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Oki Inflammazione e Dolore

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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.

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Overview of Oki Inflammazione e Dolore

Oki Inflammazione e Dolore is a branded medicinal product, manufactured by Dompé Farmaceutici SpA, primarily registered and distributed in Italy. It is positioned for self-medication as an analgesic and anti-inflammatory agent.

Property Description
Active ingredient Ketoprofen Lysine Salt
Form Granules for oral solution, Oral solution
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Relieves pain, inflammation, and fever
Origin Synthetic (Propionic acid derivative)

What Type of Medicine is Oki Inflammazione e Dolore?

Oki Inflammazione e Dolore is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), offering a three-fold therapeutic effect: analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing). The drug is a synthetic compound belonging to the propionic acid derivative group, a class of substances that has been clinically recognized for its efficacy in managing inflammatory and painful symptoms. This classification confirms the medicine's ability to act on the symptomatic responses associated with pain and fever.

Composition and Available Forms of Oki

The active ingredient in Oki Inflammazione e Dolore is Ketoprofen Lysine Salt, which is the single active compound used in its formulations. This formulation is a key differentiating factor, as the Lysine salt is designed for superior solubility compared to the standard Ketoprofen acid, aiming to accelerate the absorption of the medicine for a faster onset of action. Supported by pharmacological data, this salt modification is intended to optimize the delivery of the analgesic component. The medicine is available in patient-friendly forms such as dissolvable granules for oral solution and a prepared oral solution, including specific products like an oral mucosa spray, which enables local administration.

Regulatory References

  1. Analgesic Agents - NIH
  2. Anti-inflammatory Drugs - NIH
  3. Antipyretic Drugs - NIH
  4. Oki SmPC (AIFA)
  5. Drug Absorption and Bioavailability - NIH
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What side effects are possible with Oki Inflammazione e Dolore?

Official Safety Profile and Adverse Reactions

Ketoprofen Lysine Salt, the active ingredient in Oki Inflammazione e Dolore, is part of the Nonsteroidal Anti-inflammatory Drug (NSAID) class, whose regulatory profile is defined by two primary systemic risks: gastrointestinal and cardiovascular safety concerns. The use of this medicine is associated with a risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Additionally, an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, is documented in the safety information.

Adverse reactions are formally classified by frequency and System-Organ Class (SOC) in regulatory documents:

Frequency Classification System-Organ Classes Involved (Examples)
Common (1-10% incidence) Gastrointestinal Disorders (Dyspepsia, Nausea, Abdominal pain, Vomiting)
Uncommon (0.1-1% incidence) Nervous System Disorders (Headache, Dizziness), Skin Disorders (Skin rash, Pruritus)
Rare (0.01-0.1% incidence) Gastrointestinal Disorders (Peptic ulcer, Stomatitis)
Not Known (Cannot be estimated) Immune System Disorders (Anaphylactic shock), Renal/Hepatic Disorders, Severe Skin Reactions

Regulatory safety information notes that the risk of serious gastrointestinal and cardiovascular events increases with the duration of use and may occur early in treatment. The medicine is contraindicated during the third trimester of pregnancy due to potential fetal harm. Use is also restricted for individuals with severe hepatic or renal insufficiency, and it should not be used in the setting of coronary artery bypass graft (CABG) surgery.

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Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The official overdose profile for Ketoprofen (the active ingredient in Oki Inflammazione e Dolore) focuses on immediate recognition of clinical signs and mandated emergency actions as described in government regulatory documents.


Documented Clinical Manifestations

Symptoms of overdose, particularly those resulting from large exposure, include gastrointestinal distress such as nausea, vomiting, and abdominal pain. Central Nervous System (CNS) effects are also documented, encompassing drowsiness, confusion, dizziness, and fatigue.

Severe Outcomes and Emergency Action

Severe or large overdoses may result in life-threatening outcomes including seizures, coma, acute renal failure, and significant internal bleeding. Regulatory authorities mandate that individuals must seek medical help right away and contact a Poison Control Center or local emergency services upon suspected overdose.

Supportive Management

Management is officially described as symptomatic and supportive, as no specific antidote is known for acute Ketoprofen toxicity. Procedures for management include gastrointestinal decontamination through activated charcoal or gastric lavage, and continuous monitoring of vital signs and blood work as necessary for stabilization and observation.

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Therapeutic Uses of Oki Inflammazione e Dolore

What Oki Inflammazione e Dolore Treats: Main Uses and Benefits

Oki Inflammazione e Dolore provides symptomatic relief across therapeutic domains characterized by pain, inflammation, and fever, which helps patients cope more steadily during acute and episodic discomfort. Ketoprofen, its active ingredient, is widely used to relieve pain, tenderness, swelling, and stiffness caused by inflammatory conditions, and to reduce fever. The medicine may assist with symptomatic relief when pain and inflammation become more noticeable.

The medication is commonly used to help manage pain associated with sore throat (pharyngitis), gingivitis, stomatitis, headache, toothache, and musculoskeletal conditions like arthrosis and myalgia, as well as providing support for primary dysmenorrhea (menstrual cramps). It is applied in clinical settings that involve acute or unstable symptom patterns, such as during influenza-like syndromes or following dental therapy.

“The primary goal is easing the burden of symptoms that interfere with daily functioning, offering supportive relief when discomfort is most noticeable.”

The overall benefit is that the medication contributes to easing the overall symptom load, supports general well-being and offers symptomatic relief when acute symptoms are present.

Quick Fact: Relief for Acute Discomfort
This medicine is commonly used for mild to moderate acute pain and is relevant for easing symptoms that cluster into patterns of local irritation and noticeable pain.

Regulatory References

  1. MedlinePlus Drug Information overview
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Eligibility and Restrictions for Use

Who can and cannot use Oki Inflammazione e Dolore?

Eligibility for Oki Inflammazione e Dolore (Ketoprofen Lysine Salt) is strictly defined by regulatory authorities based on age, pre-existing conditions, and physiological status. The medicine is primarily intended for Adults who do not have any of the absolute prohibitions listed below.


Contraindicated Populations (Must Not Use) Age and Physiological Status
Hypersensitivity to ketoprofen or other NSAIDs (including aspirin-induced asthma or allergy) Third Trimester of Pregnancy (absolute prohibition)
Active Peptic Ulcer/Haemorrhage or recurrent history of GI bleeding related to NSAIDs Children and Adolescents (not recommended under 18; contraindicated under 14 in some regions)
Severe Heart Failure, Severe Hepatic Impairment, or Severe Renal Impairment Breastfeeding (not recommended)

Condition-Specific Restrictions

Use requires caution and close monitoring for Older Adults due to the increased risk of adverse effects. Caution is also necessary for patients with a history of Crohn’s disease or ulcerative colitis, uncontrolled hypertension, or non-severe hepatic/renal impairment. Use in the first and second trimesters of pregnancy is not recommended unless considered clearly necessary, with the lowest dose and shortest duration.

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What should I know about interactions with other medicines?

This section details the officially documented interaction patterns for the active ingredient, Ketoprofen Lysine Salt, as documented in government regulatory sources.

Contraindicated and High-Risk Combinations

Co-administration is formally contraindicated by regulatory bodies with several substance categories due to the high risk of severe interaction outcomes. These include other NSAIDs (Nonsteroidal Anti-inflammatory Drugs) such as selective COX-2 inhibitors and high-dose salicylates (e.g., aspirin ge 3 g/day). Due to increased risk of hemorrhage, co-administration is also contraindicated with oral anticoagulants (e.g., warfarin), heparin, and antiplatelet agents. The combination with Lithium and Methotrexate at high doses (ge 15 mg/week) is restricted due to the potential for severe toxicity.


Interactions Affecting Drug Exposure and Organ Function

Interactions documented in official labeling primarily involve pharmacodynamic effects and altered clearance. Ketoprofen can reduce the antihypertensive effect of diuretics and ACE inhibitors/Angiotensin II Receptor Antagonists, and may increase the risk of acute renal dysfunction. Concomitant use with low-dose Methotrexate (< 15 mg/week) or Lithium is noted for the risk of increased plasma concentrations of the co-administered drug, a result of reduced renal clearance. Substances such as Probenecid are also documented as increasing the exposure (plasma concentration) of Ketoprofen itself due to inhibited clearance. The risk of nephrotoxicity is increased when combined with Ciclosporin or Tacrolimus.


Interactions with Non-Medicinal Substances

Regulatory warnings note that Alcohol ingestion is documented as increasing the risk of gastrointestinal side effects, including bleeding. Certain Herbal Products, such as Ginkgo biloba, may also increase the risk of bleeding due to additive antiplatelet effects.

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Mechanism of Action

How Oki Inflammazione e Dolore Works (Mechanism of Action)


Modulating Inflammatory Mediator Synthesis

The active molecule, Ketoprofen, primarily operates by non-selectively and reversibly blocking the Cyclooxygenase (COX-1 and COX-2) enzymes. This interaction halts the conversion of arachidonic acid into pro-inflammatory prostaglandins and thromboxanes. By reducing the synthesis of these key mediators, the mechanism limits the chemical signals that drive localized fluid extravasation and vascular changes.


Interference with Pain and Temperature Regulation

Beyond COX, the mechanism also involves inhibition of the Lipoxygenase (LOX) pathway, which reduces the formation of inflammatory leukotrienes, and anti-activity against the pain-inducing peptide Bradykinin. Furthermore, the drug acts centrally in the hypothalamus by reducing the PGE2 signal that elevates the body's internal thermostat. This dual action results in peripheral nociceptor desensitization and resets the central thermoregulatory set-point.


Role of the Lysine Salt Formulation

Ketoprofen Lysine Salt is an optimized formulation where the Lysine component serves to greatly enhance the water solubility of the drug. This pharmacokinetic enhancement is crucial because it facilitates more rapid absorption, allowing the active Ketoprofen molecule to reach its COX and LOX targets more quickly. This pharmacokinetic modification results in a more rapid manifestation of the pharmacodynamic effect (enzyme inhibition).

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Dosage and Administration Information

The administration of Ketoprofen Lysine Salt is based on precise instructions that define the route, frequency, and duration of use for the approved formulations. The medicine is available for both oral systemic use (granules/powder for solution) and topical local use (oral spray solution).


Oral Systemic Administration

For oral use in adults, the standard single dose is one sachet (e.g., 25 mg Ketoprofen as Lysine Salt), which is intended for symptomatic relief and may be repeated up to two or three times a day as needed. A minimum interval of four hours must be observed between successive doses. The contents of the sachet are typically placed directly onto the tongue and swallowed or may be dissolved in water. The maximum intake is generally limited to three sachets in a 24-hour period for the 25 mg form.


Topical Local Administration

For local application, the 0.16% oral solution is administered by spraying onto the affected area within the mouth. The standard dose is typically two to four puffs per application, applied up to three times a day. A key procedural instruction for this route is that the solution must be directed toward the oral cavity and should not be swallowed.


Population Rules and Duration

Specific guidelines mandate dose adjustments for certain populations. For older adults, the recommended daily dose is lower, typically limited to one sachet per day. Furthermore, the product is not for use in children and adolescents, with specific labeling indicating exclusion for individuals under 14 or 18 years of age. Use of the medicine is generally confined to short-term management, and medical consultation is advised if use is required for more than 10 days.

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Recent Clinical Evidence

Research Evidence for Acute Pain Relief and Inflammation

The research base for Ketoprofen Lysine Salt (KLS) centers on short-term Randomized Controlled Trials (RCTs) exploring symptoms of mild to moderate acute pain (e.g., headache, toothache) and localized conditions like pharyngitis (sore throat). Studies examined changes in patient-reported pain intensity and objective signs of inflammation (e.g., swelling, redness) over short, defined time intervals. Findings describe patterns observed in measured changes in discomfort, typically focusing on the initial shift and duration of relief. This evidence reflects acute conditions and does not determine whether an individual will respond similarly to the group patterns observed.

Studies on the Formulation and Specific Populations

Pharmacokinetic (PK) studies in healthy adult volunteers specifically examined the Lysine salt formulation. Data show patterns related to absorption, with KLS associated with a faster time to reach peak blood concentration (Tmax) compared to the standard acid form. This finding helps contextualize the speed of absorption but does not translate directly into a specific clinical difference over all other available analgesics. Research has also evaluated KLS in children and adolescents (e.g., 6–18 years) for acute symptoms. Findings indicate that the observed patterns in short-term pain relief were similar to those seen in the adult population.

Long-Term Data and Research Gaps

The majority of the research is structured around acute, short-duration episodes. While the research provides insight into short-term changes, the follow-up durations were limited. Long-term effects for recurrent or continuous daily use are not well established in the available literature. Furthermore, data for specific patient groups, such as those with significant pre-existing health conditions, remain insufficient. The evidence describes group patterns, and certainty regarding sustained treatment and long-term effects is limited.

Key Studies & References

  1. Public Assessment Report Scientific discussion Okitask 25 mg granules (ketoprofen (as lysine salt))
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Frequently Asked Questions (FAQ)

Common questions about Oki Inflammazione e Dolore (FAQ)

Q: How quickly does Oki Inflammazione e Dolore typically start to work?

