Флексен

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Флексен

Medically reviewed

Laura Arias

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 Флексен

Property Description
Active Ingredient Ketoprofen
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Origin / Type Synthetic, Propionic Acid Derivative
Primary Forms Capsule, Topical Gel, Suppository
General Purpose Relief of Pain, Inflammation, and Fever

Флексен: Definition and Pharmacological Classification

Флексен is a synthetic pharmaceutical product containing the active substance Ketoprofen and is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Its core purpose is to provide symptomatic relief by targeting inflammation, pain, and fever.

The molecule is chemically classified as a propionic acid derivative, a structure it shares with other widely known NSAIDs. This pharmacological identity confirms that Ketoprofen functions as a non-selective cyclooxygenase inhibitor, interrupting the formation of prostaglandins, which are crucial mediators of pain and inflammatory pathways. Pharmacological studies have clinically recognized Ketoprofen for its effective activity.

Active Ingredient, Forms, and General Therapeutic Purpose

The medicinal efficacy of Флексен relies entirely on the single active ingredient, Ketoprofen. This substance is made available in multiple pharmaceutical forms, including oral capsules (both immediate- and extended-release), topical gels for dermal application, and suppositories. The availability of a topical form, for instance, provides the option for localized relief that avoids systemic exposure.

The drug delivers a three-pronged effect that addresses general physical discomfort: it is an analgesic (pain-reliever), an anti-inflammatory agent to reduce swelling, and an antipyretic capable of normalizing elevated body temperature. This profile supports its general use in scenarios requiring the reduction of acute discomfort.

Origin and Nature of Ketoprofen

Ketoprofen is a purely synthetic compound, manufactured through established chemical processes, rather than being isolated from natural sources. It exists as a racemic mixture of two stereoisomers. Research supports that the R-enantiomer within this mixture undergoes a metabolic inversion within the body, converting it to the active S-enantiomer. This conversion process contributes to Ketoprofen's overall systemic therapeutic effect.

Regulatory References

  1. NIH LiverTox: Ketoprofen

What side effects are possible with Флексен?

Possible Side Effects and Safety Information

Flexen (ketoprofen) is a Nonsteroidal Anti-inflammatory Drug (NSAID) and carries risks common to this class of medication. Patients should be aware of potential adverse effects, which can range from common and mild to rare but serious.


Common Side Effects

The most frequently reported side effects involve the gastrointestinal (GI) system. These often include:

  • Dyspepsia (indigestion)
  • Nausea, Vomiting
  • Abdominal pain, Diarrhea, Constipation, Gas
  • Headache, Dizziness, Drowsiness, Nervousness
  • Tinnitus (ringing in the ears)
  • Edema (swelling, usually of the hands or feet) due to fluid retention

Serious Warnings and Risks

All NSAIDs, including ketoprofen, carry a warning regarding the risk of serious cardiovascular (CV) and gastrointestinal events.

System Serious Potential Risks
Cardiovascular Increased risk of heart attack and stroke, especially with high doses or long-term use. Contraindicated for pain right before or after coronary artery bypass graft (CABG) surgery.
Gastrointestinal Increased risk of severe GI bleeding, ulceration, and perforation, which can be fatal. This risk is higher in the elderly and those with a history of GI disease. Symptoms include black, tarry stools or vomiting blood.

Other Serious Adverse Effects

Nephrotoxicity (Kidney problems) and Hepatotoxicity (Liver problems) are possible, particularly with prolonged use. Symptoms of kidney issues may include decreased urination or swelling, while liver problems can manifest as persistent nausea, yellowing of the skin or eyes (jaundice), or dark urine.

Hypersensitivity reactions (Allergic Reactions) such as rash, severe itching, swelling of the face, or difficulty breathing require immediate medical attention. Ketoprofen is contraindicated in patients with a history of aspirin or other NSAID-induced asthma or allergic-type reactions.

Photosensitivity (increased sensitivity to sunlight) may also occur. Patients should limit sun exposure and use protective measures while taking this medication.

Overdose and Emergency Response

Overdose and when to seek help

The official overdose information for Флексен (Ketoprofen) strictly defines the symptoms to monitor for and the mandated actions to take. As there is no specific antidote for Ketoprofen overdose, prompt symptomatic and supportive care is required.


