Lixidol

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Lixidol

Lixidol is a potent, prescription-only medication primarily defined by its active component, Ketorolac Tromethamine, which is used for the management of moderately severe acute pain.


Quick Facts

Property Description
Active ingredient Ketorolac Tromethamine
Forms Tablet, injectable solution, nasal spray, ophthalmic solution
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General Purpose Pain relief and anti-inflammatory activity
Origin Synthetic organic compound

Classification and Purpose

Lixidol belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) pharmacological class, functioning as a potent non-narcotic analgesic. Its active substance, Ketorolac, is a synthetic organic compound that is also classified as a Cyclooxygenase Inhibitor. This classification confirms that the medicine works by interfering with the chemical processes that cause pain and inflammation in the body. The drug's potent action is clinically recognized for its ability to provide relief comparable to certain opioid analgesics, supporting its use as an opioid sparing agent in hospital settings.


Composition and Formulation

Ketorolac is a single-ingredient product, chemically a carboxylic acid derivative, administered as a racemic mixture containing both active and inactive forms. Lixidol is distinguished by its availability across multiple pharmaceutical preparations, enabling varied routes of administration. These forms include the standard tablet for oral use, an injectable solution for rapid onset via parenteral therapy, and specialized formulations like the nasal spray and ophthalmic solution (eye drops). This versatility allows the drug to be adapted for different acute pain management needs.

Regulatory References

  1. MedlinePlus Overview

What side effects are possible with Lixidol?

Possible Side Effects and Safety Information

Lixidol (ketorolac tromethamine) is a non-steroidal anti-inflammatory drug (NSAID) with a significant risk profile, requiring strict adherence to regulatory guidelines and limitations on use.


Serious Safety Warnings

Lixidol carries specific safety warnings concerning serious and potentially fatal risks, which necessitate the limitation of its use to no more than five days total across all forms of administration. Risks include:

  • Gastrointestinal Risk: Serious adverse events such as peptic ulceration, gastrointestinal bleeding, and perforation can occur without warning.
  • Cardiovascular Thrombotic Events: An increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which may be fatal.
  • Renal Damage: Potential for acute renal failure and kidney damage, especially in patients who are dehydrated or have pre-existing renal impairment.

Common and Other Adverse Reactions

Adverse effects commonly associated with Lixidol (incidence often greater than 10%) include effects on the central nervous system and gastrointestinal system, such as drowsiness, abdominal pain, dyspepsia (indigestion), nausea, and headache.

Infrequent adverse reactions (<1%) affecting various system-organ classes have been reported, including edema, pallor, hypertension, purpura, and injection site pain. Serious hypersensitivity reactions, including anaphylaxis, can occur.


Contraindications and Restrictions

Lixidol is contraindicated in several specific populations and conditions due to elevated risk. It must not be used in patients with active peptic ulcer disease, recent gastrointestinal bleeding or perforation, advanced renal impairment, cerebrovascular bleeding, or confirmed coagulation disorders. It is also contraindicated for use during labor, delivery, or in the third trimester of pregnancy, or concomitantly with other NSAIDs or aspirin.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Lixidol (Ketorolac Tromethamine) requires immediate medical attention. Management is defined by regulatory documents as symptomatic and supportive care, as no specific antidote is known for this medication.


Documented Overdose Manifestations

Symptoms following an acute overdose are generally consistent with NSAID overexposure and may be limited, but they can include:

  • Gastrointestinal Effects: Epigastric pain, nausea, and vomiting. Serious outcomes, including gastrointestinal bleeding, peptic ulcers, and erosive gastritis, are officially documented risks.
  • CNS Effects: Lethargy, drowsiness, and hyperventilation.
  • Systemic Effects: Single overdoses have been associated with renal dysfunction that is often reversible upon drug discontinuation.

Severe Outcomes and Required Actions

Regulatory labeling notes that rare, severe outcomes are possible, including acute renal failure, hypertension, respiratory depression, and coma. Anaphylactoid reactions are also a potential severe complication.

In the event of a suspected large oral overdose or the presence of these symptoms, urgent medical care must be sought.

