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Mavidol TR

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Mavidol TR

Mavidol TR_EN

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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.

Overview of Mavidol TR

Property Description
Active Ingredients Ketorolac and Tramadol
Form Oral Tablets and Injectable Solution
Pharmacological Class Combination Analgesic (NSAID + Centrally-Acting Opioid)
General Purpose Short-term Management of Moderately Severe Acute Pain
Origin Synthetic

Mavidol TR is a prescription-only medication structurally defined as a Fixed-Dose Combination (FDC) analgesic, designed to provide robust relief for moderately severe acute pain. This dual-component nature distinguishes it from single-agent pain relievers, offering a strategic approach that addresses pain through two simultaneous physiological pathways.

What Type of Medication is Mavidol TR?

Mavidol TR is classified as a potent Combination Analgesic, a synthetic medicine whose formula pairs two pharmacologically distinct substances: Ketorolac and Tramadol. This pairing places it in two different drug groups: the potent Nonsteroidal Anti-inflammatory Drugs (NSAID) and the Centrally-Acting Opioid Analgesics. Tramadol, one of the components, acts as both an opioid receptor agonist and a monoaminergic reuptake inhibitor. This multimodal strategy is designed to achieve comprehensive pain control.

The Active Composition: Ketorolac and Tramadol

The core of Mavidol TR consists of Ketorolac Tromethamine and Tramadol Hydrochloride. Ketorolac is a high-potency NSAID that acts peripherally by inhibiting the synthesis of prostaglandins, chemical messengers that trigger pain and inflammation. In contrast, Tramadol modulates how pain signals are processed in the central nervous system. Ketorolac is a substance with potent analgesic effects. The medication is typically supplied as Oral Tablets for continued therapy and an Injectable Solution for initial, rapid pain control.

General Purpose: Why the Dual Action Matters

The essential purpose of the dual action is to ensure comprehensive, robust support for significant acute pain. This FDC is typically applied in clinical scenarios, such as following surgery or trauma, where the pain level is severe. The combination is designed to deliver superior analgesic efficacy by targeting the two main pathways of pain (inflammation and central perception), making it suitable when a powerful and integrated pain management strategy is required.

What side effects are possible with Mavidol TR?

Possible side effects and safety information

The safety profile of Mavidol TR, a combination of a potent NSAID (Ketorolac) and a Centrally-Acting Opioid (Tramadol), is defined by the adverse reactions and constraints documented in official regulatory sources (FDA, EMA). These regulatory documents classify potential effects by frequency and the organ system affected.

Frequency and Systemic Classification

Side effects documented as Very Common include nausea, dizziness, and somnolence (drowsiness), typically linked to the opioid component. Effects classified as Common include headache, edema, vomiting, constipation, and dyspepsia. Adverse reactions are formally grouped into categories such as Gastrointestinal Disorders, Nervous System Disorders, Cardiac Disorders, and Renal and Urinary Disorders, providing a structured regulatory map of potential safety concerns.

Serious Adverse Reactions and Constraints

Official labeling highlights the potential for serious adverse reactions. These include major gastrointestinal bleeding, ulceration, and perforation; serious cardiovascular thrombotic events (such as myocardial infarction or stroke); and life-threatening respiratory depression and seizures due to the opioid component. The risk of serious gastrointestinal events officially increases with the duration of use of the NSAID component.

Safety constraints include explicit warnings for specific patient groups. Older adults face an increased risk of serious GI and renal adverse events. The medicine is formally contraindicated in patients with advanced renal impairment and for peri-operative pain management in the setting of CABG surgery.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The official regulatory information for Mavidol TR (Ketorolac and Tramadol) overdose addresses the combined toxicities of its two components. Due to the presence of the opioid component (Tramadol), the greatest risk cited in official documents is life-threatening respiratory depression.