Documented Overdose Presentations

Official regulatory documents list two primary clusters of overdose manifestations:

  • Gastrointestinal Effects: These commonly include epigastric pain, nausea, vomiting, and the potential for gastrointestinal bleeding.
  • Central Nervous System (CNS) Effects: Manifestations may involve drowsiness, lethargy, lack of energy, and headache. In severe cases, seizures and coma have been documented.

Severe outcomes, such as acute renal failure, hypotension, and respiratory depression, are also specified in the regulatory labeling.


Required Emergency Actions

The regulatory guidance emphasizes immediate action in all suspected overdose situations:

Action/Condition Official Requirement (Label-Derived Phrasing)
General Overdose Contact the poison control center or seek medical attention immediately.
Life-Threatening Signs Seek medical attention immediately for symptoms such as chest pain, slurred speech, or weakness on one side of the body (signs of serious cardiovascular events).

Management is by symptomatic and supportive care, which requires continuous monitoring of vital signs. Procedures such as gastric decontamination with oral activated charcoal may be indicated following a large ingestion, as specified in the official documents.

Therapeutic Uses of Флексен

What Флексен Treats: Main Uses and Benefits

Флексен (Ketoprofen) is a supportive medication relevant across several key therapeutic domains where acute or chronic symptomatic relief is necessary. It is considered relevant in the symptomatic management of inflammatory joint diseases and various forms of acute pain and discomfort.

The medication is commonly used across conditions characterized by episodic or fluctuating symptom patterns, including Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, acute flares of gouty arthritis, as well as pain related to sprains, strains, tendinitis, or bursitis, and the severe cramping of primary dysmenorrhea. Флексен is applied in scenarios where additional management of discomfort is required, supporting general well-being during symptomatic phases.

“The medication plays a role in managing symptoms related to inflammatory or irritative states, assisting with maintaining a sense of stability when symptoms are more noticeable.”

Therapeutic Scope and Support

This approach helps address symptom clusters that may become intense or disruptive, such as those arising from musculoskeletal trauma or persistent rheumatic conditions. By moderating these manifestations, it supports patients during difficult episodes by easing distress and may assist with maintaining functional stability when symptoms interfere with routine activities. It is frequently applied during phases when symptoms become more noticeable, offering supportive relief when short-term symptomatic assistance is needed.

Quick Fact: Relief for Acute and Chronic Discomfort The overall therapeutic benefit contributes to easing the overall symptom burden in conditions involving both acute pain (like injury or headache) and chronic inflammatory conditions (like arthritis).

Regulatory References

  1. NIH MedlinePlus guidance on Ketoprofen

Eligibility and Restrictions for Use

Who can and cannot use Флексен (Ketoprofen): Official Regulatory Information

The eligibility for Флексен (Ketoprofen) use is defined by specific regulatory criteria, establishing both absolute contraindications and requirements for restricted use.

Category Official Regulatory Status
Populations Contraindicated Hypersensitivity to Ketoprofen, aspirin, or other NSAIDs (including aspirin-induced asthma). Active GI bleeding/ulceration. Peri-operative pain in the setting of CABG surgery. Third trimester of pregnancy (from 30 weeks gestation onward).
Populations with Restrictions Older Adults (ge 65 years): Use requires caution and monitoring due to increased risk of serious adverse events. Preexisting CV disease/Hypertension: Use should be approached cautiously due to risks of thrombotic events and fluid retention. Impaired Renal/Hepatic Function: Requires close monitoring, as drug clearance is altered, and use is contraindicated in severe renal impairment.
Age-Related Status Adults are the approved population for established uses. Pediatric Population: Safety and efficacy have not been established (e.g., for children under 16 years).
Pregnancy Status Contraindicated in the third trimester. Use is recommended to be avoided from 20 weeks gestation onward.

Connection to the overall eligibility profile:

Regulatory documents strictly define who can and cannot use Флексен by establishing non-negotiable contraindications (absolute exclusions based on hypersensitivity, cardiovascular risk post-surgery, active GI pathology, and late-stage pregnancy) and specific conditional use requirements for populations with organ impairment or cardiovascular risk factors. These rules solely determine population eligibility and non-eligibility status.

What should I know about interactions with other medicines?

