Keral

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Keral

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 Keral

Property Description
Active ingredient Dexketoprofen Trometamol
Form Tablets, Granules, Solution for Injection
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Systemic relief of pain, inflammation, and fever
Origin Synthetic (Propionic acid derivative)

What Type of Medicine is Keral and What is its Composition?

Keral is a medication classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) used to relieve discomfort, containing the active substance Dexketoprofen Trometamol. This medicinal product is a synthetic chemical entity, specifically a derivative of propionic acid, and is formulated as a single-ingredient product typically available by prescription (Rx status) in many regions. Dexketoprofen is classified as an NSAID under the Anatomical Therapeutic Chemical (ATC) code M01AE17. Keral utilizes Dexketoprofen, which is the pharmacologically active S-enantiomer component of the older NSAID, Ketoprofen. This precise chemical structure is noted for its potential for more rapid action, a differentiating feature from the original racemate compound.


Keral's Available Forms and General Therapeutic Role

Keral is manufactured in multiple high-level dosage forms, primarily including film-coated tablets, granules for oral solution, and a solution for injection, supporting both oral and parenteral routes of administration. The availability in these various forms, particularly the solution for injection, ensures versatility for managing acute pain scenarios. The drug's general therapeutic purpose stems from its ability to interrupt the body’s production of chemical messengers called prostaglandins. These agents initiate pain signals, inflammation, and fever. By inhibiting prostaglandin synthesis, Keral provides symptomatic relief from discomfort and swelling across different acute conditions, such as sudden musculoskeletal pain.

What side effects are possible with Keral?

Official Safety Profile for Keral (Dexketoprofen)

Keral is classified as a non-steroidal anti-inflammatory drug (NSAID), and its official safety profile is structured by government regulatory bodies based on the frequency and severity of documented adverse reactions.

Frequency-Classified Adverse Reactions

The most commonly reported side effects, typically affecting the Gastrointestinal System, include nausea, vomiting, abdominal pain, indigestion, and diarrhea. These effects are generally classified as common.

Reactions categorized as uncommon or rare involve other System-Organ Classes (SOCs), such as the Nervous System (dizziness, headache, drowsiness) and Skin (rash, urticaria).

Serious Adverse Reactions

The most clinically significant and serious risks documented in official labels relate primarily to the gastrointestinal tract and cardiovascular system. NSAIDs, including Keral, carry a risk of serious gastrointestinal complications, such as bleeding, ulceration, or perforation, which can be fatal. This risk is generally higher with prolonged use.

Other serious, though very rare, adverse effects documented include severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), acute renal failure, and severe hypersensitivity reactions (anaphylactic shock).

Safety Restrictions and Considerations

Official prescribing information includes specific restrictions and cautions:

  • Contraindications: Keral is contraindicated in individuals with known hypersensitivity to the drug or other NSAIDs, those with existing peptic ulcers or chronic digestive problems, and patients with moderate to severe renal impairment.
  • Elderly Patients: Special caution is advised for elderly patients, as they are at an increased risk of severe adverse reactions, especially gastrointestinal bleeding, which may be fatal.
  • Pregnancy: The use of Keral is contraindicated during the third trimester of pregnancy and is generally not recommended during the first and second trimesters, as it may impair fertility. Its use is also contraindicated during breastfeeding.

Note: Regulatory safety information strictly defines the risks associated with the medicine, distinguishing between expected, common adverse effects and rare, serious events.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Dexketoprofen Trometamol (Keral), consistent with Nonsteroidal Anti-inflammatory Drugs (NSAIDs), outlines specific manifestations following ingestion of excessive quantities. Documented presentations include gastrointestinal distress such as nausea, vomiting, dyspepsia, and pain in the upper abdomen. Central nervous system (CNS) effects such as somnolence, lethargy, headache, and dizziness may also occur.


Potential Serious Outcomes

Official labeling describes the potential for severe effects affecting multiple physiological systems. These include gastrointestinal bleeding and the development of acute renal failure. The elderly and patients with pre-existing renal impairment are noted to be at an increased risk of severe adverse reactions.


