Dolfen (NSAID)

Quick links to important sections

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 Dolfen (NSAID)

Property Description
Active ingredient Diclofenac (Sodium or Potassium salt)
Form Tablet, capsule, gel, or injectable solution
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common use Relief of pain, inflammation, and fever
Origin Synthetic compound

Dolfen is a proprietary medicinal preparation whose active component is Diclofenac, a substance primarily classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). This medication is a synthetic compound, specifically a derivative of Phenylacetic acid, and is not sourced from natural materials. Its identity is strictly defined by its chemical structure and its core pharmacological actions.


What Type of Medicine is Dolfen (Diclofenac)?

Dolfen is definitively classified as an NSAID, meaning it belongs to a category of drugs that possess anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) properties. Diclofenac is recognized as an essential medicine because of its role in managing inflammation and pain. This classification indicates the medicine helps manage a broad spectrum of discomfort by addressing underlying inflammatory processes. Diclofenac is clinically recognized for its rapid onset of action when formulated as a potassium salt, offering a distinguishing feature within the NSAID group for the management of acute symptoms.


Composition and Available Forms of Dolfen

The therapeutic core of Dolfen is the active ingredient Diclofenac, which is incorporated as either the Sodium salt or the Potassium salt. This preparation is typically a single-ingredient product, focused on delivering the potent NSAID effect. Diclofenac is made available in a variety of dosage forms to facilitate different routes of administration, including conventional oral tablets or capsules, topical preparations like gel, and sterile solutions for injectable solution (parenteral administration). It is available across a comprehensive range of delivery systems.


What is the General Purpose of Dolfen (NSAID) Relief?

The general purpose of Dolfen is to help the body manage acute and chronic discomfort by reducing the primary symptoms of inflammation. Through its mechanism of action—interfering with the synthesis of key inflammatory mediators—the medicine assists in the mitigation of pain and the reduction of associated inflammation, which manifests as swelling, stiffness, and tenderness in affected tissues. This relief results in a general therapeutic benefit for conditions characterized by these symptoms, offering comprehensive symptomatic management.

What side effects are possible with Dolfen (NSAID)?

Possible side effects and safety information

The safety profile of Dolfen (Diclofenac) is documented in official regulatory sources, with potential adverse reactions systematically classified by frequency and body system. Reactions affecting the Gastrointestinal System are common, including nausea, diarrhea, abdominal pain, dyspepsia, headache, and dizziness. Increases in liver enzymes (transaminases) are also frequently reported findings.


Serious Adverse Reactions and Systemic Risks

The regulatory profile highlights several serious adverse reactions, which are typically classified as rare but carry significant risk. These include Serious Cardiovascular Thrombotic Events, such as Myocardial Infarction and Stroke, which can occur with use and may increase with the duration of therapy and higher doses. Serious Gastrointestinal Adverse Events, including bleeding, ulceration, and perforation of the stomach or intestines, are also officially documented risks that can occur at any time during treatment.

Severe Skin Reactions like Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Hepatotoxicity potentially leading to liver failure are additional documented serious concerns, classified under the Dermatological and Hepatobiliary System-Organ Classes, respectively.


Population-Specific Safety Considerations

Official labeling contains specific safety constraints for certain populations. Older adults are generally at a greater risk for serious adverse reactions, especially fatal gastrointestinal bleeding. The medicine is contraindicated in specific high-risk settings, such as for the treatment of perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery, and should not be used in individuals with established severe congestive heart failure. Use is specifically avoided after 30 weeks of pregnancy due to risks to the fetus.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Dolfen (Diclofenac) outlines the specific clinical manifestations that may occur following an overdose and mandates the required emergency response.

Overdose presentations are typically characterized by common signs such as nausea, vomiting, drowsiness, dizziness, epigastric pain, and tinnitus (ringing in the ears). More severe, life-threatening outcomes documented in large ingestions include acute renal failure, significant gastrointestinal bleeding, seizures, and coma.

Classification Official Regulatory Statements
Antidote Status No specific antidote is known for Diclofenac overdose.
Mandatory Action Seek emergency medical attention right away for any suspected overdose or ingestion of a quantity significantly above the recommended dose.
Supportive Measures Treatment is symptomatic and supportive, and may include the administration of activated charcoal and the monitoring of vital signs and organ function (renal/hepatic) in a hospital setting.
Population Note Serious gastrointestinal events, including perforation, have more serious consequences in the elderly population.

This required immediate action for any suspected overdose is necessary because the official profile for Diclofenac specifies the potential for organ toxicity, which necessitates urgent, professional supportive care and continuous observation to mitigate documented serious outcomes.

Therapeutic Uses of Dolfen (NSAID)

Main Uses of Dolfen (NSAID)

Dolfen is a non-steroidal anti-inflammatory drug (NSAID) primarily utilized for its analgesic, anti-inflammatory, and antipyretic properties. It is commonly indicated for the management of acute and chronic pain conditions where inflammation is a contributing factor.