The official regulatory profile for Флексен (Ketoprofen) documents interaction patterns across several major medicinal classes.

Interaction-Related Restrictions

Co-administration with Probenecid is not recommended as it officially reduces the plasma clearance of Ketoprofen to about one-third, resulting in increased systemic exposure. Concurrent use with other NSAIDs (including COX-2 inhibitors) is generally not recommended due to the potential for increased gastrointestinal adverse events.

Pharmacokinetic and Pharmacodynamic Effects

The product may reduce the renal clearance of both Lithium and Methotrexate, which is documented to lead to elevated serum levels and increased toxicity of those drugs. A synergistic risk of serious gastrointestinal bleeding is officially established when Флексен is combined with Anticoagulants (e.g., Warfarin), Antiplatelet Agents, Corticosteroids, or SSRIs.

Additionally, the drug may diminish the antihypertensive effect of ACE-inhibitors and reduce the natriuretic effect of Diuretics.

Substance and Population Notes

Administration with food is documented to reduce the maximum plasma concentration (C max) and double the time to reach it (T max). The official label notes that Alcohol and Tobacco use increase the risk of gastrointestinal bleeding or adverse effects. Elderly patients are classified as being at a greater risk for GI bleeding complications, and the drug’s half-life officially increases in this population due to physiological changes in clearance.

Mechanism of Action

Enzyme Inhibition and Cascade Control

The primary mechanism of Флексен is the reversible, non-selective inhibition of the cyclooxygenase ( COX) enzymes ( COX-1 and COX-2). By blocking these enzymes, the drug restricts the conversion of Arachidonic Acid into prostaglandins, which are key molecular mediators involved in nociceptive and localized physiological responses. This molecular interference initiates a cascade that modifies the intensity of local physiological responses, resulting in attenuation of nociceptor sensitization and modification of local vascular permeability.

Central Nervous System Modulation

In addition to its peripheral effects, the drug’s mechanism involves direct action within the Central Nervous System (CNS), modulating the descending pain pathways and central thermoregulatory center. The inhibition of prostaglandin synthesis in the hypothalamus allows the body's elevated thermal set point to undergo modulation. This central activity, coupled with potential modulation of serotonergic pathways, provides an additional influence on nociceptive signal processing, alongside the peripheral effect of eicosanoid blockade.

Non-Eicosanoid Anti-Destructive Activity

Флексен also engages in a COX-independent mechanism by stabilizing lysosomal membranes within inflammatory cells, such as neutrophils. This cellular-level mechanism limits the uncontrolled release of destructive hydrolytic enzymes into surrounding tissues, which occurs during periods of heightened localized physiological response. This activity modifies the potential for localized enzyme-mediated tissue effects and self-amplification that can occur during such physiological responses.

Dosage and Administration Information

How to Use Флексен (Ketoprofen): Administration Guidelines

Administration of Флексен is governed by standard instructions specifying the approved routes, dosing ranges, and mandatory procedural conditions. The medication is available in two primary formats: oral capsules (Immediate-Release and Extended-Release) for systemic delivery and a topical gel for cutaneous application.


Dosing and Frequency Patterns

The usage pattern for Флексен emphasizes the principle of using the lowest effective dose for the shortest duration necessary.

Format & Condition Typical Dosing Regimen Maximum Daily Dose
Oral IR Capsules (Chronic) 50 mg four times a day (QID) or 75 mg three times a day (TID) 300 mg
Oral ER Capsules (Maintenance) 200 mg once daily (QD) 200 mg
Topical Gel 2 to 4 applications per day 15 g

Administration Conditions and Constraints

Oral capsules may be taken with food, milk, or antacids to lessen potential gastrointestinal discomfort, though this may slow the rate of absorption. Extended-release capsules are designed to be swallowed whole and must not be crushed or chewed to preserve their controlled release profile. For the topical gel, application requires gentle massage into the affected area, and the gel must be kept away from the eyes, mucous membranes, and occlusive dressings.

Population-Specific Adjustments are mandatory in certain cases; for instance, older adults or patients with severe renal or hepatic impairment should be initiated at a lower dose, and their maximum daily oral intake may be constrained to 100 mg/day.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Флексен

Information about Флексен (Ketoprofen) is derived from the official clinical evidence, which includes findings from randomized controlled trials (RCTs), systematic reviews, and meta-analyses. The available evidence is primarily derived from studies exploring conditions characterized by fluctuating or episodic manifestations of pain and inflammation. The available evidence contributes to understanding symptom patterns and short-term changes.