Emergency Response Mandates

Due to the risk of serious organ outcomes, regulators mandate that immediate medical attention must be sought if an overdose is suspected. Management is strictly defined as symptomatic and supportive treatment. The official documentation states that no specific antidote is known for Dexketoprofen Trometamol. Supportive measures such as gastric lavage and administration of activated charcoal may be considered by healthcare professionals. Hospital monitoring is required, particularly for changes in mental status or signs of renal dysfunction.

Therapeutic Uses of Keral

Keral is generally used for the symptomatic relief of discomfort, inflammation, and fever, often for conditions that involve acute, non-chronic symptoms. Keral is commonly used for symptoms of mild to moderate intensity and is applied in situations involving certain distressing symptoms across several common painful conditions. This includes application for symptoms of pain such as musculoskeletal pain, dysmenorrhea (menstrual pain), and dental pain.

This medication is applied across domains where additional symptomatic support is needed, such as in cases of sudden-onset aches from sprains or strains, or during acute flare-ups of conditions like osteoarthritis. This support can help ease the overall symptom burden and assists with maintaining functional stability. It is commonly used during phases when supportive relief is appropriate, including after surgical or dental procedures, or to address the intense, episodic symptoms of primary dysmenorrhea.


Quick Context: Managing Acute Symptom Clusters

Regulatory References

  1. Summary of Product Characteristics from the Health Products Regulatory Authority (HPRA)

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Keral

Keral (Dexketoprofen Trometamol) is officially approved for use in adult patients for short-term pain treatment. However, regulatory documents establish extensive non-eligibility rules and restrictions based on specific medical conditions and age.


Populations for Whom Use is Contraindicated

Use is strictly prohibited in patients with a known hypersensitivity to the drug, to any other Nonsteroidal Anti-inflammatory Drug (NSAID), or in those where NSAIDs trigger asthma, rhinitis, or urticaria. Absolute contraindications also apply to individuals with active or a history of peptic ulcer/gastrointestinal bleeding, severe heart failure, Crohn's disease, or ulcerative colitis. Furthermore, use is prohibited in patients with severe hepatic dysfunction, moderate to severe renal dysfunction (creatinine clearance leq 59 ml/min), and those with active bleeding disorders or severe dehydration.


Age and Life Stage Restrictions

  • Children and Adolescents (Under 18): Use is not recommended as safety and efficacy have not been established in this age group.
  • Older People (Elderly): Treatment is permitted but must start at the lowest available dose and requires close monitoring due to increased risk of serious adverse reactions, particularly gastrointestinal complications.
  • Pregnancy and Lactation: Use is contraindicated during the third trimester of pregnancy and the lactation period.

Populations Requiring Conditional Use

Patients with mild renal impairment (creatinine clearance 60-89 ml/min) or mild to moderate hepatic impairment must be started on a reduced initial dosage. Similarly, patients with uncontrolled hypertension, certain cardiovascular diseases, or a history of heart failure must be treated only after careful consideration.

What should I know about interactions with other medicines?

The interaction profile of Keral (Dexketoprofen Trometamol) is defined by documented risks associated with co-administration of various agents, based strictly on official regulatory information.

Interaction Scope

  • Medicinal product categories with documented interactions: Other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), Anticoagulants, Antiplatelet agents, Selective Serotonin Reuptake Inhibitors (SSRIs), systemic Corticosteroids, Diuretics, ACE Inhibitors, ARBs, Methotrexate, and Lithium.
  • Timing-based interaction rules: To optimize the rate of absorption for acute symptom relief, administration is recommended at least 15 to 30 minutes before meals.
  • Population-specific interaction notes: The risk of toxicity from interacting medicines is elevated in elderly patients due to the higher likelihood of impaired renal or hepatic function, which can alter drug clearance and exposure.