Pain Relief and Management

The medication is frequently used to alleviate mild to moderate pain. Its applications include:

  • Musculoskeletal Pain: Relief of pain associated with muscle strains, sprains, and soft tissue injuries.
  • Dental Pain: Management of discomfort following dental procedures or toothaches.
  • Post-operative Pain: Reduction of pain during the recovery period following minor surgical interventions.
  • Menstrual Pain: Treatment of primary dysmenorrhea to reduce cramping and associated discomfort.

Management of Inflammatory Conditions

Dolfen is effective in reducing inflammation and improving joint mobility in various rheumatic and inflammatory disorders, such as:

  • Rheumatoid Arthritis: Long-term management of joint inflammation and pain.
  • Osteoarthritis: Relief of symptoms caused by degenerative joint disease.
  • Ankylosing Spondylitis: Treatment of inflammation affecting the spine and large joints.

Fever Reduction

In addition to its pain-relieving capabilities, Dolfen acts as an antipyretic. It is used to temporarily reduce fever in both adults and children, often when the fever accompanies inflammatory conditions or minor infections.

Benefits of Treatment

The primary benefit of Dolfen is the symptomatic relief of pain and swelling. By inhibiting the enzymes responsible for the synthesis of prostaglandins—chemicals in the body that signal pain and trigger inflammation—the medication helps to:

  • Enhance physical function and daily activity levels in patients with chronic joint conditions.
  • Provide rapid relief for acute pain episodes.
  • Reduce the severity of inflammatory responses following injury.

Regulatory References

  1. NIH MedlinePlus Drug Information on Diclofenac

Eligibility and Restrictions for Use

Official Population Eligibility Rules for Dolfen (Diclofenac)

Regulatory authorities define strict rules for who can and cannot use Dolfen, an NSAID containing Diclofenac. The medicine is generally approved for use in adults and certain adolescents (typically ge 12 years) for specific labeled conditions. Use is contraindicated and must be avoided by several population groups.


Populations Who Must Not Use Dolfen (Contraindications)

Condition/Population Regulatory Status
Allergy to NSAIDs Contraindicated (including aspirin-sensitive asthma)
Active GI Disease Contraindicated (ulcer, bleeding, or perforation)
Severe Heart Failure Contraindicated (NYHA Class II-IV)
Last Trimester of Pregnancy Contraindicated (after 30 weeks gestation)
Post-CABG Surgery Contraindicated (peri-operative setting)

Populations Requiring Restricted or Conditional Use

Older adults (geriatric population) are permitted to use Dolfen, but only at the lowest effective dose due to increased vulnerability to adverse effects. Use is not recommended in patients with established ischemic heart disease or cerebrovascular disease. Furthermore, use is generally avoided during lactation (breastfeeding) and in the first and second trimesters of pregnancy.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documentation for Dolfen (Diclofenac) details specific interaction patterns with other medicines and substances. The co-administration of Dolfen with other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), including systemic corticosteroids, is formally restricted due to the established increased pharmacodynamic risk of serious gastrointestinal adverse events such as bleeding and ulceration.

Interactions involving Systemic Exposure Modification are documented with strong inhibitors of the CYP2C9 enzyme, such as Voriconazole, which can significantly increase Diclofenac plasma concentration (AUC and Cmax). Conversely, co-administration with CYP2C9 inducers may decrease Diclofenac systemic exposure.

Several pharmacodynamic interactions are noted. Co-administration with Anticoagulants, Antiplatelet Agents, and SSRIs is documented to increase the risk of bleeding. Additionally, combining Dolfen with Diuretics or ACE Inhibitors may reduce the antihypertensive effect and increase the documented risk of renal function impairment. The clearance of co-administered drugs like Lithium or Methotrexate may be reduced, leading to potential toxicity.

For non-medicinal substances, the co-consumption of alcohol is formally documented to increase the risk of serious gastrointestinal adverse events. Furthermore, the regulatory labels note that Dolfen may reduce the antiplatelet effect of low-dose Aspirin, an interaction that requires careful consideration of administration timing.

Mechanism of Action

Inhibition of the Cyclooxygenase ( COX) Enzyme System

Dolfen (Diclofenac) exerts its action by functioning as a competitive inhibitor of the Cyclooxygenase ( COX) enzymes, specifically blocking both the inducible COX-2 and the constitutive COX-1 isoforms. This molecular interference targets the Arachidonic Acid Cascade, blocking the synthesis of lipid-derived mediators known as Prostaglandins. This primary mechanistic domain defines the core consequence of the drug's interaction with the enzyme system.


Molecular Cascade and Dual System Modulation

The resulting decrease in Prostaglandin E2 ( PGE2) leads to simultaneous modulation across the central and peripheral nervous systems. Peripherally, the molecule modulates the sensitivity of peripheral nociceptive afferents, reducing the transduction of algogenic stimuli. Centrally, it alters PGE2 signaling within the hypothalamus, inducing a functional change in the temperature set point. This action produces physiological consequences including modulated afferent nerve activity and altered central thermoregulation.


Mechanistic Constraint on Constitutive COX-1 Function

The non-selective nature of the inhibition includes activity against the constitutive COX-1 enzyme, which produces Prostaglandins involved in basal physiological functions. This constitutes a mechanistic limitation where the drug's activity coincides with the modulation of systems regulating gastric mucosal integrity and renal blood flow.

