Lactor

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Lactor

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 Lactor

Lactor is a medicinal preparation whose active ingredient is Ketorolac tromethamine, classified as a highly potent Nonsteroidal Anti-Inflammatory Drug (NSAID). Its core function is to deliver strong analgesic and anti-inflammatory effects, a distinction confirmed by its use profile which is often compared to the efficacy level of opioid analgesics.

Quick Facts Description
Active Ingredient Ketorolac tromethamine
Form Tablet, injectable solution, ophthalmic solution
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General Purpose Relief of moderate to severe pain
Origin Synthetic

What is Lactor and What Class of Medicine Does It Belong To?

Lactor belongs to the NSAID class of medicines, specifically identified as a synthetic member of the pyrrolo-pyrrole group. This classification means the substance acts to manage inflammation and pain without the use of steroidal hormones. The high analgesic potency of Ketorolac tromethamine distinguishes it within the NSAID group. This makes Lactor a powerful prescription-only tool generally reserved for controlled, short-term use in acute settings, such as relief following a surgical procedure.

Composition, Origin, and Available Forms

The composition of Lactor is defined by the Ketorolac tromethamine substance, functioning as a single-ingredient product delivered alongside its specific pharmaceutical vehicles and excipients. As a synthetic compound, it is prepared for various routes of administration to match clinical requirements. The medicine is available across multiple common dosage forms, including the oral tablet, a sterile injectable solution, and specialized preparations like the ophthalmic solution. The availability of these distinct forms, including the rapid-acting injectable route, is a key differentiating factor designed for urgent pain control in supervised settings.

What is the General Purpose of Lactor?

The general purpose of Lactor is to deliver robust, non-narcotic pain relief by targeting the chemical pathways responsible for generating discomfort. It achieves this by acting as a non-selective cyclooxygenase (COX) inhibitor, effectively blocking the production of prostaglandins, which are the chemical messengers that transmit pain signals and promote inflammation. This foundational action is why Lactor is designated for the rapid, efficient control of significant pain and the associated physical effects of the inflammatory response.

Regulatory References

  1. Omidria (phenylephrine/ketorolac) EMA EPAR Summary

What side effects are possible with Lactor?

Possible Side Effects and Safety Information for Lactor

This section summarizes the officially documented adverse reactions and safety restrictions for Lactor, as classified by government regulatory authorities. Safety information is grouped by the frequency of occurrence and the body system affected.

Documented Adverse Reactions

Adverse reactions reported in regulatory documents are classified by the affected System-Organ Class (e.g., Nervous System Disorders, Gastrointestinal Disorders, Hepatobiliary Disorders) and are assigned a frequency category based on observations from clinical trials. These categories include Very Common (ge 1/10), Common (ge 1/100 to < 1/10), Uncommon, and Not Known (cannot be estimated from available data).

Serious Adverse Reactions and Safety Limitations

Regulatory safety profiles specifically document Serious Adverse Reactions (SARs). These are defined as adverse outcomes resulting in death, being life-threatening, requiring hospitalization, or other medically significant events. Unexpected Serious Adverse Reactions (SUSARs) are also prioritized for regulatory reporting.

Safety-Related Restrictions:

  • Population-Specific: Safety and efficacy have not been established for patients under 18 years old. Use is not recommended in patients with advanced heart failure, as experience in this group is limited.
  • Excipient Intolerance: The medicine carries a safety restriction requiring avoidance in individuals with a documented intolerance to the excipient (non-active ingredient) listed in the official documents.
  • Exposure: Data on safety and efficacy for long-term exposure beyond the duration of the pivotal trials are explicitly noted as limited.

Regulatory Safety Summary

The medicine's safety profile is formally structured to communicate risk by classifying reactions by frequency and body system. This official classification ensures that all reported adverse events, especially serious and unexpected reactions, are prioritized for continuous regulatory evaluation. Additionally, the profile includes formal statements that restrict the use of Lactor in specific populations and circumstances where its safety has not been fully established.

Overdose and Emergency Response

The official regulatory documents for Lactor (Ketorolac tromethamine) describe the acute overdose profile, focusing on clinical manifestations and the required immediate supportive measures.

Overdose Scope

Domain Official Regulatory Statements
Documented overdose presentations Overdose may be associated with Lethargy, Nausea, Vomiting, Epigastric pain, and Abdominal pain or Hyperventilation.
Physiological systems affected Gastrointestinal (Peptic ulcers, Erosive gastritis, Gastrointestinal bleeding), Renal (Acute renal failure, Renal dysfunction), CNS (Coma, Respiratory depression), and Cardiovascular (Hypertension).
Dose-related or exposure-related factors Procedures such as activated charcoal may be indicated following a large oral overdose (defined as 5 to 10 times the usual dose) or in patients seen within four hours of ingestion.
When immediate medical help is required Patients must seek immediate medical attention and contact a Poison Control Centre immediately for suspected overdose, even in the absence of observable symptoms.

