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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 Top

This section provides a factual overview of the medicinal entity Top based on its active ingredient, Ketoprofen, defining its identity and general therapeutic function.

Property Description
Active ingredient Ketoprofen
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Form Oral Capsule, Extended-Release Capsule, Tablet
Common use Relief of pain, inflammation, and fever
Origin Synthetic; Propionic acid derivative

What Type of Medicine is Top (Ketoprofen)?

Top is a single-ingredient medicine containing Ketoprofen, which is recognized as a Nonsteroidal Anti-inflammatory Drug (NSAID). This classification identifies it as a synthetic compound within the propionic acid derivative chemical family. It is used to address inflammation and pain. Its mechanism involves the inhibition of chemical mediators that drive the body's inflammatory response.

Composition and Available Forms of Ketoprofen

The composition of Top focuses on Ketoprofen as the exclusive active pharmaceutical ingredient, intended for oral administration. The medicine is commonly supplied in solid dosage forms, including standard and extended-release capsules, as well as tablets. The availability of these varied oral preparations ensures the substance can be absorbed systemically to provide relief throughout the body. Top is typically marketed as an immediate-release capsule designed for rapid analgesic effect, distinguishing its application when quick symptom relief is prioritized.

General Purpose and Triple Therapeutic Action

The primary general purpose of Top is to provide symptomatic relief from general physical discomfort and systemic symptoms related to inflammatory processes, such as the pain associated with a strained muscle or common headache. Its therapeutic benefit is characterized by a distinctive triple action: it functions simultaneously as an analgesic (pain-relieving), an anti-inflammatory agent (reducing swelling and redness), and an antipyretic (fever-reducing) medicine. Ketoprofen is utilized for these core pain-relieving and anti-inflammatory effects in the management of these common symptoms.

Regulatory References

  1. WHO
  2. WHO Essential Medicines List

What side effects are possible with Top?

Possible side effects and safety information

The medicine Top (Ketoprofen) is an NSAID whose safety profile is officially documented and categorized by regulatory bodies, including the FDA and the EMA. Adverse reactions are classified by frequency and the body system affected, providing a structured view of the possible risks associated with use.

System-Organ Classes and Frequency

Side effects most often reported in regulatory documents are concentrated in the Gastrointestinal and Nervous Systems, and are classified as Common (1% to 10% frequency). These commonly reported effects include dyspepsia, nausea, abdominal pain, diarrhea, headache, and dizziness. Effects like fatigue are considered Uncommon (0.1% to 1%).

Serious Adverse Reactions

The official label highlights the potential for serious adverse reactions that are severe and may occur without prior warning symptoms. These serious events include Cardiovascular Thrombotic Events such as Myocardial Infarction and Stroke, and Gastrointestinal Adverse Events such as bleeding, ulceration, and perforation of the stomach or intestines. Serious allergic reactions (anaphylactoid reactions) and severe skin reactions (like SJS) are also documented risks.

Population and Exposure-Related Safety Notes

The safety profile differs for specific patient groups. Older adults are documented to have a greater risk for serious gastrointestinal events. Use is restricted by regulators at or after 30 weeks of pregnancy due to potential fetal toxicity. Furthermore, the risk of serious cardiovascular events is officially noted to increase with the duration of use of the medicine. The medicine is formally contraindicated for treating peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the official, regulator-documented information concerning overdose and emergency response, based on authoritative government sources.

Documented Overdose Manifestations

An overdose with this medication may present as a severe extension of known pharmacological effects. Documented signs may include severe drowsiness, dizziness, nausea, and vomiting. More serious manifestations listed in official labeling can include significant cardiovascular changes (e.g., hypotension), altered consciousness, and potentially life-threatening complications such as seizures or coma.

Emergency Intervention Requirements

Immediate medical attention is required upon any suspicion of overdose or accidental ingestion of an excessive amount. Regulatory documentation explicitly instructs individuals to contact emergency services or a Poison Control Center immediately.