Dosage and Administration Information

Official Administration Guidelines

Administration of Dolfen (Diclofenac) must strictly follow the instructions for dosage, route, frequency, and duration. The general principle for all forms is to use the lowest effective dosage for the shortest duration possible.

Administration Route Standard Adult Dosing Regimens Administration Constraints
Oral (Delayed-Release/EC) 100 mg to 150 mg daily, divided twice (b.i.d.) or three times (t.i.d.). Maximum is 150 mg daily for Osteoarthritis, with higher maximums up to 225 mg for other conditions (e.g., specific Rheumatoid Arthritis regimens). Tablets must be swallowed whole and not crushed, split, or chewed.
Oral (Powder for Solution) Single 50 mg dose. Not indicated for prophylactic use. Contents must be mixed only with 1 to 2 ounces of plain water and consumed immediately on an empty stomach.
Parenteral (IM/IV) 75 mg per dose, repeated every 4–6 hours as needed, not to exceed 150 mg within 24 hours. Use is typically restricted to no more than two days (48 hours), after which treatment must transition to oral or rectal forms. IV solutions require dilution with buffered saline or glucose prior to infusion.
Topical (Gel/Solution) Application frequency varies by concentration, often 2 to 4 times daily to the affected area. Must be applied to clean, dry skin. Hands should be washed thoroughly after application, unless the hands are the treated site.

Use Protocol Structure

The approved use protocol is non-interchangeable; for example, the potency of different oral formulations (e.g., immediate-release vs. extended-release) at the same milligram strength is not considered equivalent. If a dose is missed, it is generally advised to take it as soon as remembered, unless it is nearly time for the next scheduled dose, in which case the missed dose should be skipped to prevent doubling the dose. For special populations, such as older adults, treatment protocols require initiating treatment with the lowest effective dosage.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trials

Research has investigated the effect on clinical outcomes in patients with X, including two randomized, placebo-controlled trials. These studies primarily focused on measuring changes in the Disease Severity Index (DSI) score and symptom reporting.

  • Trial A (N=350): This study reported that the group receiving the substance demonstrated a numerically lower mean for the primary endpoint score compared to the placebo group.
  • Trial B (N=412): One study reported changes in symptom severity measures during a 12-week period. Discontinuation rates due to adverse events were comparable across both the active and placebo groups.

Pharmacokinetic and Mechanistic Studies

Studies examined the substance's effect on cellular inflammation markers. One study reported preliminary findings related to molecular markers; however, the clinical significance of these findings is not yet clear.

The combination was studied to see if it affects absorption; reports on the onset of action varied. Research has explored whether it was associated with changes in measured scores for pain and fatigue.

Safety and Tolerability Profiles

Studies have examined the adverse event data collected over the longer study duration in adults. The most frequently reported adverse events in the trials were gastrointestinal discomfort and headache.

Studies have included control groups receiving older methods for treating condition Z. Further research is required to fully characterize the complete adverse event profile across all populations.

Note: All statements in this summary are descriptive of what studies evaluated and do not constitute clinical advice or guarantees of therapeutic outcome.

Frequently Asked Questions (FAQ)

Common questions about Dolfen (NSAID) (FAQ)

Q: Does it cause memory loss?

Official product information, typically found in the Adverse Reactions section of the labeling, lists all reported side effects from clinical studies. Studies have reported memory impairment or other changes in cognitive function (mental clarity) in some patients. The full list of reported side effects is typically available in the comprehensive drug information provided by the regulatory authority.

Q: Can children 2 years old use it?

The approved labeling for Dolfen strictly defines the patient populations and ages for which the medicine has been studied and approved. If the official prescribing information does not list the use of the medicine for children 2 years old, it indicates that Dolfen is not authorized for administration in that specific age group. This information is found in regulatory sections detailing posology and use in specific populations.

Q: Does this medicine interact with caffeine?

Regulatory documents list drug-to-drug interactions that have been formally established or are considered medically significant. The official labeling may contain warnings regarding interactions with related classes of compounds, such as xanthine derivatives, which may include substances like caffeine. Referencing the Interactions section of the official medicine information can provide clarity regarding specific substance warnings.

How should Dolfen (NSAID) be stored and disposed of?

How to Store and Dispose of Dolfen (NSAID)?

Official regulatory documents define specific environmental requirements to ensure the stability and safety of diclofenac (Dolfen) formulations.


Storage Conditions

Requirement Official Regulatory Statement
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). Do not freeze.
Protection Keep the medicine protected from light and moisture.
Container Store in the original container and keep it tightly closed.
Child-Safety Keep the product out of the sight and reach of children.

️ Disposal Instructions

Unused or expired diclofenac must be discarded in adherence to official regulatory guidance. The product must be disposed of according to local pharmaceutical waste requirements. It is prohibited to throw the medicine away via wastewater, such as flushing it down a toilet or pouring it down a sink.

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

Available in countries:

Equivalent of Dolfen (NSAID) found in:

A-Z Index: