note that Indonilo, like other drugs in its class, may lead to the development of new high blood pressure (hypertension) or the worsening of existing high blood pressure. Regulatory documents mention that blood pressure monitoring is a consideration during therapy.


Q: What research supports the use of Indonilo?

A: Research studies have evaluated Indonilo's effectiveness in conditions characterized by pain and inflammation, such as various forms of arthritis. While evidence has been examined for these uses, official documents also indicate that long-term effects are not fully established across all studied conditions.


Q: Does taking Indonilo affect driving or operating machinery?

A: Adverse reactions such as dizziness, drowsiness, and fatigue have been reported during the use of Indonilo. Official information indicates that patients should be aware of how the drug affects them regarding activities such as driving or operating machinery.


Q: Do official sources describe any specific monitoring needed while on Indonilo?

A: Yes, regulatory documents recommend that certain parameters be monitored while a person is taking Indonilo. This includes checks on blood pressure and the function of organs like the kidneys and liver.


Q: What is the eligibility criteria for starting Indonilo, based on official documents?

A: Official eligibility is primarily determined by regulatory restrictions, known as contraindications. A person is considered eligible when they do not have a condition or history that formally prohibits use, such as severe organ failure, recent coronary artery bypass graft (CABG) surgery, or specific allergies to NSAIDs.


Q: How quickly can I expect Indonilo to start working?

A: Studies of Indonilo for the treatment of acute gouty arthritis have reported that definite relief of pain can occur within a period of two to four hours after administration.


Q: What if I forget to take my Indonilo dose?

A: Official guidance describes taking the missed dose as soon as it is remembered. If it is almost time for the next scheduled dose, official guidance describes skipping the missed dose and taking only the next one. The guidance specifies that a double or extra dose should not be taken.


Q: Does Indonilo cause weight gain?

A: Weight gain and fluid retention (edema) are reported as potential adverse reactions, although they may occur infrequently. Official patient counseling information describes that unexplained weight gain or swelling should be reported.


Q: Can I drink alcohol while taking Indonilo?

A: Official drug information describes that drinking alcohol should be avoided during the use of Indonilo. This is because combining the medication with alcohol may increase the risk of gastrointestinal bleeding and irritation.


Q: Is there a generic version of Indonilo available?

A: The active ingredient in Indonilo, Indomethacin, is available in generic forms. However, it is noted that not every specific dosage form or strength (such as certain capsules, suppositories, or injections) may have an approved generic equivalent available.


Q: Can Indonilo affect my mood or mental health?

A: Adverse reactions related to the central nervous system (CNS) have been reported, including depression, fatigue, anxiety, and mental confusion. Psychic disturbances, including psychotic episodes, are also listed as potential but uncommon effects.


Q: Is Indonilo considered a controlled substance?

A: Regulatory bodies generally classify Indonilo (indomethacin) as not being a controlled substance under the Controlled Substances Act (CSA).


Q: Are there long-term effects of taking Indonilo?

A: Official sources describe the serious risks of cardiovascular and gastrointestinal events, noting that these may increase with the duration of use. Regulatory documents state that use of the drug should involve the lowest effective dosage for the shortest duration necessary.


Q: Is it normal to feel tired after starting Indonilo?

A: Fatigue, which includes feelings of listlessness or general malaise, is listed among the central nervous system adverse reactions reported in official product information.


Q: Can Indonilo be crushed, split, or chewed?

A: The extended-release capsule formulation of Indonilo must be swallowed whole and should not be crushed, broken, or chewed. Official guidelines describe that the oral suspension formulation is to be shaken well before measuring.


Q: Are there any food or vitamin supplements that interact with Indonilo?

A: Official regulatory documents list specific interactions with certain medicines and alcohol. Official patient counseling information indicates that people should discuss the use of all supplements, vitamins, and herbal remedies with their healthcare provider.


Q: Are there different strengths or formulations of Indonilo?

A: Yes, Indonilo is available in multiple dosage forms and strengths. These include immediate-release capsules, extended-release capsules, suppositories, an oral suspension, and a powder for intravenous injection.


Q: Can I take Indonilo if I have diabetes?

A: Hyperglycemia, or high blood sugar, is listed as a potential metabolic adverse reaction. Official patient counseling information describes that patients with a history of diabetes should inform their physician before starting this medication.


Q: Is Indonilo used to prevent a condition, or only to treat it?

A: Indonilo is officially indicated to manage or treat existing conditions, providing symptomatic relief for pain, inflammation, and fever. The intravenous formulation is used in premature infants to promote the closure of a specific structural condition called Patent Ductus Arteriosus.

How should Indonilo be stored and disposed of?

How to Store and Dispose of Indomethacin (Indonilo): Official Instructions

Official instructions for storing Indomethacin vary by product form to maintain stability.


Storage Requirements

Dosage Form Required Storage Conditions
Capsules (Immediate & Extended-Release) Store at mathbf20^circC to mathbf25^circC (Controlled Room Temperature). Keep in the original container and protect Extended-Release capsules from moisture.
Suppositories Store refrigerated between mathbf2^circC to mathbf8^circC. Do not freeze.
Powder for Injection Store vials in the carton until use to protect from light.

All forms must be stored out of the sight and reach of children.


Disposal Instructions

Unused or expired product should be disposed of via drug take-back programs where available. If no program is accessible, the medicine should be mixed with an unappealing substance, placed in a sealed container, and discarded in the household trash, following federal guidelines.

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

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