Documented Manifestations and Severe Outcomes

Symptoms documented in regulatory labeling for overdose include:

  • Tramadol Overdose: Signs of severe central nervous system (CNS) depression such as extreme drowsiness, loss of consciousness (coma), miosis (pinpoint pupils), and seizures. Circulatory effects like hypotension may occur.
  • Ketorolac Overdose: Symptoms are often limited to lethargy, nausea, vomiting, and epigastric pain, but severe complications like gastrointestinal bleeding or acute renal dysfunction are documented risks.

Required Emergency Actions

Immediate medical attention must be sought if any signs of a severe overdose occur, including slow or shallow breathing, confusion, or inability to wake up. Regulatory guidance mandates the immediate re-establishment of a patent and protected airway.

Naloxone, an opioid antagonist, is cited as the specific antidote for the Tramadol-related respiratory depression. Patients receiving naloxone require continuous monitoring as the effect of the antidote may wear off before the effects of Tramadol subside. Supportive care, including the use of activated charcoal for the NSAID component, may also be required. Accidental ingestion, particularly by children, is cited as a risk for fatal overdose.

Therapeutic Uses of Mavidol TR

What Mavidol TR Treats: Main Uses and Benefits

The medication's therapeutic scope is focused on the short-term management of moderately severe acute pain. This framework is applied across domains where additional symptomatic support is needed due to the intensity of the discomfort. It is commonly used across conditions presenting with acute episodes involving significant pain manifestations, such as post-operative discomfort, pain following traumatic injury, and severe dental pain. The medication provides supportive symptomatic relief by targeting pain related to physical discomfort and symptoms associated with inflammatory states.

The dual-component approach is considered relevant when short-term symptomatic assistance is needed for pain. It is applied in clinical settings that involve acute or unstable symptom patterns, offering supportive relief, which is relevant in contexts involving heightened systemic burden.

Quick Fact: Relief for Acute Pain
Primary Target: Moderately severe, acute pain episodes
Common Contexts: Post-surgical recovery, trauma, painful procedures
Benefit: Contributes to easing the overall symptom load during difficult episodes

Eligibility and Restrictions for Use

The eligibility for Mavidol TR, a dual-component analgesic (NSAID and opioid), is strictly governed by the contraindications and restrictions of both active ingredients as defined by regulatory bodies.

Contraindicated Populations (Must Not Use)

The medicine is contraindicated for patients with:

  • Active peptic ulcer disease, recent gastrointestinal bleeding, or a history of these conditions (due to the NSAID component).
  • Advanced renal impairment or severe hepatic impairment.
  • Hypersensitivity to Ketorolac, Tramadol, or other NSAIDs (e.g., aspirin-induced asthma).
  • Hemorrhagic diathesis or suspected cerebrovascular bleeding (high risk of bleeding).
  • Significant respiratory depression or acute, severe bronchial asthma.
  • Concurrent use of Monoamine Oxidase Inhibitors (MAOIs).

Age and Pregnancy Restrictions

  • Pediatrics: Mavidol TR is contraindicated in children younger than 12 years of age. It is also contraindicated for use in adolescents younger than 18 years following tonsillectomy/adenoidectomy.
  • Pregnancy/Lactation: Use is contraindicated during labor and delivery and not recommended for women who are breastfeeding or after 20 weeks of pregnancy.

What should I know about interactions with other medicines?

Mavidol TR (tramadol extended-release) has a complex interaction profile stemming from its dual activity as an opioid agonist and an inhibitor of norepinephrine and serotonin reuptake in the central nervous system.

