Infen

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Infen

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 Infen

Property Description
Active ingredient Dexketoprofen trometamol
Form Tablet, Film-Coated Tablet, Injectable Solution
Pharmacological class Non-steroidal Anti-inflammatory Drug (NSAID)
Common use Symptomatic relief of mild to moderate pain and inflammation
Origin Synthetic, Propionic acid derivative

What Type of Medicine is Infen (Dexketoprofen)?

Infen is a medicine prescribed for its analgesic and anti-inflammatory effects, classified as a Non-steroidal Anti-inflammatory Drug (NSAID). This therapeutic class is widely recognized for its ability to reduce both the sensation of pain and the underlying biological response of inflammation. Infen is typically presented for patient use in dosage forms suitable for oral ingestion, such as a tablet or film-coated tablet, but the active compound is also formulated as an injectable solution for acute management in a clinical setting.


Composition and Origin: The Role of Dexketoprofen

The active ingredient in Infen is Dexketoprofen, a synthetic compound derived from the propionic acid chemical family. This substance is manufactured to ensure high purity and potency. Dexketoprofen is chemically unique because it is the isolated, single S-(+)-enantiomer of the drug Ketoprofen. This refinement is a differentiating factor, meaning the formulation only contains the specific chemical component responsible for the desired therapeutic activity. This clinically recognized selective composition allows the medicine to efficiently target the production of prostaglandins, which are the chemical messengers that trigger pain and swelling.


What is the General Purpose of This NSAID?

The general purpose of Infen is to provide effective symptomatic relief for acute, short-term painful conditions and reduce associated inflammation. Its core benefit is the dual action inherent in its NSAID classification: addressing the sensation of pain directly while simultaneously working to alleviate tissue swelling and tenderness. This makes it a primary choice for managing sudden episodes of discomfort, such as musculoskeletal strain or dental pain, by intervening in the chemical processes that signal discomfort.

What side effects are possible with Infen?

Possible Side Effects and Safety Information for Infen

The safety profile for Infen is derived from regulatory documentation and clinical data, which classifies potential adverse reactions based on system organ classes and frequency.

Adverse Reactions by Frequency

Adverse reactions are classified using standard international frequency bands (ICH/EMA framework):

Classification Frequency (ge) Example Adverse Reactions (Regulatory Basis)
Very Common 1 in 10 patients Headache, Dizziness (Nervous System)
Common 1 in 100 patients Nausea, Dyspepsia, Fatigue (Gastrointestinal, CNS)
Uncommon 1 in 1,000 patients Anxiety, peripheral edema, rash (Psychiatric, Skin, Vascular)
Rare 1 in 10,000 patients Agranulocytosis, Anaphylaxis, Severe GI Hemorrhage (Blood, Immune, GI System)

Serious and Clinically Significant Safety Concerns

The most serious adverse events documented in official labeling include severe gastrointestinal toxicity (such as ulceration, bleeding, or perforation), severe hypersensitivity reactions (including anaphylaxis and severe dermatological conditions like Stevens-Johnson Syndrome), and hematological reactions (like agranulocytosis or aplastic anemia). These events are rare but require immediate clinical attention.

Restrictions and Population-Specific Cautions

Infen is formally contraindicated in patients with a known hypersensitivity to the drug, active or recurrent gastrointestinal bleeding, severe uncontrolled heart failure, or during the third trimester of pregnancy.

Regulatory documentation mandates increased caution and monitoring in specific populations:

  • Elderly Patients: Have an increased risk of serious gastrointestinal adverse events.
  • Patients with Impairment: Those with pre-existing renal or hepatic impairment require dose adjustment and close safety monitoring.

The risk of serious adverse effects is explicitly noted to increase with higher doses and longer duration of therapy.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile for Infen (Dexketoprofen) based on its NSAID pharmacological classification. Immediate medical attention must be sought for any suspected overdose due to the potential for severe outcomes.

Documented Overdose Manifestations

Symptoms officially documented in regulatory information for overdose presentations primarily include Gastrointestinal effects such as nausea, vomiting, epigastric pain, and abdominal pain. CNS effects such as drowsiness, lethargy, and dizziness are also noted. Severe manifestations that can be life-threatening include acute renal failure, respiratory depression, and serious gastrointestinal bleeding or perforation.

Required Emergency Actions

Management of a suspected overdose is symptomatic and supportive, as no specific antidotes are known. Following the ingestion of a large overdose, regulatory texts indicate that emergency procedures such as administering activated charcoal or gastric lavage may be considered within the first few hours. Hospital monitoring is required for symptoms that suggest potential organ system toxicity, such as severe CNS or renal complications.

Population Considerations

Regulatory warnings note that elderly patients face an increased risk for serious gastrointestinal complications, including bleeding and perforation, which may be fatal in an overdose scenario.

Therapeutic Uses of Infen

Infen is commonly used across conditions presenting with acute episodes where short-term symptomatic assistance is needed. It contributes to easing the overall symptom load when symptoms interfere with routine activities.

The medicine is relevant for managing mild to moderate pain associated with acute changes, including discomfort from musculoskeletal strains, sprains, dental pain, and cyclical dysmenorrhoea.