Official product information describes the active ingredient, Ketoprofen Lysine Salt (KLS), as being formulated to promote rapid absorption into the body. Studies on similar immediate-release forms of the drug describe initial pain relief occurring within 30 minutes in some participants following an oral dose.

Q: What is the expected duration of the effects of Oki Inflammazione e Dolore?

The administration schedule for the oral dose form requires a minimum of four hours between successive doses. This dosing instruction is consistent with studies where pain relief persisted for up to six hours in certain groups of participants.

Q: What are the signs of an allergic reaction to Oki Inflammazione e Dolore?

Safety information notes that signs of a severe allergic reaction to the medicine may include symptoms like hives, swelling in the face or throat, and difficult breathing. Serious skin reactions, such as blistering or peeling skin, are also documented. The appearance of these signs is noted in regulatory information as requiring medical assistance.

Q: Is Oki Inflammazione e Dolore effective for joint pain that is not injury-related?

The active ingredient, Ketoprofen, is officially indicated for the relief of symptoms related to mild to moderate pain and inflammatory conditions. This includes the management of painful symptoms associated with non-injury-related joint issues, such as osteoarthritis and rheumatoid arthritis.

Q: Are there different side effects for the Oki Inflammazione e Dolore mouthwash compared to the tablets?

The most significant systemic risks, such as gastrointestinal and cardiovascular safety concerns, are primarily related to the oral dosage form. Official documents for the local oral spray solution mention a different kind of side effect: an inactive ingredient (excipient) has the potential to cause nausea or diarrhea if the solution is swallowed accidentally.

Q: Can Oki Inflammazione e Dolore be taken with food to reduce stomach issues?

Regulatory safety information indicates that the medicine may be taken alongside food or milk, which is often done to help prevent stomach upset. It is noted that taking the drug with food may, however, slightly slow the rate at which the active ingredient is absorbed into the body.

Q: Can the Oki Inflammazione e Dolore mouthwash or spray be swallowed accidentally without harm?

Official procedural instructions describe that the oral spray solution is intended for local application and is not to be swallowed. Regulatory documents indicate that if the solution is ingested accidentally, an inactive ingredient (excipient) in the formulation is documented as potentially causing side effects such as nausea or diarrhea.

Q: What is the risk of overdose associated with Oki Inflammazione e Dolore?

Official safety documents list observed symptoms associated with an overdose, which include general effects like drowsiness, vomiting, and abdominal pain. In cases of severe overdose, more serious outcomes such as seizures or coma have been reported, and internal bleeding is possible.

Q: Does Oki Inflammazione e Dolore contain any sodium or sugar?

As with most medicines, specific Oki formulations contain a full list of inactive ingredients, known as excipients. The presence of compounds such as sodium or sugar is detailed within the excipient list provided in the official regulatory documentation for that specific product presentation.

Q: Is it possible to have an allergic reaction to the excipients (non-active ingredients) in Oki Inflammazione e Dolore?

Regulatory safety information for certain formulations of Ketoprofen Lysine Salt, such as some oral spray products, notes that an inactive ingredient, Methylparaben (E218), has the potential to cause allergic reactions. This information is separate from the documented allergy risk to the active ingredient itself.

Q: What should I do if the expected effect of Oki Inflammazione e Dolore does not occur?

Official labeling contains statements regarding when to consult a health professional. It is advised that a consultation is needed if symptoms persist or worsen during use. Furthermore, medical advice is recommended if the product is required for use beyond the typically short-term duration described, such as more than 10 days.

Q: Are there any known drug interactions specifically for the Oki mouthwash formulation?

Regulatory information for the local oral spray formulation of Ketoprofen Lysine Salt indicates that no specific interactions were reported when this local product was used at the same time as other topical or systemic (body-wide) drugs.

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How should Oki Inflammazione e Dolore be stored and disposed of?

How to Store and Dispose of Oki Inflammazione e Dolore?

This section outlines the official regulatory instructions for storing and disposing of Oki Inflammazione e Dolore, which contains Ketoprofen Lysine Salt.

Storage Conditions

Requirement Instruction
Temperature Store at room temperature, away from excess heat.
Environment Keep the product away from excess moisture; do not store in the bathroom.
Packaging Keep the medication in the container it came in and ensure it is tightly closed.
Safety The medicine must be kept out of the sight and reach of children.

Disposal Instructions

Dispose of unused or expired medication by following local community guidelines, such as utilizing drug take-back programs. Do not dispose of the medicine by flushing it down a toilet or pouring it down a drain, as this can contaminate the environment.

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

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