Mavidol

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Mavidol

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Method of action: Anti-Inflammatory

Treatment option: Pain, Postoperative Pain

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 Mavidol

Quick Facts

Property Description
Active Ingredient Ketorolac Trometamol (Ketorolac)
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Forms Tablets (Oral, Sublingual), Injection Solution, Nasal Spray, Ophthalmic Solution
Common Use Acute, moderately severe pain management
Origin Synthetic

What Type of Medicine is Mavidol?

Mavidol is a pharmaceutical preparation classified as a powerful, non-narcotic analgesic intended for the management of moderate to severe acute pain. It belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) pharmacological class. The active ingredient, Ketorolac, is recognized for its pain-relieving efficacy, which allows it to function as an opioid-sparing agent, providing relief in acute pain settings.

Composition: Ketorolac Trometamol and Mechanism

The core substance in Mavidol is Ketorolac Trometamol, a synthetic chemical entity and a single-ingredient product. The underlying mechanism involves the competitive inhibition of the cyclooxygenase (COX) enzyme system. This action prevents the biochemical creation of prostaglandins, which are chemical messengers responsible for initiating and mediating pain and inflammation. By blocking prostaglandin synthesis, the drug achieves its dual analgesic and anti-inflammatory effect.

Available Preparations and Primary Purpose

A significant characteristic of Mavidol is the variety of its pharmaceutical preparations, which include oral tablets, solutions for injection (parenteral), nasal sprays, and ophthalmic solutions. This allows the medicine to be administered through oral, parenteral, nasal, or topical routes. This flexibility ensures that the medication can be administered in the form required for the management of acute-onset pain, intended to meet the therapeutic goal of prompt, targeted relief.

What side effects are possible with Mavidol?

Possible Side Effects and Safety Information

Mavidol (Ketorolac Trometamol) is an NSAID whose official safety profile is strongly defined by major adverse events concerning the gastrointestinal and cardiovascular systems. Regulatory documents explicitly state that the risk of serious complications increases with both higher doses and longer duration of treatment.


Documented Serious Adverse Reactions

Official labeling classifies several potential serious adverse outcomes, which can occur without warning and may be fatal:

  • Gastrointestinal (GI) Effects: Risk of peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines.
  • Cardiovascular (CV) Events: Increased risk of serious cardiovascular thrombotic events, including myocardial infarction (MI) and stroke.
  • Renal and Hepatic Effects: Potential for acute renal failure and rare cases of severe hepatic failure or jaundice.
  • Hypersensitivity: Severe reactions, including anaphylaxis and angioedema, are documented.

Frequency Classification of Common Effects

Adverse reactions are formally grouped by incidence, according to regulatory data:

Incidence Common Adverse Reactions
Greater than 10% Headaches, Nausea, Dyspepsia, Abdominal pain
1% to 10% Dizziness, Drowsiness, Edema (swelling), Hypertension, Rashes

Population-Specific Safety Constraints

Specific patient groups are noted in official documents as being at higher risk or subject to strict limitations:

  • Older Adults (≥65 years): Increased risk for serious adverse events, particularly GI bleeding.
  • Advanced Renal Impairment: The medicine is contraindicated in this condition.
  • Pregnancy and Lactation: Contraindicated during the third trimester, labor, delivery, and for use by nursing mothers.

This regulatory structure emphasizes that the medicine is limited to short-term use and has strict contraindications based on defined patient risks.

Overdose and Emergency Response

The official overdose profile for Mavidol (Ketorolac Trometamol) outlines clinical manifestations that are usually reversible with supportive management. Documented presentations are often limited to gastrointestinal effects such as nausea, vomiting, and epigastric pain, alongside neurological signs like drowsiness and lethargy. Single overdoses have also been associated with hyperventilation and mild renal dysfunction.

Crucially, regulatory information emphasizes the potential for severe or life-threatening outcomes that may occur, including Acute Renal Failure, Gastrointestinal Bleeding, and Hypertension. Rare but serious events like Respiratory Depression and Coma are also cited in government documentation. The risk for serious adverse events is generally noted to be increased in the Elderly population.

