Ketanor SL

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Medically reviewed

Laura Arias

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 Ketanor SL

Property Description
Active Ingredient Ketorolac (as tromethamine salt)
Form Sublingual Tablet (SL)
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
General Purpose Management of acute, moderate-to-severe pain
Origin Synthetic Organic Molecule

What Type of Medicine is Ketanor SL? (Identity and Classification)

Ketanor SL is a medicinal preparation defined by its primary active component, Ketorolac, which is a powerful Nonsteroidal Anti-inflammatory Drug (NSAID). This compound is a synthetic organic molecule classified within the pyrrolo-pyrrole chemical group. The drug's classification as an NSAID establishes its foundational role as a systemic agent for modulating the body's response to pain and inflammation. Ketorolac's efficacy is clinically recognized for providing a high degree of analgesic effect, positioning it among the most potent compounds in its class.

Composition and the Unique Sublingual Form

The finished product, Ketanor SL, is a single-ingredient preparation containing Ketorolac, typically as the tromethamine salt, uniquely presented in a Sublingual Tablet form. The designation SL denotes the sublingual route of administration, instructing that the tablet is dissolved and absorbed directly under the tongue. This specific design is a key differentiator from standard oral NSAIDs because the sublingual absorption is engineered to achieve a rapid systemic effect by partially bypassing the digestive tract. This rapid delivery system is preferred when swift onset of pain relief is the primary therapeutic goal.

Ketorolac's General Purpose as a Potent Analgesic

The overarching general purpose of the active compound, Ketorolac, is to provide robust pain management and reduce associated inflammation. This benefit is realized through its mechanism: the strong inhibition of prostaglandin synthesis—compounds that mediate pain signals. This potent action positions Ketorolac for the short-term relief of significant discomfort. For instance, Ketorolac is typically considered when the level of pain surpasses what can be effectively managed by common, less potent, over-the-counter NSAIDs.

What side effects are possible with Ketanor SL?

Possible side effects and safety information

Ketorolac, as a nonsteroidal anti-inflammatory drug (NSAID), has a documented safety profile emphasizing serious risks that necessitate strict constraints on use. Regulatory agencies mandate that the total combined duration of therapy across all formulations must not exceed five days due to the increased risk of severe adverse events.


Serious Systemic Risks and Warnings

Critical warnings highlight the potential for serious gastrointestinal complications, including peptic ulceration, bleeding, or perforation of the stomach or intestines, which may be fatal and can occur at any time during treatment. Additionally, an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke, is documented. This risk may begin early in treatment and generally increases with dose and duration of use. Rare but serious hypersensitivity reactions, including anaphylaxis, and severe skin reactions like Stevens-Johnson Syndrome (SJS), are also official safety concerns.


Common and System-Specific Adverse Reactions

Adverse reactions are classified by their incidence rates. Reactions reported as Very Common (incidence greater than 10%) include abdominal pain, nausea, dyspepsia, and headache. Reactions categorized as Common (incidence 1% to 10%) affect several organ systems, including: dizziness, drowsiness (Nervous System); diarrhea, vomiting, flatulence (Gastrointestinal System); edema, hypertension (Cardiovascular); and pruritus, rash (Dermatological).


Population-Specific Safety Notes

The medicine is generally contraindicated in patients with advanced renal impairment and in those with recent GI bleeding or active ulcer disease. Older adults (the elderly) are at a significantly higher risk for serious gastrointestinal and renal adverse events. Use is also restricted during the third trimester of pregnancy due to potential adverse effects on the fetal cardiovascular system.

Overdose and Emergency Response

Ketorolac tromethamine overdose information is strictly derived from official government regulatory documents. Following acute overdose, clinical signs are typically limited to transient and reversible manifestations such as lethargy, drowsiness, nausea, vomiting, and epigastric pain.

Other documented manifestations include abdominal pain, hyperventilation, and signs of renal dysfunction, alongside localized gastrointestinal effects like peptic ulcers or erosive gastritis.