Overdose Classifications (High-Level)

Classification Official Regulatory Statements
Severity classification Manifestations are typically reversible upon discontinuation, but severe outcomes like gastrointestinal bleeding, acute renal failure, and coma have been reported.
Regulatory basis Government-mandated labeling (e.g., FDA, Health Canada).
Overdose-context constraints No specific antidotes are known for this overdose, and procedures like hemodialysis are not generally useful due to high protein binding.

Resulting Overdose Structure

Official overdose statements:

  • No specific antidotes are known for Lactor overdose, making treatment purely symptomatic and supportive.
  • The official documents list the potential for severe, though rare, outcomes, including acute renal failure, hypertension, and coma.
  • Activated charcoal may be used in management for a large overdose if performed promptly.

Connection to the overall overdose profile (2–4 sentences): The regulatory documents define the overdose profile primarily through its potential clinical effects on the gastrointestinal and renal systems, which necessitates immediate medical evaluation. Given the lack of a specific antidote, the mandated emergency action centers on urgent contact with medical professionals for symptomatic management and supportive care, as dictated by authoritative labeling.

Therapeutic Uses of Lactor

What Lactor Treats: Main Uses and Benefits

Lactor is prescribed specifically for the short-term management of acute, pronounced symptomatic episodes. The medication's therapeutic profile involves the relief of moderately severe pain. Its therapeutic role is to deliver potent symptomatic relief by simultaneously addressing intense discomfort and the underlying physical signs of inflammation.

This medication is commonly used in clinical settings that involve acute or disruptive symptom patterns, such as managing postoperative pain following surgical procedures, providing support for the intense, cramping symptoms of renal colic, and addressing the discomfort of acute musculoskeletal injuries. “It is relevant in contexts involving heightened systemic burden where symptoms interfere with daily functioning.”

Lactor offers supportive relief that helps ease the overall burden of these distressing manifestations. The key patient-oriented benefit is its ability to offer potent, non-narcotic symptomatic relief and may be part of symptomatic management to help reduce the need for narcotic pain relief.

Supportive Symptom Management Description
Symptom Level Moderate-to-Severe Acute Discomfort
Symptom Types Sharp, throbbing, or inflammatory symptoms
Application Scenarios Short-term management in supervised settings

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Lactor's high-potency NSAID classification results in specific, mandatory eligibility rules established by regulatory authorities.

Populations Who Must Not Use Lactor (Contraindications)

The medicine is strictly contraindicated and must not be used in the following populations or clinical settings, as stated in official labeling:

  • Active or History of GI Issues: Patients with active peptic ulcer disease, recent gastrointestinal bleeding, or perforation.
  • Bleeding Risk: Individuals with confirmed cerebrovascular bleeding, hemorrhagic diathesis, or high risk of hemorrhage due to incomplete hemostasis.
  • Renal Impairment: Patients with advanced renal impairment or those at risk for kidney failure due to volume depletion.
  • Hypersensitivity: Patients who have experienced asthma, rhinitis, or urticaria after taking aspirin or other NSAIDs.
  • Pregnancy/Lactation: Use is contraindicated in breastfeeding women and during labor, delivery, or at 30 weeks gestation or later.
  • Surgery: Contraindicated for peri-operative pain in the setting of CABG surgery and as a prophylactic analgesic before any major surgery.

Age and Condition-Based Restrictions

Population Group Eligibility Status (Label-Based)
Pediatric Patients (< 17 years) Use is not established for systemic forms; generally not indicated for minor or chronic pain.
Older Adults (65+ years) Permitted, but require a reduced maximum daily dose due to increased risk of serious adverse events.
Low Body Weight (< 50 kg) Requires a reduced maximum daily dose.
Use Duration Total combined use (all forms) must not exceed 5 days.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Lactor is significantly influenced by its status as a substrate for the CYP3A4 enzyme and the P-glycoprotein (P-gp) transporter, as documented in official regulatory labeling. These interactions necessitate careful evaluation before concurrent use with certain medicinal products and substances.

