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Кетолак

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Кетолак

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Кетолак

Quick Facts: Кетолак

Property Description
Active ingredient Ketorolac tromethamine
Form Injection solution, Tablets, Ophthalmic solution, Nasal spray
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General purpose Strong relief of acute pain and reduction of inflammation
Origin Synthetic, Pyrrolizine carboxylic acid derivative

What Type of Pain Reliever is Кетолак?

Кетолак is a potent, non-narcotic medication containing the active component Ketorolac tromethamine. It is officially classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID), a category recognized globally in pharmacological practice. This classification indicates that the medicine provides strong relief by targeting inflammatory pathways. The compound is chemically defined as a Pyrrolizine carboxylic acid derivative. Ketorolac is clinically recognized for its analgesic efficacy, positioning it as a controlled substance for managing high-intensity, short-term discomfort, such as acute post-operative pain.


Composition and Pharmaceutical Forms of Ketorolac

The drug Кетолак is a synthetic, single-ingredient product, where its effects are derived from the Ketorolac tromethamine compound. This established composition ensures a predictable pharmacological profile. A key distinguishing feature of this INN is its diverse range of dosage forms, encompassing an Injection solution for rapid systemic action, Oral tablets, an Ophthalmic solution, and a Nasal spray. This unique versatility allows healthcare professionals to select the optimal route of administration, ranging from parenteral and oral to topical use.


General Therapeutic Purpose and Analgesic Strength

The core therapeutic purpose of Кетолак is to provide strong relief from acute pain and reduce inflammation. It achieves this by acting peripherally to inhibit the creation of biological substances called prostaglandins, which are essential triggers for pain and inflammatory responses in the body. This mechanism results in a potent analgesic action, combined with an anti-inflammatory effect. Its specific strength distinguishes it from general, milder analgesics. This dual functionality ensures the medication addresses both the sensation of pain and the underlying biological factors contributing to acute discomfort, making it a tool in short-term intensive pain management.

Regulatory References

  1. MedlinePlus, National Library of Medicine
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What side effects are possible with Кетолак?

Possible side effects and safety information

Кетолак (Ketorolac tromethamine) is associated with officially documented adverse reactions classified by frequency and affected body system, according to regulatory documents from health authorities such as the FDA and EMA.

General Regulatory Safety Patterns

The medicine carries a risk for serious gastrointestinal (GI) adverse events, including ulceration, bleeding, and perforation, which can be fatal. It is also associated with an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke. These risks are noted in regulatory labeling to increase with higher doses and with a longer duration of use, leading to a strict limitation on the total duration of treatment, which should not exceed five days.

Classification of Adverse Reactions

The most common adverse reactions reported (occurring in approximately 1% to 10% of patients) often involve the gastrointestinal and nervous systems. These include nausea, dyspepsia, abdominal pain, headache, dizziness, drowsiness, and edema.

  • System-Organ Classes affected include Gastrointestinal, Nervous System, Cardiovascular, Renal, and Skin/Dermatologic. Rare but documented serious reactions include acute renal failure and severe skin reactions like Stevens-Johnson syndrome.

Population-Specific Constraints

Safety characteristics are defined for specific populations. The drug is contraindicated in the third trimester of pregnancy and in nursing mothers due to potential harm to the infant. It is also contraindicated in patients with advanced renal impairment due to the risk of renal toxicity, and heightened caution is required when prescribing to older adults due to increased risk for serious GI adverse events.

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Overdose and Emergency Response

Кетолак Overdose and When to Seek Help

An overdose of Ketorolac tromethamine is detailed in official regulatory labeling with specific clinical manifestations. Common presentations include nausea, vomiting, epigastric pain, abdominal pain, lethargy, and drowsiness. The possibility of progression to severe, life-threatening outcomes, such as acute renal failure, hypertension, respiratory depression, or coma, is officially noted in prescribing information. Gastrointestinal complications like peptic ulcers, erosive gastritis, or severe GI bleeding are also documented consequences associated with the drug class in overdose settings.

Overdose Manifestations Severe Outcomes
Epigastric pain, Nausea, Vomiting Acute renal failure, Coma, Respiratory depression
Drowsiness, Lethargy, Hyperventilation Gastrointestinal bleeding, Hypertension

The required management approach is symptomatic and supportive care, as regulatory documentation confirms that no specific antidote is known. For instance, procedural steps like administering activated charcoal are described as potentially useful for patients observed within four hours of ingesting a large oral overdose (defined as 5 to 10 times the usual dose). Due to the risk of severe complications, individuals must seek emergency medical attention or immediately contact the Poison Help line upon any suspicion of overdose.

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Therapeutic Uses of Кетолак

What Кетолак Treats: Main Uses and Benefits

This medication is applied to situations requiring additional symptomatic support for symptoms related to physical discomfort, especially acute symptoms. Ketorolac is commonly used to help with symptoms related to physical discomfort, often following procedures or acute events, and is relevant across domains where short-term symptom management is appropriate. It is indicated for the management of pain and inflammation.

Ketorolac is commonly applied for symptom management in conditions where symptoms may intensify temporarily. It is relevant in contexts where symptoms related to inflammatory or irritative states may become more noticeable.

“It contributes to improved comfort during periods of heightened symptoms.”

Clinical scenarios where it is commonly applied include discomfort after surgery, pain from sudden injuries, and conditions associated with inflammatory or systemic imbalance. By managing these acute manifestations, it supports general well-being during symptomatic phases and assists with maintaining functional stability.

Quick Fact: Symptomatic Support
Commonly used across conditions presenting with acute episodes that require short-term symptomatic assistance.

Regulatory References

  1. NIH MedlinePlus Drug Information
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Eligibility and Restrictions for Use

Who Can and Cannot Use Кетолак (Ketorolac)

The eligibility for using Ketorolac is strictly defined by regulatory documents, emphasizing short-term use in adults and prohibiting its use in several specific populations. The medicine is contraindicated for patients with active peptic ulcer disease, a history of gastrointestinal bleeding or perforation, and advanced renal impairment. Use is also prohibited in individuals with any suspected or confirmed bleeding disorders, such as cerebrovascular bleeding, and in those with hypersensitivity to aspirin or other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).

Ketorolac must not be used concurrently with other NSAIDs or aspirin, and the total systemic treatment duration must not exceed five days. Use is contraindicated during labor and delivery, and in women who are breastfeeding. While generally approved for adults (ge 17 years), the medicine requires mandatory dose reduction for elderly patients (ge 65 years) and those with low body weight. The safety and efficacy of the systemic forms are not established for children under two years of age.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes interactions documented in official government regulatory sources for Ketorolac tromethamine (Кетолак), focusing only on formal prohibitions and pharmacokinetic/pharmacodynamic effects.


Formally Contraindicated Combinations

Co-administration with several substances is officially prohibited:

  • Other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Combining with Aspirin or other NSAIDs is contraindicated due to a cumulative risk of serious gastrointestinal events.
  • Probenecid: Use is contraindicated because it significantly decreases the renal clearance of Ketorolac, leading to high increases in plasma exposure.
  • Anticoagulants: Co-administration with agents like Warfarin or low-dose Heparin is prohibited due to the heightened risk of bleeding resulting from inhibited platelet function.
  • Lithium salts: The combination is contraindicated as it reduces lithium clearance, resulting in elevated plasma lithium levels.

Documented Interaction Effects

Interaction Type Interacting Substance/Class Official Documented Effect
Exposure Modification Methotrexate Reduced renal clearance, increasing Methotrexate plasma levels.
Pharmacodynamic Risk SSRIs, Corticosteroids, Antiplatelet agents Increased risk of hemorrhage, particularly in the gastrointestinal tract.
Effect Reduction Diuretics, ACE Inhibitors, ARBs Reduction of the natriuretic or antihypertensive effect due to prostaglandin synthesis inhibition.
Timing Restriction Systemic Formulations The total cumulative duration of all systemic use (oral, IV, IM) must not exceed 5 days.
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Mechanism of Action

How Кетолак Works

Molecular Mechanism: Non-Selective COX Inhibition

The core mechanism involves the competitive inhibition of the Cyclooxygenase (COX) enzymes—specifically, both the COX-1 and COX-2 isoforms. The drug's mechanism suppresses the metabolism of arachidonic acid and blocks the synthesis of prostaglandins and thromboxane at the cellular level.

Causal Cascade: Modulation of Nociceptive and Inflammatory Signals

This molecular action initiates a cascade that modifies the physiological response to injury. The reduction of prostaglandins decreases the sensitization of peripheral nerve endings (nociceptors) and limits the chemical processes that cause localized swelling and vasodilation, leading to a systemic dampening of nociceptive signaling and the physiological cascade that mediates inflammation.

Mechanistic Constraint: Interference with Homeostatic Processes

The non-selective nature of the mechanism inherently modulates systems regulated by the constitutive COX-1 enzyme, which regulates key physiological functions, contributing to homeostasis. This involves suppressing prostaglandin-mediated maintenance of the gastric mucosal barrier and inhibiting the synthesis of Thromboxane A2 in platelets, thereby interfering with prostaglandin-dependent hemostatic regulation.

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Dosage and Administration Information

Ketorolac tromethamine is administered through distinct administration routes, which include Intravenous (IV), Intramuscular (IM), Oral tablets, and Intranasal spray formulations. Use via epidural or spinal injection is explicitly prohibited.

Dosing Schedules and Duration Constraints

The administration is strictly limited in duration. The total combined duration of use for all systemic formulations (IV, IM, Oral) must not exceed five days in adults. The lowest effective dose is used for the shortest duration necessary.

For non-elderly adults weighing 50 kg or more, the standard multiple-dose regimen for the injection is 30 mg IV or IM every 6 hours, with a maximum daily dose of 120 mg. The IV bolus is administered over no less than 15 seconds. The 10 mg Oral Tablet is indicated only as continuation therapy following initial parenteral administration; it is not indicated for starting treatment. The maximum oral dose is 40 mg per day, taken every four to six hours.

Population-Specific Administration Rules

Adherence to specific administration rules is required for special populations. The maximum total daily dose for the injection is 60 mg for individuals 65 years or older, patients weighing less than 50 kg, or those with established renal impairment. Furthermore, the parenteral duration is restricted to 2 days in some protocols.

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Recent Clinical Evidence

Research evidence / Overview of studies for Кетолак

Evidence for Short-Term Acute Postoperative Pain

The research into Ketorolac's use was conducted to explore discomfort immediately following surgery, primarily relying on short-term Randomized Controlled Trials (RCTs) and meta-analyses. These studies were mostly applied in research exploring how symptoms change over time in adult patients who had undergone various surgical procedures. Researchers examined how measured outcomes related to physical discomfort changed in the study populations, including pain intensity scores and whether the use of Ketorolac was associated with a reduction in the need for opioid pain medications.

Research exploring short-term symptom changes in this context contributes to understanding symptom patterns. However, the available data are focused only on the immediate, acute phase of recovery, which is consistent with the maximum study duration specified in the research (up to five days). Long-term effects and sustained outcomes beyond this acute phase are not fully established, and follow-up durations were limited in these trials.


Evidence for Acute Pain in Emergency Settings

Ketorolac was evaluated in settings with varying symptom burdens, such as hospital emergency departments. Research primarily consisted of short-term RCTs applied in studies examining patient-reported experiences for acute conditions. Studies monitored how rapidly outcomes related to physical discomfort changed after the medication was administered. Data show patterns related to what is sometimes described as a dose-related plateau, where increasing the dose was not necessarily associated with proportionally greater measured changes in pain scores. The research focus is highly acute, and studies provide limited information for long-term outcomes, or the post-discharge evolution of symptoms.


Evidence for Use in Ophthalmic Procedures

The research for the use of Ketorolac was studied for topical (eye drop) or intra-surgical use to address outcomes linked to inflammatory or irritative states and discomfort following eye surgery. This research was primarily conducted using RCTs on adult populations undergoing specific procedures, such as cataract removal. Studies monitored outcomes such as the level of acute post-operative ocular pain. This evidence is highly specific to the eye; these results apply only to the populations studied and the topical route of administration, and their focus remains specific to the observed ocular context.


What Is Still Uncertain About Кетолак Research

Key limitations in the research structure include the short duration of most clinical trials, which means that comprehensive long-term effects or the durability of response are not well characterized. Data for certain groups, particularly specific pediatric subgroups and patients with certain chronic underlying health conditions, remain insufficient. While research describes patterns related to short-term symptom changes, comparative evidence is lacking in some pain management scenarios. The research is ongoing, and findings describe group patterns, not personal outcomes; research provides context but not individual predictions.

Key Studies & References

  1. Comparison of Ketorolac at 3 Doses in Children With Acute Pain: Protocol for A Randomized Controlled Trial (KETODOSE trial - reflects current research uncertainty in pediatrics)
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Frequently Asked Questions (FAQ)

Common questions about Кетолак (FAQ)

Q: How quickly does Кетолак start working for pain?

According to official product information, pain reduction is related to when the drug reaches its peak concentration. For oral tablets, the peak pain-relieving effect is typically reached within 2 to 3 hours after administration. When given intravenously (IV), pain reduction may begin more quickly, though the time to peak effect varies.

