Katafenac

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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 Katafenac

Property Description
Active ingredient Diclofenac (often as Sodium or Potassium salt)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Origin Synthetic Phenylacetic acid derivative
Core Action Analgesic, Anti-inflammatory, Antipyretic
Forms Tablet, Injection, Topical Gel, Suppository

Defining Katafenac: Type, Composition, and Origin

Katafenac is a trade name for a medicinal product whose active ingredient is Diclofenac, which is officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). The compound is a synthetic derivative of phenylacetic acid, utilizing salts like Diclofenac Sodium or Diclofenac Potassium to ensure optimal delivery. Diclofenac is a well-established substance recognized globally for its efficacy. The product is manufactured under pharmaceutical quality controls, typically holding a Prescription-Only Medicine (Rx) status depending on the specific formulation and regulatory jurisdiction.

Classification and General Therapeutic Purpose

The pharmacological class of NSAIDs dictates that Katafenac provides three concurrent therapeutic effects: it acts as an analgesic (pain reliever), an anti-inflammatory agent, and an antipyretic (fever reducer). Diclofenac is widely used for its robust anti-inflammatory properties across various formulations. This means the medicine is scientifically verified to address the root causes of swelling and discomfort.

Its general therapeutic purpose is to deliver comprehensive symptomatic relief, supporting recovery from transient inflammatory events or chronic conditions. For example, it is clinically recognized for managing discomfort associated with flares of rheumatic disorders and musculoskeletal strains. Diclofenac is recognized for its foundational role in alleviating pain and reducing inflammation globally.

Available Forms and Entity Versatility

The Diclofenac entity is a versatile substance, prepared in multiple dosage form(s) to support different routes of administration. Forms include oral preparations such as tablets and capsules, alongside formulations for localized use, such as topical gels and ophthalmic drops. The Katafenac entity is frequently available in forms like enteric-coated tablets, which are designed to protect the active ingredient from stomach acid, a differentiating compositional feature intended to enhance gastrointestinal tolerance. This broad availability ensures that the active ingredient can be tailored for efficient delivery, whether the goal is widespread systemic absorption or concentrated localized action where it is most needed.

Regulatory References

  1. MedlinePlus: Diclofenac (Oral Route)
  2. WHO Essential Medicines

What side effects are possible with Katafenac?

Possible Side Effects and Safety Information

The safety profile of Katafenac, whose active ingredient is Diclofenac, is formally classified by government regulatory authorities based on the affected System-Organ Class (SOC) and frequency of occurrence. Adverse reactions are grouped from Common to Very Rare according to official regulatory conventions.

Frequency and System-Organ Classifications

Classification System-Organ Class (SOC) Affected (Examples)
Common Nervous System Disorders (headache, dizziness); Gastrointestinal Disorders (nausea, dyspepsia, abdominal pain); Hepato-biliary Disorders (elevated transaminases); Skin Disorders (rash).
Rare Immune System Disorders (anaphylactic/anaphylactoid reactions); Gastrointestinal Disorders (gastrointestinal hemorrhage or ulceration); Hepato-biliary Disorders (hepatitis).

Serious Adverse Reactions and Safety Patterns

The official labeling documents severe, serious adverse reactions primarily affecting the Cardiovascular and Gastrointestinal systems. These include the risk of thrombotic events, such as myocardial infarction and stroke, which regulatory documents note are often dose- and duration-dependent, increasing with the length of use and higher dosage. Severe gastrointestinal complications, including bleeding and perforation, are also explicitly listed as serious risks.

Population-specific safety constraints are imposed by regulatory bodies. The medicine is contraindicated for peri-operative pain management following Coronary Artery Bypass Graft (CABG) surgery and during the third trimester of pregnancy. Furthermore, older adults are officially recognized as having an increased risk for serious gastrointestinal adverse events.

Overdose and Emergency Response

The overdose profile for Katafenac (Diclofenac) is documented in official regulatory prescribing information, defining specific clinical manifestations and required emergency actions. Immediate medical help must be sought for any suspected overdose.

Officially documented manifestations may include a range of symptoms. Gastrointestinal signs can involve nausea, vomiting (potentially bloody), stomach pain, diarrhea, and bloody or tarry stools. Central nervous system effects are also documented, such as dizziness, drowsiness, headache, confusion, blurred vision, and ringing in the ears.

Overdose has the potential for severe and life-threatening outcomes. These documented complications include coma, seizures, significant internal bleeding, and severe kidney damage that may require temporary dialysis. A large overdose is noted as being harmful to both children and adults. Furthermore, patients with preexisting asthma may experience aggravated wheezing or difficulty breathing.

Regulatory documents mandate that management is symptomatic and supportive, as no specific antidote is known for Katafenac. Procedures involve continuous monitoring of vital signs, blood and urine tests, and potentially the administration of activated charcoal to reduce absorption. Individuals must seek medical help right away and contact emergency services for immediate guidance.

Therapeutic Uses of Katafenac

Katafenac is commonly used to provide symptomatic relief across several therapeutic domains where pain and inflammation are the primary symptoms. The medication is used to help with symptoms related to physical discomfort and inflammatory or irritative states associated with various conditions. It is considered relevant in conditions presenting with acute episodes and chronic inflammatory processes.

The medication is used for managing conditions such as Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, acute Gout flares, pain from musculoskeletal injuries, Primary Dysmenorrhea, and acute Migraine Attacks. It helps ease the overall symptom burden in situations where symptoms create noticeable physiological strain.

“It is applied in clinical settings that involve acute or unstable symptom patterns, offering supportive relief that helps patients cope more steadily.”

The application of Katafenac assists with maintaining comfort when symptoms interfere with routine activities, contributing to improved day-to-day comfort during periods of heightened symptoms.


Quick Fact: Relief for Inflammatory Discomfort

Katafenac is relevant when supportive symptom management is appropriate for acute episodes, chronic disease flares, and episodic pain manifestations, including those linked to fever.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Katafenac — Official Regulatory Information

The official population eligibility for Katafenac (Diclofenac) is strictly defined by government regulatory documents, creating categories of absolute exclusion and restricted use.

Category Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Generally, adults (18 years and older) who do not possess any specified contraindications [FDA/EMA].
Populations for whom use is contraindicated Patients with known hypersensitivity to Diclofenac or other NSAIDs; those with active peptic ulceration or GI bleeding; patients with severe hepatic or severe renal failure; and patients with established congestive heart failure (NYHA Class II-IV), ischaemic heart disease, or peripheral arterial disease [EMA SmPC]. Contraindicated immediately before or after CABG surgery [FDA Label].
Pregnancy and lactation eligibility status Contraindicated during the third trimester of pregnancy [FDA/EMA]. Not recommended while breastfeeding or for women attempting to conceive [EMA SmPC].
Age-related eligibility rules Systemic use is not recommended in children and adolescents below a threshold (e.g., 14 to 16 years) [Health Canada]. Older adults are eligible but must use the lowest effective dose for the shortest duration due to higher risk [NIH MedlinePlus].
Eligibility-related restrictions Caution is mandatory for patients with mild-to-moderate renal or hepatic impairment and those with risk factors for cardiovascular events (e.g., hypertension, diabetes), requiring close monitoring [GOV.UK, EMA].

Connection to the overall eligibility profile: Regulatory documents define who can and cannot use the medicine by establishing absolute exclusions based on a patient's pre-existing conditions and allergies, particularly related to cardiovascular and gastrointestinal risks. For populations not absolutely excluded, the official labels restrict use to conditional scenarios, mandating the application of the lowest effective dose for the shortest duration.

What should I know about interactions with other medicines?

The official regulatory interaction profile for Katafenac (Diclofenac) is structured around documented pharmacokinetic (PK) and pharmacodynamic (PD) alterations with other substances.

Formal Interaction Restrictions

Co-administration with other systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or Aspirin is officially classified as not recommended, due to an additive risk of serious gastrointestinal adverse events, including ulceration and bleeding. The medicine is formally contraindicated for use in the perioperative setting of Coronary Artery Bypass Graft (CABG) surgery.

Drug-Drug Interaction Outcomes

Pharmacokinetic Effects: Strong metabolic enzyme inhibitors, such as Voriconazole, reduce Diclofenac clearance, leading to a documented increase in its plasma concentration. Diclofenac also reduces the renal clearance of agents including Lithium and Digoxin, resulting in increased serum levels of those co-administered medicines.

Pharmacodynamic Effects: Combining Katafenac with Anticoagulants, Antiplatelet Agents, or Selective Serotonin Reuptake Inhibitors (SSRIs) establishes an increased, additive risk of serious bleeding. Additionally, co-administration with ACE Inhibitors, ARBs, or Diuretics risks the diminution of the antihypertensive or natriuretic effect of those medicines.

Substance and Timing Constraints

Ingestion of Alcohol is explicitly noted as an interaction risk factor that increases the potential for gastrointestinal bleeding. Furthermore, regulatory labels for specific formulations may include mandatory administration-timing rules, such as taking the medicine on an empty stomach.

Mechanism of Action

How Katafenac Works

The action of Katafenac (Diclofenac) is defined by a multimodal mechanism that targets two distinct systems: the chemical production of inflammatory mediators and the electrical signaling of pain.


Inhibition of the Prostaglandin Synthesis Pathway

This core mechanism involves the competitive inhibition of the Cyclooxygenase (COX) enzymes, particularly COX-2, which are central to the Arachidonic Acid Cascade. By suppressing these enzymes, the drug restricts the formation of inflammatory signaling molecules, such as Prostaglandin E2 ( PGE2) . This molecular action subsequently leads to the physiological outcome of modulating vascular responses, which influences local tissue edema and the hypothalamic set-point for core body temperature.


Direct Modulation of Peripheral Nociceptive Signals

Beyond enzyme inhibition, the drug engages a unique non-COX mechanism by activating ATP-sensitive Potassium Channels ( K ATP channels) on peripheral nerve endings and reducing the local concentration of the neuropeptide Substance P. This molecular modulation hyperpolarizes the nerve membrane, reducing electrical excitability. The physiological result is an increase in the pain threshold, which modulates the initiation and transmission of pain signals to the central nervous system.

Dosage and Administration Information

How to Use Katafenac (Diclofenac) — Administration Guidelines

Instructions for using Katafenac, a medication containing diclofenac, are based on prescribing information and Summary of Product Characteristics. Patients must adhere to the specific procedural steps and dosing rules detailed for each formulation.


Administration Procedures

Dosage Form Route Key Administration Instruction
Delayed-Release Tablets Oral Swallow tablets whole; do not crush, chew, or split. Can be taken with or without food.
Oral Powder for Solution Oral Mix the contents of the packet with 1 to 2 ounces of plain water and drink immediately. Must be taken on an empty stomach.
Topical Gel Topical (Skin) Measure the dose (e.g., 2g or 4g) using the provided dosing card. Apply to clean, dry, intact skin.
Injection Intravenous (IV) Must be administered as a rapid bolus (e.g., over 15 seconds) only after ensuring the patient is well-hydrated.

Dosing and Schedule

Treatment must always use the lowest effective dose for the shortest duration consistent with the individual's prescribed regimen. Dosing frequency is dependent on the specific formulation and condition, commonly requiring administration two to four times a day for daily regimens, or as needed for acute indications (e.g., migraine). The maximum daily dose for adult oral use is generally within a range (e.g., 150 mg to 200 mg) and must not be exceeded.

If a dose is missed, individuals should take the next scheduled dose; a double dose must not be taken to compensate for the missed one. Usage in pediatric patients or those with severe renal or hepatic impairment may require starting with the lowest possible dose, where use is established.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Katafenac

The research base for Katafenac (Diclofenac) consists mainly of clinical trials and comprehensive systematic reviews that evaluate outcomes related to physical discomfort and functional imbalance. Studies help show what has been observed so far, providing context about how patient-reported symptoms are measured across various conditions.


Evidence for Use in Chronic Joint and Rheumatic Conditions

Research has examined the medicine’s use in chronic conditions, primarily Osteoarthritis (OA), via Randomized Controlled Trials (RCTs). These studies focused on adult populations, measuring patient-reported outcomes like pain intensity, joint stiffness, and physical activity level over defined study durations. Research often describes measurements of functional metrics and pain scores over intervals typically lasting six to twelve weeks.


Evidence for Use in Acute Pain and Musculoskeletal Injuries

The evidence base also includes short-duration RCTs exploring Acute Pain and Musculoskeletal Injuries and specific Acute Pain Syndromes such as Migraine and Primary Dysmenorrhea. These trials monitored acute pain severity and outcomes related to daily activity level, often focusing on formulations applied to the skin. Study findings describe patterns related to symptomatic response over very short intervals, such as 24 to 72 hours.


Research Gaps and Areas of Uncertainty

Research has examined the medicine in older adults, but data remains insufficient for the pediatric population and groups with specific existing health conditions. Furthermore, the observation periods in acute pain trials are extremely short, limiting insight into symptom recurrence. Overall, key limitations across the research include modest sample sizes, trial heterogeneity (variability) in pooled data, and the lack of long-term data needed to establish sustained functional outcomes.

Key Studies & References

  1. Diclofenac - MedlinePlus Drug Information
  2. WHO Model List of Essential Medicines (relevant edition for classification and context)

Frequently Asked Questions (FAQ)

Common questions about Katafenac (FAQ)

Q: How long does it take for the oral tablets to start working for pain relief?

Official product information on the absorption of Katafenac can vary based on the specific tablet type. For immediate-release oral tablets, measurable amounts of the active ingredient may be detected in the bloodstream as quickly as 10 minutes after administration, with peak levels often occurring around one hour in fasting individuals. Delayed-release tablets typically reach their highest concentration in the body over a longer period, generally around two hours, as indicated in regulatory data.

Q: What should I do if my topical gel application causes a burning sensation?

A burning sensation or irritation at the application site is a reported side effect of the topical gel, according to official safety documentation. If you experience this or other localized skin reactions, such as pain or tingling, and they become severe or do not go away, official labeling indicates that users should seek medical attention if these symptoms become severe or persistent.

How should Katafenac be stored and disposed of?

How to Store and Dispose of Katafenac (Diclofenac Potassium)

Official regulatory documents require Katafenac tablets to be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). The medicine must be kept in its original container, which should be tightly closed, and stored in a dry place protected from moisture and excessive heat. It is a mandatory requirement that the product be kept out of the sight and reach of children to prevent accidental ingestion.

Expired or unused Katafenac must not be stored. Patients should dispose of unused product according to local regulations or via official drug take-back programs, and must generally avoid disposal in household waste, drains, or wastewater.

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

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