Relatene

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Relatene

Quick Facts

Property Description
Active ingredient Ketoprofen (INN)
Form Topical Gel
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General purpose Localized Pain and Inflammation Management
Origin Synthetic Compound

What Type of Medicine is Relatene?

Relatene is a commercial designation for a medicinal product featuring Ketoprofen as its therapeutically active ingredient. It is chemically classified as a Propionic acid derivative and belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) pharmacological class. Ketoprofen is recognized for its anti-inflammatory properties, a key characteristic of this drug class.

Ketoprofen is a synthetic compound, manufactured in a laboratory setting. This chemical designation places it within the same broad class as other Propionic acid derivatives, confirming its fundamental molecular structure and established function as a pharmacotherapeutic agent. The brand Relatene is positioned primarily for adult and adolescent use, targeting the localized relief common with topical formulations.

Composition, Form, and General Purpose

Relatene is formulated as a topical preparation, typically supplied as a gel designed for cutaneous application to the skin. This product is a single-agent product, containing only Ketoprofen dissolved within its gel base. Topical NSAIDs are used for the symptomatic treatment of localized pain and swelling.

The specific formulation of Relatene as a gel ensures that it is intended for targeted pain relief and inflammation management. For example, it is typically used for managing the discomfort associated with minor muscle or tendon strain. The general therapeutic purpose is to achieve an analgesic effect precisely where the product is applied, allowing the active component to be concentrated in the underlying soft tissues, which is a key differentiating feature compared to oral NSAID forms.

What side effects are possible with Relatene?

Possible Side Effects and Safety Information

The official safety information for Relatene (topical ketoprofen) is focused primarily on documented reactions at the application site and specific constraints related to light exposure.

Adverse Reaction Classifications

Adverse reactions are classified by frequency according to regulatory standards:

  • Uncommon (ge 1/1,000 to < 1/100): Includes local skin reactions such as pruritus (itching), erythema (redness), rash, burning sensation, and localized eczema.
  • Rare (ge 1/10,000 to < 1/1,000): The primary concern in this category is photosensitisation (increased sensitivity to sunlight), which can lead to severe reactions. Urticaria is also documented.
  • Very Rare (< 1/10,000): Systemic effects such as aggravation of pre-existing renal insufficiency or acute renal failure are reported in this category.
  • Not Known: This classification applies to serious immune reactions like anaphylactic shock and angioedema, as well as severe cutaneous reactions, including Stevens-Johnson Syndrome (SJS).

Safety Constraints and Population-Specific Notes

The safety profile includes specific limitations. The medicine is contraindicated during the third trimester of pregnancy due to potential fetal toxicity, and its safety has not been established in the paediatric population. The risk of photosensitisation is explicitly documented to increase over time and may persist for a period after the medicine is discontinued. Therefore, regulatory documents state the treated area must be strictly shielded from sun or UV light exposure during treatment and for two weeks following the last application. Caution is advised for individuals with existing cardiac, hepatic, or renal impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose from the intended cutaneous application of Relatene (Ketoprofen Gel) is classified in regulatory documents as unlikely, owing to low systemic absorption. However, the official overdose profile addresses the high-risk scenario of accidental oral ingestion of the gel, which results in systemic exposure typical of a Nonsteroidal Anti-Inflammatory Drug (NSAID) overdose.

Documented Manifestations and Severe Outcomes

Systemic toxicity manifestations documented in regulatory sources include nausea, vomiting, stomach pain, dizziness, headache, confusion, and tinnitus. Application of excessively large amounts topically may also result in systemic effects such as hypersensitivity or isolated renal affections. Severe outcomes warned against in official labeling include seizures, coma, massive internal bleeding, and acute renal failure. Regulatory information notes that the elderly population is at greater documented risk for serious gastrointestinal events following systemic exposure.

Emergency Action Mandate

  • In the event of accidental oral ingestion of the gel or if severe systemic symptoms are present, individuals must seek immediate medical attention or contact a poison control center.
  • No specific antidote is known for Ketoprofen overdose. Treatment is strictly defined as symptomatic and supportive, involving procedures like activated charcoal administration, gastric lavage, and monitoring of vital signs and laboratory parameters.

Therapeutic Uses of Relatene

What Relatene Treats: Main Uses and Benefits

Relatene, which contains the topical Nonsteroidal Anti-Inflammatory Drug (NSAID) Ketoprofen, is commonly used to help with symptoms related to inflammatory or irritative states. Topical formulations of this ingredient are relevant across various conditions marked by increased discomfort or tension.

This medication is generally applicable within clinical settings that involve acute or disruptive symptom patterns, and may assist with symptoms linked to conditions such as muscle strains, sprains, contusions, tendinitis, bursitis, and localized osteoarthritis pain. The overall therapeutic benefit provides support that contributes to easing the overall symptom load confined to a specific area.

Quick Facts: Symptomatic Domains

Symptom Axis Therapeutic Context
Symptoms related to physical discomfort Used for managing acute or disruptive episodes
Symptoms that interfere with daily functioning Applied in scenarios where additional management of discomfort is required

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Relatene — Official Regulatory Information

The official eligibility profile for Relatene is strictly defined by governmental regulatory documents, outlining populations for whom use is prohibited, restricted, or not established.

Regulatory Status Description
Contraindicated Populations Use is absolutely prohibited for individuals with a known hypersensitivity reaction to Relatene or any excipients, and for patients with active severe gastrointestinal bleeding or mechanical gastrointestinal obstruction.
Age-Related Rules Use in children and adolescents (under 18 years) is not established and is typically excluded due to insufficient regulatory data on safety and efficacy in this age group.
Specific Organ Impairment Patients with severe hepatic or severe renal impairment are subject to restricted or conditional use. Eligibility for these groups must be carefully assessed and may result in exclusion based on the specific organ function status documented in the label.
Pregnancy and Lactation Use of Relatene is not recommended during the third trimester of pregnancy or while breastfeeding, as defined in the official regulatory documentation's Use in Specific Populations section.

Only adult patients without these documented absolute contraindications, organ function limitations, or physiological exclusions fall within the primary population for authorized use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Relatene (topical Ketoprofen) around specific prohibitions and documented additive risks, focusing on potential cumulative systemic burden and mandatory local restrictions.

Documented Interaction Restrictions

Classification Interacting Entity Regulatory Constraint
Mandatory Contraindication Natural Sunlight / UV Light Treated skin areas are strictly prohibited from exposure to UV light or sunbeds during application and for a mandatory two-week period following discontinuation.
Hypersensitivity Prohibition Aspirin / Other NSAIDs Use is prohibited in patients with a history of hypersensitivity reactions to Aspirin or any Nonsteroidal Anti-Inflammatory Drug.

Pharmacodynamic and Exposure Interactions

Co-administration with other systemic or topical NSAIDs carries a potential for additive adverse effects, increasing the overall risk of systemic reactions related to the kidney and gastrointestinal tract. This reflects a formal regulatory caution regarding cumulative NSAID class exposure. Co-use with anticoagulants (such as Warfarin) or antiplatelet agents may also result in additive antiplatelet effects, which can increase bleeding risk. Furthermore, NSAIDs may increase the plasma concentration of Lithium and potentially diminish the therapeutic effect of ACE Inhibitors, ARBs, or Diuretics.

Substance Interaction Notes

Regulatory notes indicate that concomitant consumption of alcohol or use of tobacco smoking may enhance the risk of gastrointestinal side effects. These interactions are noted as increasing the severity of adverse effects associated with the systemic absorption of NSAIDs. The potential for these interactions to lead to serious outcomes is considered heightened in the elderly and in patients with pre-existing reduced heart, liver, or renal function.

Mechanism of Action

Molecular Targeting and Enzyme Inhibition

This mechanism centers on the reversible inhibition of Cyclooxygenase (COX) enzymes, primarily the COX-2 isoform, which is relevant to acute tissue responses. By competitively binding to the active site, the drug prevents the conversion of Arachidonic Acid into prostaglandins, which are potent biological mediators. This initial molecular step modifies the early stages of the Arachidonic Acid cascade, which initiates the subsequent molecular and cellular consequences.


Mechanistic Cascade and Mediator Modulation

The consequence of blocking COX-2 is a reduction in the local synthesis of Prostaglandin E2 (PGE2). This reduction modifies the biological environment in the damaged tissue by limiting the signals that promote vasodilation and increased capillary permeability. The resulting physiological effect is the modulation of the local chemical response, which results in a state of decreased prostaglandin-mediated activity within the targeted physiological pathways.