In the case of suspected overdose, immediate medical attention must be sought. Official regulatory documents explicitly state that no specific antidote is known for Mavidol, and management relies on providing symptomatic and supportive care. Medical professionals may consider gastric decontamination using Activated Charcoal for a large oral overdose when presented for treatment within approximately four hours of ingestion.

Therapeutic Uses of Mavidol

What Mavidol Treats: Main Uses and Benefits

Mavidol is a medication generally used in situations involving certain distressing symptoms of moderately severe acute pain. It is primarily applied across domains where short-term symptomatic assistance is needed to help manage symptoms related to physical discomfort that are intense or disruptive.

Primary Therapeutic Scope

The medication is generally relevant for symptoms in the moderate to severe range and is used in conditions presenting with acute or disruptive episodes. Commonly used indications include managing pain following surgical procedures, addressing pronounced acute dental issues, and providing relief for musculoskeletal injuries. This application assists with maintaining functional stability and contributes to improved comfort during periods of heightened symptoms.

The overall benefit is focused on symptomatic support:

“Mavidol provides effective supportive relief, which helps ease the overall symptom burden during difficult episodes of acute pain.”

In clinical settings, Mavidol is relevant where strong symptomatic support is needed, often supporting symptomatic management that favors non-opioid options.


Quick Fact: Relief for Acute Pain
Symptom Severity Symptoms in the moderate to severe range
Typical Contexts Post-surgical discomfort, acute injuries, dental pain
Main Benefit Offers symptomatic relief that helps patients cope more steadily

Regulatory References

  1. NIH DailyMed drug information

Eligibility and Restrictions for Use

Mavidol is officially approved for adult patients (typically 17 years and older) for the short-term management of moderately severe acute pain. Use is restricted by numerous contraindications documented in government regulatory labels (FDA, EMA, etc.).


Eligibility and Exclusionary Rules

Classification Rule Summary (Official Labeling)
Contraindicated Patients with active GI ulceration or bleeding, advanced renal impairment, severe hepatic failure, or any condition causing high risk of bleeding (e.g., suspected cerebrovascular hemorrhage). Also contraindicated for peri-operative pain management in CABG surgery and during concomitant use with other NSAIDs or Probenecid.
Age Restriction Not recommended for children under 16 years of age as safety and efficacy have not been established. Older adults (ge 65 years) are a Special Population requiring restricted use and a reduced maximum daily dose.
Physiological Status Contraindicated in the third trimester of pregnancy and during labor and delivery. Use is also contraindicated in nursing mothers.

Official regulatory documents classify these groups as ineligible or requiring restricted use to establish clear patient safety boundaries for this potent medication.

What should I know about interactions with other medicines?

Mavidol (Ketorolac Trometamol) has formally documented interaction patterns that are strictly detailed in government regulatory labeling. Co-administration is contraindicated with Probenecid, Pentoxifylline, and all other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), including Aspirin, due to the severely increased risk of gastrointestinal bleeding, ulcers, and drug accumulation resulting from pharmacodynamic and pharmacokinetic synergy. Concomitant use with other formulations of Ketorolac is also prohibited.

The official interaction profile includes significant exposure-modifying effects on co-administered substances. Mavidol decreases the renal clearance of drugs like Lithium and Methotrexate, resulting in increased plasma concentrations of these medicines and a risk of toxicity. The interaction with Probenecid is classified as transporter-mediated inhibition, directly elevating Mavidol's plasma exposure.

A primary pharmacodynamic risk involves combining Mavidol with agents that increase bleeding risk, such as Anticoagulants (e.g., Warfarin) and Antiplatelet agents, which leads to an additive risk of hemorrhage. Co-administration with ACE Inhibitors, ARBs, or Diuretics may formally antagonize their therapeutic effect, potentially diminishing their efficacy while increasing the risk of renal impairment. Regulatory restrictions mandate that Mavidol must not be taken for 8 to 12 days after taking mifepristone. Dose consideration is required for elderly patients and those with moderately impaired renal function to account for slower drug clearance and potential accumulation.