Management and Monitoring

Official management is typically symptomatic and supportive. This may involve procedures like gastrointestinal decontamination (e.g., activated charcoal) if deemed appropriate by healthcare professionals. If available, a specific antidote may be listed in the regulatory labeling. Due to the potential for severe, delayed, or systemic effects, continuous clinical monitoring, including observation of vital signs and specific laboratory tests, may be necessary in a hospital setting, as advised in the official prescribing information.

Therapeutic Uses of Top

What Top Treats: Main Uses and Benefits

Top (Ketoprofen) is commonly used to help with symptomatic discomfort and heightened manifestations across key therapeutic domains, generally offering supportive relief in situations where symptoms create noticeable interference with daily stability. This medication is relevant for easing symptoms related to inflammatory or irritative states.

This medicine is applied across conditions characterized by periods of heightened symptoms, including chronic joint diseases like Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis; acute inflammatory episodes such as Acute Gouty Arthritis, tendinitis, and soft tissue injuries; and episodic pain like Primary Dysmenorrhea. The medicine is generally used for managing symptoms related to pain, tenderness, swelling, and fever, supporting patients during episodes of heightened discomfort.

“The primary goal of using this medicine is to provide supportive relief that helps ease the overall symptom burden during both acute and chronic phases.”

Quick Fact: Supportive Role in Easing Inflammation and Stiffness

Top assists with maintaining functional stability in joints and contributes to easing the symptom load of stiffness, particularly in chronic conditions.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Top (Ketoprofen) — official regulatory information

Eligibility Scope

The use of Ketoprofen is established for Adults (18 years and older for prescription oral forms) and Adolescents (16 years and older for Over-the-Counter forms). Prescription use in those younger than 18 years is officially classified as not established due to insufficient data. Older adults require cautionary use and close monitoring due to an increased risk of adverse events, particularly those affecting the gastrointestinal tract and kidneys.

Populations for whom use is Contraindicated

Regulatory labeling specifies that this medicine must not be used in patients with:

  • A history of hypersensitivity to Ketoprofen, aspirin, or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs).
  • Active gastrointestinal ulceration, bleeding, or perforation.
  • The peri-operative setting of Coronary Artery Bypass Graft (CABG) surgery.
  • Severe uncontrolled heart failure, severe renal impairment, or severe hepatic impairment.

Pregnancy and Lactation Eligibility Status

Ketoprofen is contraindicated during the third trimester of pregnancy. During the first and second trimesters, use is generally not recommended unless considered essential. Use while breastfeeding is also not recommended due to a lack of adequate studies establishing infant risk.

Connection to the overall eligibility profile

Official regulatory documents strictly define who can and cannot use this medicine by establishing absolute contraindications and setting restricted-use conditions for populations with known vulnerabilities, such as the elderly and those with impaired organ function, thereby confining the medicine's approved scope of use.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Top (Ketoprofen)


Interaction Scope

Category Official Regulatory Information
Medicinal product categories with documented interactions Anticoagulants, Other NSAIDs, Methotrexate, Lithium, ACE Inhibitors, Diuretics, SSRIs, Oral Corticosteroids.
Specific interacting medicines (if explicitly listed) Aspirin, Warfarin, Methotrexate, Lithium, Probenecid.
Mechanistic basis of interactions (only if stated in label) Inhibition of renal tubular secretion (Methotrexate); reduction in renal clearance (Lithium); officially documented as not inducing drug-metabolizing enzymes.
Timing-based interaction rules (if applicable) None explicitly listed in searched regulatory documents as a mandatory time-based separation window.
Population-specific interaction notes (if applicable) Elderly Patients: Noted to be at a greater risk for serious GI adverse events; exhibit reduced renal clearance of the drug conjugate [FDA].
Interaction-related restrictions Must not be used for peri-operative pain in the setting of CABG surgery; co-administration with other NSAIDs or Aspirin is contraindicated in patients with known hypersensitivity [FDA].