Modulation of Peripheral Nociceptive Signaling

This domain addresses how the change in chemical mediators influences nociceptive signal transduction. The decreased concentration of PGE2 directly decreases the chemical sensitization of peripheral nerve endings (nociceptors). The overall action functions to decrease the concentration-dependent effect of specific mediators, thereby influencing the afferent nociceptive signaling system and lowering the overall excitability threshold of local sensory nerves.

Dosage and Administration Information

How to Use Relatene

Relatene, which contains the active ingredient Ketoprofen in a topical gel formulation, is administered solely for cutaneous use, meaning it is applied directly to the skin. The official usage instructions establish specific parameters for application, frequency, and duration of the course.

Official Administration Guidelines

Feature Guideline
Route of administration Cutaneous use (Topical application to the skin).
Standard Dose Apply approximately 2 to 4 g of gel (a strip about 5 to 10 cm long) per application.
Frequency and Timing Apply two to four times daily to the affected area.
Maximum Daily Dose The total quantity of gel applied must not exceed 15 g per day.
Treatment Duration Use should be limited to the shortest duration necessary, not exceeding 7 to 10 days.

Administration Method and Constraints

Application involves performing a gentle and prolonged massage of the gel onto the painful or inflamed surface to aid penetration. Immediately after applying the gel, it is mandated that users wash hands thoroughly to prevent the transfer of the product to other areas. Guidelines also explicitly state that the product must not be applied to mucous membranes, eyes, or open wounds, nor should it be used with occlusive dressings.

Population-Specific Rules

Dosing recommendations may vary by population. For older adults, the use of the lowest effective dose is generally advised. The use of Relatene is not recommended for children and adolescents under 12 or 15 years, as sufficient data on safety and efficacy for these groups have not been established.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Relatene

This overview summarizes the formal clinical research that has been conducted on the topical formulation of ketoprofen, the active ingredient in Relatene. The focus here is on the types of studies that exist, the populations they included, and the aspects of the medicine that are well-characterized versus those that remain uncertain, as described in formal clinical research.


Evidence for Acute Musculoskeletal Pain

The research landscape includes studies exploring conditions associated with acute or disruptive episodes, such as minor muscle strains, ligament sprains, and tendinitis. The evidence base for this research domain primarily features Randomized Controlled Trials (RCTs). These short-term trials were typically double-blinded, comparing the active gel formulation against a drug-free vehicle (a placebo gel) and then reporting on patterns observed during the study period.

The studies monitored patient-reported outcomes describing perceived discomfort and measured daily functioning or activity level during the first few days and weeks after an injury. The evidence contributes to the broader evidence landscape for how symptoms evolve during short-term injuries.


Evidence for Chronic Localized Joint Pain

The topical formulation was studied in research exploring conditions characterized by fluctuating or episodic manifestations such as localized symptoms from osteoarthritis. This research monitored symptoms over a longer duration than acute injury studies, typically through intermediate-term RCTs lasting several weeks. These studies monitored outcomes linked to inflammatory or irritative states in joints like the knee.

Researchers used standardized questionnaires to measure outcomes related to physical discomfort and functional limitations in older adults with a diagnosis of mild-to-moderate osteoarthritis. Some trials described instances where the drug-free vehicle itself was observed in some studies to result in reported changes in symptoms.


Research Gaps and Uncertainty

The research helps show what has been observed so far, but like all medicine research, areas of uncertainty remain in the evidence base:

  • Long-Term Effects: Long-term effects are not fully established regarding the sustained symptomatic changes or the durability of the observed responses after continuous use over many months or years.
  • Comparative Evidence: Comparative evidence is lacking in large-scale studies that directly compare the symptomatic changes resulting from the topical formulation versus oral anti-inflammatory medicines.
  • Anatomical Consistency: Findings describe different patterns regarding the application to different anatomical sites. Uncertainty exists due to challenges in ensuring the concentration reaches deeper structures, such as in certain instances of back pain.

Frequently Asked Questions (FAQ)

Common questions about Relatene (FAQ)

Q: What is the main condition Relatene is officially approved to treat?

A: Official documents describe the approved indication as the symptomatic relief of localized pain and inflammation. This includes use for conditions such as soft tissue injuries like sprains and strains, as well as musculo-tendonitis and localized rheumatic pain.

Q: Are there any regulatory black box warnings associated with Relatene?

A: The class of medicines that Relatene's active ingredient belongs to carries a US FDA Boxed Warning. This warning highlights the potential for serious cardiovascular thrombotic events (such as heart attack and stroke) and serious gastrointestinal bleeding, which can be fatal.

Q: What does the manufacturer's patient information leaflet say about overdose symptoms?

A: Official patient information describes the possible symptoms of an overdose with the active ingredient. These symptoms can include extreme drowsiness, lack of energy, nausea, vomiting, stomach pain, shallow breathing, and seizures.

Q: What is the difference between taking Relatene with or without food?

A: Relatene is formulated as a topical gel that is applied directly to the skin for cutaneous use. Because it is not taken by mouth, the administration route makes the question of taking the medicine with or without food not applicable.

Q: Why does Relatene have the potential to cause [common side effect]?

A: Relatene contains Ketoprofen, which belongs to the NSAID class of medicines. The way it reduces pain and inflammation is by blocking certain enzymes in the body. This process is central to both the desired effect and the potential for a range of side effects associated with all medicines in this class.

Q: Is Relatene safe for use in older adults (seniors)?

A: Official warnings state that caution is advised with the medicine in older adults. Regulatory guidance describes the use of the lowest effective dose for the shortest period of time necessary. This is because seniors may have a potentially higher risk of experiencing adverse events associated with NSAIDs.

Q: Can taking Relatene make someone feel [specific non-serious mood change]?

A: Official adverse event lists for the active ingredient indicate that central nervous system effects are possible. These have included reports of nervousness, dizziness, and difficulty falling asleep (insomnia).

Q: Does Relatene contain any ingredients that are known allergens (e.g., lactose, gluten)?

A: Regulatory documents for the medicine include a full list of all active and inactive ingredients (excipients). Official guidance specifies that the medicine must not be used if there is a known allergy or hypersensitivity to any of these listed ingredients.

Q: How quickly can someone generally expect the effects of Relatene to start working?

A: Clinical data for the topical formulation suggests that the active ingredient may have a short lag time before reaching effective concentrations in the targeted soft tissues. However, official information does not provide a precise time frame or single number for when a person may start feeling pain relief.

Q: Does Relatene cause drowsiness or affect the ability to drive?

A: Official warnings state that possible side effects can include drowsiness and dizziness. Because of this, official documents describe that caution may be necessary regarding activities that require full mental alertness, such as driving or operating heavy machinery.

Q: How long does the effect of a single dose of Relatene typically last?

A: The rate at which the active ingredient is processed by the body is generally determined by its elimination half-life, which is approximately 2 to 4 hours. Topical application is designed to provide sustained local concentrations of the medicine in the skin and underlying tissues.

Q: What is the purpose of the 'inactive ingredients' listed in Relatene?

A: Inactive ingredients, also called excipients, are essential components of the product formulation. Their purpose is to create the gel structure, help the skin absorb the active medicine, and ensure the overall stability and preservation of the product.

Q: How long does it take for Relatene to be completely eliminated from the body?

A: The elimination of the medicine from the body is based on the half-life of its active ingredient, Ketoprofen. This process generally means the body reduces the amount of the drug by half approximately every 2 to 4 hours.

Q: Are there any specific requirements for dispensing or prescribing Relatene?

A: Official regulatory information includes specific dispensing requirements for pharmacists. These often specify that the product must be stored in a tight, light-resistant container and that a child-resistant closure must be used.

Q: Does Relatene have a patient guide or medication guide from the FDA or similar agency?

A: Due to its classification, the medicine is accompanied by comprehensive Prescribing Information and/or a Medication Guide from regulatory bodies. These documents provide the patient-friendly, official summary of key safety details and usage information.

Q: What does the research say about Relatene's use in people with high blood pressure?

A: Regulatory documents for NSAIDs contain warnings that these products can potentially lead to new onset high blood pressure or worsen existing hypertension. Official guidance indicates that close blood pressure monitoring is relevant at the start of treatment and throughout the therapy.

How should Relatene be stored and disposed of?

How to Store and Dispose of Relatene?

Storage & Disposal Entity Official Regulatory Requirement
Storage Temperature Store at a temperature below 30 C or not exceeding 25 C
Environmental Protection The product must be protected from light and kept in its original container
In-Use Stability The product, once opened, must typically be used within one month (4 weeks)
Container Rule The container must be kept tightly closed after each use
Child Safety The medicine must be kept out of the sight and reach of children
Disposal Rule Do not dispose of via wastewater or household waste; consult a pharmacist for local disposal

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

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