Mechanism of Action

Non-Selective Inhibition of the COX Enzyme System

The mechanism of Mavidol (Ketorolac) is defined by a rapid and effective non-selective chemical interference with the body’s main enzyme system responsible for generating inflammation and nociceptive signals. This involves the drug’s primary molecular targets: the Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) enzymes. Mavidol acts by competitively inhibiting the active sites of both isoforms, directly halting the critical step of converting Arachidonic Acid into prostaglandins. This interference initiates the main analgesic and anti-inflammatory physiological consequences by preventing the very creation of these key local mediators.

Dual Modulation of Nociceptive Signaling

This action exhibits both central and peripheral components. By inhibiting COX enzymes both at the peripheral site of injury and centrally within the spinal cord, the mechanism reduces the sensitization of peripheral pain fibers and attenuates the amplification of nociceptive signals within the central nervous system. This dual action supports a substantial modulation of nociceptive signal processing.

Constraint by Homeostatic Pathway Interference

The necessary inhibition of COX-1 compromises the enzyme's role in producing protective prostaglandins, which are essential for maintaining the integrity of the gastric lining and regulating renal blood flow. The mechanism functionally impairs these protective physiological processes.

Dosage and Administration Information

Mavidol (Ketorolac Trometamol) is administered through several routes, including intravenous (IV), intramuscular (IM), oral (tablet), and intranasal (spray). The medicine is structured for use in a sequential pattern; the 10 mg oral tablet is designated strictly for continuation therapy following initial parenteral (IV or IM) use, and is not indicated as a standalone starter dose.

The standard multiple-dose parenteral regimen for adults typically involves 30 mg administered every six hours, with a total daily maximum of 120 mg. When transitioning to oral therapy, the starting dose is 20 mg, followed by 10 mg every four to six hours, not to exceed 40 mg per day. Administration involves specific technical requirements, such as giving the IV bolus over a period of no less than 15 seconds.

A fundamental constraint governs all systemic use: the total combined duration of IV, IM, and oral administration must not exceed five days. Dosage adjustments are required for certain populations, including patients 65 years of age or older, those weighing less than 50 kg, or individuals with moderately impaired kidney function, for whom dosing is reduced to not exceed 60 mg per day.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Clinical Research

Studies have evaluated the use of this compound in the target population. Research has explored whether the compound was associated with changes in quality of life among participants with the condition. The overall body of evidence is extensive.


Key Research Findings

Research examined the compound's impact in preclinical and early-phase studies.

Efficacy and Symptom Changes

Several trials examined whether the treatment was associated with a reduction in pain and assessed changes in symptom onset time among study participants. Research has also explored whether the compound was associated with changes in the frequency of flare-ups, which was a secondary endpoint in many of the phase III trials.

Studies compared the combination of X and Y to monotherapy to determine if differences in outcomes could be observed across the two regimens.

Safety and Tolerability Profiles

Clinical trials monitored the occurrence of adverse events across all studied doses. Adverse events were reported across all studied doses. Study results documented the frequency of serious adverse events.

Research has examined whether the compound was associated with sustained changes in symptoms over the 12-month follow-up period in randomized controlled trials. Studies also included elderly patients in their cohorts to monitor for age-specific safety signals and tolerability differences.

Administration and Dosage

In clinical trials, the drug was administered with a meal. Various dosages were explored across Phase II and Phase III studies to identify the range of exposures used in the research.

Frequently Asked Questions (FAQ)

Common questions about Mavidol (FAQ)


Q: How long does it typically take for Mavidol to start working?

Official information indicates that pain relief has been observed as early as 30 minutes after administration. The drug's peak pain-relieving effect usually occurs within two to three hours after the dose is administered.


Q: Can Mavidol be taken for conditions other than the ones listed in the official uses?

According to the official product information, Mavidol is only indicated for the short-term (typically up to five days) management of moderately severe acute pain. It is not approved for use in minor aches or long-term (chronic) painful conditions.


Q: How is Mavidol different from over-the-counter pain relievers?

Mavidol is a powerful prescription NSAID intended for short-term use in managing acute pain that may require analgesia comparable to an opioid. Because it carries an increased risk of serious adverse events, such as gastrointestinal bleeding, its use is strictly restricted and requires a prescription.


Q: Are there any specific foods or supplements that are known to interact with Mavidol?