Officially Described Procedures: If an overdose is detected within four hours, specific regulatory procedures may involve the administration of activated charcoal and/or an osmotic cathartic. Procedures like hemodialysis are noted to be potentially ineffective due to the drug's high protein binding.

Therapeutic Uses of Lixidol

Lixidol is commonly used to help with the short-term management of moderately severe acute pain. This is relevant in contexts involving heightened systemic burden and requires a high level of supportive relief. The therapeutic benefit is to offer symptomatic relief that helps patients cope more steadily during these short-term episodes.

Lixidol is primarily relevant in clinical settings that involve acute symptom patterns, such as managing pain after surgery, providing support during acute musculoskeletal discomfort, and addressing symptoms linked to organ-specific functional stress. It is applied across domains where additional symptomatic support is needed, particularly for symptoms related to inflammatory or irritative states.

“The primary intent of its use is to provide supportive relief during acute phases of pain and inflammation.”

When applied, it assists with maintaining functional stability by addressing symptom clusters that may become intense or disruptive. The medication is considered relevant because it offers supportive pain relief while being a non-narcotic agent, helping to reduce reliance on opioid medications for strong pain control.


Quick Fact: Relief for Acute Pain
Therapeutic Role: Supports symptom management for moderately severe acute pain.
Key Symptom Groups: Symptoms related to physical discomfort, inflammatory or irritative states, and symptoms linked to organ-specific functional stress.
Patient Benefit: Contributes to improved comfort and assists with maintaining functional stability during difficult, short-term episodes.

Eligibility and Restrictions for Use

Population Eligibility and Contraindications

Lixidol eligibility is strictly determined by official regulatory documents, primarily allowing use only for adult patients who require short-term management of moderately severe acute pain, with total combined treatment not exceeding five days.


Absolute Contraindications

Lixidol is strictly prohibited for individuals with a known history of active gastrointestinal disease (such as peptic ulcers or recent bleeding) or any condition that poses a high risk of bleeding (including cerebrovascular bleeding). It is contraindicated in cases of severe heart, kidney, or liver failure and must not be used concurrently with aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).


Age and Conditional Use

Use is generally not established or not recommended for children under the age of 16. Geriatric patients (age 65 and older) and patients with low body weight require a mandatory reduced maximum daily dose. The medicine is contraindicated throughout the third trimester of pregnancy, during labor and delivery, and in breastfeeding mothers. Lixidol is not indicated for the management of chronic painful conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the Lixidol interaction profile with several mandatory constraints, primarily focusing on risks of bleeding, systemic toxicity, and altered drug exposure.

Formal Contraindications

Co-administration is officially prohibited with other Ketorolac formulations, Aspirin or any other NSAID, and certain anticoagulants (such as Warfarin), due to the cumulative risk of bleeding and gastrointestinal toxicity. The combination with Probenecid is also contraindicated, as it significantly increases Lixidol’s plasma levels by decreasing its clearance. Similarly, Lithium is contraindicated due to a high risk of increased plasma concentrations and toxicity resulting from reduced clearance.

Documented Pharmacodynamic Effects

Lixidol carries documented pharmacodynamic risks when combined with other agents. Concomitant use with Selective Serotonin Reuptake Inhibitors (SSRIs) or Oral Corticosteroids increases the officially noted risk of bleeding or gastrointestinal ulceration. When co-administered with Diuretics (e.g., Furosemide) or ACE Inhibitors/ARBs, Lixidol may diminish the diuretic/antihypertensive effect and increase the risk of renal function deterioration, particularly in volume-depleted or elderly patients.

Administration Restrictions

The total cumulative duration of Lixidol treatment across all formulations must not exceed 5 days. For the ophthalmic solution, a 5-minute separation is required if used with other topical eye medications. Alcohol consumption should be avoided due to the officially documented heightened risk of gastrointestinal bleeding.

Mechanism of Action

Key Mechanism: Inhibition of COX Enzymes

The primary action of Lixidol is the non-selective inhibition of the Cyclooxygenase ( COX) enzyme isoforms, specifically COX-1 and COX-2. By blocking the active sites of these enzymes, the drug fundamentally stops the conversion of Arachidonic Acid into key signaling molecules called Prostaglandins. This molecular interference modifies the early steps of the eicosanoid cascade, which are involved in acute physiological responses.


