Indolar SR

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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 Indolar SR

Quick Facts

Property Description
Active Ingredient Indometacin (Indomethacin)
Form Sustained-Release Capsule (SR)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General Purpose To mitigate inflammation, pain, and fever
Origin Synthetic Compound

1. Indolar SR: Classification and the Active Ingredient

Indolar SR is a potent, synthetic Non-Steroidal Anti-Inflammatory Drug (NSAID) primarily used to reduce inflammation and pain. Its active ingredient is Indometacin (also referred to as Indomethacin), which belongs to the indole-3-acetic acid derivative subclass.

This classification identifies Indolar SR as belonging to a pharmacological group that is clinically recognized for its powerful anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) effects. Indometacin is a single-ingredient product derived synthetically, and its established mechanism is supported by extensive pharmacological studies, making it one of the more potent NSAIDs available.


2. Understanding the Sustained-Release (SR) Capsule

The SR in Indolar SR stands for Sustained-Release, indicating that this is an extended-release capsule designed for oral administration. This specialized solid oral dosage form is engineered to control the rate at which the active ingredient is released into the bloodstream over a prolonged time frame.

Modified-release formulations like the SR capsule are designed for maintaining more stable therapeutic levels over longer periods. This design helps manage persistent conditions by providing continuous relief without the sharp fluctuations often associated with immediate-release medication. The SR capsule utilizes a specialized matrix system to ensure a gradual and continuous therapeutic effect.


3. General Purpose: Mitigating Pain, Inflammation, and Fever

The general purpose of Indolar SR is to provide relief from three primary physiological symptoms: inflammation, pain, and fever. As an NSAID, its high-level mechanism involves the potent inhibition of specific enzymes that produce prostaglandins, the chemical messengers driving these symptoms.

By reducing prostaglandin synthesis, Indolar SR mitigates the associated signs of inflammation, such as swelling, while simultaneously decreasing the experience of physical discomfort and helping to normalize an elevated body temperature. This action underscores its general utility in controlling the core symptoms related to various inflammatory conditions.

What side effects are possible with Indolar SR?

Possible Side Effects and Safety Information

As a potent Non-Steroidal Anti-Inflammatory Drug (NSAID), Indolar SR (Indometacin) carries specific risks and safety classifications documented in official regulatory labeling.

Serious Adverse Reactions and Major Regulatory Warnings

Official prescribing information includes mandatory warnings regarding the potential for serious cardiovascular (CV) thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Furthermore, there is a risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time without warning symptoms.

Common and System-Specific Effects

Adverse reactions are formally categorized by the physiological systems affected. Headache is consistently reported as the most common adverse reaction, categorized in the Nervous System disorders. Other frequent effects include those in the Gastrointestinal System, such as dyspepsia, nausea, and abdominal distress. Less common effects involve the Renal System, potentially causing fluid retention and edema, or affecting the Blood and Lymphatic System, leading to changes like anemia.

Population-Specific Safety Constraints

The label defines safety considerations for specific groups. Older adults are subject to a greater documented risk for serious GI events. Use is strictly contraindicated from approximately 30 weeks of gestation due to the risk of fetal cardiovascular harm. The medication is also officially contraindicated for managing peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery and in patients with a history of allergic-type reactions to other NSAIDs.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory information confirms that Indolar SR (Indometacin) overdose typically presents with acute disturbances in the Central Nervous System (CNS) and Gastrointestinal (GI) tract. Documented symptoms include severe headache, dizziness, confusion, and delirium, often coupled with GI signs such as nausea, vomiting (potentially bloody), and intense epigastric pain. Tinnitus and blurred vision are also officially documented signs of toxicity.

Regulatory labeling defines specific, severe outcomes that may follow a significant overdose, including seizures, a coma state, and serious organ toxicity, such as acute renal failure and severe internal gastrointestinal bleeding. Individuals must seek immediate medical attention and contact a poison control center immediately upon known or suspected overdose.

Management is constrained by the fact that no specific pharmacological antidote is known. Treatment is therefore strictly symptomatic and supportive. This may involve procedures like the administration of activated charcoal or gastric lavage, considered within specified timeframes following ingestion of a potentially toxic amount. Hospital monitoring is required for all severe cases, including continuous assessment of vital signs and renal function.