Key Interacting Agents and Constraints

The following categories of products and specific agents are documented to interact with Lactor, leading to necessary clinical management:


  • Potent CYP3A4 Inhibitors: Co-administration with potent inhibitors (e.g., Ketoconazole) increases the systemic exposure of Lactor. This requires adjustment of Lactor's use to manage the potential increase in drug effects.
  • Potent CYP3A4 Inducers: Concomitant use with potent inducers (e.g., Rifampin) significantly reduces Lactor's plasma concentration and is a contraindicated combination due to the high risk of treatment failure.
  • Acid-Reducing Agents: Agents such as Proton Pump Inhibitors (e.g., Omeprazole) and Antacids impair the absorption of Lactor. Regulatory documents mandate timing-based separation of at least two hours between the administration of Lactor and these agents.
  • Food Interactions: Consumption of Grapefruit or Grapefruit juice must be avoided as it can inhibit intestinal CYP3A4, leading to increased Lactor concentrations.

These constraints define the use-with-caution and contraindicated combinations for Lactor, ensuring that the necessary exposure levels are maintained and adverse interactions are mitigated.

Mechanism of Action

The mechanism of action for Lactor (Ketorolac tromethamine) is rooted in the targeted suppression of eicosanoid mediators responsible for nociceptive and inflammatory signaling.

Inhibition of Eicosanoid Synthesis at the Source

The drug's primary action is the non-selective competitive inhibition of the Cyclooxygenase (COX) enzymes (both COX-1 and COX-2). By blocking these enzymes, Lactor interferes with the Arachidonic Acid Cascade, effectively halting the production of prostaglandins and other eicosanoids . This molecular step limits the availability of these potent signaling molecules.

Dual Action on Nociceptive Signaling: Peripheral and Central

Lactor's mechanism provides simultaneous action at two key points. Peripherally, the reduction in prostaglandins lowers the sensitivity of local nociceptors (pain nerve endings), decreasing the transmission of nociceptive impulses. Centrally, the drug inhibits COX enzymes in the spinal cord and brain, which reduces the hyperexcitability associated with central sensitization. This combined action affects signaling dynamics across the entire length of the nociceptive pathway.

Mechanism Limitations and Physiological Homeostasis

The mechanism’s reliance on non-selective COX inhibition means it necessarily suppresses the synthesis of prostaglandins that perform homeostatic roles, such as those crucial for maintaining renal blood flow under conditions of stress. This physiological constraint is inherent to the mechanistic domain and relates to the mechanism's influence on compensatory renal pathways.

Dosage and Administration Information

How to Use Lactor

Lactor (ketorolac tromethamine) is intended for short-term use only, with the systemic treatment duration strictly limited to five days across all formulations combined. The medication is officially administered via multiple routes, including Intravenous (IV) injection, Intramuscular (IM) injection, Oral tablet, and Intranasal spray.

Administration and Dosage Regimens

The usage protocol is structured around an initial parenteral (IV or IM) dose, followed by a transition to oral or intranasal continuation therapy. The oral 10 mg tablet is not approved for use as an initial dose but is used for maintenance, typically at a frequency of every 4 to 6 hours as needed.

For standard adult patients (under 65 years and over 50 kg), the multiple-dose regimen for the IV or IM route is 30 mg every 6 hours, with a total maximum daily dose of 120 mg/day. The IV bolus injection must be administered slowly, taking at least 15 seconds to ensure proper delivery.

Population-Specific Dosing Rules

Official labeling mandates a dose reduction for certain populations to control overall exposure. A total maximum daily dose of 60 mg/day for all routes is required for patients who are 65 years of age or older, weigh less than 50 kg, or have a diagnosed renal impairment. This reduced ceiling dose is the overriding restriction for these groups, regardless of the route of administration chosen for the continuation phase.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lactor (Ketorolac Tromethamine)


Evidence for Short-Term Management of Postoperative Pain

Research exploring Lactor was studied in the context of pain management and involves short-term Randomized Controlled Trials (RCTs) and subsequent systematic reviews. These studies were applied in research exploring how symptoms change over time immediately after various surgical procedures. Measured outcomes included scores on pain intensity scales and monitoring the amount of rescue pain medication administered to the patient. Findings describe patterns observed in the studies related to pain measurements, with some trials reporting lower measurements of opioid consumption compared to placebo groups. The evidence reviewed by regulatory bodies for this specific, acute use is generally considered to reflect a High level of evidence.

Research on Acute Pain from Renal Colic

Lactor was also studied for conditions characterized by fluctuating or episodic manifestations, specifically the intense, acute pain associated with renal colic. Research examined the use of the drug in studies focusing on episodes where symptoms become more noticeable, primarily in adults presenting to emergency settings. Findings indicate patterns related to early measurements of changes in pain intensity within the first hour of administration. Some trials reported lower measurements of subsequent narcotic pain medication administered when compared against patients initially receiving alternative treatments. The evidence for this indication is generally assessed as having Moderate quality, meaning that while evidence exists, the degree of consistency may vary.

