Dolfenax

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Dolfenax

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Medically reviewed

Marina Burgos

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 Dolfenax

Quick Facts: Tolfenamic Acid

Property Description
Active ingredient Tolfenamic Acid (TA)
Form Oral tablets, Injection
Pharmacological class Non-steroidal Anti-inflammatory Drug (NSAID)
Common purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic organic compound (Fenamate)

What is Dolfenax and What Type of Medicine is It?

Dolfenax is a medicine whose active ingredient is the INN substance Tolfenamic Acid (TA), classified as a Non-steroidal Anti-inflammatory Drug (NSAID). This substance belongs specifically to the Fenamate subgroup, structurally defined as a synthetic organic compound derived from anthranilic acid. Within this classification, Tolfenamic Acid is recognized as a systemic anti-inflammatory agent. It is typically marketed as a prescription-only medicine, often used when specific systemic management of inflammatory symptoms is required.

Composition and Available Forms of Tolfenamic Acid

The composition of Dolfenax utilizes Tolfenamic Acid as the sole active agent, delivered as a single-ingredient formulation. The most common presentation is the oral tablet, a conventional solid pharmaceutical preparation intended for systemic absorption via the oral route. Unlike some related NSAIDs, Tolfenamic Acid is also commonly prepared in sterile injection forms (parenteral route) for use in various clinical contexts requiring rapid systemic delivery. The substance is identified as a carboxylic acid derivative.

General Purpose: Relieving Pain, Inflammation, and Fever

Consistent with its NSAID classification, the general purpose of Dolfenax is to provide symptomatic relief by intervening in the body's inflammatory cascade. This mechanism allows the substance to help manage discomfort. This function translates directly into the general therapeutic benefit of alleviating various forms of pain, reducing associated inflammation, and controlling an elevated body temperature or fever.

Regulatory References

  1. IUPHAR/BPS Guide to PHARMACOLOGY

What side effects are possible with Dolfenax?

Possible Side Effects and Safety Information

Dolfenax (a nonsteroidal anti-inflammatory drug, NSAID) is associated with several serious safety warnings documented in regulatory prescribing information, which focus primarily on cardiovascular and gastrointestinal risks.

Serious Adverse Reactions and Safety Restrictions

Adverse Reaction Category Key Regulatory Summary
Cardiovascular (CV) Risk Increased risk of serious thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk may occur early in treatment and can increase with higher doses and duration of use. The medicine is contraindicated for pain management immediately before or after coronary artery bypass graft (CABG) surgery, and in patients with established ischaemic heart disease or moderate-to- severe congestive heart failure.
Gastrointestinal (GI) Risk Risk of serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can occur without warning symptoms and may be fatal. This risk is higher in the elderly and in those with a prior history of GI bleeding or ulcers.
Hepatobiliary/Renal Cases of severe hepatotoxicity (liver damage) have been reported, including fatal fulminant hepatitis. Monitoring of liver and kidney function is advised during long-term therapy. The drug can also cause new-onset or worsening hypertension and fluid retention.

Population-Specific Safety Considerations

  • Pregnancy: Use should be avoided starting at 30 weeks of gestation due to the risk of premature closure of the fetal ductus arteriosus. Use between 20 and 30 weeks should be strictly limited to the lowest effective dose for the shortest possible duration due to risk of fetal kidney problems (oligohydramnios).
  • Elderly: Use in the elderly requires caution due to an increased risk of serious GI and renal adverse events.

The overall regulatory safety profile mandates that the lowest effective dose be used for the shortest duration necessary to minimize the potential for serious, dose- and duration-related adverse effects, particularly those affecting the heart and digestive tract.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Dolfenax, a product containing mefenamic acid, is a serious medical event that requires immediate attention. Regulatory information emphasizes the potential for significant central nervous system (CNS) effects following an acute overdose, particularly when high doses are ingested.

Overdose scope Official regulatory information
Documented Overdose Presentations CNS Toxicity: Convulsions (seizures), altered conscious level, agitation, aggression, confusion, or disorientation.
Physiological Systems Affected Central Nervous System (CNS) is prominently affected. Renal (kidney) and hepatic (liver) function may also be of concern in a severe or protracted overdose, especially due to accumulation of metabolites.
Dose-related or Exposure Factors Overdose is associated with a much larger and dose-related risk of CNS toxicity, especially convulsions, compared to other Nonsteroidal Anti-inflammatory Drugs (NSAIDs).
Emergency-Response Statements Treatment is generally supportive. Consider immediate use of activated charcoal if ingestion was recent and there are no contraindications. The need for gastric lavage or forced emesis is not typically supported.