Evidence Base for Inflammatory Joint Conditions

Research involving the compound for Osteoarthritis (OA) and Rheumatoid Arthritis (RA) has used short-term RCTs, with trials covering both oral and topical formulations. These studies monitored adult populations, assessing patient-reported outcomes related to physical discomfort, pain intensity, and daily functioning.

Studies reported measurements of patient-reported outcomes during short-to-intermediate observation periods, typically up to 12 weeks. Findings describe patterns observed related to the symptomatic phases of these conditions. Uncertainty exists regarding the implications of long-term use and the sustained symptomatic changes over many months in chronic joint conditions.


Research on Acute Pain and Injury Management

Studies focused on the compound in acute, time-limited conditions, such as soft tissue injuries (sprains/strains) and primary dysmenorrhea (menstrual pain). These are generally short-term RCTs that measured outcomes capturing phases of heightened symptom activity, such as the time to report changes in pain intensity.

Research provides insight into short-term changes during the acute symptomatic phase. Data for long-term recovery rates following acute injury, or the effects of use across multiple years for dysmenorrhea, remain limited in the existing body of evidence.


Research in Specific Patient Groups and Evidence Gaps

Research has explored studies involving older adults, noting their inclusion in general study populations, though specific subgroup findings are often limited. For children and adolescents, evidence exists in certain contexts, such as studies evaluating short-term responses to pain and fever following minor surgical procedures, but data remain insufficient for many groups.

Overall, long-term effects are not fully established for continuous use in chronic conditions, as follow-up durations were limited across many trials. Comparative evidence against all modern treatment alternatives is lacking, and research provides context but not individual predictions of response.

Key Studies & References

  1. Ketoprofen 2.5% gel: a clinical overview (Review of efficacy in chronic and acute musculoskeletal disorders, including OA and soft tissue injuries)
  2. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome gel (IDEA-033)

Frequently Asked Questions (FAQ)

Common questions about Флексен (FAQ)


Q: Is it safe to drink alcohol while taking Флексен?

Official information indicates that the concurrent use of alcohol may significantly increase the risk of serious gastrointestinal adverse events, such as bleeding or ulcers. Because of this potential for increased risk, official warnings advise that caution be exercised regarding alcohol consumption while using this medication.


Q: What specific conditions might make a person ineligible to use Флексен?

Regulatory documents state that the drug is contraindicated (meaning its use is not permitted) in several specific situations. These include having a severe allergy to aspirin or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), active gastrointestinal bleeding or ulcers, and for pain treatment right before or after coronary artery bypass graft (CABG) surgery.


Q: Can pregnant women safely use Флексен?

The use of this drug is contraindicated after 30 weeks of pregnancy. Official warnings state that use at 20 weeks gestation or later may cause kidney problems in the fetus. Before 20 weeks of pregnancy, official product information indicates that use be determined based on an assessment of benefits versus potential risks.


Q: Is it safe to use Флексен while breastfeeding?

Official sources report that the active substance, Ketoprofen, is present in breast milk, though typically at low levels. There have been noted reports of adverse renal (kidney) and gastrointestinal effects in breastfed infants. For this reason, official information suggests that alternative agents may be considered, especially when nursing a newborn or premature infant.


Q: Can I take Флексен with herbal supplements or vitamins?

The official product label generally does not detail specific interactions with all herbal supplements or vitamins. However, because this drug is an NSAID, official documents indicate that caution be exercised if combining with any other pain reliever due to the risk of increased side effects.


Q: Is Флексен a narcotic or an addictive medication?

Флексен is pharmacologically classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). According to regulatory and government classifications, it is not listed as a narcotic or controlled substance.


Q: Does long-term use of Флексен require regular monitoring or blood tests?

Official warnings indicate that long-term use may be associated with potential kidney (nephrotoxicity) and liver (hepatotoxicity) problems. For patients on long-term treatment, medical monitoring may be necessary, which can include monitoring for signs of toxicity and checking blood pressure.


Q: What does it mean that Флексен has a 'Black Box Warning'?

