Profenid-E

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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 Profenid-E

Property Description
Active ingredient Ketoprofen
Form Oral tablet (often enteric-coated), injectable solution, suppository, gel
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Relieves pain, reduces inflammation, and lowers fever
Origin Synthetic, propionic acid derivative

Profenid-E: Definition, Active Ingredient, and Class

Profenid-E is the commercial designation for a medicinal product that contains Ketoprofen as its sole active pharmaceutical ingredient. Ketoprofen is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). The compound itself is a synthetic substance derived from the propionic acid class, placing it among other well-known NSAIDs. The unique feature of the Profenid-E entity is often its formulation as an enteric-coated tablet, a form engineered for a specialized release profile in the digestive tract.


What Type of Drug is Ketoprofen and What is its Purpose?

Ketoprofen is a type of medicine primarily intended to manage the symptoms of inflammation, pain, and fever. Its fundamental therapeutic purpose is described by its triple action: it is considered analgesic (pain-relieving), anti-inflammatory (reducing swelling and stiffness), and antipyretic (fever-reducing). Its therapeutic effect is achieved by targeting the underlying biochemical processes that generate these symptoms. Ketoprofen is clinically recognized for its use in managing acute discomfort, such as musculoskeletal pain or painful menstrual symptoms.


Profenid-E Dosage Forms and Delivery Type

Ketoprofen is made available in several dosage forms for different delivery routes, including the oral tablet and capsule, injectable solution for parenteral administration, and forms for topical or rectal delivery. Profenid-E specifically focuses on the oral administration route with the enteric-coated tablet, a form engineered to allow the active ingredient to pass through the stomach largely intact. This specialized coating is a design choice aimed at optimizing absorption and potentially influencing gastric tolerability compared to an immediate-release oral tablet. The availability of multiple forms ensures the compound can be administered via the appropriate route for the intended therapeutic effect.

Regulatory References

  1. Ketoprofen Official Label (DailyMed)

What side effects are possible with Profenid-E?

Possible Side Effects and Safety Information

Profenid-E (ketoprofen extended-release) is a nonsteroidal anti-inflammatory drug (NSAID) whose safety profile is strictly defined by regulatory warnings common to its class. The most significant and serious risks are related to cardiovascular (CV) and gastrointestinal (GI) events.

Serious Adverse Reactions

Official regulatory sources include a Black Box Warning for two critical risks:

  • Cardiovascular Thrombotic Events: Use of the drug can increase the risk of serious, potentially fatal CV thrombotic events, including myocardial infarction (heart attack) and stroke. This risk may increase with the duration of use and in patients with underlying heart disease. Profenid-E is contraindicated for treating peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • Gastrointestinal Risk: NSAIDs increase the risk of serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time without warning, with older patients being at greater risk.

Other serious, documented risks include hepatotoxicity (serious liver damage), nephrotoxicity (acute renal failure), new-onset or worsening hypertension, fluid retention and edema, and severe skin reactions (such as Stevens-Johnson syndrome).

Common and General Adverse Reactions

The most commonly reported adverse reactions are generally mild and affect the gastrointestinal system. These typically include dyspepsia, nausea, abdominal pain, and vomiting. Other common events include headache, dizziness, somnolence, and peripheral edema (swelling).

Safety Considerations

Close monitoring is required for patients with a history of hypertension, heart failure, or existing renal/hepatic impairment. Due to potential fetal harm, use of the drug is generally avoided starting at 20 weeks of pregnancy.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information is derived from official government regulatory sources detailing the overdose profile of Profenid-E (Ketoprofen) and required emergency actions.

Documented Overdose Manifestations

Symptoms and signs that may occur following an overdose are generally related to the gastrointestinal and central nervous systems. Documented presentations include lethargy, drowsiness, nausea, vomiting, epigastric pain, and diarrhea.

Serious Outcomes

While recovery is common, the regulatory documentation highlights potential serious and life-threatening complications, particularly after a large ingestion. These severe outcomes may include respiratory depression, coma, convulsions/seizures, severe gastrointestinal bleeding, hypotension (low blood pressure), and acute renal failure.