Q: How long does the pain relief from Кетолак typically last?

The duration of effect is related to the drug's half-life, which is the time it takes for the body to eliminate half of the medicine. In healthy adults, this period is generally around 5 to 6 hours. Regulatory information indicates that this half-life may be longer in older adults or in individuals with reduced kidney function.

Q: Are there any common foods or drinks that interact with Кетолак?

Official information states that the oral absorption of ketorolac may be slowed if it is taken after a high-fat meal, which can delay when the medicine reaches its maximum effect. The tablet form may be taken with food, which may help minimize stomach upset, according to regulatory notes. Antacids generally do not appear to impact how much of the drug is absorbed by the body.

Q: Is it safe to take Кетолак if I drink alcohol occasionally?

Regulatory warnings note that combining ketorolac with alcohol may increase the risk of serious gastrointestinal adverse events, such as bleeding and ulcers. Official documentation advises caution regarding this combination.

Q: What happens if I forget a dose of Кетолак?

Patient information from official sources indicates that a missed dose should be skipped. The next dose is then taken at the usual time. The guidance notes that extra medicine should not be taken to try and catch up for a missed dose.

Q: Is Кетолак available over the counter?

No. Official regulatory documents indicate that ketorolac tromethamine is a potent NSAID analgesic that is indicated for the management of moderately severe acute pain. As a result, this medication is only available by prescription (Rx only).

Q: Is it possible to develop a dependency on Кетолак?

Official labeling describes ketorolac as a non-narcotic medication. It is noted in regulatory documents that the drug possesses no sedative or anxiolytic properties, indicating it does not carry the same risk of dependence as opioid pain relievers.

Q: What is the difference between generic Кетолак and the brand name?

Generic ketorolac tromethamine contains the exact same active ingredient as the brand-name product. Regulatory agencies require that generic versions meet the same standards for quality, strength, and therapeutic effect. The primary difference often lies in the inactive ingredients, such as the colorants or fillers used by different manufacturers.

Q: Does taking Кетолак with food change how it works?

The official product labeling indicates that taking oral tablets with a high-fat meal may delay the time it takes for the medication to reach its highest level of effectiveness in the blood. Regulatory materials note that taking the tablets with food or milk may help minimize the risk of stomach irritation.

Q: Does Кетолак interact with common supplements like multivitamins?

The official label's interaction section focuses primarily on drug-drug combinations that increase risks, such as other blood-thinning agents. While common supplements are not specifically listed, regulatory guidance notes the importance of disclosing the use of all supplements, herbal, or non-prescription products.

Q: Does the dose of Кетолак need to be adjusted for people with liver issues?

Ketorolac is largely processed (metabolized) in the liver. Official warnings identify liver failure as a rare but serious adverse event associated with the drug. While specific dose reduction guidelines for liver impairment are not standard across all labels, caution and monitoring are noted in official information for patients with existing liver issues.

Q: Is it okay to crush or chew Кетолак tablets?

Official drug labels state the product is an oral tablet that is swallowed. The regulatory label does not provide instruction or authorization to cut, crush, or chew the tablets, which suggests the tablets are intended to be swallowed whole.

Q: What color are Кетолак tablets usually?

The physical appearance of the tablets, including the color and shape, can vary depending on the specific manufacturer and the dose prescribed. Regulatory documents may list the visual description of a particular product. For instance, some officially cited tablets are described as being white and round, though generic versions may differ.

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How should Кетолак be stored and disposed of?

Storage and Disposal Requirements for Ketorolac

The official labeling mandates strict conditions to maintain the stability of Ketorolac tromethamine.

Storage Conditions

The medicine must be stored at Controlled Room Temperature, typically 20°C to 25°C (68°F to 77°F). It is prohibited to refrigerate or freeze the injection solution. Certain forms, such as the injection, must be protected from light and kept in the original carton. As a non-negotiable safety requirement, all forms of Ketorolac must be stored out of the sight and reach of children.

Stability and Handling

The injection solution is designated for single use only, and any unused portion must be immediately discarded. The ophthalmic solution often has a limited stability, requiring disposal within 15 days of first opening.

Disposal Rules

Unused or expired Ketorolac must not be thrown into household trash or disposed of in wastewater. Disposal must be strictly completed according to local pharmaceutical waste requirements, often involving a pharmacy take-back program. Used needles or syringes must be placed in a puncture-proof container.

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

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