The Black Box Warning (or Boxed Warning) is a type of serious alert required by the FDA. It informs users about the increased risk of two major categories of serious issues: cardiovascular thrombotic events, such as heart attack or stroke, and serious gastrointestinal adverse events, which include bleeding, ulceration, and perforation.


Q: What are the signs of a serious, but rare, allergic reaction to Флексен?

Regulatory information advises that signs of a serious allergic reaction may include difficulty breathing, swelling of the face, throat, or tongue, or hives. If any signs of an allergic reaction occur, regulatory documents describe that the drug should be discontinued and immediate medical attention sought.


Q: Why is Флексен sometimes considered for menstrual pain (dysmenorrhea)?

Official indications for Флексен state that it is used to relieve pain from various conditions. This includes acute symptoms such as menstrual cramps, which is also referred to as primary dysmenorrhea.


Q: Does Флексен affect my ability to operate machinery or drive?

Because side effects can include dizziness, drowsiness, and blurred vision, official precautions indicate that caution should be exercised. Individuals should be aware of their own response to the medication before attempting to drive or operate heavy machinery.


Q: What are the possible signs of an overdose of Флексен?

Official sources describe potential signs of an overdose. These symptoms may include nausea, vomiting (which may contain blood), severe stomach pain, extreme drowsiness, and ringing in the ears (tinnitus). In the most severe cases, seizures are a possibility.


Q: Does Флексен affect fertility in men or women?

Official prescribing information states that the use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may impair female fertility by potentially delaying or preventing ovulation. Therefore, its use is not generally authorized for women who are actively trying to conceive.


Q: What happens if I accidentally miss a dose of Флексен?

Regulatory guidance typically advises to take the dose as soon as remembered. However, if it is too close to the time for your next scheduled dose, the missed dose should be skipped, and the regular schedule should be resumed. It is explicitly stated that two doses must not be taken at once to make up for a missed one.


Q: Are there any dietary restrictions I need to follow while using Флексен?

Regulatory documents do not impose general dietary restrictions. However, official warnings state that the use of alcohol and tobacco significantly increases the risk of serious gastrointestinal bleeding and other adverse effects.


Q: Can Флексен cause changes in mood or nervousness?

Nervousness is listed in regulatory documents as a common adverse reaction. Official information also notes that mental or mood changes may potentially occur and indicates that individuals should speak with a healthcare professional if they notice these effects.


Q: Why is it important to check labels for other pain relievers while taking Флексен?

The official label advises against combining Флексен with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or aspirin. This is because taking two or more of these medications together can increase the risk of side effects, particularly serious gastrointestinal issues like stomach upset and ulcers.


Q: Can a minor side effect like a rash become serious while taking Флексен?

Official safety warnings indicate that the use of the drug should be discontinued immediately if any type of rash or fever develops. This is because even a minor-appearing rash may be an early sign of a more serious hypersensitivity or severe skin reaction.


Q: Are there different strengths of Флексен available, and what are they for?

Флексен is available in multiple strengths, such as 50 mg, 75 mg, and 100 mg capsules. These various strengths are authorized for conditions including the symptomatic management of rheumatoid arthritis, osteoarthritis, and acute pain. The determination of the specific regimen is based on the use of the lowest effective dose.


Q: What are the rules regarding the use of Флексен in children?

According to regulatory documents, the safety and effectiveness of Флексен have not been established for the pediatric population. Therefore, based on current regulatory status, this medication is not authorized for use in the pediatric population.


Q: Does Флексен affect blood pressure?

Official warnings state that this medication may cause new high blood pressure or worsen existing hypertension. Because of this risk, official guidance indicates that blood pressure monitoring is necessary while using the drug.

How should Флексен be stored and disposed of?

How to Store and Dispose of Флексен (Ketoprofen)

Storage Requirements

Флексен (ketoprofen) must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The medicine must be kept in its original container, which should be tightly closed and protected from direct light and excess moisture.

It is strictly required to keep from freezing and to store the medication out of the sight and reach of children.

Disposal Instructions

Do not keep outdated or unused medicine. For proper disposal, instructions recommend consulting a healthcare professional or pharmacist. Unused Флексен should not be poured down a drain or flushed down the toilet and must be disposed of in accordance with local regulatory requirements for pharmaceutical waste.

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

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