Severe Outcomes and Required Emergency Action

Urgent medical attention must be sought for the management of any suspected overdose, particularly if severe clinical manifestations occur. The regulatory labeling highlights the potential for serious, life-threatening complications, which, although rare, can include gastrointestinal bleeding, acute renal failure, respiratory depression, and coma.

Official Management Mandate:

The official documentation specifies that there is no specific antidote known for Ketorolac overdose. Therefore, patients must be managed by comprehensive symptomatic and supportive care. Specific decontamination procedures, such as the administration of activated charcoal or an osmotic cathartic, may be indicated by a healthcare professional if the ingestion is large and recent. Certain supportive measures like hemodialysis are generally not effective.

Therapeutic Uses of Ketanor SL

The active ingredient in Ketanor SL is commonly used for the short-term relief of acute pain that is classified as moderate-to-severe. This medication is generally applied in situations where symptoms may intensify temporarily, and is not intended for managing mild or chronic discomfort. It is applicable across domains where additional symptomatic support is needed, addressing conditions characterized by heightened symptoms such as postoperative discomfort following surgical procedures, pain from acute trauma, or intense, episodic manifestations like renal colic.

The therapeutic focus is on easing the overall symptom burden, and this medication is relevant in clinical settings that involve acute or unstable symptom patterns. It supports patients during episodes of heightened discomfort by assisting with maintaining functional stability when symptoms disrupt routine activities. It is considered relevant when supportive symptom management is appropriate for pain that creates noticeable physiological strain.

“It is commonly used to help with groups of symptoms that may become intense or disruptive, especially in post-procedural contexts.”

Quick Fact: Support for Acute, Moderately Severe Pain The primary benefit assists with providing strong, supportive symptomatic relief during temporary periods of high-intensity discomfort, and contributes to improved comfort during periods of heightened symptoms.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Ketanor SL (ketorolac) is intended for use by adult patients for the short-term management of moderately severe acute pain. Official regulatory documents establish comprehensive eligibility rules that define who is restricted or entirely prohibited from using this medicine.


Populations and Conditions Prohibited (Contraindicated)

Use is strictly contraindicated for several populations due to the drug’s potential for serious adverse effects, including risks of bleeding and severe organ impairment:

  • Gastrointestinal Risk: Patients with active peptic ulcer disease, a history of GI bleeding or perforation, or recent GI bleeding must not use this medicine.
  • Bleeding Risk: Patients with known or suspected cerebrovascular bleeding, hemorrhagic diathesis, or any condition involving a high risk of bleeding are prohibited from use.
  • Renal/Cardiac Impairment: Patients with advanced renal impairment, those at risk for renal failure due to volume depletion, or those with severe uncontrolled heart failure are ineligible.
  • Pregnancy/Lactation: The medicine is contraindicated during labor and delivery and in nursing mothers.
  • Surgical Context: Use is prohibited as a prophylactic analgesic before any major surgery and in the peri-operative setting of Coronary Artery Bypass Graft (CABG) surgery.

Restricted and Special Populations

Use is not recommended for pediatric patients as safety and efficacy have not been established. Older adults (aged 65 years and older) and patients with moderately elevated serum creatinine are classified as Special Populations; their eligibility is conditional, requiring increased caution due to greater risk for adverse events, as defined in regulatory labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Ketanor SL, which contains the active ingredient Ketorolac, is defined by regulatory restrictions related to cumulative toxicity and effects on drug clearance. The official government documentation classifies several combinations as contraindicated due to high-risk pharmacokinetic and pharmacodynamic outcomes.

Formal Interaction Restrictions

Classification Interacting Substance Official Restriction Basis
Contraindicated Other NSAIDs, Aspirin Cumulative risk of gastrointestinal and renal toxicity.
Contraindicated Warfarin, Heparin Synergistic increase in bleeding risk.
Contraindicated Probenecid Markedly increases Ketorolac plasma levels due to reduced clearance.