Dual Modulation of Eicosanoid-Mediated Signaling

The suppression of Prostaglandin E2 ( PGE2) production results in a dual action: peripheral and central. Peripherally, it reduces PGE2's ability to sensitize nociceptor nerve endings in peripheral tissue, while centrally, it modulates PGE2-mediated signaling within the spinal cord and the hypothalamus. This mechanism influences pathways involved in heightened signaling and alters the PGE2-driven reset of hypothalamic thermal set points, resulting in the attenuation of nociceptive signaling and modulation of thermal set points.


Functional Constraints of COX-1 Involvement

The non-selective nature of the mechanism means it engages not only the inflammatory COX-2 but also the constitutive COX-1 enzyme, which is integral to essential homeostatic functions. This inhibition of the COX-1 pathway represents an inherent functional constraint on the mechanism, as it simultaneously modulates processes like renal blood flow and Thromboxane synthesis which are outside the core pain-signaling domain.

Dosage and Administration Information

How Lixidol is Used

Lixidol (Ketorolac Tromethamine) administration is governed by a strictly defined protocol emphasizing short-term use and specific routes for systemic delivery. The total combined duration of all systemic forms (IV, IM, Oral, Nasal) must not exceed five days in adult patients.


Administration Routes and Sequence

Systemic administration is approved via Intravenous (IV) injection, Intramuscular (IM) injection, Oral (PO) tablet, and Intranasal (IN) spray. The oral tablet is designated only as continuation therapy following initial IV or IM treatment; it is not indicated as a starting dose.


Official Dosing Regimens

Systemic doses are administered on an as-needed schedule, typically every 4 to 8 hours depending on the route. The standard adult (under 65 years and ge 50 kg) maximum daily dose for the injectable form is 120 mg, with maintenance doses often set at 30 mg every 6 hours. For oral continuation, the maximum is 40 mg per day.


Procedural and Population Constraints

Special procedural conditions apply to parenteral use: the IV bolus must be administered over no less than 15 seconds, and IM injection must be administered slowly and deeply.

A reduced dosage regimen is mandated for specific populations. Patients ge 65 years of age, those weighing less than 50 kg, or patients with renal impairment must receive a lower dose, with the maximum daily parenteral dose restricted to 60 mg. The systemic formulations are generally not indicated for pediatric patients.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lixidol

Evidence for use in Moderate to Severe Acute Pain

Lixidol (ketorolac) was studied for the short-term management of moderately severe acute pain, most commonly in the postoperative setting. The research primarily used Randomized Controlled Trials (RCTs) to evaluate outcomes related to physical discomfort, specifically by monitoring changes in patient-reported outcomes using pain scales. Studies typically focused on adult populations who required a level of pain management comparable to that offered by opioids. Findings describe patterns where Lixidol was observed to reduce pain scores over the initial 6-hour period following administration. Research has also explored its use as a component of multimodal analgesia, where it was associated with reducing the need for additional opioid pain medication in the immediate short-term post-surgery.

Evidence for use in Renal and Biliary Colic

Clinical trials have also examined the use of Lixidol for conditions characterized by acute or disruptive episodes, such as pain associated with renal and biliary colic. These studies often compare different doses or different routes of administration. Research highlights changes measured during the study period related to the intensity of acute symptoms. For instance, studies explored whether lower doses achieve patterns similar to higher doses within the short-term timeframe (e.g., 30 to 60 minutes). Findings were mixed regarding the comparative effectiveness of different formulations, and evidence remains limited in terms of long-term follow-up for these specific acute manifestations.

Long-term Studies and Follow-up

Lixidol was studied for short-term use, typically up to five days, and long-term outcomes are not well characterized. The existing evidence focuses on short-term changes and immediate postoperative outcomes, such as opioid consumption and early hospital discharge. Data on durability of response or extended-duration symptom management for chronic conditions are insufficient, as research has emphasized acute relief. Certainty remains low regarding the safety profile beyond the mandated short-term treatment duration.

