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Indocollyre 0,1 %

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Indocollyre 0,1 %

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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.

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Overview of Indocollyre 0,1 %

Property Description
Active ingredient Indometacin (Indomethacin)
Form Ophthalmic solution (Eye drops)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Anti-inflammatory and analgesic (pain-relief) action
Origin Synthetic compound (Indole acetic acid derivative)

What Type of Medicine is Indocollyre 0,1 %?

Indocollyre 0,1 % is a specific pharmaceutical preparation formulated as an ophthalmic solution for topical ocular use, commonly referred to as eye drops. Its active medicinal substance, Indometacin, is scientifically classified as a potent Non-Steroidal Anti-Inflammatory Drug (NSAID). This product is a synthetic compound, characterized chemically as an indole acetic acid derivative. The final formulation is designed for local application to the eye, intended for delivering therapeutic concentrations directly to the anterior ocular segment.

The Composition and Ocular Formulation

The medication is a single active ingredient product containing Indometacin suspended in a sterile aqueous vehicle, ensuring it is suitable for direct application to the ocular surface. The numerical designation of 0,1 % precisely refers to the concentration of the active substance within the solution, a strength specifically optimized for use as eye drops. The choice of a specialized aqueous vehicle helps maintain the sterility and stability required for sensitive eye preparations, offering a distinct advantage over non-specialized compounding.

General Purpose: Anti-inflammatory and Analgesic Action

The general purpose of the Indometacin solution is to provide localized anti-inflammatory and analgesic (pain-relieving) action. The fundamental mechanism involves its function as a cyclooxygenase inhibitor, which means it works by interrupting the synthesis of prostaglandins, the chemical messengers that naturally trigger swelling, redness, and pain sensitivity. By performing this function, the medicine is purposed to mitigate ocular discomfort and swelling resulting from local inflammatory processes, a typical scenario being the management of inflammation following ophthalmic surgical procedures.

Regulatory References

  1. Indomethacin - StatPearls - NCBI Bookshelf
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What side effects are possible with Indocollyre 0,1 %?

Possible Side Effects and Safety Information

The safety profile for Indometacin ophthalmic solution, as classified in official regulatory documents, is primarily characterized by local ocular adverse reactions, with a distinct risk profile for rare, serious complications.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped by their rate of occurrence as documented by regulatory authorities. The most frequent reactions are typically transient, occurring upon instillation, while the most serious events are classified as very rare.

Classification Example Adverse Reaction System-Organ Class
Very Common Transient stinging or burning sensation Eye Disorders
Common Ocular irritation, Temporary blurred vision Eye Disorders
Uncommon Superficial punctate keratitis, Hypersensitivity reactions Eye and Immune System Disorders
Very Rare Corneal thinning, Corneal melting, Perforation Eye Disorders

Safety Considerations and Constraints

The regulatory safety structure includes specific warnings regarding patient status and duration of use. Corneal thinning, melting, or perforation are documented as serious adverse reactions, with the risk elevated in patients with pre-existing corneal compromise, such as those with diabetes mellitus, rheumatoid arthritis, or severe dry eye. Furthermore, the risk of epithelial defects is noted to increase when the drops are used concurrently with topical ophthalmic corticosteroids.

The official labeling also addresses exposure patterns, noting that the risk of serious corneal complications is associated with long-term or excessive use. Additionally, the presence of a preservative requires that soft contact lenses be removed prior to application.

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Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Indometacin ophthalmic solution primarily addresses the risk of systemic toxicity that may occur following accidental oral ingestion of the eye drops. The systemic effects are consistent with those of a Non-Steroidal Anti-Inflammatory Drug (NSAID) overdose, and do not reflect typical topical use.

Documented Overdose Manifestations

Overdose presentations, as documented in official labeling, include gastrointestinal (GI) disturbances such as nausea, vomiting, epigastric pain, and diarrhea. Central Nervous System (CNS) effects are also noted, including headache, lethargy, drowsiness, and confusion.

Physiological System Severe Outcomes Documented in Labeling
GI Tract Bleeding and ulceration, which may be fatal in severe cases.
Renal/CNS Acute renal failure; seizures, and coma in life-threatening scenarios.

Regulator-Mandated Emergency Actions

The primary action required in case of suspected overdose or accidental ingestion is to seek immediate medical attention and contact a poison control center immediately for guidance. Urgent hospitalization and vital sign monitoring are required for severe or life-threatening manifestations, such as evidence of GI bleeding or a decreased level of consciousness. Management of this overdose is strictly symptomatic and supportive, as no specific antidote is known. For significant recent oral ingestion, regulator-listed procedures may include administering activated charcoal and gastric lavage to minimize absorption. Special caution is noted for the elderly and individuals with pre-existing renal impairment due to their increased risk of severe GI and renal complications.

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Therapeutic Uses of Indocollyre 0,1 %

The primary therapeutic utility of Indocollyre 0,1 % is relevant in areas where short-term symptom management is appropriate.

Indomethacin may assist with managing symptoms that create noticeable physiological strain, particularly pain and inflammation following eye procedures.

Therapeutic Scenarios

This eye solution is commonly used to help with symptom clusters of acute pain, redness, and swelling associated with ophthalmic surgical procedures, such as cataract extraction. The medication may also be part of symptomatic management in the clinical context of conditions associated with inflammatory complications, such as cystoid macular edema (CME), that may follow surgery. It is applied in clinical settings where supportive symptomatic assistance is considered relevant for non-infectious conditions characterized by episodic inflammation, such as an inflamed pterygium or pinguecula.

“The medication contributes to easing the overall symptom load during periods of physiological stress.”


Quick Fact: Relief for Ocular Pain

The solution is relevant for easing the discomfort and ache associated with acute postoperative inflammation. It supports patients during difficult episodes by easing distress and helps maintain a sense of stability when symptoms are more noticeable.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Indocollyre 0,1 %

Eligibility for Indocollyre 0,1 % (Indometacin ophthalmic solution) is determined by regulatory rules that establish specific population exclusions and restrictions.

Contraindicated Populations (Must Not Use)

Use is contraindicated in patients with a known hypersensitivity to the active ingredient, Indometacin, or any component of the formulation. This absolute prohibition extends to those with known allergies to Aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including individuals with a history of NSAID-induced asthma attacks. The medicine is also strictly contraindicated for pregnant women from the sixth month of pregnancy (third trimester) onwards.

Restricted and Conditional Use

Population Group Regulatory Status
Children (Pediatrics) Safety and efficacy have not been established; use is generally not recommended.
Pregnancy (First 5 Months) Use is not recommended.
Lactation (Breastfeeding) Use is not recommended.
Bleeding Tendency Requires caution due to potential for increased ocular bleeding risk.
Contact Lens Wearers Wearing contact lenses is inadvisable during treatment.

Eligibility is primarily established for the adult population, subject to these critical restrictions and contraindications as specified in official product labeling.

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What should I know about interactions with other medicines?

Documented Interactions with other Medicines and Products

Official regulatory information for Indocollyre 0,1 % (Indometacin ophthalmic solution) establishes several critical interaction patterns, primarily related to potential systemic effects from minimal absorption or additive risks.

Contraindicated Combinations and Additive Risk

Concomitant use with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including high-dose Aspirin and Diflunisal, is generally not recommended or classified as contraindicated due to the documented additive risk of serious gastrointestinal events or bleeding. The risk of bleeding is also increased when co-administered with drugs that interfere with hemostasis, such as Warfarin and SSRIs/SNRIs. Use of alcohol is also cited as increasing the risk for gastrointestinal bleeding.

Alteration of Drug Exposure and Efficacy

Interacting Medicine Official Regulatory Finding
Lithium Indometacin reduces the renal clearance, which officially leads to increased serum concentration of Lithium.
Digoxin Concomitant use can increase serum concentration and prolong the half-life of Digoxin.
ACE Inhibitors/ARBs May diminish the antihypertensive effect and, in elderly or volume-depleted patients, may result in deterioration of renal function.
Diuretics NSAIDs can reduce the natriuretic effect of Furosemide and Thiazide diuretics.

Administration Requirements

When co-administering Indocollyre 0,1 % with other eye drop preparations, regulatory labeling requires a time interval of at least 15 minutes between the application of the two different solutions.

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Mechanism of Action

Blockade of Prostaglandin Synthesis

This mechanism centers on the active ingredient’s role as a nonselective inhibitor of Cyclooxygenase (COX) enzymes ( COX-1 and COX-2). By occupying the active site of these enzymes, Indometacin interrupts the Arachidonic Acid Cascade, thereby halting the local production of Prostaglandins. This molecular blockade directly reduces the concentration of key signaling molecules that modulate physiological responses.


Modulation of Local Ocular Vascular and Cellular Response

The resulting reduction in Prostaglandins yields changes in physiological consequences, particularly influencing the permeability characteristics of the blood-aqueous barrier and local tissue. The mechanism involves the modulation of the Prostaglandin-driven increase in local blood flow and fluid leakage, while also influencing the integrity of inflammatory cell membranes. This leads to a lower degree of excessive chemical mediator activity and influences the influx of cellular components into the ocular segment.


Attenuation of Peripheral Nociceptive Sensitization

The final cascade involves the attenuation of nociceptive signaling. Prostaglandins are key chemical sensitizers; thus, by suppressing their synthesis, the drug's mechanism elevates the activation threshold of local pain-sensing nerve endings (nociceptors). This peripheral action modifies early molecular steps that shape the systemic physiological outcome, influencing the threshold of sensory responses to chemical or physical stimuli.

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Dosage and Administration Information

How to Use Indocollyre 0,1 % (Indomethacin Ophthalmic Solution)

The administration of Indocollyre 0,1 % focuses on the timing and technique for topical use in the eye. The usage protocol involves distinct schedules for pre-operative and post-operative application.

Administration Scope and Dosage

Usage Context Administration Protocol (Examples)
Inhibition of Miosis (Pre-surgery) 1 drop every 30 minutes for 2 hours immediately preceding the operation.
Prevention of Inflammation (Post-surgery) 1 drop 4 times a day for up to one month following the operation.
Pain Treatment (Post-PRK) 1 drop 4 times daily for the first few days post-surgery.

Procedural and Handling Rules

The route of administration is Ocular Instillation. Instructions specify the procedural steps to ensure correct delivery.

  1. Preparation: If supplied as a powder and solvent, the solution must be reconstituted prior to use.
  2. Instillation: Gently pull down the lower eyelid to form a small pocket and instill one drop while looking up. Do not allow the dropper tip to touch the eye or any other surface.
  3. Concurrent Medications: If another eye drop is being used, administer the two different solutions at least 15 minutes apart.
  4. Contact Lenses: Wearing contact lenses is inadvisable during treatment.

Population-Specific Use

Dosage is established for adults. The safety and effectiveness of this product for use in children have not been established, and therefore its use is not recommended for pediatric patients.

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Recent Clinical Evidence

Indocollyre 0,1 %: Recent Clinical Evidence

This section summarizes clinical research concerning Indocollyre 0.1% (indomethacin ophthalmic solution). The information is descriptive of research findings and is not a substitute for professional medical advice or treatment recommendations.

Clinical Applications Explored in Research

Studies have evaluated the use of indomethacin ophthalmic solution in several post-surgical and inflammatory contexts. The primary focus of research relates to its non-steroidal anti-inflammatory drug (NSAID) properties.

Post-Cataract Surgery

Clinical trials have explored the role of Indocollyre 0.1% in managing inflammation following cataract extraction. Research suggests that administration of the solution may be associated with reduced post-operative inflammation and may play a role in prophylaxis against cystoid macular edema (CME). Studies documented differences in the incidence of CME between patients receiving the solution and those receiving placebo.

Pain Management

Research has investigated the use of this formulation for acute pain relief following procedures like photorefractive keratectomy (PRK). Studies examined whether the topical NSAID was associated with decreased reported pain intensity compared to controls in the immediate post-operative period.

Pharmacokinetics and Safety Profile Research

Research has established that indomethacin, when applied topically to the eye, achieves relevant concentrations in the aqueous humor. Studies on the safety profile have explored common adverse effects, which typically include temporary stinging, burning sensation, or ocular irritation upon instillation. Serious adverse events are infrequently reported in the research literature, but clinicians monitor for potential effects such as corneal epithelial damage, especially with prolonged or frequent use.

Key Studies & References

  1. Clinical Effectiveness of Topical NSAIDs in Reducing Pain Following Photorefractive Keratectomy (PRK): A Systematic Review
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Frequently Asked Questions (FAQ)

Common questions about Indocollyre 0,1 % (FAQ)


Q: How quickly do the effects of Indocollyre 0,1 % usually begin?

Official documents do not generally specify a precise time-to-onset for the full range of effects. However, clinical research has examined the use of this solution for managing acute pain relief following procedures like photorefractive keratectomy (PRK), focusing on effects in the immediate post-operative period.


Q: What is the difference between Indocollyre 0,1 % and other eye drops that treat pain?

Indocollyre 0,1 % is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Its action is based on inhibiting the production of prostaglandins, which are key chemical messengers that modulate swelling and pain sensitivity.


Q: Are there any common vision changes reported with Indocollyre 0,1 %?

According to the official safety profile, a common adverse reaction that may occur after instillation is temporary blurred vision. This effect is usually transient.


Q: Is it normal to feel a sting when putting in Indocollyre 0,1 %?

Regulatory documents list a transient stinging or burning sensation upon instillation as a very common reaction. This sensation is typically brief.


Q: What age groups are usually prescribed Indocollyre 0,1 %?

The use of Indocollyre 0,1 % is primarily established for adults. Official labeling states that the safety and effectiveness for use in children have not been established, and therefore its use is not recommended for pediatric patients.


Q: Is Indocollyre 0,1 % the same as generic indomethacin eye drops?

The active substance in this medication is Indometacin, which is also known by the generic name indomethacin. Indocollyre 0,1 % is a specific brand name formulation that contains this active ingredient at a defined concentration.


Q: Can Indocollyre 0,1 % be used for a long period of time?

Official safety constraints note that the risk of serious corneal complications, such as thinning or melting of the cornea, is documented as being associated with long-term or excessive use of the solution.


Q: What is the purpose of Indocollyre 0,1 % beyond pain relief?

The solution is purposed for localized anti-inflammatory action to manage swelling. Additionally, it is indicated for the inhibition of miosis (the prevention of the pupil from constricting) during specific surgical procedures.


Q: What happens if I use Indocollyre 0,1 % more often than prescribed?

Regulatory safety information warns that the risk of serious corneal complications, including damage to the corneal surface, is noted to increase with long-term or excessive use of the solution.


Q: Is Indocollyre 0,1 % an antibiotic eye drop?

No, Indocollyre 0,1 % is not an antibiotic. It is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Its function is to mitigate inflammation and pain.


Q: Can Indocollyre 0,1 % be used for all types of eye inflammation?

The official indications define its approved uses, which primarily include preventing and treating inflammation subsequent to specific eye surgeries like cataract surgery, as well as managing ocular pain following procedures such as photorefractive keratectomy (PRK).


Q: Does Indocollyre 0,1 % contain preservatives?

Official safety warnings state that soft contact lenses must be removed prior to application. The warning regarding contact lenses is issued because preservatives, which are common in eye drop solutions, may interact with the lens material.


Q: Can Indocollyre 0,1 % be used with other types of anti-inflammatory eye drops?

Regulatory labeling requires a time interval of at least 15 minutes between the application of Indocollyre 0,1 % and any other eye drop preparation. Official documents also mention that indomethacin eye drops may be combined with eye-drops containing corticosteroids if necessary.


Q: What are the general expectations for improvement when using Indocollyre 0,1 %?

The medicine is purposed for localized anti-inflammatory and analgesic (pain-relieving) action. In indicated conditions, its use is intended to mitigate ocular discomfort and swelling related to local inflammatory processes.


Q: Is the medication absorbed into the body after use, or does it only affect the eye?

Official information indicates that after ocular instillation, only small amounts of the active substance, indomethacin, are typically absorbed into the systemic bloodstream. Regulatory constraints note that interactions observed with NSAIDs administered systemically should still be taken into account.


Q: Are there any reported interactions with common cold or allergy medications?

Official documentation advises considering drug interactions observed with NSAIDs administered generally. This includes the finding that combining Indocollyre 0,1 % with other NSAIDs carries an established additive risk.


Q: Is Indocollyre 0,1 % approved for treating seasonal allergies?

Official regulatory indications define the approved uses for post-operative inflammation, inhibition of miosis, and pain management post-PRK. Seasonal allergies are not listed as an approved therapeutic indication in the official labeling.


Q: Does Indocollyre 0,1 % treat the cause of inflammation or just the symptoms?

The medicine's mechanism involves inhibiting the synthesis of prostaglandins, which are the chemical messengers responsible for triggering inflammation and pain. By interrupting this process, the medicine modifies the underlying local biological response that leads to the symptoms.


Q: What if the eye irritation seems to get worse after starting Indocollyre 0,1 %?

Official warnings state that if a hypersensitivity reaction is noted, treatment cessation is required. Regulatory documents indicate that the emergence of worsening or new symptoms necessitates review by a qualified healthcare provider.


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How should Indocollyre 0,1 % be stored and disposed of?

How to Store and Dispose of Indocollyre 0.1%

Indocollyre 0.1% must be stored and disposed of according to mandatory regulatory requirements to maintain its stability and ensure environmental safety.


Storage Requirements

Condition Regulatory Requirement
Temperature Store below 25°C; Do not freeze
Protection Protect from light; Keep in original container
Child Safety Keep out of the sight and reach of children
Post-Opening Multi-dose: Discard after 15 or 30 days of first opening. Single-dose: Discard immediately after use (Do not reuse).

Disposal Instructions

Unused or expired Indocollyre must not be thrown away with household waste or poured down the drain. Regulatory documents instruct disposal by returning the product to a pharmacist or an authorized local collection point to ensure appropriate handling of pharmaceutical waste.

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

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