Therapeutic Uses of Indolar SR

Indolar SR is commonly used to provide continuous symptomatic support for patients managing chronic, systemic inflammatory joint conditions. This usage is considered relevant in clinical settings that involve acute or unstable symptom patterns.

It is primarily applied in situations involving certain distressing symptoms related to conditions like moderate to severe rheumatoid arthritis, ankylosing spondylitis, and acute inflammatory states such as gouty arthritis flares, bursitis, and tendinitis.

The medication helps address symptom clusters that may become intense or disruptive, such as severe joint swelling, tenderness, morning stiffness and symptoms that interfere with daily functioning. It also plays a role in managing inflammation-driven pain and associated fever.

“It provides support that helps ease the overall symptom load and contributes to easing distress during periods of heightened symptoms.”

This usage assists with maintaining functional stability and provides supportive relief when symptoms interfere with routine activities.


Quick Fact: Relief for Symptoms Related to Inflammatory States

Condition Category Symptom Cluster Addressed Primary Benefit
Chronic Inflammatory Disease (e.g., RA) Joint swelling, persistent tenderness, severe stiffness Supports general well-being during symptomatic phases
Acute Localized Inflammation (e.g., Bursitis) Heightened pain, acute localized heat, symptoms that create noticeable physiological strain Assists with moderating noticeable acute manifestations

Regulatory References

  1. NIH MedlinePlus overview of Indomethacin

Eligibility and Restrictions for Use

Who Can and Cannot Use Indolar SR? Official Regulatory Information

Regulatory agencies define the eligibility for Indolar SR (Indometacin Sustained-Release) through a structured profile of contraindications and restrictions.

Contraindicated Populations (Must Not Use)

Category Non-Eligibility Criteria
Allergy History Known hypersensitivity to Indometacin or other NSAIDs/Aspirin, including a history of aspirin-sensitive asthma or allergic-type reactions.
Surgical Treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.
Organ Status Patients with severe heart failure, hepatic failure, or renal failure.
Gastrointestinal Patients with active peptic ulceration or a history of recurrent GI bleeding/perforation.

Population Restrictions and Limitations

Category Eligibility Rule
Age Group Not recommended for children and adolescents (safety and efficacy not established). Older adults require greater care due to increased risk.
Pregnancy/Lactation Contraindicated in the third trimester of pregnancy (starting at 30 weeks). Not recommended during breastfeeding.
Comorbidities Use cautiously in patients with a history of epilepsy, Parkinsonism, or psychiatric disorders, and in those with pre-existing cardiovascular disease.

The official eligibility profile limits use to Adult Patients (18 and older) for labeled indications while placing mandatory restrictions on use for individuals with specific organ impairments or systemic diseases.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction scope

Feature Documented Regulatory Information
Medicinal product categories with documented interactions Anticoagulants, Antihypertensives (ACE Inhibitors, ARBs, Beta-Blockers), Diuretics, Other NSAIDs, Drugs that interfere with Hemostasis (SSRIs/SNRIs).
Specific interacting medicines (if explicitly listed) Ketorolac, Diflunisal, Aspirin (analgesic doses), Warfarin, Lithium, Digoxin, Methotrexate, Probenecid, Cyclosporin.
Mechanistic basis of interactions (only if stated in label) Decreased tubular secretion (Methotrexate interaction); Pharmacodynamic antagonism (diminishing antihypertensive effect).
Population-specific interaction notes (if applicable) Increased risk of deterioration of renal function with ACE Inhibitors/ARBs in the elderly, volume-depleted, or renal impairment populations.

Interaction classifications (high-level)

Classification Feature Documented Regulatory Information
Interaction severity classification (as defined in official documents) Contraindicated (e.g., Diflunisal, Ketorolac, CABG setting); Clinically Significant / Use with Caution (e.g., Lithium, Methotrexate, Antihypertensives).
Interaction-context constraints (as defined in official documents) Contraindicated for peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) Surgery.