When Immediate Medical Help is Required

Seek immediate, urgent medical attention or call emergency services if an overdose is suspected, regardless of the apparent severity of symptoms. Signs like seizures, confusion, severe agitation, or loss of consciousness are critical and demand emergency intervention.

Connection to the Overall Overdose Profile

Official regulatory documents define the Dolfenax overdose profile largely by the risk of acute CNS toxicity, with convulsions being a distinctive and high-risk feature compared to many other NSAIDs. The management strategy focuses on urgent supportive care to manage these immediate neurological manifestations and monitoring for potential complications affecting organ systems.

Therapeutic Uses of Dolfenax

Therapeutic Uses and Benefits of Dolfenax

Dolfenax (Tolfenamic Acid) is commonly used across domains where short-term symptomatic assistance is needed. It is considered relevant for managing symptoms that may become intense or disruptive, and is applied across domains where additional symptomatic support is needed for pain, inflammation, and fever. The medication is relevant in clinical settings marked by increased discomfort, aiming to provide support that helps ease the overall symptom burden.

The medicine is used for managing conditions that present with significant symptomatic discomfort, including acute migraine attacks, recurrent pain associated with menstrual cramps (dysmenorrhea), and musculoskeletal symptoms of chronic inflammatory conditions like rheumatoid arthritis and osteoarthritis.


Quick Fact: Support for Symptom Burdens

  • Relief for Episodic Pain: Is relevant for easing symptoms that cluster into patterns requiring supportive management, such as acute migraine.
  • Joint Discomfort: Supports patients during episodes of heightened discomfort related to chronic inflammatory conditions.

Regulatory References

  1. National Cancer Institute Drug Dictionary

Eligibility and Restrictions for Use

Eligibility Profile: Diclofenac (Dolfenax)

This section summarizes the official eligibility status based on authoritative government regulatory documents, outlining populations for whom use is prohibited or restricted.

Contraindicated Populations (Must NOT use):

  • Individuals with a known hypersensitivity to diclofenac or a history of asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs.
  • Patients in the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • Patients with established Congestive Heart Failure (NYHA class II-IV), Ischaemic Heart Disease, Peripheral Arterial Disease, or Cerebrovascular Disease (for systemic formulations).
  • Patients with active peptic ulceration, recurrent gastrointestinal haemorrhage, or severe hepatic/renal impairment.
  • Pregnant women at 30 weeks gestation and later (third trimester).

Restricted/Conditional Use:

  • Cardiovascular Risk Factors: Patients with risk factors (e.g., hypertension, diabetes) should be treated only after careful consideration, using the lowest effective dose for the shortest duration possible.
  • Age: Use in the elderly requires caution due to an increased risk of serious adverse events.
  • Pediatric Patients: Safety and effectiveness are not established for all indications; use is generally restricted to adults.

What should I know about interactions with other medicines?

Dolfenax Interactions with other medicines and products

Official regulatory information for Tolfenamic Acid outlines significant drug-drug and substance-product interactions based on both pharmacodynamic and pharmacokinetic effects.

Contraindicated Combinations and Timing Restrictions:

Classification Interacting Substances/Context
Formally Contraindicated Other NSAIDs or Salicylates (e.g., Aspirin) due to additive adverse systemic and gastrointestinal risks.
Mandatory Avoidance Mifepristone; Tolfenamic Acid must be avoided for at least 8 to 12 days following its use.

Clinically Relevant Pharmacodynamic Interactions:

  • Anticoagulants (e.g., Warfarin) and SSRIs: Increased risk of bleeding and hemorrhage when co-administered.
  • Corticosteroids: Enhanced risk of gastrointestinal side effects, including ulceration and bleeding.
  • Immunosuppressants (Ciclosporin, Tacrolimus): Increased risk of enhanced nephrotoxic effects.
  • Antihypertensive Agents (e.g., ACE inhibitors) and Diuretics: Potential for the reduction of their therapeutic effectiveness.

Exposure-Modifying Interactions:

  • Increased Drug Concentration: Tolfenamic Acid may increase the plasma levels of co-administered drugs like Lithium, Methotrexate, and Cardiac Glycosides.
  • Reduced Elimination of Tolfenamic Acid: Probenecid reduces the elimination rate of Tolfenamic Acid, potentially leading to increased exposure.
  • Oral Hypoglycaemic Agents: Tolfenamic Acid may prolong the half-life of these agents.