Interaction Classifications (High-Level)

  • Contraindicated combinations: Co-administration with other NSAIDs (including high-dose salicylates and COX-2 inhibitors) is formally contraindicated due to synergistic gastrointestinal toxicity. Methotrexate at high doses (>15 mg/week) is also contraindicated due to enhanced hematological toxicity from reduced renal clearance.
  • Combinations not recommended: Use with Anticoagulants (e.g., Warfarin, Heparins) is not recommended because of the enhanced anti-platelet effect, which significantly increases bleeding risk. Consumption of alcohol is not recommended due to an elevated risk of severe gastrointestinal bleeding.

Resulting Interaction Structure The regulatory profile mandates caution with agents like Diuretics and ACE Inhibitors due to the documented risk of acute renal function compromise. Co-administration of Lithium requires monitoring due to the potential for increased plasma concentrations. The structure strictly manages combinations based on pharmacodynamic and pharmacokinetic outcomes documented in official sources.

Mechanism of Action

Molecular Target: Inhibition of Cyclooxygenase Enzymes

The mechanism of action for Dexketoprofen Trometamol is defined by its precise interaction with fundamental biochemical pathways, resulting in modulation of eicosanoid-driven signaling. The drug operates at the molecular level by functioning as a non-selective inhibitor of the Cyclooxygenase (COX) enzymes, specifically targeting both the inducible COX-2 and the constitutive COX-1 isoforms. This inhibition prevents the initial enzymatic step in the conversion of arachidonic acid into prostaglandins, the powerful signaling molecules that mediate inflammatory responses.

Pathway Modulation: Desensitizing Nociception and Resetting Temperature

By suppressing prostaglandin synthesis, particularly Prostaglandin E2 ( PGE2), the drug limits the sensitization of peripheral nociceptors (pain-sensing nerves), which is the biological outcome for limiting afferent nociceptive signaling. This systemic reduction of PGE2 also acts centrally on the hypothalamus, supporting the regulation of the body's elevated thermoregulatory set-point.

️ Mechanistic Constraint: The Homeostatic Trade-Off

The drug's non-selective action functionally constrains the body's ability to produce protective prostaglandins, which are necessary for COX-1-mediated homeostatic functions. This functional relationship is an inherent feature of the non-selective inhibition mechanism.

Dosage and Administration Information

How Keral (Dexketoprofen Trometamol) is Used

Keral is used for acute symptomatic relief under standardized administration protocols. The medication is available for both oral (tablets, granules) and parenteral (intravenous or intramuscular injection) use, allowing for flexibility in managing sudden onset pain.


Administration and Dosage

Instruction Category Statement
Oral Dosing Standard dose is 12.5 mg every 4–6 hours, or 25 mg every 8 hours. The total maximum daily oral dose is 75 mg.
Parenteral Dosing The typical dose is 50 mg every 8–12 hours. The maximum total daily dose for the injectable form is 150 mg.
Duration Limit Treatment is strictly short-term. Parenteral use is limited to no more than two days, with a prompt switch to oral therapy advised. Oral treatment is generally limited to four days or less.
Timing Oral forms may be taken at least 30 minutes before meals to achieve a more rapid effect. Granules must be fully dissolved in water.

Population Adjustments and Special Conditions

Administration involves specific adjustments for certain patient groups. For older adults and patients with mild renal or hepatic impairment, therapy should start at the lower end of the dosage range, typically a maximum total daily dose of 50 mg.

The intravenous form involves specific handling, including administration as a slow IV infusion lasting 10 to 30 minutes or a slow bolus, and it should not be mixed with certain other solutions. These specific instructions define the operational sequence for using the medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Keral


Evidence for use in Acute Post-operative Pain (Dental and General)

Research exploring Keral's role in acute pain management has been frequently applied in clinical settings, particularly for pain following dental or other surgical procedures. These studies primarily use short-term, randomized controlled trials (RCTs) and systematic reviews, which compare the drug to a placebo or other active pain relievers. The key outcomes monitored were related to physical discomfort, such as total pain relief scores collected and the length of time before patients requested additional pain medication.

Evidence gathered in these research scenarios often describes patterns related to the initial timeline at which a change in symptoms was observed. What remains uncertain is the applicability of these findings to all types of surgical recovery, as a large portion of the evidence is derived from highly specific models, such as third molar extraction. Follow-up durations were typically limited to the very short term (a few hours or days), meaning there is limited information for long-term outcomes.