Resulting interaction structure

Official interaction statements detail that co-administration with other NSAIDs, including Diflunisal and Ketorolac, is officially restricted or contraindicated. Indolar SR may increase the serum concentration and toxicity risk of medicines like Lithium and Digoxin due to altered clearance. The regulatory label states that Indometacin may diminish the antihypertensive effect of ACE Inhibitors, ARBs, and Diuretics. Concomitant use with Anticoagulants and drugs that interfere with hemostasis is documented to increase the risk of serious bleeding. Additionally, co-use with Alcohol or Smoking may predispose to gastric and duodenal ulceration. The profile is structured by formal prohibitions and specific pharmacokinetic and pharmacodynamic consequences, as defined by government health authorities.

Mechanism of Action

How Indolar SR Works

The mechanism of Indolar SR (Indometacin) is centered on the rapid, non-selective interference with the enzyme system responsible for generating chemical mediators of physiological responses.

Targeting the Eicosanoid Enzyme System

The active mechanism involves the molecule acting as a non-selective inhibitor of the Cyclooxygenase (COX) enzymes, specifically both COX-1 and COX-2. This core action blocks the conversion of Arachidonic Acid into prostaglandins, which are key chemical messengers that influence local eicosanoid dynamics.

Modulating Peripheral and Central Signaling

By reducing the synthesis of Prostaglandin E2 ( PGE2) at the tissue level, the drug modulates the peripheral nociceptive signaling pathway, thereby decreasing the sensitization of nociceptive receptors. Furthermore, the molecule acts centrally to inhibit PGE2 synthesis in the hypothalamus, engaging mechanisms that regulate the body’s thermoregulatory set-point.

The Resulting Physiological Cascade

This targeted intervention modifies early molecular steps that shape systemic physiological outcomes. The reduction in local mediators alters the local inflammatory pathway dynamics, while the central action leads to a predictable physiological adjustment that restores the thermoregulatory set-point and reduces the transmission of nociceptive signals.

Dosage and Administration Information

How to Use Indolar SR

Indolar SR is an oral medication administered as a 75 mg Sustained-Release (SR) capsule. This specialized dosage form is strictly for oral intake, utilizing a design that controls the rate of drug release over time. To ensure the integrity of this extended-release mechanism, the capsule must be swallowed whole with a full glass of water; it is critical that the capsule is not crushed, broken, or chewed, as this action would compromise the intended continuous drug delivery.

Administration guidelines for adults outline standard dosing based on the condition being managed. For chronic conditions such as rheumatoid arthritis or ankylosing spondylitis, the typical adult starting and maintenance dose is 75 mg once daily. The total daily dosage for the SR formulation must not exceed 150 mg, which can be administered as two divided 75 mg doses when appropriate. The general principle governing the duration of therapy is the use of the lowest effective dosage for the shortest necessary duration.

To adhere to official administration conditions, Indolar SR must always be taken with food, immediately after meals, or alongside antacids. Administration rules also define limits for specific populations: a safe and effective dosage for the extended-release capsule is not established for pediatric patients, and older adults are generally advised to use the medication with increased caution due to the possibility of adverse reactions.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Indolar SR

1. Evidence for Chronic Systemic Inflammatory Diseases

Research exploring the active ingredient of Indolar SR for chronic conditions, such as moderate to severe rheumatoid arthritis (RA) and ankylosing spondylitis (AS), primarily consists of Randomized Controlled Trials (RCTs). These studies were applied in research contexts involving fluctuating or unstable symptoms, examining outcomes related to conditions characterized by functional limitations. Research explored how symptoms change over time by monitoring outcomes related to systemic or functional imbalance, such as changes in joint swelling and tenderness metrics. Researchers also studied the duration of morning stiffness and assessed changes in daily functioning or activity level using specialized functional scales.

Studies conducted during periods of increased symptom activity reported measurements of these physical and functional outcomes over defined time intervals. Findings describe patterns observed in the studies related to the measurements of symptom intensity or variability in the observed patient populations. The evidence contributes to understanding symptom patterns in these complex, long-term conditions.

2. Research Supporting Use in Osteoarthritis (OA)

Research examined the active ingredient of Indolar SR in patients managing moderate to severe osteoarthritis, a condition marked by functional limitations. The evidence base includes Randomized Controlled Trials (RCTs) and systematic reviews. The primary study outcomes examined were related to physical discomfort, such as the intensity of joint-related pain, and outcomes reflecting daily functioning, such as changes in mobility metrics.

