Дексонал

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Дексонал

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Treatment option: Pain, Toothache

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 Дексонал

Property Description
Active ingredient Dexketoprofen (as the trometamol salt)
Form Film-coated tablets, solution for injection
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Relief from pain, inflammation, and fever
Origin Synthetic, enantiopure derivative

Дексонал is a synthetic medicinal product containing the active component Dexketoprofen. It is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), a group of medications clinically recognized for their ability to provide comprehensive relief from pain and inflammation. Its primary therapeutic value lies in its combined analgesic, anti-inflammatory, and antipyretic actions, offering a multifaceted approach to discomfort.


What Type of Medicine is Дексонал and What is its Purpose?

Дексонал is a non-opioid analgesic primarily classified within the NSAID group, specifically the Propionic acid derivatives (WHO ATC Code M01AE17). The medication's core function is to reduce pain, diminish localized inflammation, and help normalize an elevated body temperature. The drug serves a role in alleviating acute pain, making it suitable for general pain relief, such as managing the discomfort following a dental procedure.

The medicine achieves its general purpose by temporarily limiting the production of prostaglandins, which are chemical mediators responsible for signaling pain and driving the inflammatory process.


What is the Composition and Origin of Dexketoprofen?

The active ingredient in Дексонал is Dexketoprofen, typically administered as the highly water-soluble salt, Dexketoprofen trometamol. This compound is a synthetic medication and is structurally classified as an enantiopure drug, meaning it consists only of the S(+)-enantiomer, which is the sole therapeutically active component of the related racemic drug, Ketoprofen. This chemical refinement, known as a chiral switch, isolates the most potent fraction. The inclusion of the trometamol salt is a key compositional feature designed to enhance the drug's solubility, facilitating rapid absorption into the bloodstream for prompt symptomatic relief.


In What Pharmaceutical Forms is Дексонал Available?

Дексонал is made available in several high-level pharmaceutical preparations to suit different patient needs. These forms include film-coated tablets designed for convenient oral administration and a clear solution for injection contained within ampoules for parenteral administration. The brand is known across several international markets for offering this dual-form approach, ensuring the medicine can be utilized across a spectrum of requirements, whether for managing persistent discomfort (tablets) or when immediate, systemic action is necessary (injection).

What side effects are possible with Дексонал?

Possible Side Effects and Safety Information

Дексонал (Ketoprofen) is a nonsteroidal anti-inflammatory drug (NSAID) whose safety profile includes risks common to its class, which require adherence to specific precautions.

Key Adverse Reactions and Frequencies

Adverse reactions most commonly involve the gastrointestinal and nervous systems. Common effects (occurring in 1% to 10% of patients) often include nausea, indigestion (dyspepsia), vomiting, abdominal pain, diarrhea, constipation, headache, dizziness, and swelling (edema).

System Organ Class Classification (CIOMS/ICH Frequency)
Gastrointestinal Common, Uncommon, Rare
Nervous System Common, Uncommon, Rare
Skin/Subcutaneous Uncommon, Rare (including photosensitivity)
Cardiovascular Rare (Hypertension, Palpitations)

Serious Safety Information

The most serious documented safety concerns are related to the potential for fatal outcomes and include:

  • Gastrointestinal (GI) Risk: An increased risk of serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines. These events can occur without warning symptoms at any time during use, particularly in the elderly or with prolonged high-dose use.
  • Cardiovascular Risk: NSAIDs are associated with a small increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. This risk may increase with the duration of use.
  • Hypersensitivity: Rare, but potentially life-threatening, severe allergic reactions (anaphylaxis) and severe skin reactions (e.g., Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) have been reported.

Safety Restrictions and Monitoring

Дексонал is formally contraindicated in patients with active peptic ulceration, a history of recurrent GI bleeding, severe heart failure, severe renal insufficiency, and in the third trimester of pregnancy due to the risk of fetal cardiovascular effects (premature ductus arteriosus closure) and renal complications. Caution is advised for patients with existing cardiovascular risk factors, impaired kidney function, or a history of GI disease. Official labeling recommends use be limited to the lowest effective dose for the shortest possible duration to minimize the risk of serious side effects.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The official overdose profile for Dexketoprofen ( Дексонал) is defined by a spectrum of documented clinical manifestations and regulator-mandated emergency actions.

Property Official Regulatory Statement
Documented Overdose Manifestations Nausea, vomiting (sometimes with blood), epigastric pain, headache, lethargy, drowsiness, dizziness, and ringing in the ears ( tinnitus).
Physiological Systems Affected Gastrointestinal (bleeding, ulceration), Cardiovascular (myocardial infarction, stroke), Central Nervous System (seizures, coma), and Renal (acute renal failure).
Population-Specific Notes The elderly have a higher risk for serious Gastrointestinal events (bleeding/perforation) which may be fatal. Caution is required in patients with impaired renal or hepatic function due to heightened risk of toxicity.
When Immediate Medical Help is Required Seek immediate medical attention for symptoms indicative of severe cardiovascular events, including Chest pain, Shortness of breath or trouble breathing, Sudden weakness or numbness, or Sudden slurred speech. Call local emergency number or Poison Help hotline immediately.

Officially Described Overdose Management:

Management is primarily by symptomatic and supportive care. Decontamination procedures may include Gastric lavage or administration of Activated charcoal. No specific antidote is known for Dexketoprofen. Hospital monitoring, including an ECG and blood tests, may be required.

This information defines the high-risk potential of the overdose, requiring urgent help upon critical symptom presentation.

Therapeutic Uses of Дексонал

Dexketoprofen, a non-steroidal anti-inflammatory drug (NSAID), is used across domains where additional symptomatic support is needed, primarily addressing symptoms related to physical discomfort and systemic imbalance. It is commonly used for the symptomatic treatment of pain of mild to moderate intensity.


Targeting Key Symptom Domains

The medication is commonly used to address pain and accompanying inflammation that arises from the muscles, ligaments, and joints, relevant in situations following sprains, strains, or minor soft tissue injuries, as well as for the symptomatic relief during acute flares of joint disorders. It is also applied in contexts requiring short-term symptom management for conditions marked by a sudden onset of severe discomfort, including managing the intense cramping associated with primary dysmenorrhea, localised pain associated with procedures, and managing acute, high-distress episodes such as the pain of renal colic.

The focus is on offering symptomatic relief that may help patients cope more steadily with symptom fluctuations.

“It is relevant in clinical settings where symptoms of discomfort and inflammation require supportive management to help ease the overall symptom load.”

In symptomatic management, the medication plays a role in managing both pain and inflammation symptoms. Furthermore, it is also relevant for easing symptoms related to fever when an elevated body temperature accompanies the pain and inflammation, which contributes to improved day-to-day comfort during symptomatic periods.


Symptomatic Focus Dexketoprofen is relevant for easing symptoms that are episodic, sudden, or post-procedural, helping to address symptom clusters that may become intense or disruptive.

Eligibility and Restrictions for Use

Eligibility Profile for Dexketoprofen

This section describes the official regulatory criteria defining which patient populations may or may not use Dexketoprofen (Дексонал), based strictly on governmental drug authority documents.


Contraindicated Populations (Must Not Use)

Use of this medicine is strictly prohibited for individuals with the following conditions or characteristics:

  • Hypersensitivity or Allergy: Known allergy to dexketoprofen, any Non-Steroidal Anti-Inflammatory Drug (NSAID), or excipients, or if NSAIDs have previously caused asthma, rhinitis, or urticaria.
  • Gastrointestinal Health: Active or history of gastrointestinal (GI) bleeding, peptic ulceration, perforation, chronic dyspepsia, Crohn's disease, or ulcerative colitis.
  • Major Organ Failure: Severe heart failure, severe liver dysfunction (Child-Pugh score 10–15), or moderate to severe kidney dysfunction (creatinine clearance le 59 mL/min).
  • Bleeding Risk: Active bleeding, haemorrhagic diathesis, or other coagulation disorders.
  • Age and Pregnancy: Children and adolescents (under 18 years of age) and women in the third trimester of pregnancy.

Restricted or Conditional Use

Use requires special caution, dose adjustment, and close monitoring by a healthcare professional in the following groups:

  • Elderly Patients: Recommended to start at the lowest effective dose due to increased risk of severe adverse reactions.
  • Mild Organ Impairment: Patients with mild-to-moderate liver or kidney dysfunction.
  • Cardiovascular Conditions: Those with controlled hypertension, mild-to-moderate heart failure, or established cardiovascular disease.
  • Reproductive Status: Women who are breastfeeding or attempting to conceive are not recommended to use this medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Officially documented interaction patterns for Dexketoprofen are primarily categorized based on the specific substance or class of medicine co-administered. The regulatory profile outlines constraints related to Pharmacodynamic (PD) Risk Reinforcement and Pharmacokinetic (PK) Interference.

Interaction-Related Restrictions

Co-administration is not recommended or formally discouraged with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors, and high-dose Acetylsalicylic acid due to the additive risk of serious gastrointestinal adverse effects. The use of Dexketoprofen with Anticoagulants (e.g., Warfarin) is also not recommended as the drug interferes with haemostasis.

Pharmacodynamic and Pharmacokinetic Effects

The combined use with Oral Corticosteroids or SSRIs increases the documented risk of gastrointestinal bleeding. A risk of nephrotoxicity exists when co-administered with Diuretics, ACE-Inhibitors, or Angiotensin II Antagonists. Furthermore, Dexketoprofen reduces the renal clearance of substances such as Lithium and high-dose Methotrexate (doses ge 15 mg/week), which can lead to increased plasma concentrations of these medicines.

Procedural Constraints

For the oral formulation, a specific timing rule exists due to the effect of food on absorption rate. Administration is recommended at least 15 to 30 minutes before meals when rapid onset is required. Elderly patients are identified in regulatory documentation as having a heightened risk of gastrointestinal adverse effects when receiving concomitant risk medications.

Mechanism of Action

The mechanism of Dexketoprofen is executed by interaction with specific enzyme targets, initiating a molecular cascade that alters physiological signaling.

Targeting the Cyclooxygenase Enzyme System

The central mechanism involves the non-selective competitive reversible inhibition of the Cyclooxygenase (COX-1 and COX-2) enzymes . By blocking this key enzymatic step, the drug limits the conversion of arachidonic acid into prostanoids, which are vital chemical mediators. This modulation limits the production of prostanoids and reduces the sensitization threshold of peripheral nociceptors, which defines the resulting peripheral physiological effect.

Dual Systemic and Localized Activity

Dexketoprofen exhibits simultaneous activity in both peripheral tissues (at sites of local cellular disruption) and centrally within the brain's hypothalamus. The peripheral action suppresses localized inflammatory mediator signaling, while the central action involves blocking prostaglandin synthesis in the brain's thermoregulatory center. This dual-context modulation influences the pathways associated with both localized signaling responses and systemic temperature control.

Accelerated Pathway Access

The formulation utilizes the highly soluble trometamol salt, which is a chemical refinement designed to rapidly increase the bioavailability of the active S(+)-enantiomer in the bloodstream. This accelerated absorption allows the active molecule to rapidly achieve the necessary concentration for enzyme engagement and inhibition, resulting in a fast onset of the molecular mechanism.

Dosage and Administration Information

Official Administration Guidelines for Дексонал

Дексонал (dexlansoprazole) is a delayed-release capsule intended for oral administration and is typically taken once daily. The capsule may be taken without regard to food and should be swallowed whole; it must not be chewed.

Official Dosing for Adults

Indication Dosage Duration
Healing of Erosive Esophagitis (EE) One 60 mg capsule once daily Up to 8 weeks
Maintenance of Healed EE One 30 mg capsule once daily Up to 6 months
Symptomatic Non-Erosive GERD One 30 mg capsule once daily 4 weeks

For patients with moderate hepatic impairment (Child-Pugh Class B), a maximum dose of 30 mg once daily for up to eight weeks should be considered for the healing of EE.

Missed Dose Instructions

If a dose is missed, it should be administered as soon as possible. However, if the time for the next scheduled dose is approaching, the missed dose should be skipped, and the patient should resume the regular dosing schedule. Do not take two doses at one time to compensate for a missed dose.

Alternative Administration

If the capsule cannot be swallowed whole, it can be opened and the granules sprinkled intact onto one tablespoon of applesauce, then swallowed immediately without chewing. Alternatively, the capsule's contents can be mixed with 20 mL of water and administered immediately using an oral syringe or a nasogastric (NG) tube (≥ 16 French); the mixture should not be saved for later use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Дексонал (Dexketoprofen Trometamol)


Evidence for use in Acute Pain

Research examining Dexketoprofen Trometamol, the active ingredient in Дексонал, includes studies involving conditions characterized by acute, short-term symptomatic manifestations, such as musculoskeletal and post-operative pain. The research examined short-term, double-blind trials comparing the study drug to a placebo (a control pill) and to other treatments included in the research design.