Evidence for use in Primary Dysmenorrhea (Menstrual Pain)

Research examined Keral in adult women experiencing primary dysmenorrhea, a condition characterized by acute or disruptive episodes of menstrual pain. The evidence primarily consists of single-cycle, double-blind RCTs, which were applied in studies examining patient-reported experiences related to pain intensity. The evidence quality for this indication is classified as High regarding its evaluation in conditions characterized by fluctuating or episodic manifestations measured over a single cycle. However, there is limited information for long-term outcomes or the patterns of the medication when used over repeated, successive menstrual cycles.


Evidence for use in Acute Musculoskeletal Pain

Keral was evaluated in studies for conditions marked by functional limitations and periods of heightened symptoms, such as acute low back pain or temporary exacerbations of osteoarthritis. The consistency of the evidence varies across studies, and the overall weight is classified as Moderate, partly due to the broad nature and heterogeneity of the 'musculoskeletal pain' category. Long-term effects are not fully established, as the research primarily explores short-term symptom changes.


What is Still Uncertain About Keral Research

A key limitation is the focus on acute, episodic symptom evaluation, meaning long-term effects are not fully established. Furthermore, evidence remains limited, with data for certain groups (such as those with significant pre-existing health conditions or the very young) remaining insufficient.

Key Studies & References

  1. Summary of Product Characteristics (SmPC) for Keral (Dexketoprofen Trometamol) - Health Products Regulatory Authority (HPRA)
  2. Research on Dexketoprofen Efficacy in Acute Pain (General PubMed Reference from Initial Scoping)

Frequently Asked Questions (FAQ)

Common questions about Keral (FAQ)


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

If a dose is missed, official guidance generally recommends that the patient takes only the next scheduled dose. Regulatory warnings state that taking a double dose to compensate for a missed dose should be avoided.


Q: How long does it take for Keral tablets to start working?

The official product information does not specify an exact time frame for the onset of pain relief after taking Keral tablets. However, the label does note that administration at least 30 minutes before food may be associated with a more rapid effect for the management of acute pain.


Q: What is the official recommended storage temperature for Keral tablets?

According to regulatory documents, Keral tablets should not be stored above 30 C. To maintain the medicine's quality, it must also be kept in the original outer carton to protect the tablets from light.


Q: Is Keral safe to use while breastfeeding?

The use of Keral is officially contraindicated (prohibited) during the period of breastfeeding (lactation). Official prescribing information notes that this restriction is due to the fact that it is unknown if the drug passes into breast milk.


Q: What is Keral used for in children or teenagers?

Official prescribing information indicates that Keral is not recommended for use in children and adolescents under the age of 18. This is because the safety and effectiveness of the medicine have not been sufficiently established for this younger age group.


Q: How should I switch from the Keral injection to the tablet?

Parenteral use (injection) of Keral is typically limited to no more than two days for short-term pain management. Regulatory documents advise a prompt transition to oral therapy, and this clinical decision regarding the switch is determined by a healthcare professional.


Q: What is the difference between Keral and Ketoprofen?

Keral contains Dexketoprofen, which is the single, pharmacologically active component known as the S-enantiomer of the drug Ketoprofen. Regulatory information and studies indicate that this specific structure is recognized for its potential to support a more rapid onset of action compared to the original racemic mixture, Ketoprofen.

How should Keral be stored and disposed of?

The official regulatory documents specify storage and disposal requirements for Keral (dexketoprofen trometamol).

Storage Requirements

Film-coated tablets in PVC-aluminium blisters must not be stored above 30 C. All forms of Keral must be kept out of the sight and reach of children and protected from light. Tablets must remain in the original outer carton.

Disposal Instructions

Unused or expired Keral must be disposed of in accordance with local regulatory requirements. The medicine must not be thrown away via wastewater or household waste to avoid environmental contamination. Patients should consult a pharmacist for guidance on proper disposal procedures.

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

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