Findings from these studies describe patterns related to patient-reported outcomes describing perceived discomfort and documented how symptoms evolved in the observed populations, which included cohorts of older adults. This research provides insight into short-term changes observed during the study periods.

3. Evidence for Acute Localized Inflammatory States

Research exploring short-term symptom changes associated with acute conditions, such as gouty arthritis flares and acute painful shoulder (bursitis/tendinitis), involved short-term Randomized Controlled Trials (RCTs). These trials were relevant in evidence describing how symptoms are measured in conditions associated with acute or disruptive episodes. Studies monitored outcomes describing episodic or acute changes, such as the time elapsed until a change in pain intensity was first reported, and measured physical signs like tenderness and swelling.

The studies conducted during periods of increased symptom activity reported measurements of how quickly changes in pain intensity were observed, and described patterns related to the measurements of physical signs of inflammation over brief courses. Research highlights changes measured during the study period, helping to contextualize how patients reported their experience during acute, temporary physiological imbalance.


4. What Remains Uncertain About Indolar SR Research

Research provides context but not individual predictions, and the evidence highlights what is known—and what is still uncertain. Evidence quality varies across studies, and findings were mixed in some areas, particularly concerning the head-to-head symptomatic comparison between the Sustained-Release capsule and the immediate-release formulation.

Key limitations include that the follow-up durations were limited in many controlled trials, providing incomplete insight into outcomes over many years. Furthermore, comparative evidence is lacking for the SR formulation against other extended-release medications. Research does not determine whether an individual will respond similarly, and continued study monitoring is ongoing to further contextualize the evidence landscape.

Key Studies & References NIH MedlinePlus overview of Indomethacin

Frequently Asked Questions (FAQ)

Common questions about Indolar SR (FAQ)

Q: Is it common to experience dizziness or drowsiness while taking Indolar SR?

Official product information on reported side effects lists headache as the most frequent adverse reaction involving the nervous system. However, regulatory documents also include dizziness and drowsiness (also called somnolence) among the other reported effects that patients may experience while using this medicine.

Q: Can Indolar SR be taken with other types of pain medication?

Regulatory labeling advises against or restricts the use of Indolar SR with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including aspirin when it is used for pain relief. Regulatory labeling focuses on interactions with other NSAIDs and blood thinners, and patients should rely on a healthcare professional for guidance regarding non-listed pain relievers.

Q: Are there any specific foods or supplements that are known to interact with Indolar SR?

While specific foods are not listed as interactions, official guidance recommends that patients avoid alcohol and smoking. This is due to a documented increased risk of serious gastrointestinal side effects, such as ulceration and bleeding, when co-administered.

Q: Is Indolar SR intended for short-term use or is it often used long-term?

The general administration guidelines state that the drug should be used at the lowest effective dosage for the shortest duration necessary for treatment goals. However, official regulatory indications do include the management of chronic conditions, such as rheumatoid arthritis, which often require long-term management.

Q: Are there different forms of Indolar SR available besides the extended-release capsule?

Yes, the active ingredient Indometacin is manufactured in various forms in addition to the sustained-release capsule. These forms include immediate-release capsules, an oral suspension (liquid form), and rectal suppositories.

Q: What are the reported effects of Indolar SR on fertility or planning for pregnancy?

According to official product information, Indolar SR is not recommended for women who are actively attempting to conceive. This is due to the potential for the class of drugs to temporarily impair female fertility, though this effect has been described as usually temporary following discontinuation.

Q: Are there any known neurological side effects associated with Indolar SR, such as headaches or confusion?

Yes, headache is consistently listed in regulatory documents as the most common nervous system side effect. Other central nervous system effects that have been reported include dizziness, drowsiness, and, less commonly, confusion.

Q: What is the estimated duration of pain relief provided by one dose of the SR formulation?

The sustained-release (SR) capsule is designed to release the medication slowly over an extended period to maintain stable concentrations. This sustained action is consistent with the product's typical administration schedule of once daily or in two divided doses.

Q: Why is Indolar SR generally not recommended during the third trimester of pregnancy?

Official regulatory warnings strictly contraindicate the use of Indolar SR starting at 30 weeks of gestation (third trimester). This is due to a known risk of fetal cardiovascular harm, specifically the premature closure of a blood vessel in the fetus called the ductus arteriosus.

Q: Why is Indolar SR typically taken with food?

Regulatory guidance requires that Indolar SR must always be taken with food, immediately after meals, or alongside antacids. This practice is a safety measure primarily recommended to help reduce the potential for gastrointestinal irritation or stomach discomfort.

Q: What is the difference between Indolar SR and regular (immediate-release) Indolar?

The primary difference lies in the release rate of the active ingredient. The sustained-release (SR) formulation is designed to prolong the drug's effects and maintain stable levels, while the regular (immediate-release) formulation is absorbed more quickly and is typically associated with a shorter duration of effect.

Q: Can the long-term use of Indolar SR lead to tolerance or decreased effectiveness?

Official labeling emphasizes that Indolar SR should be used for the shortest duration possible consistent with treatment goals. Clinical research summaries note that long-term follow-up studies are limited, and findings regarding the sustained-release versus the immediate-release form have been mixed in some areas, providing incomplete insight into long-term outcomes.

Q: Does the efficacy of Indolar SR vary based on the patient's age?

Official documentation states that the safety and efficacy of the extended-release capsule are not established for pediatric patients (children). For older adults, greater caution is advised due to an increased safety risk, particularly concerning serious gastrointestinal events. Official documentation focuses on the increased safety risk in older adults, stating only that efficacy and safety are not established for pediatric patients.

Q: Is it known to interact with herbal supplements like St. John's Wort?

The official regulatory label does not list specific herbal supplements. However, it is known that many supplements, including St. John's Wort, can alter drug-metabolizing enzymes (like CYP450) in the body, which may change the concentration and potential effects of Indolar SR or other medications.

Q: How does the extended-release formulation compare to other NSAIDs that are immediate-release?

Official documentation states that comparative evidence specifically comparing the Indolar SR formulation against other brands of extended-release medication is currently lacking. Efficacy is established against other forms of the same drug, but general comparative claims versus all other immediate-release NSAIDs are not provided.

Q: What are the common symptoms that warrant stopping Indolar SR and seeking medical attention?

Regulatory patient information advises stopping the medication and seeking immediate medical attention for signs associated with serious warnings. These include symptoms of a severe allergic reaction (such as swelling of the face or throat), a serious cardiovascular event (such as chest pain or difficulty breathing), or gastrointestinal bleeding (such as black, tarry stools or vomiting blood).

Q: Does Indolar SR have a cautionary statement regarding driving or operating machinery?

Yes, regulatory documents note that some patients may experience nervous system side effects such as dizziness, drowsiness, or lightheadedness. These effects may potentially impair a person’s ability to drive safely or operate machinery.

Q: What is the difference in action between Indolar SR and Tylenol (acetaminophen)?

The mechanism of Indolar SR is the potent inhibition of cyclooxygenase (COX) enzymes, which reduces inflammation, pain, and fever. In contrast, acetaminophen has a different mechanism of action and typically provides only pain and fever relief without significant anti-inflammatory effects.

Q: Why is Indolar SR considered one of the more potent NSAIDs?

The official description of Indolar SR's action describes the active ingredient, Indometacin, as a potent inhibitor of prostaglandin synthesis. This high level of activity in blocking the chemical messengers of pain and inflammation is the basis for its documented potency.

How should Indolar SR be stored and disposed of?

Storage and Handling

Indolar SR (indomethacin extended-release capsules) must be stored at Controlled Room Temperature, which is defined as 20 C to 25 C (68 F to 77 F). The container can safely tolerate temporary temperature variations between 15 C and 30 C (59 F and 86 F). For stability, it is required to protect from moisture.

All medications, including Indolar SR, must be kept out of the reach of children and pets to prevent accidental ingestion.

Disposal Requirements

The best method for disposing of unused or expired Indolar SR is to utilize a community drug take-back program or a drug mail-back service. If these options are not readily available, the medicine should be thrown into the household trash. Before disposal in the trash, mix the capsules with an unappealing substance, such as used coffee grounds or cat litter, and place the mixture into a sealed bag or container. Do not flush Indolar SR down the toilet.

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

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