These studies monitored patient-reported outcomes describing perceived discomfort, focusing on how pain intensity scores evolved in the observed populations, typically within the first few hours or days. Trials also monitored and reported the incidence of general adverse events and the overall tolerability observed in participants. However, data for sustained patterns of change or administration over many consecutive weeks remain insufficient.


Evidence for use in Primary Dysmenorrhea (Menstrual Pain)

This part of the overview describes the research studies and clinical trials that evaluated the drug in conditions characterized by episodic manifestations, focusing on acute menstrual pain. Studies monitored outcomes describing episodic or acute changes in physical discomfort, using standardized scales to track symptom intensity and the use of rescue medication in adult female populations. Researchers also monitored and documented the overall adverse event patterns and tolerability during the treatment period.

Findings were mixed across certain methodologies, and research contributes to the broader evidence landscape related to short-term changes in symptoms experienced during these acute episodes. What remains uncertain is the evidence related to the study drug when administered across multiple consecutive cycles, as follow-up durations were limited.


Evidence in Special Populations and Uncertainties

Research describes that specific studies were conducted examining older adult populations, and findings indicate patterns of outcomes monitored in these groups. However, the results of the main trials apply only to the general adult populations studied, as certain patient groups were often excluded from the primary research. Comparative evidence against many alternative treatments remains limited within the published studies.

Certainty remains low for long-term outcomes across all indications, as research exploring short-term symptom changes provides limited insight into sustained patterns. Data for complex subgroups and specific comorbidities remain insufficient for describing broad, consistent findings.

Frequently Asked Questions (FAQ)

Common questions about Дексонал (FAQ)

Q: What is the active ingredient in Дексонал?

The active substance in Дексонал is dexketoprofen trometamol. This ingredient belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs, or NSAIDs. According to official product information, it is included to help with pain relief and inflammation.

Q: How quickly does Дексонал start working after taking it?

Studies and official information indicate that the analgesic (pain-relieving) effect of dexketoprofen, the active component of Дексонал, begins relatively quickly. The onset of action is generally observed to start within 30 minutes after taking the medicine. Maximum concentrations in the blood are usually reached within 15 to 60 minutes after administration.

Q: Can I use Дексонал for headaches?

Regulatory documents state that Дексонал is indicated for the symptomatic treatment of acute pain of mild to moderate intensity. The listed indications include musculoskeletal pain, dysmenorrhea (period pain), and dental pain. Any use for pain, including headaches, should align with the medicine's licensed indications as described in the official product information.

Q: Is Дексонал an opioid or a steroid?

No, Дексонал is neither an opioid nor a steroid medicine. According to the official product information, the active ingredient, dexketoprofen, is classified as a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs work by blocking certain enzymes in the body to help reduce pain and inflammation.

Q: Can I take Дексонал on an empty stomach?

According to the official product information, it is generally recommended to take Дексонал with food. To achieve a faster absorption, the product information notes that it can be taken at least 30 minutes before meals. Taking it with food is typically recommended to help lower the potential for gastrointestinal adverse effects.

Q: Does Дексонал cause drowsiness?

Regulatory documents mention that dizziness or somnolence (drowsiness) are reported as possible side effects, though generally uncommon. Due to the possibility of these effects, the official product information cautions that this medicine may impair the ability to drive or use machines.

How should Дексонал be stored and disposed of?

Official Storage and Disposal Requirements

Storage and disposal requirements for Дексонал (dexketoprofen trometamol, injectable solution) are defined by government regulatory documents to maintain the product's quality and ensure safe handling.

Storage Component Official Requirement
Temperature Store below the maximum temperature specified on the label (e.g., 25 C or 30 C).
Protection Keep ampoules/vials in the original outer carton to protect the solution from light.
Access Must be stored out of the sight and reach of children and pets.
Stability Do not use the medicine after the labeled expiry date. Follow specific guidelines for stability after dilution.

For disposal, unused or expired Дексонал should be taken to an authorized drug take-back point. If a take-back program is unavailable, follow the standard non-controlled substance procedure of mixing the drug with an undesirable substance, sealing it in a bag, and disposing of it in the household trash.

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

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