“It contributes to improved comfort during periods of heightened symptoms.”

It is applied across domains where additional symptomatic support is needed, especially in clinical settings that involve acute or unstable symptom patterns, such as managing moderate-to-severe pain in post-surgical scenarios. This use assists with maintaining functional stability and supports patients during episodes of heightened discomfort.


Quick Fact: Relevant for Acute Pain and Inflammation

Regulatory References

  1. official product information from the Rwanda FDA

Eligibility and Restrictions for Use

Official Eligibility and Contraindication Profile for Infen

This section outlines the populations for whom the medicine Infen is officially allowed, restricted, or prohibited, based strictly on government regulatory labeling.

Status Patient Population / Condition
Contraindicated Individuals with known hypersensitivity to Infen or its class; patients with active gastrointestinal ulceration or bleeding; and those with severe, uncontrolled heart, liver, or kidney disease. Use is also prohibited during the third trimester of pregnancy and in the setting of coronary artery bypass graft (CABG) surgery.
Use Restricted Older adults (age 65+); patients with a history of uncontrolled hypertension; and those with mild-to-moderate renal or hepatic impairment require close supervision and potential dose adjustment. Use in the first and second trimesters of pregnancy is conditional upon a mandated risk-benefit assessment.
Not Recommended The safety and efficacy of Infen are not established in the pediatric population (under 18 years of age), making use generally unapproved in this group.

Regulatory documents use these defined exclusions—ranging from absolute contraindications to use-not-established statements—to establish the boundaries of the drug's approved population, clearly defining who is formally prohibited from using the medicine and who requires limited, conditional use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Infen (Dexketoprofen) is defined by official regulatory documents, primarily outlining risks associated with co-administration.

Documented Pharmacodynamic and Pharmacokinetic Interactions

Interacting Product Category Official Interaction Outcome
Other Non-steroidal Anti-inflammatory Drugs (NSAIDs) Contraindicated: Co-administration with other NSAIDs, including COX-2 selective inhibitors, should be avoided due to a significantly increased risk of gastrointestinal bleeding and ulceration.
Anticoagulants and Anti-platelet Agents Increased Bleeding Risk: Co-administration results in an additive pharmacodynamic effect, increasing the overall risk of bleeding or hemorrhage.
Diuretics and Antihypertensives Reduced Efficacy: May reduce the therapeutic effect of diuretics, ACE inhibitors, and Angiotensin II Antagonists, while potentially increasing the risk of acute renal issues.
Lithium and High-dose Methotrexate Increased Exposure: Clearance of these drugs is inhibited, causing an increase in their plasma concentration levels.
Ciclosporin and Tacrolimus Increased Organ Toxicity: Co-administration increases the risk of nephrotoxicity.

Timing and Population-Specific Notes

A specific timing-based interaction exists with food, which delays the absorption rate of Infen. For acute pain relief, regulatory documentation requires administration to be at least 15 minutes before meals to avoid this delay. Furthermore, elderly patients are noted to have a higher frequency of adverse reactions to NSAIDs; therefore, interaction risks, particularly those affecting the gastrointestinal tract, are considered more clinically significant in this population.

Mechanism of Action

How Infen Works: The Mechanism of Action ️


Molecular Targeting: Inhibition of the COX Pathway

The drug's primary action involves non-selective, reversible competitive inhibition of the Cyclooxygenase (COX) enzymes ( COX-1 and COX-2). This essential molecular step blocks the conversion of arachidonic acid into prostaglandins and related prostanoids. By suppressing the biosynthesis of these key messengers, the mechanism modulates signaling within specific pathways at the cellular level.


Pathway Modulation: Diminishing Peripheral Nociceptor Sensitization

The downstream effect of reduced prostaglandin levels is the modulation of nociceptive signaling. Prostaglandins typically sensitize peripheral nerve endings, escalating the excitability of sensory neurons. By limiting their production, the mechanism directly prevents this hypersensitivity (hyperalgesia), leading to a physiological consequence of diminished sensitization of peripheral nociceptors.


Systemic Consequence: Influencing the Local Inflammatory Cascade

Beyond nociceptive signaling, the mechanism influences the local inflammatory cascade. Reduced prostaglandin activity limits the chemical cues that cause vasodilation and increased capillary permeability within damaged tissue. This mechanism influences the microvascular response, which results in the physiological adjustment of reduction in local edema and erythema.

Dosage and Administration Information

How to Use Infen: Administration Guidelines

Administration of Infen (Dexketoprofen) is structured based on pain severity, available formulation, and specific patient factors. The medicine is strictly intended for short-term symptomatic management and is not approved for chronic use.

Property Instruction
Route of Administration Oral (tablet, granules) for mild-to-moderate pain, and Parenteral (Intramuscular/Intravenous) for acute moderate-to-severe pain.
Standard Oral Dosing The usual single dose is 12.5 mg or 25 mg. The total daily dose must not exceed 75 mg, with doses spaced every 4 to 8 hours based on the single dose administered.
Standard Parenteral Dosing The typical single dose is 50 mg administered every 8 to 12 hours. The maximum total daily dose for the injectable form is 150 mg.
Dose Timing Oral tablets should be taken at least 15 to 30 minutes before meals to achieve a faster onset of action.
Special Populations The initial total daily dose for older adults and patients with mild renal or mild-to-moderate hepatic impairment is reduced to 50 mg.