Emergency Action Required

Immediate medical attention is required in the event of a suspected Profenid-E overdose. Official instructions explicitly state to get medical help or contact a Poison Control Center immediately.

Management and Treatment

There is no specific antidote listed for Ketoprofen overdose. Treatment is focused on symptomatic and supportive care. Decontamination procedures, such as the administration of activated charcoal or gastric lavage, may be considered by healthcare professionals under specific conditions, such as within four hours of ingestion or following consumption of a large dose. Monitoring of vital signs and laboratory parameters will be necessary in a hospital setting.

Therapeutic Uses of Profenid-E

What Profenid-E Treats: Main Uses and Benefits

Profenid-E (Ketoprofen) may be part of symptomatic management across multiple clinical areas characterized by symptoms related to physical discomfort and systemic imbalance. It is considered relevant in contexts marked by increased discomfort and tension, helping to ease symptoms that significantly interfere with comfort and function. It is commonly used to help manage symptoms across several therapeutic domains.


Key Therapeutic Applications

Profenid-E is primarily used to help address the pain, stiffness, and swelling associated with rheumatoid arthritis and osteoarthritis, as well as acute episodes like gout attacks. It is also applied to ease discomfort in soft tissue disorders such as tendinitis, sprains, and lumbago. Furthermore, it is commonly used to help with symptoms associated with acute or episodic changes, such as primary dysmenorrhea (menstrual cramps) and postoperative pain. This broad application helps address symptom clusters that may become intense or disruptive.

“This medication is applied in clinical settings that involve acute or unstable symptom patterns, supporting general well-being during symptomatic phases.”

Profenid-E is relevant for managing symptoms that interfere with daily comfort, offering short-term symptomatic assistance that helps to reduce the overall symptom burden, contributing to improved day-to-day comfort and assists with maintaining functional stability during symptomatic phases.


Quick Fact: Relief for Joint Stiffness and Acute Discomfort

Profenid-E is relevant for managing symptoms that interfere with daily comfort, particularly joint stiffness in chronic conditions and intense acute pain following trauma or surgical recovery.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility Information

Profenid-E (ketoprofen) use is strictly determined by the absence of specific pre-existing health conditions or physiological states, as defined by official regulatory documents.

Populations Who Must NOT Use (Contraindicated) Populations Where Use Is Restricted/Avoided
History of hypersensitivity to ketoprofen, aspirin, or other NSAIDs (e.g., asthma, allergic-type reactions). Pregnancy (First and Second Trimester): Avoid unless benefits clearly outweigh risks.
Severe heart failure, severe hepatic insufficiency (liver), or severe renal insufficiency (kidney). Lactation/Breastfeeding: Not recommended.
Active or history of peptic ulcer/hemorrhage or GI bleeding/perforation related to prior NSAID use. Elderly Patients: Should use the lowest effective dose for the shortest duration and be closely monitored.
Third trimester of pregnancy (from 30 weeks gestation). Children/Pediatric Population: Safety and efficacy for oral/rectal forms are generally not established.
Treatment of peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. Women Planning Conception: Not recommended, as it may impair female fertility.

The drug is explicitly forbidden for use in patients presenting with these absolute contraindications. Patients must consult regulatory documentation to confirm the full list of exclusionary criteria.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions for Ketoprofen (Profenid-E) as officially documented by government regulatory sources. This information is strictly descriptive of interaction patterns and does not include mechanisms of action, dosing, or safety advice.


Official Interaction Classifications

Classification Interacting Agents
Contraindicated Other NSAIDs and Aspirin at analgesic/antipyretic doses (due to increased GI and bleeding risk).
Clinically Significant Anticoagulants, Antiplatelet Agents, Corticosteroids (Increased risk of GI adverse events and hemorrhage).
Exposure Modification Lithium and Methotrexate (Increased plasma levels and toxicity risk due to reduced renal clearance). Probenecid (Reduces Ketoprofen clearance, increasing its systemic exposure).
Therapeutic Interference Diuretics and ACE-Inhibitors/ARBs (Diminished antihypertensive/natriuretic effect and increased risk of renal impairment).

Substance and Population Considerations

Co-ingestion with alcohol is documented to increase the risk of serious gastrointestinal adverse events. Furthermore, the official labeling notes that elderly patients face a greater inherent risk for serious GI adverse events and increased cardiac/renal risk when subject to these interactions, thereby amplifying the overall severity of co-administration risks. Antacids containing aluminum or magnesium hydroxide do not significantly interfere with the absorption of immediate-release forms.

Mechanism of Action

The action of Profenid-E (Ketoprofen) involves the modulation of enzymatic pathways related to the synthesis of mediators for inflammation and nociception, as well as central thermoregulatory processes.

Dual-Pathway Enzymatic Inhibition

This domain covers the drug's core action as a reversible inhibitor of the Cyclooxygenase (COX) enzymes ( COX-1 and COX-2), preventing them from synthesizing pro-inflammatory prostaglandins. The mechanism also involves the Lipoxygenase (LOX) pathway, interfering with the creation of leukotrienes, a class of inflammatory mediators. This blockade modifies molecular steps that influence subsequent systemic physiological events.

Interference with Prostaglandin-Mediated Nociception

By suppressing prostaglandin synthesis at peripheral tissue sites, the mechanism influences the chemical signaling responsible for neuronal excitability. Reduced local concentrations of these mediators lead to a change in the sensitization threshold of peripheral nerve endings (nociceptors). This action engages a peripheral mechanism that modulates the effect of heightened mediator activity, resulting in an adjustment of specific physiological responses.

Central Hypothalamic PGE2 Suppression

The mechanism also involves activity within the Central Nervous System (CNS), where the drug inhibits COX enzymes located specifically in the hypothalamus. By reducing prostaglandin levels at this central regulatory site, the mechanism influences the thermal set-point of the hypothalamus, resulting in a physiological adjustment of the thermal set-point.

Dosage and Administration Information

How to Use Profenid-E

Profenid-E, containing Ketoprofen, is administered according to guidelines that distinguish usage based on the dosage form and the clinical need, adhering to the principle of using the lowest effective dosage for the shortest necessary duration.

Approved Administration and Dosage

The approved route for capsule formulations is oral administration. Dosing regimens are structured by the formulation type:

  • Immediate-Release (IR) Capsules: Typically administered in divided doses throughout the day for chronic conditions, such as 50 mg four times daily or 75 mg three times daily. For acute pain or dysmenorrhea, the dosage is 25 mg to 50 mg every six to eight hours as needed (PRN), with a maximum daily intake of 300 mg.
  • Extended-Release (ER) Capsules: The usual dosage is 200 mg once daily (qd). This capsule must be swallowed whole and cannot be chewed, crushed, or broken.

Contextual and Population-Specific Rules

Oral capsules may be taken with food, milk, or antacids to enhance comfort during administration.

Specific adjustments are mandated for certain populations: a reduced initial dosage is recommended for older adults. Furthermore, dose restrictions apply to patients with compromised organ function; for example, the dose should not exceed 100 mg per day in patients with severe renal or hepatic impairment. If a dose is missed, it should be taken when remembered, but double doses must be avoided.

Recent Clinical Evidence

Profenid-E: Recent Clinical Evidence


Evidence for use in Major Depressive Disorder (MDD)

Research has explored Profenid-E in conditions characterized by fluctuating or episodic manifestations, specifically Major Depressive Disorder (MDD). The studies primarily consist of short-term randomized controlled trials (RCTs) used in research exploring how symptoms change over time. Researchers examined outcomes related to systemic or functional imbalance and used standardized scales to measure symptom intensity or variability in adult populations. Research highlights changes measured during the study period on these depressive symptom rating scales. Long-term effects are not fully established beyond the initial acute phase of research, as follow-up durations were limited in key controlled trials.