Studies Supporting Ophthalmic (Eye) Use

Lactor was evaluated in studies examining symptom intensity or variability specifically within the eye, using the topical ophthalmic solution. The research base includes randomized, vehicle-controlled clinical trials for procedures like cataract surgery. Research describes patterns related to lower ocular pain measurements and descriptions of reduced physical signs of inflammation when compared to control groups receiving the inactive solution. This evidence, which is specific to the eye, contributes to the broader evidence landscape for the topical use of the medication.

Evidence Gaps and Research Uncertainty

The primary evidence gap identified by regulatory reviews is the lack of long-term data for the systemic formulations, which is directly addressed by the maximum five-day use limit. Follow-up durations were limited in the pivotal systemic trials. Subgroup findings are uncertain, as data for certain groups (e.g., those with multiple severe comorbidities) remain insufficient in the primary clinical trial base. The studies help show what has been observed so far, but the research does not determine whether an individual will respond similarly.

Key Studies & References

  1. Ketorolac Tromethamine - Label: KETOROLAC- ketorolac tromethamine tablet, film coated (Adult Short-Term Use and 5-Day Limit)
  2. Critical appraisal of ophthalmic ketorolac in treatment of pain and inflammation following cataract surgery (Ophthalmic Use Summary)

Frequently Asked Questions (FAQ)

Common questions about Lactor (FAQ)


Q: Does Lactor contain gluten or lactose?

A: According to the official product information, certain formulations of Lactor (ketorolac tromethamine) tablets do contain lactose as an inactive ingredient, or excipient. The official drug label does not specify whether gluten is present in the formulations. Patients with known sensitivities to lactose or other non-active ingredients should be aware of this information.


Q: Is it safe to drive after taking Lactor?

A: Official information indicates that this medication may cause certain side effects, such as dizziness or drowsiness. Patients who experience these effects are generally advised to avoid driving or operating heavy machinery until they know how the medication affects them, to maintain safety.


Q: Can I take Lactor with a meal or on an empty stomach?

A: Regulatory guidance describes that taking Lactor tablets with food or an antacid can help lessen the potential for stomach upset, also known as dyspepsia. It is noted in official documents that consuming the tablets after a high-fat meal can delay the speed at which the medication reaches its peak concentration in the body.


Q: Can I drink alcohol while I’m taking Lactor?

A: Official drug labeling states that the combined use of Lactor (ketorolac tromethamine) and alcohol may increase the risk of serious gastrointestinal side effects, such as gastrointestinal bleeding. Regulatory documents state that patients who consume three or more alcoholic drinks per day are a population that requires specific caution regarding this risk.


Q: What are the most common side effects from Lactor?

A: Clinical trial data summarized in regulatory documents indicate that the most frequently reported side effects include nausea and dyspepsia (indigestion), reported in more than 10% of patients. Other common reactions reported in 1% to 10% of patients include abdominal pain, dizziness, drowsiness, headache, and diarrhea or constipation.


Q: Is it normal to experience stomach upset or nausea when taking this medication?

A: Official safety summaries indicate that nausea and dyspepsia (a term for indigestion or stomach upset) are among the most frequently reported gastrointestinal side effects associated with Lactor. These effects were observed with an incidence greater than 10% in clinical trials.


Q: Will Lactor cause weight gain or weight loss?

A: Studies and official information indicate that weight change has been reported as an adverse reaction under the Metabolic and Nutritional System category. This reaction was classified as an uncommon effect, occurring in less than 1% of patients in clinical trials.


Q: How long after my surgery can I take Lactor?

A: Official regulatory documents emphasize that Lactor (ketorolac tromethamine) is designated for short-term pain management only. The total combined duration of use for all systemic forms—including tablets and injections—must not exceed 5 days for the management of moderately severe acute pain.


Q: Can I take Lactor with over-the-counter supplements like fish oil or curcumin?

A: The official product label does not specifically list interactions with common dietary supplements. However, it does contain a general caution against using Lactor alongside other therapies that are known to affect hemostasis (the blood clotting process). The concurrent use of agents that influence clotting may increase the risk of bleeding.

How should Lactor be stored and disposed of?

How to Store and Dispose of Lactor?

Lactor (Ketorolac tromethamine) requires specific storage and disposal procedures defined by regulatory documents to ensure product stability and safety.

Storage Requirements

The medication must be stored at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F). The product must be protected from light and excess moisture and should not be refrigerated or frozen. Keep the container tightly closed and store the medicine out of the reach of children using locked safety caps.

Stability and Disposal

Stability rules vary by form; for instance, the injectable solution must be used immediately after opening. For disposal of unused or expired medicine, regulatory guidance recommends using an authorized drug take-back program. If this is unavailable, the product must be mixed with an undesirable substance, sealed in a bag, and thrown into household trash, with the rule to never dispose of the product in wastewater.

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

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