Interaction Classifications (High-Level)

Category Official Regulatory Statement
Interaction severity classification (as defined in official documents) Contraindicated (e.g., CABG setting); Clinically Significant / Serious Risk (e.g., Anticoagulants, Methotrexate, Lithium combinations).
Regulatory basis (EMA / FDA / etc.) FDA Prescribing Information, Health Canada Monograph, NIH/MedlinePlus.
Interaction-context constraints (as defined in official documents) Alcohol increases the documented risk of GI bleeding; a high-fat meal delays the peak concentration of the extended-release form [FDA].

Resulting Interaction Structure

The official regulatory documents define the product's interaction structure primarily through severe risk classifications. The risk of serious gastrointestinal bleeding is synergistically increased when combined with Anticoagulants, Oral Corticosteroids, or SSRIs. Furthermore, the combination may diminish the antihypertensive effect of Diuretics or ACE Inhibitors. The regulatory profile formally mandates that the drug reduces the clearance of substances like Lithium and Methotrexate, leading to officially documented increased plasma levels of the co-administered drugs.

Mechanism of Action

Top exerts its pharmacodynamic activity primarily within the central nervous system (CNS) through several independent molecular pathways. A core action involves modulation of voltage-gated ion channels; Top stabilizes the inactive state of certain neuronal voltage-gated sodium channels, thereby reducing high-frequency firing of action potentials. This limits sustained depolarization across the neuronal membrane.

Additionally, Top enhances inhibitory signaling by acting as a positive allosteric modulator of the GABAA receptor. This interaction increases the frequency of chloride ion influx, leading to hyperpolarization and reduced neuronal excitability. It also decreases excitatory neurotransmission by inhibiting the activity of the AMPA/Kainate subtype of glutamate receptors.

Furthermore, the compound acts as a weak inhibitor of several isoenzymes of carbonic anhydrase (CA), specifically CA-II and CA-IV. The combination of enhanced GABAergic inhibition, reduced glutamatergic excitation, and stabilized sodium channels results in a net physiological consequence of membrane stabilization and an overall reduction in pathological network excitability.

Dosage and Administration Information

The medicine Top (Ketoprofen) is administered primarily via the oral route, utilizing either immediate-release (IR) or extended-release (ER) forms. The approved regimen is dependent on the specific formulation and the required duration of use.

For continuous long-term management of chronic conditions, the IR form is typically scheduled for administration three to four times daily, while the ER form is intended for once-daily administration. The maximum daily dose for the IR form is limited to 300 mg, and the ER form is limited to 200 mg. Conversely, acute painful episodes are managed with IR forms taken on an as-needed basis (PRN), generally every 6 to 8 hours.

Specific conditions govern proper intake. Oral doses may be administered with food, milk, or an antacid to lessen gastrointestinal discomfort. Extended-release capsules must be swallowed whole and must not be crushed, chewed, or opened, as this compromises the intended release profile. Standard administration guidelines specify that patients should avoid lying down for 10 minutes following administration.

Furthermore, standard clinical protocols indicate that therapy for older adults should be initiated with lower doses (e.g., 25 mg or 50 mg), and the maximum daily dose must be reduced in patients with known severe renal or hepatic impairment, defining a high-level population-specific use rule.

Recent Clinical Evidence

Research Evidence for Addressing Chronic Joint Conditions

Research on Top (Ketoprofen) has been conducted using Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews to explore its use for conditions where symptoms require attention, related to chronic joint conditions, specifically Rheumatoid Arthritis (RA) and Osteoarthritis (OA). These studies were applied in research contexts involving fluctuating or unstable symptoms where patient-reported outcomes describing perceived discomfort were key. For conditions like RA and OA, research has explored outcomes related to physical discomfort and functional activity level.

Studies monitored changes in how patients rated their pain intensity using scales and assessed functional outcomes reflecting daily functioning, such as joint mobility and stiffness. The body of evidence for these chronic conditions is primarily focused on evaluating short-term symptom patterns. While studies reported patterns in measured outcomes, the follow-up durations were limited. There is limited information for long-term outcomes or the persistence of these patterns over years of addressing the condition. Furthermore, the existing studies provide limited insight into the agent's research exploring its potential for influencing the underlying causes of the condition.


Evidence for Acute Pain and Inflammation Episodes

The evidence base also includes studies focused on conditions associated with acute or disruptive episodes, such as Acute Gouty Arthritis and Primary Dysmenorrhea. For these indications, research was designed to examine symptoms over defined time intervals. RCTs, sometimes with modest sample sizes, were applied in studies examining patient-reported experiences during the acute phase. For acute gout, the research examined outcomes describing episodic or acute changes, focusing on metrics related to the duration of symptoms and the overall length of the acute episode. Data show patterns related to these measurements, often describing short-term changes in perceived discomfort during the observed episodes.

Research exploring these acute measurements is necessarily very short-term, often spanning only a few days or a single menstrual cycle. Long-term effects or the agent's role in preventing the recurrence of these acute episodes are not fully established by the existing efficacy studies.

Frequently Asked Questions (FAQ)

Common questions about Top (FAQ)


Q: Is Top considered a long-term or short-term treatment?

Official product information indicates that Top is described for both short-term and long-term use, depending on the formulation. Immediate-release forms are typically administered as needed for acute painful episodes, while extended-release forms are intended for continuous, long-term management of chronic conditions.


Q: Is it true that Top can be used for headache prevention?

The medicine is officially indicated for the relief and management of pain related to specific conditions. However, preventive use for conditions such as headache is not specified in the approved product labeling and indications.


Q: Does Top carry a specific regulatory boxed warning?

Regulatory documents confirm that Top (Ketoprofen), like other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), carries a Boxed Warning. This warning highlights the potential for serious side effects, specifically related to cardiovascular thrombotic events (like heart attack or stroke) and serious gastrointestinal adverse events (like bleeding or perforation).


Q: What does the term 'off-label use' mean, and why is it not discussed in official documents for Top?

Off-label use is a term defined by regulatory agencies for using a medicine for a purpose, dosage, or patient group that has not been officially approved. Manufacturers are legally permitted to promote the drug only for the indications that have been formally approved and listed on the product label.


Q: How is Top’s effect on children and adolescents described in research summaries?

Official prescribing information states that the safety and effectiveness of Top in patients younger than 18 years are generally not established. This classification is based on a lack of sufficient data from controlled studies to support use in this age group.


Q: What are the components of Top, as listed on the label?

The active pharmaceutical ingredient in Top is Ketoprofen. The full product label includes this active component along with a list of inactive ingredients, which may differ depending on the specific formulation or the manufacturer.


Q: Is Top used for conditions other than the primary ones listed?

The medicine is officially indicated for the conditions listed in the approved product label. These indications generally include the management of pain, inflammation, and specific conditions like rheumatoid arthritis, osteoarthritis, and primary dysmenorrhea.


Q: Is there a known interaction between Top and caffeine?

According to the official regulatory prescribing information for Top, no known interaction between the medicine and caffeine is explicitly documented.


Q: How long does it typically take to notice the effects of Top?

Studies on how the medicine is absorbed indicate a relatively rapid effect for the immediate-release forms. The maximum concentration of the substance in the bloodstream is typically reached within 30 to 90 minutes after taking a dose.


Q: What is the general duration of effect described for Top?

Official pharmacological data indicates that the substance has an elimination half-life of approximately 2 to 2.5 hours. Dosing schedules are generally set within this timeframe, such as taking the medicine every 6 to 8 hours for acute pain relief, to maintain a consistent effect.


Q: If I miss a dose of Top, what guidance is generally provided in official sources?

Official guidance is generally provided for if a dose is missed. The common protocol states that the missed dose should be taken as soon as remembered, unless it is almost time for the next scheduled dose, in which case the missed dose should be skipped. Official documentation specifies that a double dose should not be taken to catch up.


Q: What should I do if I experience a mild side effect while using Top?

Official information contains guidance stating that patients should consult a healthcare provider if they experience any symptoms that are severe, persist over time, or if they experience any unexpected symptoms.