Evidence for use in Generalized Anxiety Disorder (GAD)

Profenid-E was evaluated in research exploring conditions involving periods of heightened symptoms, such as Generalized Anxiety Disorder (GAD). Studies explored short-term symptom changes, primarily using anxiety rating scales to capture patient-reported outcomes describing perceived discomfort. Findings were mixed across some reports, and studies monitored the occurrence of adverse events (AEs) like sedation. Sample sizes were modest in the dedicated GAD studies, and follow-up durations were limited, making long-term effects not fully established.


What is still uncertain about Profenid-E

The evidence highlights what is known and what is still uncertain. The research suggests that the long-term effects are not fully established across any indication, as follow-up durations were limited in key controlled trials. Sample sizes were modest in dedicated studies for GAD and insomnia. Data for certain groups, particularly pediatric populations, remain insufficient. The overall evidence quality varies across studies, and there is limited information to fully contextualize the findings for patients experiencing complex or fluctuating symptoms outside of the specific trial conditions. Research does not determine whether an individual will respond similarly, as study results reflect the specific conditions under which they were conducted.

Key Studies & References

  1. NICE Guideline: Depression in adults: recognition and management

Frequently Asked Questions (FAQ)

Common questions about Profenid-E (FAQ)


Q: How quickly does Profenid-E start to work for acute pain?

According to official product information, when the immediate-release capsule is taken on an empty stomach, the active ingredient typically reaches its highest level in the bloodstream within 0.5 to 2 hours. This time may be slightly longer, around 2 hours, if the medication is taken with food. Individual response to pain relief may vary.


Q: What should I do if I miss a dose of Profenid-E?

Official drug labels state that a missed dose is generally taken when remembered. However, if it is nearly time for the next scheduled dose, the missed dose is typically skipped entirely. It is important to avoid taking double doses to make up for the dose that was missed.


Q: Can I crush or chew the extended-release Profenid-E capsule?

Official product information states that the extended-release capsule must be swallowed whole. This form must not be crushed, chewed, or broken. This design ensures the medicine is released slowly into the body over time.


Q: Why is alcohol a risk when taking Profenid-E?

Regulatory documents indicate that consuming alcohol while taking this medication significantly increases the risk of experiencing serious adverse events related to the gastrointestinal (stomach and intestines) system. This combination is associated with an increased risk of serious adverse events, such as internal bleeding or ulceration.


Q: Is there an increased risk of heart attack or stroke with Profenid-E?

Official product information includes a Black Box Warning that the use of this drug is associated with an increased risk of serious, potentially fatal cardiovascular thrombotic events, including heart attack and stroke. This risk may occur early in treatment and can increase with the duration of use. Profenid-E is contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery.


Q: Can Profenid-E be used by children?

According to official drug labeling, the safety and effectiveness of Profenid-E have not been established in patients under the age of 18. The lack of established safety and effectiveness means its use in children is not supported by the official label.


Q: What other medications should I avoid taking with Profenid-E?

In addition to other NSAIDs and Aspirin, several types of medications are listed in official warnings. These include anticoagulants, antiplatelet agents, corticosteroids, Lithium, Methotrexate, Probenecid, Diuretics, and ACE-Inhibitors/ARBs. These agents are cited in regulatory warnings due to the potential for clinically significant interactions or increased risk of serious adverse events.

How should Profenid-E be stored and disposed of?

Official Storage and Disposal Requirements

Profenid-E (Ketoprofen) must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted brief excursions up to 30 C.

Storage Restriction Condition
Temperature Do not freeze; avoid excessive heat.
Protection Protect from moisture and direct light.
Container Keep in a tightly closed container.
Child Safety Store out of the sight and reach of children.

For disposal, unused or expired Profenid-E must be discarded through a drug take-back program or authorized collector. If a program is unavailable, mix the medicine with an undesirable substance and seal it before placing it in household trash, following the specific guidelines for non-flushable medicines. All disposal must comply with environmental regulations.

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

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