Scelto

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Medically reviewed

Marina Burgos

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 Scelto

Property Description
Active ingredient Ketorolac tromethamine
Form Tablets, Injection, Nasal Spray, Ophthalmic Solution
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Relief from acute pain, inflammation, and fever
Origin Synthetic (Pyrrolo-pyrrole group)

What is Scelto and What Type of Drug is Ketorolac?

Scelto is the trade name for a medication whose core component is the active substance ketorolac tromethamine, formally classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Ketorolac is a synthetic compound derived from the pyrrolo-pyrrole group, representing a first-generation NSAID. The drug is generally designated as prescription-only (Rx), and its identity is established by its capability to provide significant pain relief, reduce inflammation, and manage fever simultaneously. Ketorolac acts as a non-selective inhibitor of the cyclooxygenase enzyme. This mechanism is clinically recognized for its potent analgesic properties in managing acute distress.

Scelto's Available Forms and Composition

Ketorolac tromethamine is supplied in several distinct pharmaceutical preparations, enabling varied routes of administration. These forms include oral tablets, a sterile solution for parenteral injection (intravenous or intramuscular), an intranasal solution, and a liquid ophthalmic solution for ocular use. The unique availability of an injectable form distinguishes ketorolac within the NSAID class, providing a route for rapid systemic absorption. The formulation utilizes the tromethamine salt to enhance the water solubility required for these varied liquid and solid products. The drug is a single-entity product, focusing its therapeutic action exclusively on the established properties of ketorolac.

General Purpose: How Scelto Provides Relief

The general purpose of Scelto is to deliver powerful, short-term relief from physical distress. Its classification as a Cyclooxygenase (COX) inhibitor means it works by blocking the production of prostaglandins, which are chemical messengers responsible for driving pain, swelling, and elevated body temperature. This fundamental mechanism enables the drug to effectively alleviate pain, reduce localized inflammation, and control associated fever. A typical neutral use scenario for the medication is the short-term management of moderately severe acute discomfort.

What side effects are possible with Scelto?

Possible side effects and safety information

The official safety profile for Scelto (ketorolac tromethamine), a Nonsteroidal Anti-inflammatory Drug (NSAID), is primarily structured around risks documented in governmental regulatory sources. Adverse reactions are classified by frequency and grouped into System-Organ Classes (SOCs).


Frequency and System Classification

Adverse effects are categorized based on their incidence reported in clinical data:

  • Very Common: Frequently reported effects often involve the nervous system and gastrointestinal tract, such as headache, nausea, and dyspepsia.
  • Common: Includes dizziness, drowsiness, edema (fluid retention), and hypertension.

Major systems involved, as classified in regulatory documents, include Gastrointestinal Disorders, Nervous System Disorders, Renal and Urinary Disorders, and Cardiovascular Disorders.


Serious Adverse Reactions and Safety Constraints

The regulatory labeling highlights serious adverse reactions that are central to the drug's safety profile, including potentially life-threatening Gastrointestinal (GI) bleeding, ulceration, and perforation, and serious Cardiovascular thrombotic events (such as myocardial infarction or stroke). Acute renal failure and severe skin reactions are also documented.

Safety is significantly constrained by duration of use. The risk of serious GI and CV events is explicitly stated to increase with the duration of use and at higher doses, leading to regulatory mandates for short-term use only (e.g., typically a maximum of 5 days for systemic administration).

Population-Specific Safety: The labeling identifies certain groups with increased risk. Older adults have a higher susceptibility to serious GI and renal events. The medication is contraindicated in patients with advanced renal impairment and those in the third trimester of pregnancy due to fetal risk.

Overdose and Emergency Response

Overdose and When to Seek Help

A suspected overdose of Scelto (Ketorolac tromethamine) requires immediate medical attention. Since no specific antidote is known, regulatory guidance mandates that patients be managed with symptomatic and supportive care.

Documented Manifestations (Common) Severe Outcomes (Life-Threatening)
Gastrointestinal: Epigastric pain, nausea, vomiting Gastrointestinal: Severe bleeding, ulceration, perforation
Systemic/CNS: Lethargy, drowsiness, hyperventilation Renal: Acute renal failure, renal dysfunction
General: Symptoms are generally reversible with supportive care Rare: Respiratory depression, coma, anaphylactoid reactions

Official Emergency Action and Management:

  • Seek immediate medical attention for all suspected overdose cases.
  • Management is strictly focused on symptomatic and supportive care to control clinical effects.
  • Activated charcoal may be indicated if ingestion is recent and the dose was large.
  • Procedures such as forced diuresis or hemodialysis are generally not useful for elimination due to the drug's high protein binding.
  • Elderly patients are noted in the labeling to be at an increased risk for serious gastrointestinal and renal adverse effects, requiring careful consideration.

The entire profile centers on preventing escalation of dose-related organ toxicity, particularly in the gastrointestinal and renal systems, as symptoms can progress to life-threatening complications. Because no specific reversal agent exists, the regulatory response strictly mandates seeking immediate medical attention to initiate supportive management and continuous observation.

Therapeutic Uses of Scelto

Scelto is used across domains where additional symptomatic support is needed, primarily focusing on managing symptoms related to physical discomfort, including common aches, muscle discomfort, menstrual cramps, and headaches. The medication is also applied in settings marked by temporary physiological imbalance, specifically addressing inflammatory or irritative states and fever. This supportive function may assist with easing the overall symptom load when manifestations intensify.

“Applied during phases when symptoms become more noticeable, it may help patients cope more steadily.”

The medication is relevant in conditions characterized by acute or disruptive symptom patterns, such as those seen in minor soft-tissue injury or episodic discomfort. By addressing symptoms that interfere with routine activities, Scelto may assist with supporting functional stability during challenging symptomatic phases.

Quick Fact: Support for Acute Discomfort The medication is applied to provide supportive relief when symptoms create noticeable physiological strain, assisting in easing the impact of sudden discomfort.

Regulatory References

  1. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) overview

Eligibility and Restrictions for Use

This section summarizes the official rules and restrictions for using Scelto (or similar product) as defined in governmental regulatory documents.

Official Eligibility and Contraindications

Classification Rule Summary (Regulatory Basis)
Populations Allowed Adults for the specified therapeutic use (e.g., treatment of idiopathic macular telangiectasia type 2 for a similar product, ENCELTO).
Contraindicated Use is prohibited in patients with a known hypersensitivity to the active substance or any component. Use is also contraindicated in the presence of specific conditions, such as ocular or periocular infections (for ENCELTO).
Not Recommended Use may be not recommended in specific populations, such as those with severe organ impairment (e.g., severe hepatic impairment for ENTRESTO), or when used concurrently with certain medications (e.g., ACE inhibitors for ENTRESTO).

Specific Population Restrictions

  • Age-Related Rules: Pediatric use is often not established due to limited data in this population. Use in the Geriatric population may require special consideration.
  • Pregnancy/Lactation: Use during pregnancy (particularly the second and third trimesters) is often contraindicated due to the risk of fetal toxicity. Use while breastfeeding is typically not recommended.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Scelto (ketorolac tromethamine) has officially documented interaction patterns primarily related to its Nonsteroidal Anti-inflammatory Drug (NSAID) classification. Co-administration with certain substances is strictly contraindicated. These include other NSAIDs and aspirin (acetylsalicylic acid) due to a compounded risk of gastrointestinal toxicity and bleeding. The combination with probenecid is prohibited because it inhibits the renal clearance of ketorolac, a pharmacokinetic interaction that leads to significantly increased plasma concentrations. Co-administration is also contraindicated with pentoxifylline due to an elevated risk of bleeding, and with lithium due to the potential for reduced lithium clearance.

Interactions with agents like anticoagulants (such as warfarin) and antiplatelet agents (including SSRIs) carry an increased risk of hemorrhage due to combined antiplatelet effects. Scelto may also interfere with the clearance of other drugs, potentially leading to increased plasma concentrations of digoxin and methotrexate. Pharmacodynamic interactions with diuretics and ACE inhibitors/ARBs are documented to reduce the efficacy of these agents and increase the potential for acute renal compromise. Food intake delays the rate of oral absorption, which lowers the peak plasma concentration ( C max), but does not alter the total amount absorbed (AUC). Increased susceptibility to adverse interaction effects is noted for elderly patients.

Mechanism of Action

Scelto functions as a high-affinity modulator of synaptic vesicle glycoprotein 2A (SV2A), a transmembrane protein located on presynaptic vesicles in neurons, particularly in the central nervous system. Its primary molecular interaction is competitive binding to SV2A, which regulates the synaptic vesicle cycle, including docking and fusion. This binding event modifies SV2A's function, leading to a downstream attenuation of neurotransmitter release from the presynaptic terminal. Concurrently, Scelto acts as an antagonist at voltage-dependent N-type calcium channels (CaV2.2), causing a direct blockade of calcium influx into the presynaptic neuron. The combination of reduced calcium current and modulated SV2A function results in a system-level stabilization of neuronal hyperexcitability and a restoration of neurotransmitter release equilibrium across the affected neural networks.

Dosage and Administration Information

How to use Scelto

Scelto is an implant intended for surgical administration and must be handled and administered strictly according to guidelines to ensure patient safety and product integrity. It is administered as a single ENCELTO implant per affected eye.


Administration Details

Feature Official Instruction
Route Surgical intravitreal implantation (into the vitreous cavity of the eye).
Frequency Single administration (one implant per affected eye).
Timing Not applicable; administration is a one-time surgical procedure.
Missed Dose Not applicable; the treatment is a single procedure.

Procedural Requirements

Administration of Scelto requires specific procedural steps and conditions as outlined in the official instructions.

Qualified Personnel: The procedure must be performed by a qualified ophthalmologist.

Aseptic Conditions: The entire implantation process must be carried out under strict aseptic conditions to minimize the risk of infection.

Implant Preparation: Prior to insertion, the implant and its packaging must be thoroughly inspected. Key steps include:

  • Verification of the use-by date and disposable temperature recording device (must display a green checkmark).
  • Confirmation that the liquid medium is at the correct pH using the provided color guide reference card.
  • The implant must be gently rinsed with sterile Balanced Saline Solution (BSS) after removal from its container and kept moist until insertion.

Implantation Sequence: The ophthalmologist follows a structured surgical sequence, including site preparation, creating a sclerotomy, inserting the implant perpendicularly into the eye, and securing it with sutures through the fixation loop to the sclera to confirm centration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Scelto


Evidence for Short-Term Acute Pain Management

The core research supporting the systemic use of Scelto (via injection, tablet, or nasal spray) primarily consists of short-term randomized controlled trials (RCTs). These studies were used in research exploring how symptoms change over time, applying the medication in settings involving acute or disruptive episodes of pain, such as post-operative distress. Research examined adult patients in patients studied for acute, moderately severe pain and included specific conditions characterized by acute pain, such as renal colic.

Studies explored outcomes related to physical discomfort, monitoring patient-reported outcomes describing discomfort using standardized pain scales. Research also monitored the quantity of supplemental opioid analgesia required by patients during the study period. Research describes patterns observed over very short durations, typically assessing the patient response within the first few hours and days of administration.


️ Evidence for Ophthalmic Use and Ocular Symptoms

The topical (eye drop) form of Scelto was evaluated in a separate body of research, consisting of controlled clinical trials specific to eye care. This research was studied for its use in patients undergoing specific procedures, such as cataract extraction and refractive surgery. Studies monitored outcomes capturing phases of heightened symptom activity, particularly ocular pain scores and objective signs of internal eye irritation, known as inflammation. The results apply only to the populations studied in the trials, focusing on these specific post-surgical or allergic scenarios.


️ Follow-up Duration and Characterization of Long-Term Use

The research base for systemic Scelto is consistently focused on short-term symptom changes. The pivotal trials and subsequent regulatory summaries are based on follow-up durations that were limited, covering a maximum treatment time of up to five days across all formulations. The evidence remains limited regarding effects or outcomes extending beyond this brief window. The research base does not include studies for chronic discomfort or long-term functional imbalance, reflecting that the drug was not studied for these conditions.


Research in Subgroups and Special Populations

Research has explored the drug's use in older adult patients (aged 65 and up) and individuals with low body weight, although findings for these specific groups often use smaller sample sizes. Controlled, high-quality data on the use of Scelto in pediatric patients (children) are not fully established in the research, and the available controlled data for use in this population remain highly limited.

Key Studies & References

  1. Efficacy of Ketorolac in Postoperative Pain Management: A Systematic Review and Meta-Analysis

Frequently Asked Questions (FAQ)

Common questions about Scelto (FAQ)

Q: How quickly does Scelto typically start working to notice a difference?

A: Studies on Scelto's injection form indicate that the maximum pain-relieving effect is typically seen within one to two hours after administration. For the oral form, the full effect usually occurs within two to three hours. However, some patients may begin to notice a change as early as 30 minutes after an injection.

Q: What should a patient expect to feel when Scelto is working?

A: Scelto is officially indicated for the short-term management of moderately severe acute pain. Official information indicates that when the medication is working as intended, it is designed to deliver relief from the physical distress or discomfort being treated. The drug's purpose is to manage acute symptoms that might otherwise require stronger relief.

Q: Are there any common early signs that Scelto is having an effect?

A: As a pain reliever, an observed early sign of effect is typically described as a gradual reduction in the pain or discomfort. Official sources note that the effect can begin within 30 minutes after initial administration, though the full pain-relieving peak occurs later.

Q: Is it normal to feel a specific side effect (e.g., headache, nausea) when starting Scelto?

A: Yes, regulatory information classifies headache and nausea as very common adverse reactions, reported by more than 10% of patients in clinical experience. While these effects can occur at any time during the short course of use, they are frequently reported reactions.

Q: Does the risk of side effects from Scelto change over time?

A: Official warnings state that the risk of serious adverse events—specifically gastrointestinal bleeding, ulceration, perforation, and cardiovascular complications—is known to increase with the duration of use. This is why Scelto is approved only for short-term treatment, typically for no more than five days.

Q: Is it necessary to avoid alcohol completely while using Scelto?

A: Official information advises caution regarding alcohol use while taking Scelto. Combining the medication with alcohol is associated with an increased risk of gastrointestinal irritation and bleeding, which is a key safety concern for this class of drug.

Q: What kind of changes in mood or behavior have been associated with Scelto in studies?

A: Studies have reported various effects on the nervous system and mood. Adverse reactions cited in regulatory documents include abnormal dreams, changes in thinking, anxiety, confusion, depression, euphoria, and hallucinations.

Q: What is the official guidance on taking Scelto with other prescription medications?

A: Official guidance strictly prohibits the use of Scelto with specific drugs, including other nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin, pentoxifylline, probenecid, and lithium. Caution is also strongly advised when combining Scelto with blood thinners, certain blood pressure medications, or diuretics due to potential interactions.

Q: What happens to Scelto in the body (e.g., how is it processed or eliminated)?

A: Scelto is mainly processed, or metabolized, in the liver via glucuronic acid conjugation. The primary route of elimination for the drug and its breakdown products is through the kidneys (renal elimination). The drug is also highly protein-bound in the bloodstream.

Q: Is there a link between Scelto use and changes in body weight?

A: While direct changes in body weight are not listed as a side effect, fluid retention, or edema, is classified as a common adverse reaction. Edema involves temporary swelling due to excess fluid, which can sometimes result in minor, temporary weight fluctuations.

Q: Why does the packaging for Scelto have a specific caution label/box warning?

A: The packaging includes a Boxed Warning, the strongest type of warning required by regulators, because of the elevated risk of serious side effects. These risks include potentially fatal gastrointestinal adverse events (bleeding, ulceration) and serious cardiovascular thrombotic events (like heart attack or stroke).

Q: What are the established themes in research about Scelto's long-term safety?

A: Official research and labeling are focused exclusively on the drug's use for short-term management, typically limited to a maximum of five days for systemic use. This focus is due to the established finding that the risk of serious adverse events increases significantly with prolonged duration.

Q: Is Scelto known to cause dependency or withdrawal symptoms if stopped suddenly?

A: Official product information confirms that Scelto (ketorolac) is classified as a non-opioid Nonsteroidal Anti-inflammatory Drug (NSAID) and is not a controlled substance. It is documented to lack properties associated with dependence or abuse risk.

Q: Does Scelto affect my ability to drive or operate machinery?

A: Official warnings indicate that if a patient experiences side effects such as drowsiness, dizziness, or vertigo, tasks requiring mental alertness, such as driving or operating machinery, should be avoided. These effects are reported in association with the use of Scelto.

Q: Is Scelto a controlled substance in any region?

A: Scelto's active ingredient, ketorolac tromethamine, is a Nonsteroidal Anti-inflammatory Drug (NSAID). It is not classified as a controlled substance or narcotic in official drug schedules.

Q: How long does Scelto stay in the body after the last dose?

A: Official pharmacokinetic data indicates that the half-life of the active component is typically in the range of 5 to 6 hours for healthy individuals. The half-life is the time it takes for the concentration of the drug in the blood to be reduced by half.

Q: Can Scelto cause problems with sleep (insomnia or excessive drowsiness)?

A: Official safety data lists both excessive drowsiness (somnolence) and insomnia as reported adverse reactions affecting the nervous system. Patients may experience either sleep-related issue while taking Scelto.

Q: Can Scelto cause skin reactions or rashes?

A: Yes, a range of dermatologic reactions are documented in regulatory sources. Common skin reactions include rashes and pruritus (itching), and rarer, more severe reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis are also listed.

Q: How do medical professionals monitor a patient's response to Scelto?

A: Official documents require monitoring for potential adverse events such as signs of gastrointestinal bleeding and changes in renal (kidney) function. The patient's coagulation status may also be assessed, especially when the drug is used alongside other interacting medications.

Q: Does Scelto impact bone density or bone health?

A: While the primary label does not specifically address long-term bone density, drugs in the NSAID class, like Scelto, have been noted in scientific literature to potentially impair bone healing in certain settings. This relates to the drug's mechanism of action affecting biological processes linked to bone metabolism.

Q: Can Scelto affect the results of common lab tests?

A: Official warnings indicate that Scelto can interfere with the results of certain lab tests. It is documented to inhibit platelet function, which affects coagulation tests (bleeding time). It may also lead to changes in lab values such as elevated liver enzymes and abnormal renal function results.

Q: Is it common to need a higher dose of Scelto over time?

A: Scelto is only intended for short-term use, with regulatory instructions defining a maximum treatment period (e.g., up to five days). Regulatory bodies emphasize that the daily dose must not exceed the maximum recommended amount, meaning official guidance does not support dose escalation over time, as the drug is intended only for short-term use.

How should Scelto be stored and disposed of?

How to Store and Dispose of Scelto (Ketorolac Tromethamine)

Scelto requires specific storage and disposal protocols as defined in official regulatory labeling to ensure stability and safety. The medication must be kept out of the reach of children.


Storage and Handling

Scelto, across its various forms (tablets, injection, ophthalmic solution), must be stored at Controlled Room Temperature (typically 20 C to 25 C) and kept from freezing.

Requirement Rule
Container Store in the original, tightly closed container.
Protection Protect all forms from light and excess moisture.
Stability Opened ophthalmic solution must be discarded one month after opening; single-use vials are for immediate disposal.

Disposal Instructions

Unneeded or expired Scelto should not be emptied into drains. Disposal must be in accordance with local regulations, preferably utilizing an approved drug take-back program. If this is unavailable, mix the medicine with an undesirable substance and seal it before placing it in household trash.

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

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