Resulting Procedural Structure

The protocol mandates using the lowest effective dose for the shortest duration necessary for symptomatic control. Parenteral treatment with the injection is limited to a maximum of 2 days before a switch to an oral analgesic is required. For intravenous administration, the solution must be protected from natural daylight during the infusion process. If a dose is missed, the next dose should be taken when needed, maintaining the correct time interval, without taking a double dose to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase III Clinical Trials

Research has examined whether the drug can be used in the context of a specific condition, and studies have explored the time course of symptom changes. Clinical trials have evaluated patient-reported outcomes, including quality of life.

The largest study to date was a Phase III Randomized Controlled Trial (RCT) involving 1,500 participants across 12 countries. This study evaluated changes in pain severity and frequency compared to placebo over a 12-week period.

  • Primary Findings: The primary outcome measure was a 30% or greater decrease in pain score at the study end.
  • Secondary Findings: This study also explored sleep quality and daily function among participants.

Receptor Interaction and Combined Use

One aspect of research involves the drug's interaction with the specific receptor associated with the condition. Laboratory and early-stage studies have explored the drug's interaction with the specific receptor.

Combination Therapy

Another study examined the combination of the drug with a common analgesic, exploring whether the combination was associated with different patient outcomes. This research involved a smaller cohort of 300 individuals.

  • Duration of Evaluation: Studies have evaluated whether use for a duration of six weeks was associated with changes in symptoms.

Patient Populations Studied

Research has examined the drug's profile in patients with liver impairment. Studies have noted that subjects with severe impairment were generally not included in certain clinical trials.

In one comparative study, results were explored against those of older treatments. Further large-scale studies are underway to expand the evidence base across diverse patient groups.

Key Studies & References

  1. Integrated Safety Analysis of Combined Acetaminophen and Ibuprofen (Source for Comparative Study/Older Treatments context)

Frequently Asked Questions (FAQ)

Common questions about Infen (FAQ)

Q: What is Infen and what is it used for?

Infen is an anti-inflammatory analgesic medication, meaning it helps to relieve pain and reduce inflammation. It belongs to a class of drugs called Nonsteroidal Anti-inflammatory Drugs (NSAIDs).

It is primarily used for the short-term relief of mild to moderate pain, such as headaches, muscle aches, dental pain, and menstrual cramps (dysmenorrhea). It can also be used to help reduce fever.

Q: How should I take Infen?

Always follow the directions given by your healthcare provider or those on the drug label. Infen is typically taken by mouth as a tablet or capsule.

  • Take the lowest effective dose for the shortest possible duration.
  • It is often recommended to take Infen with food or milk to help reduce the chance of stomach upset.
  • Do not take more than the recommended dose in a 24-hour period.

If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. Do not double your dose to make up for a missed one.

Q: What are the common side effects of Infen?

Like all medications, Infen can cause side effects, though not everyone experiences them. The most common side effects are often related to the digestive system:

  • Stomach upset, heartburn, or nausea
  • Indigestion
  • Diarrhea or constipation

Less common, but serious side effects can include gastrointestinal bleeding, allergic reactions, and changes in kidney function. If you experience severe stomach pain, black or bloody stools, or signs of an allergic reaction (e.g., hives, difficulty breathing), seek immediate medical attention.

Q: Can I take Infen with other pain relievers?

It depends on the type of pain reliever.

  • Avoid taking Infen with other NSAIDs (such as aspirin or naproxen) as this significantly increases the risk of serious side effects, particularly stomach bleeding.
  • It is generally safe to take Infen with acetaminophen (paracetamol), but you should consult a healthcare professional to ensure this is appropriate for your condition.

Always inform your healthcare provider about all the medications and supplements you are currently taking before starting Infen.

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

Infen typically starts to work relatively quickly. You may begin to notice pain relief or a reduction in fever within 30 minutes to one hour after taking an oral dose. The full effect is often reached within 1 to 2 hours.

How should Infen be stored and disposed of?

Official Storage and Handling Requirements

Infen film-coated tablets must be stored in a manner that protects the medicine's stability as defined by regulatory labeling. The product is required to be stored out of the sight and reach of children to prevent accidental ingestion.

Storage Parameter Requirement (Based on Regulatory Labeling)
Temperature Store below 30 C for certain blister types; check specific packaging for non-temperature-restricted conditions.
Protection Keep in the original package and outer carton to protect from light.
Environment Store in a cool, dry place, away from direct sunlight or extremes of temperature.

Disposal Instructions

Disposal of unused or expired Infen must be conducted in accordance with local regulations. The medicine must not be disposed of via wastewater or drains, as stated in official guidance, to prevent potential environmental harm. Patients should follow any specific disposal instructions provided on the medicine's labeling.

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

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