Q: What evidence exists regarding Top's effect on sleep patterns?

Adverse event summaries indicate that side effects related to sleep patterns may occur. These include drowsiness as well as insomnia (difficulty falling asleep or staying asleep).


Q: What are the general rules for stopping Top treatment?

Official guidance is non-directive, stating that patients should avoid stopping the medicine without first speaking to the prescribing healthcare professional. Guidance recommends consultation with a doctor if symptoms worsen or if new or unexpected symptoms develop.


Q: What does the term 'therapeutic window' mean for Top?

The term therapeutic window describes the range of plasma concentration that provides a desired therapeutic effect without causing unacceptable toxic effects. Maintaining this range requires adherence to the prescribed doses and maximum daily limits described in the product information.


Q: What is the role of Top in a wider treatment plan?

As a Nonsteroidal Anti-inflammatory Drug (NSAID), the medicine's role in a wider treatment plan is to provide symptomatic relief from inflammation, pain, and fever. It is described as addressing symptoms but is not intended to modify the underlying cause of the condition.


Q: Is there a risk of dependency or withdrawal described for Top?

The official product label for Top (Ketoprofen) does not list drug dependency or withdrawal syndrome among the documented risks or adverse events associated with its use.


Q: What is described in the official documents about Top's potential impact on mood?

Adverse event reports mention psychiatric side effects that may relate to mood. These include nervousness and depression, although official documents classify these as typically less common occurrences.


Q: What are the restrictions on activities while taking Top?

Regulatory documents list side effects that could potentially affect concentration and motor skills. These reported side effects may have the potential to impair activities such as driving or operating machinery.


Q: What are the official recommendations for laboratory monitoring while using Top?

The official prescribing information notes that monitoring of kidney function may be appropriate in certain situations. Official information describes that monitoring is often deemed appropriate when the medicine is used long-term or when taken alongside certain other medicines that affect the kidneys.


Q: Why is Top sometimes used alongside other medicines?

Top is classified as an anti-inflammatory and pain reliever. Its use alongside other medicines is typically to provide symptomatic relief for inflammation and pain that may not be fully managed by a patient's primary therapy.


Q: Are there different brand names or generic versions of Top?

The medicine Top contains the active ingredient Ketoprofen, which is available in a generic version. Regulatory and official drug information confirms that other brand names exist internationally for different formulations of Ketoprofen.


Q: What is the description of Top's effect on appetite or weight?

Official adverse event summaries list loss of appetite (anorexia) as a possible gastrointestinal side effect. Weight gain and weight loss have also been noted in rare cases in post-marketing or other reports.


Q: Is Top a controlled substance, according to government classification?

Top (Ketoprofen) is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Based on government classification systems, it is not listed as a controlled substance.


Q: What are the risks if Top is taken in a higher amount than prescribed?

Official documents describe that taking a higher amount than prescribed may result in symptoms such as drowsiness, stomach pain, vomiting, or nausea. Overdose may also lead to more serious events like seizures or problems with kidney function.

How should Top be stored and disposed of?

Top (Ketoprofen) must be stored and handled according to regulatory requirements to ensure product integrity and safety.

Storage Conditions

  • Temperature: Store the medication at controlled room temperature, specifically 20 C to 25 C (68 F to 77 F). Brief temperature excursions are permitted between 15 C and 30 C (59 F and 86 F).
  • Protection: The product must be protected from excess heat, direct light, and moisture; do not store the container in damp areas like the bathroom.
  • Container Rules: Keep the medicine in its original container and ensure the container remains tightly closed.

Handling and Disposal

  • Prohibitions: Do not keep outdated medicine, and the product must be kept from freezing.
  • Child Safety: Store the medication out of the sight and reach of children.
  • Disposal: Unused or expired medication should be discarded using a drug take-back program as the preferred method. If a take-back program is unavailable, mix the medicine with an undesirable substance (e.g., used coffee grounds) and place it in a sealed bag or container before disposal in household trash. Do not flush the product down the toilet or drain.

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

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