Evidence in Special Populations and Uncertainties

Few data are available for certain special populations, including pediatric patients and specific patient groups (e.g., those with existing renal or cardiovascular conditions). Most evidence applies only to the adult populations studied in trials. Furthermore, the optimal dosing strategy, particularly in children, is an area where research is ongoing. Key limitations across the research landscape include small sample sizes in some non-postoperative trials and variability across studies regarding measurement methods, which contributes to the broader evidence landscape being somewhat heterogeneous.

Frequently Asked Questions (FAQ)

Common questions about Lixidol (FAQ)


Q: Does Lixidol treat inflammation or fever, or just pain?

As a Non-Steroidal Anti-Inflammatory Drug (NSAID), the active ingredient in Lixidol, ketorolac tromethamine, has three primary actions. Official regulatory documents confirm that the drug is used for its analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) effects. Its mechanism of action involves modulating the body's thermal set points, which contributes to its fever-reducing capability.


Q: Can I start my Lixidol treatment with the oral tablet?

According to the official product information, the oral tablet formulation is indicated for use only as continuation therapy following initial administration of the injectable form (IV or IM). The oral form is intended to complete the short-term course of treatment, and it is not authorized to be used as the starting dose.


Q: What is the reduced maximum daily dose for elderly patients or those with kidney problems?

Regulatory documents mandate a lower maximum daily dose for specific patient populations. This reduction applies to individuals aged 65 and older, patients who weigh less than 50 kg (110 lbs), and patients with moderately impaired kidney function. For these individuals, a reduced daily maximum dose is required across all formulations, and it is lower than the standard adult maximum dose.


Q: Can Lixidol affect my blood pressure or heart function?

The medication carries specific safety warnings indicating that it may affect blood pressure and heart function. This includes a documented risk of serious cardiovascular thrombotic events, such as heart attack and stroke. Additionally, label information indicates that Lixidol may worsen pre-existing high blood pressure.


Q: Will Lixidol interact with my diuretic medication (e.g., Furosemide)?

Official drug interaction information confirms that taking Lixidol with diuretics (like Furosemide) or certain blood pressure medicines (ACE inhibitors/ARBs) may reduce their effectiveness. This combination has also been associated with an increased risk of worsening kidney function, particularly in certain patient populations such as the elderly or those who are dehydrated.


Q: How long does it typically take for Lixidol (oral tablet) to start working?

Regulatory pharmacokinetics data indicates that the peak pain-relieving effect of ketorolac tromethamine generally occurs within 2 to 3 hours after the oral tablet is administered. The time it takes for a patient to feel the full effect of the pain relief may vary.


Q: What should I do if I miss a dose of Lixidol?

Official patient information often describes what to do in case of a missed dose. This typically involves taking the missed dose as soon as it is remembered, unless it is close to the time for the next scheduled dose. Guidance states that if this is the case, the patient should skip the missed dose. A standard warning is included against taking a double dose to make up for a missed one.


Q: How quickly is Lixidol cleared from my body after the last dose?

According to regulatory pharmacokinetics data, the time it takes for the concentration of the drug to be halved (the half-life) is generally 5 to 6 hours in healthy young adults. This half-life can be longer—up to 10 hours or more—in elderly patients or those with impaired kidney function, which means the drug stays in the body longer for those groups.


Q: Is it safe to take Lixidol if I am pregnant or trying to conceive?

Regulatory information advises caution regarding Lixidol during pregnancy. Its use is strictly contraindicated during the third trimester due to documented risks to the unborn baby. Furthermore, as a Non-Steroidal Anti-Inflammatory Drug (NSAID), it may impair fertility and is generally not recommended for women who are actively trying to conceive.

How should Lixidol be stored and disposed of?

How to Store and Dispose of Lixidol (Ketorolac Tromethamine)

Storage Requirements

Lixidol must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The product requires protection from light and moisture and must be kept in its original, tightly closed container.

Crucially, the medication must not be frozen or stored in environments with excess heat. All Lixidol products must be stored out of the sight and reach of children to prevent accidental ingestion.


Disposal Instructions

Unused or expired Lixidol must be handled as pharmaceutical waste. Do not dispose of the medicine by flushing it down a toilet or throwing it into common household trash. Disposal must be conducted in accordance with local, regional, and national regulations for pharmaceutical waste to avoid environmental release.

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

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