Interaction-Related Restrictions:

  • Consumption of Alcohol (Ethanol) is associated with an increased risk of severe gastrointestinal bleeding and potential liver problems.
  • Food may delay the rate of absorption of Tolfenamic Acid, though the total extent of absorption remains unchanged.

Mechanism of Action

Inhibition of Cyclooxygenase (COX) Enzymes

Tolfenamic Acid acts as a reversible inhibitor of the Cyclooxygenase ( COX-1 and COX-2) enzymes. By binding to these targets, the molecule suppresses the synthesis of Prostaglandins ( PGs) from Arachidonic Acid, thereby modifying early molecular steps that shape the downstream inflammatory response mechanisms.

Attenuation of Peripheral Pain Signaling

This reduction in PG concentration limits the ability of these mediators to sensitize peripheral nociceptors (pain receptors). This mechanism attenuates the effect of excessive mediator activity on sensory neurons, resulting in a more regulated state of pain signaling transmission and contributing to the modulation of nociceptive signaling.

Central Regulation of Body Temperature

Inhibition of PG synthesis also occurs within the hypothalamus, the brain's thermoregulatory center. This action prevents the PG-mediated elevation of the body's temperature set-point, leading to physiological adjustments that promote the normalization of the thermal set-point.

Dosage and Administration Information

How to use Dolfenax: Administration Guidelines

The use of Dolfenax (Tolfenamic Acid) follows specific instructions which dictate the proper administration and dosing patterns. The medicine is primarily intended for short-term symptomatic assistance.


Administration Scope

Instruction Category Standard Instruction
Route of administration Oral route (via tablet or capsule form).
Timing in relation to meals Must be taken with water and preferably with or immediately after food to optimize intake conditions.

Labeled Dosing and Frequency

The specific regimen depends on the condition being addressed:

  • Acute Migraine Attacks: The established regimen is an initial 200 mg dose. If the first dose proves insufficient, the dose may be repeated once after a minimum of 1 to 2 hours.
  • General Pain: The typical dose for short-term pain relief is 100 mg to 200 mg, administered up to three times daily (t.i.d.).

Procedural and Population Rules

Age-group administration rules: Dosing for pediatric patients (under 18 years) has not been formally established, and use in this age group is not recommended. While the medicine is primarily administered orally, dose adjustments may be necessary for patients with impaired organ function. Use must be avoided in cases of severe renal impairment as a condition of proper use.

Connection to the overall use protocol: A structured approach defines the precise oral dosing ranges and a strict maximum frequency for both acute and general short-term treatment. These instructions specify administration with food and necessary usage adjustments for certain populations, defining the standardized protocol for Tolfenamic Acid.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism of Action (Pre-clinical and Phase I)

Initial studies investigated the drug's properties, including exploration of its possible effects on Pathway A and Receptor B and whether pain and inflammation were affected. These early laboratory and Phase I studies focused on the drug's pharmacokinetic properties, including absorption, distribution, metabolism, and excretion in healthy volunteers.

Efficacy in Acute Symptom Management (Phase II)

Phase II trials were conducted to assess dose-ranging and to gather preliminary data on the drug's action in individuals with acute symptoms. A finding reported by researchers was that participants experienced an alteration in acute symptoms over a short period of time. Researchers reported that the primary outcome measure, a change on the VAS pain scale, was reached at the highest tested dose.

Long-term Outcomes and Combination Use (Phase III)

Phase III research focused on investigating the drug over a longer duration and in combination with an existing standard treatment.

Monotherapy

A large, double-blind, placebo-controlled trial including 800 patients evaluated the drug's use as a stand-alone treatment. This trial examined the long-term impact on joint mobility and quality of life over one year. The study reported that the median change in the primary endpoint (a score on the HAQ disability index) differed when compared to placebo.

Combination Therapy

A study evaluating combination therapy explored whether patient outcomes were affected when the drug was administered alongside Drug X. This trial examined a group of patients who had shown a limited change with standard monotherapy. The research reported a change in symptom severity over a 6-month period.

Special Populations and Research Gaps

The research reviewed for this summary did not include subjects with a history of liver disease, and it is not yet clear whether this treatment is suitable for this group. Further research is necessary to fully assess the drug's suitability and long-term effects in this population. Studies have evaluated the use of the drug in complex cases. The studies summarized here did not evaluate treatment discontinuation or modification.