Clinically Significant Interactions

Co-administration with Lithium can elevate its plasma concentrations and reduce its renal clearance, a pharmacokinetic effect documented in the official labeling. Similarly, Ketorolac may enhance the toxicity of Methotrexate by reducing its accumulation and clearance. For antihypertensive agents, including ACE Inhibitors and Diuretics (such as Furosemide), Ketorolac may diminish their intended blood pressure-lowering or natriuretic effects. Combining Ketorolac with SSRIs may result in an increased risk of gastrointestinal bleeding. A high-fat meal can delay the time to peak concentration (Tmax) of Ketorolac by approximately one hour. Furthermore, the official prescribing information mandates that the total combined use of all Ketorolac formulations must not exceed 5 days.

Mechanism of Action

The mechanism of action for Ketanor SL is rooted in the inhibition of the body's cyclooxygenase (COX) enzyme system. This action is purely pharmacodynamic, designed to modulate specific physiological pathways.


Targeting the Cyclooxygenase Enzyme System

This domain covers the drug's interaction with its primary biological targets, Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2). Ketorolac acts as a non-selective, reversible inhibitor, competitively blocking the active sites of both enzymes. This interference halts the enzymatic conversion of Arachidonic Acid into key lipid mediators, most notably the prostaglandins that function as nociceptor sensitizers. This action is the initial step in a cascade that reduces the level of generated lipid mediators.


Modulation of Nociceptive Signaling

This domain addresses the resulting physiological effect on the nociceptive signaling pathway, encompassing both peripheral and central systems. By reducing prostaglandin synthesis, the mechanism lessens the sensitivity of peripheral nerve endings (nociceptors) and, due to its ability to cross the blood-brain barrier, decreases signal amplification in the spinal cord and brain. This dual peripheral and central adjustment results in a suppression of the body's nociceptive signaling.


️ Non-Selective Mechanistic Constraints

This domain clarifies the physiological trade-off inherent in the drug's mechanism. The non-selective inhibition means the drug unavoidably reduces the production of homeostatic prostaglandins synthesized by the constitutive COX-1 enzyme. While the inhibition of COX-2 supports the desired modulation of mediators, the parallel suppression of COX-1-dependent processes is a mechanism-dependent constraint that affects the sustainability of pathway modulation.

Dosage and Administration Information

How to Use Ketanor SL

This section describes the administration principles and dosing limitations for Ketorolac Sublingual (SL).

Administration Scope

Property Instruction
Route of administration The medicine is administered sublingually (SL).
Dosing schedule The standard single dose is 10 mg of Ketorolac. The maximum dose for the oral/sublingual component is restricted to 40 mg within a 24-hour period.
Frequency pattern Dosing is permitted on an as-needed basis, typically requiring a minimum interval of 4 to 6 hours between doses.
Age-group rules A reduced daily dose is generally required for patients who are 65 years or older and for individuals with established renal impairment.
Duration constraint The total combined duration of therapy involving all formulations of Ketorolac (parenteral, oral, and sublingual) must not exceed five days.

Procedural Guidelines

Step sequence for Sublingual Administration:

  • The sublingual tablet should be placed precisely under the tongue.
  • The tablet must be allowed to dissolve completely in this position; it must not be chewed, crushed, or swallowed whole.
  • Adherence to the prescribed 4-to-6 hour interval is necessary before the next dose is considered.
  • The patient must ensure the maximum daily dose of 40 mg is never exceeded.

These instructions establish a structured, time-limited protocol for use. The specific sublingual route facilitates rapid systemic absorption, while the strict 5-day maximum duration and fixed dosing limitations define the short-term nature of the treatment.

Recent Clinical Evidence

Research evidence / Overview of studies for Ketanor SL

Evidence for use in Acute Postoperative Pain

The primary research base for Ketorolac, the active ingredient in Ketanor SL, is built upon Randomized Controlled Trials (RCTs). These are a key type of study design where groups of patients are randomly assigned to receive either the study medication, a placebo, or a different comparator. These short-term RCTs, along with reviews that aggregate their results (meta-analyses), was studied in research exploring how symptoms change over time immediately following various surgical procedures, such as orthopaedic or dental surgery.