Official documents note that taking the oral tablet with a high-fat meal may impact how the drug works by delaying the time it takes to reach its peak concentration in the body by approximately one hour. Simple antacids do not appear to affect absorption.


Q: How long do the therapeutic effects of Mavidol usually last?

Regulatory documents do not specify a fixed duration for how long the pain-relieving effects last. Clinical research has indicated that the largest difference between various doses relates primarily to the duration of the pain relief achieved.


Q: Is there a risk of physical dependence associated with Mavidol?

Mavidol is classified as a non-narcotic analgesic. Official sources state that the drug is not a controlled substance and is not classified as having the dependence or abuse potential associated with opioid medications.


Q: Why is Mavidol only available by prescription and not over the counter?

Mavidol is available by prescription because its use is associated with an increased risk of serious adverse events, including gastrointestinal bleeding and severe cardiovascular thrombotic events. Due to these potential serious outcomes, regulatory bodies mandate that its use be restricted to a maximum of five days and necessitates use under close clinical monitoring.


Q: Does Mavidol commonly cause constipation or other gastrointestinal changes?

Constipation is not typically listed among the most common adverse reactions in official documents. However, diarrhea is a reported gastrointestinal side effect, particularly with the oral formulation. Other common digestive effects include nausea, dyspepsia, and abdominal pain.


Q: What general clarification is provided if a scheduled dose of Mavidol is missed?

General patient information outlines that if a dose is missed, the subsequent dose should be administered at its normal scheduled time. It is generally advised that extra or double doses are not taken to compensate for a missed one.


Q: Is Mavidol a brand name or is the active component also available as a generic medication?

Mavidol is considered a brand name for the active chemical component, which is Ketorolac Trometamol. The active ingredient, Ketorolac Trometamol, is also available under its generic name.


Q: Can Mavidol be taken on an empty stomach?

While the oral form is fully absorbed whether taken with food or not, clinical documents indicate that a high-fat meal can delay the time it takes to reach peak effect. Regulatory documents emphasize the importance of following the prescribing clinician's specific directions for use.


Q: Does Mavidol affect the results of common lab tests or blood work?

Official documents state that Mavidol may affect the results of certain laboratory tests. Because of the drug's mechanism of action and potential effects, regulatory information states that monitoring may include checking kidney function (such as BUN and creatinine levels), liver enzymes, and bleeding time.


Q: How is Mavidol structurally or functionally similar to other drugs in its class?

Mavidol is functionally similar to many traditional NSAIDs because it operates as a first-generation drug in this class. Its mechanism involves the non-selective inhibition of both the COX-1 and COX-2 enzymes, which prevents the creation of pain and inflammation mediators in the body.


Q: What is the approximate half-life of Mavidol in the human body?

In healthy adults, the average half-life (the time it takes for the drug concentration in the body to reduce by half) is reported to be between five to six hours. This duration may be longer in elderly individuals or in patients with impaired kidney function.


Q: Does Mavidol interact with hormonal birth control pills?

Observational research suggests that NSAIDs in this class may slightly increase the risk of venous thromboembolism (VTE), which involves blood clots, when used alongside combined hormonal contraceptives (estrogen-containing pills).


Q: Are there specific safety warnings for people who drive or operate machinery while initiating Mavidol?

Official patient counseling information notes the need for caution when performing tasks that require mental alertness, such as driving a vehicle or operating machinery. This warning is based on the fact that dizziness and drowsiness are listed as common side effects of Mavidol.

How should Mavidol be stored and disposed of?

How to Store and Dispose of Mavidol

Official Storage Conditions

Mavidol (ketorolac tromethamine) must be stored at controlled room temperature, maintaining a required range of 20 C to 25 C (68 F to 77 F), with excursions permitted up to 30 C (86 F). The product must be protected from both moisture and light and should remain in its original, tightly closed container. It is strictly required that the medication be stored out of the reach of children.

Disposal Instructions

Unused or expired Mavidol must be disposed of according to local regulatory requirements to ensure pharmaceutical waste is handled correctly. Disposal via wastewater (e.g., flushing down the toilet) is generally not recommended unless explicitly advised by a regulatory body. The preferred method is often a local drug take-back program or mixing with an undesirable substance for household trash disposal.

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

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