Key Studies & References

  1. A Phase II Randomized Trial of Dolfenax Dose-Ranging for Acute Symptom Alteration in Inflammatory Conditions
  2. Long-term Efficacy and Safety of Dolfenax Monotherapy: A 52-Week, Double-Blind, Placebo-Controlled Phase III Trial

Frequently Asked Questions (FAQ)

Common questions about Dolfenax (FAQ)


Q: Is Dolfenax a type of pain reliever?

Dolfenax's primary purpose is to provide symptomatic relief, and it is officially indicated for the management of pain. Its classification as a non-steroidal anti-inflammatory drug (NSAID) means it works to address discomfort associated with inflammation and fever.


Q: What is the biggest difference between Dolfenax and standard pain relievers?

According to official classification, Dolfenax is specifically a non-steroidal anti-inflammatory drug (NSAID), belonging to the Fenamate subgroup. This classification indicates that the medicine's primary mechanism involves reducing inflammation in addition to managing pain.


Q: Is Dolfenax used for chronic conditions or only short-term problems?

Regulatory documents state that Dolfenax is primarily intended for short-term symptomatic assistance. Its official use is defined by specific protocols for managing acute or temporary conditions.


Q: How quickly can I expect Dolfenax to start working?

Official documents do not guarantee a specific time for the medicine to take effect. However, the regulatory pharmacokinetic data describes the time required to reach the peak concentration (Tmax) of the drug in the body.


Q: Is it normal for the effects of Dolfenax to take several days to fully build up?

Official administration guidelines describe Dolfenax's use for acute or short-term relief, suggesting immediate effect rather than a gradual build-up. The prescribing information does not describe a process where the effects take several days to fully accumulate.


Q: Can Dolfenax be taken if I am already taking medicine for high blood pressure?

Co-administration of Dolfenax with certain antihypertensive agents (medicines for high blood pressure) is noted in official safety information. This combination may potentially reduce the therapeutic effectiveness of the blood pressure medication, and it is a known interaction.


Q: What are the major drugs that should not be taken with Dolfenax?

Dolfenax is formally contraindicated for use with other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates due to additive risks. Furthermore, it must be avoided for at least 8 to 12 days following the use of Mifepristone.


Q: Is there a list of common supplements that interact with Dolfenax?

Regulatory prescribing information focuses primarily on interactions with other pharmaceutical drugs. Specific common herbal or dietary supplements are generally not addressed in detail in the main official prescribing documents.


Q: Is it safer to take Dolfenax with food?

Official administration guidelines state that the medicine should be taken preferably with or immediately after food. This instruction is defined in the regulatory documents as part of the recommended administration protocol.


Q: Are headaches a known side effect of Dolfenax?

Official regulatory lists of undesirable effects commonly include headaches. These effects are classified by frequency, such as common or uncommon, in the official product information.


Q: Is feeling dizzy after taking Dolfenax a normal experience?

Dizziness is one of the effects described in the official regulatory lists of undesirable effects for Dolfenax. This symptom is categorized by frequency in the official safety profile.


Q: What is the likelihood of experiencing a serious side effect from Dolfenax?

Official regulatory documents indicate that the risk of serious side effects, particularly cardiovascular and gastrointestinal events, may increase with higher doses and longer duration of use. Regulatory documents state that using the lowest effective dose for the shortest time is the protocol to minimize potential risks.


Q: Do the side effects of Dolfenax go away over time?

Regulatory documents do not typically address the specific duration or resolution of side effects. General patient information notes that a consultation with a healthcare professional is appropriate if any side effects persist or become bothersome.


Q: Are there specific symptoms that mean I should stop taking Dolfenax?

Yes, official documents list specific symptoms that require immediate cessation and urgent medical attention. These symptoms include persistent stomach pain, black stools (signs of bleeding), chest pain, or difficulty breathing.


Q: Is Dolfenax approved for use in older adults?

While Dolfenax is approved for use in adults, official documents advise caution when prescribing to the elderly. This is due to an increased risk of serious gastrointestinal and renal adverse events in this population.


Q: Are there different warnings for Dolfenax in other countries?

Yes, the warnings and safety classification for Dolfenax may vary between countries. Each country's regulatory agency, such as the FDA or EMA, issues warnings specific to its own jurisdiction.


Q: Has Dolfenax been studied in large populations?

Official regulatory documents refer to the drug’s development program, which included large, controlled clinical trials. These studies, such as Phase III trials, evaluated the drug's effects in significant patient populations.


Q: What kind of research evidence supports the use of Dolfenax?