Researchers explored outcomes related to physical discomfort, often measuring changes in patient-reported pain scores using standardized scales. They also monitored the amount of supplemental opioid pain medication required by patients post-procedure. Findings describe patterns observed in the studies that compared pain score changes and the amount of opioid pain medication required by patient groups receiving Ketorolac. Bioequivalence studies specifically for the Sublingual (SL) form was evaluated in research that examined its absorption rate compared to other types of the medication, where data showed patterns related to its rate and extent of absorption being similar to reference forms.

Evidence for use in Acute Non-Surgical Pain

The research examined the use of Ketorolac in acute, non-surgical situations, such as those conditions associated with acute or disruptive episodes like renal colic or moderate-to-severe pain from traumatic injuries, in trials conducted in settings with varying symptom burdens, such as emergency departments.

The main outcomes describing episodic or acute changes that were examined were the change in pain score at very specific, short time intervals and was evaluated in studies tracking the amount of additional analgesic medication required by the patient. The overall evidence base for this type of use is limited compared to the postoperative setting, and fewer data are available for the specific sublingual form across this broad range of acute non-surgical conditions.

What is Still Uncertain About Ketorolac Research

The body of evidence describes patterns related to short-term changes but carries several areas where research remains incomplete or uncertain. As noted, long-term effects are not fully established, and there is a complete lack of evidence for its use beyond the acute limit of five days. Comparative evidence is lacking for how the sublingual form performs against other routes of administration outside of basic absorption studies. Furthermore, subgroup findings are uncertain or incomplete for many special populations, particularly those who have complex underlying health conditions.

Key Studies & References Ketorolac Overview (General Information on Uses and Precautions)

Frequently Asked Questions (FAQ)

Common questions about Ketanor SL (FAQ)

Q: What makes Ketanor SL different from regular pain relievers?

Official information describes Ketanor SL as a potent pain reliever intended for the short-term management of moderately severe acute pain. The level of pain relief is officially indicated for acute pain that requires stronger management than typically provided by over-the-counter pain relievers. It is administered via the sublingual route, which is designed for rapid systemic effect.

Q: Is Ketanor SL used for chronic pain conditions like arthritis?

Regulatory documents state that Ketorolac is not indicated for the management of minor or chronic painful conditions. Its use is strictly intended only for the short-term relief of acute pain, typically limited to a maximum of five days.

Q: Why is Ketanor SL sometimes used as an alternative to stronger pain medications?

The medicine is officially indicated for managing moderately severe acute pain that requires an analgesic effect comparable to the level achieved by opioid pain relievers. This positioning allows it to be used as a potent, non-opioid option for significant pain.

Q: How does Ketanor SL differ from a standard pain pill that is swallowed?

The primary difference lies in the route of administration, which affects how quickly the medication enters the bloodstream. The sublingual (SL) form is designed to be absorbed rapidly under the tongue. The oral tablet form of the drug typically reaches its peak concentration in the blood within approximately 44 minutes, though the sublingual (SL) form is designed to provide a rapid effect by partially bypassing the digestive tract.

Q: Can Ketanor SL be swallowed instead of placed under the tongue?

No, the sublingual tablet must not be swallowed whole, chewed, or crushed. To ensure the intended absorption characteristics of the sublingual design, the tablet should be placed under the tongue and allowed to dissolve completely.

Q: How long does it take for Ketanor SL to start working?

The sublingual form is intended for rapid absorption to achieve a swift effect. Studies examining the related oral tablet form indicate that the medicine typically reaches its peak concentration in the blood within approximately 44 minutes.

Q: Can I eat or drink right after the tablet has dissolved?

Regulatory information indicates that a high-fat meal taken with the medicine may delay the time it takes for the drug to reach its peak concentration in the bloodstream. No specific instructions are provided for immediate eating or drinking after the tablet has fully dissolved.

Q: Does Ketanor SL cause drowsiness or dizziness?

Yes. According to official product information, dizziness and drowsiness are commonly reported side effects. Due to the possibility of these effects, caution is advised when engaging in activities that require full attention, such as driving or operating machinery.

Q: Is it possible to become dependent on Ketanor SL?

Ketorolac is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is not associated with the same dependency risks as controlled substances. Official information states that the medicine does not possess sedative or anxiety-reducing properties.

Q: Is it safe to consume alcohol while taking Ketanor SL?