Key Interaction Categories

Interacting Product Category Potential Consequence Mechanism/Notes
CNS Depressants (e.g., alcohol, benzodiazepines, other opioids) Profound sedation, severe respiratory depression, coma, or death. Additive CNS depressant effects. Avoid consumption of alcohol-containing beverages.
Serotonergic Drugs (e.g., SSRI/SNRI antidepressants, MAOIs, triptans) Increased risk of Serotonin Syndrome, a potentially life-threatening condition. Additive serotonergic activity. Monoamine Oxidase Inhibitors (MAOIs) are typically contraindicated.
Drugs that Lower the Seizure Threshold (e.g., some antidepressants, neuroleptics) Increased risk of seizures. Tramadol itself can lower the seizure threshold; this effect is cumulative with other similar agents.
CYP450 Inhibitors/Inducers (CYP2D6, CYP3A4) Altered plasma concentrations of tramadol and its active metabolite (M1). CYP3A4 inducers like Carbamazepine may reduce the analgesic effect. CYP2D6 inhibitors (e.g., Quinidine) may increase tramadol concentration.
Mixed Agonist/Antagonist Opioid Analgesics Reduced analgesic effect or precipitation of withdrawal symptoms. Avoid co-administration.
Anticoagulants (e.g., Warfarin) Rare reports of altered anticoagulant effect, including elevated prothrombin time. Requires careful monitoring of coagulation parameters.

Co-administration with other tramadol-containing products is specifically restricted due to the increased risk of overdose and severe adverse events.

Mechanism of Action

Dual Mechanism: mu-Opioid Receptor Engagement

Mavidol TR operates through a dual mechanism affecting neural signaling in the central nervous system. The primary action involves its active metabolite, which acts as an agonist by binding to mu-opioid receptors (mu-OR) located across the brain and spinal cord. This interaction inhibits the release of excitatory neurotransmitters from nerve terminals. This receptor engagement directly alters the processing and interpretation of incoming afferent signals within the central nervous system.

Neurotransmitter Reuptake Inhibition

The complementary mechanism involves the parent drug's function as an inhibitor of the serotonin (SERT) and norepinephrine (NET) transporters. By blocking the reabsorption of these monoamines into the nerve terminals, the drug increases their concentration in the synaptic cleft. This augmentation strengthens the activity of the body's descending inhibitory pathways, contributing to the overall modulation of neural activity and limiting neuronal excitability in the spinal cord.

Resulting Physiological Modulation

This convergence of mu-OR agonism and monoamine reuptake inhibition initiates a dual modulation of neural activity. The resulting action is a combined reduced excitability of defined neural circuits that constitutes the drug's core pharmacodynamic effect.

Dosage and Administration Information

Mavidol TR is administered through a controlled sequence involving both parenteral (Intravenous or Intramuscular) and oral routes. Usage protocols require that therapy must be initiated with the Injectable Solution, as the Oral Tablets are designated solely for continuation and transition, and are not to be used as a starting dose.

The medication is prescribed at the lowest effective dose for a duration that must not exceed five days total for the combined parenteral and oral treatments. Standard adult dosing for non-special populations typically follows a multiple-dose schedule, with the injectable form dosed, for example, every six hours (maximum 120 mg of the Ketorolac component daily) and the oral tablets dosed every four to six hours (maximum 40 mg daily).

Dose reductions apply to certain patient groups. A reduced total daily dose is required for older adults (ge 65 years old), patients with low body weight (<50 kg), and those with reduced kidney function (renal impairment). For these populations, the maximum daily parenteral dose is halved to 60 mg of the Ketorolac component.

Administration also includes specific procedural rules: intravenous bolus doses must be administered slowly over a minimum of 15 seconds, and oral tablets may be taken with food or an antacid. These strict time and procedural constraints define the standardized approach to using Mavidol TR.

Recent Clinical Evidence

Mavidol TR: Recent Clinical Evidence

Core Efficacy and Study Design

Research evaluated the effects of the compound on overall lung function and explored whether the compound was associated with a reduction in the frequency of severe exacerbations. The primary evidence originated from a Phase 3 randomized controlled trial (RCT) involving 550 participants over 12 months, which compared the compound against a placebo.

Studies focused on the compound's effect on specific signaling pathways that mediate inflammation.

  • Lung Function: The RCT assessed changes in forced expiratory volume in one second (FEV1). The study reported a median change in this metric among participants.
  • Exacerbation Rate: The primary outcome measure explored the annual rate of severe exacerbations.

Investigated Secondary Effects and Safety Profile

Research assessed whether the compound was associated with a prolonged change in inflammatory markers and explored its effect on the rapid onset of relief for acute symptoms. This was assessed via patient-reported symptom scales in a smaller, open-label study (n=85).