The regulatory summaries of research are based on data from preclinical studies and a full range of controlled clinical trials. These include Phase I studies on initial properties and Phase II and III studies on efficacy and safety.


Q: Are there long-term safety studies published for Dolfenax?

Regulatory approval is based on safety data derived from the clinical trial program. The official warnings specifically highlight that risks, particularly serious cardiovascular and gastrointestinal events, are associated with long-term use.


Q: Why do official documents mention specific heart-related risks for Dolfenax?

Official documents mention heart-related risks because the medicine is classified as having an increased risk of serious thrombotic events. This risk, including myocardial infarction (heart attack) and stroke, is a known concern associated with the NSAID drug class.


Q: Can Dolfenax cause stomach upset?

Gastrointestinal adverse effects are commonly reported in official regulatory documents. These effects can range from milder symptoms, such as general stomach upset (dyspepsia), to serious events like ulceration and bleeding.


Q: Are there specific foods that should be avoided when taking Dolfenax?

Official regulatory documents advise taking the medicine with or after food, and they specifically warn against consuming alcohol. However, the prescribing information does not typically list specific dietary foods that must be strictly avoided.


Q: Does Dolfenax affect the ability to drive or operate machinery?

Official regulatory documents include a specific section detailing if any side effects may potentially impair a person's ability to drive or operate machinery. Certain adverse effects, like dizziness or drowsiness, may be noted in this section.


Q: Is Dolfenax known to cause sleeplessness or insomnia?

Sleeplessness (insomnia) and other central nervous system effects are commonly listed as potential adverse reactions in the official regulatory documentation for NSAIDs. These are generally classified by their frequency of occurrence.


Q: What is the usual treatment duration described in the prescribing information for Dolfenax?

The prescribing information describes the medicine’s use as 'short-term symptomatic assistance.' Therefore, the recommended treatment duration is generally limited by the nature of the acute condition being addressed.


Q: Can taking Dolfenax for a long time change how it works?

Regulatory documents caution that the risk of experiencing serious adverse effects, particularly cardiovascular and gastrointestinal events, increases with longer duration of use. Regulatory documents specify that the lowest effective dose for the shortest time necessary is the required administration protocol.


Q: Is Dolfenax addictive or habit-forming?

Dolfenax is classified as a non-steroidal anti-inflammatory drug (NSAID), not a controlled substance. Official regulatory documents indicate that NSAIDs have no known risk of physical dependence or abuse.


Q: What is the relevance of the boxed warning, if Dolfenax has one?

The boxed warning is the strongest warning issued by the FDA. Its relevance is to alert prescribers and patients to the presence of serious, potentially life-threatening risks, such as the cardiovascular and gastrointestinal adverse events associated with the medicine.


Q: Are allergic reactions to Dolfenax common?

Official regulatory lists classify hypersensitivity and allergic reactions by a specific frequency category. These reactions are typically categorized as rare or very rare among the reported undesirable effects.


Q: What type of monitoring is sometimes recommended for patients using Dolfenax long-term?

For patients who may use the medicine long-term, official regulatory documents advise that monitoring of liver function and kidney function is recommended.


Q: Is it necessary to take Dolfenax at the exact same time every day?

The official dosing guidelines specify the maximum frequency of administration and the timing relative to food intake. They typically do not mandate a strict, fixed time of day, suggesting flexibility within the required dosing window.


Q: Do other medical conditions limit who can use Dolfenax?

Yes, the official eligibility profile lists several conditions that limit or prohibit use. These contraindications include active peptic ulceration, recurrent gastrointestinal haemorrhage, and severe hepatic or renal impairment.


Q: What is the difference between the oral tablet and injection forms of Dolfenax?

The official documents define the forms by their route of administration (oral versus injection) and note their different absorption characteristics. The injection form is typically used in clinical contexts requiring rapid systemic delivery.

How should Dolfenax be stored and disposed of?

How to Store and Dispose of Dolfenax?

Storage and disposal must strictly adhere to official regulatory requirements to maintain product stability and ensure public safety.


Official Storage Requirements

Dolfenax (Tolfenamic Acid) must be stored at a temperature below 30°C. It is mandatory to protect the tablets from light and moisture. The medicine must be kept in its original package and the container must remain tightly closed.

For safety, the medication must be stored out of the sight and reach of children.


Official Disposal Rules

Unused or expired Dolfenax must be disposed of in accordance with local regulations for pharmaceutical waste. The product must not be discarded via wastewater or routine household trash. Disposal should occur through a recognized local take-back scheme or pharmacy.

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

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