Official warnings advise against consuming alcohol while taking this medicine. Alcohol may significantly increase the risk of serious gastrointestinal side effects, including stomach bleeding.

Q: Can Ketanor SL affect the kidneys?

Yes, regulatory documents indicate the medicine can affect the kidneys, and it is contraindicated in patients with advanced renal impairment. Its use requires increased caution in individuals with impaired renal function.

Q: Can people with a history of heart issues use Ketanor SL?

The medicine is strictly contraindicated in patients with severe, uncontrolled heart failure. It carries an increased risk of serious cardiovascular events, such as heart attack or stroke, and the official warning notes that the risk may be higher in patients with existing cardiovascular disease.

Q: What are the considerations for taking Ketanor SL during pregnancy or while breastfeeding?

The medicine is strictly contraindicated during labor and delivery, and in nursing mothers. It is also prohibited for pregnant individuals at or after 20 weeks of gestation due to regulatory concerns regarding potential harm to the fetus and complications during delivery.

Q: Can Ketanor SL cause an allergic reaction in people with asthma?

Yes. Official guidelines state the medicine is contraindicated in patients with allergic manifestations to aspirin or other NSAIDs. Hypersensitivity reactions, including the reported risk of bronchospasm or exacerbation of asthma, have occurred in some patients.

Q: Are there signs of a serious reaction to Ketanor SL that a person should know?

Regulatory documents describe critical warnings regarding serious systemic risks. Reported signs of these serious risks include symptoms of gastrointestinal bleeding, such as black or tarry stools, vomiting that resembles coffee grounds, or stomach pain. Symptoms of a cardiovascular event may include chest pain, shortness of breath, or sudden weakness.

Q: Does Ketanor SL affect fertility?

The adverse reaction of female infertility has been reported in association with Ketorolac use.

Q: Does the SL form of the medicine work differently in people with different body weights?

Yes. Official dosing principles indicate that for patients weighing less than 50 kg (110 lbs), a reduced daily dose is generally indicated by regulatory documents.

Q: Is Ketanor SL primarily used to reduce inflammation or to treat pain?

The primary indication established by regulatory bodies is for the management of acute, moderately severe pain. The drug's mechanism involves inhibiting substances in the body that cause both pain and inflammation.

Q: Can Ketanor SL be used to treat a severe toothache or dental pain?

The drug is indicated for the short-term management of moderately severe acute pain. This indication can apply to pain experienced after dental surgery or a severe toothache.

Q: Are there potential visual side effects associated with taking Ketanor SL?

Yes. Official regulatory records indicate that visual side effects, including abnormal vision or blurred vision, have been reported rarely.

Q: What kind of research evidence supports the use of Ketanor SL?

Official information indicates that support for the drug's use is built primarily upon Randomized Controlled Trials (RCTs) that examined its effectiveness in acute postoperative pain. Research also includes bioequivalence studies confirming the absorption characteristics of the sublingual form.

Q: What is the difference between the R- and S-enantiomers of Ketorolac?

Ketorolac is administered as a mixture of two related forms, known as enantiomers. Official prescribing information states that the primary biological activity and pain-relieving effect are specifically associated with the S-form of the molecule.

Q: What are the possible effects of an accidental overdose of Ketanor SL?

Reported symptoms associated with overdose may include nausea, vomiting, stomach pain, signs of GI bleeding, drowsiness, or changes in breathing.

How should Ketanor SL be stored and disposed of?

How to Store and Dispose of Ketanor SL?

Ketanol SL (ketorolac tromethamine tablets) must be stored and disposed of according to strict regulatory guidelines to maintain potency and ensure safety.


Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature (20°C to 25°C / 68°F to 77°F).
Protection Keep tightly closed and protect from moisture and excessive heat; do not freeze.
Safety The medication must be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired tablets should be disposed of by following local government regulations for pharmaceutical waste, ideally through an official drug take-back program. If a program is unavailable, mix the tablets with an undesirable substance (e.g., dirt, used coffee grounds), place the mixture in a sealed bag, and discard it in household trash. Do not flush this medication down a toilet or pour it down a sink.

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

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