Research investigated whether the combination with a standard inhaled corticosteroid was associated with changes in patient outcomes. The safety profile in adult patients was evaluated in clinical trials.

The research reported the incidence of adverse events, including headache and mild gastrointestinal discomfort, with rates similar to those observed in the placebo group.

Observation Area Trial Context Finding
Dosing Clinical trials and research protocols typically involved starting doses at the lowest evaluated level.
Kidney Conditions Individuals with pre-existing kidney conditions were often excluded from the study population.

Studies also evaluated whether the compound was associated with a reduction in the severity of an accompanying skin rash, a secondary endpoint in the primary Phase 3 trial. The relationship between the compound and rash severity is being investigated in ongoing post-market observational studies.

Key Studies & References

  1. A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (OBERON)
  2. Efficacy and Safety of Combination Therapy with Ketorolac and Morphine in Patient with Acute Renal Colic; A Triple-Blind Randomized Controlled Clinical Trial
  3. Inhaled Corticosteroids - Mechanism of Action and Clinical Relevance in Asthma and COPD

Frequently Asked Questions (FAQ)

Common questions about Mavidol TR (FAQ)

Q: How quickly does the injectable solution start working for pain relief?

Regulatory information indicates the injectable solution is intended for rapid action. The onset of pain relief is typically expected within minutes of intravenous (IV) administration. The time to reach the full pain-relieving effect can still vary, as with any medication.

Q: How should I dispose of unused Mavidol TR tablets or injection vials?

Because Mavidol TR contains an opioid component, official product information emphasizes safe disposal. Unused or expired medication should be returned through medicine take-back programs or authorized collectors when available. If you cannot access a take-back program, follow specific local regulations, which may involve mixing the medicine with an undesirable substance (such as coffee grounds or cat litter) before discarding it in the trash, to prevent accidental exposure.

Q: What is the maximum duration I can take Mavidol TR?

Regulatory documents state that this medicine is strictly indicated for short-term use. The total treatment duration is limited to five days or less for the combined injectable and oral forms, according to regulatory guidelines. This restriction is defined as a necessary safety constraint for using this combination product.

Q: Can Mavidol TR be used by children?

Mavidol TR is officially contraindicated in children younger than 12 years of age. Official prescribing information also states use is generally restricted for adolescents younger than 18 years of age after undergoing tonsillectomy and/or adenoidectomy procedures.

Q: What are the risks if I take Mavidol TR with an antidepressant?

Official warnings state that combining Mavidol TR with other serotonergic drugs, such as certain common antidepressants (e.g., SSRIs or SNRIs), is associated with an increased risk of Serotonin Syndrome. Serotonin Syndrome is a potentially serious condition that can involve symptoms like agitation, confusion, sweating, or a fast heart rate. This risk arises because Mavidol TR affects serotonin levels in the central nervous system.

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

Regulatory guidance for this type of medication generally suggests taking a missed dose as soon as it is remembered. However, if it is already close to the time of the next scheduled dose, the missed dose should be skipped entirely. It is advised that two doses should not be taken at the same time to make up for a missed dose.

Q: Can Mavidol TR be cut or crushed before taking it?

The tablets are formulated to be swallowed whole and should not be split, crushed, chewed, or dissolved. Official prescribing information warns that altering the extended-release tablet could release the medicine too quickly, which is associated with a serious risk of overdose.

How should Mavidol TR be stored and disposed of?

Storage and Disposal Requirements

This section outlines the official, label-based storage and disposal requirements for Mavidol TR (Ketorolac/Tramadol).

Storage Conditions

Mavidol TR must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medication must be protected from light and moisture, and the container should be kept tightly closed in its original packaging. Due to the opioid component, it is mandatory to store the product securely and out of the sight and reach of children.

️ Disposal Instructions

Unused or expired medication must be disposed of strictly in accordance with local requirements. The product should not be disposed of via wastewater or household waste. Patients are advised to utilize medicine take-back programs or follow specific local regulations for discarding opioid-containing medicines.

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

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