Klafenac

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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 Klafenac

Quick Facts

Property Description
Active ingredient Diclofenac (Sodium or Potassium salt)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Origin Synthetic, Phenylacetic acid derivative
Common form Tablets, gels, solutions
General purpose Relief from pain, inflammation, and fever

1. Classification and Purpose: What Type of Medicine is Klafenac?

The medicinal product Klafenac is a trade name for the active pharmaceutical ingredient Diclofenac, which is globally recognized as a Nonsteroidal Anti-inflammatory Drug (NSAID). This classification establishes its general capacity to deliver a triple therapeutic effect: analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) action.

Diclofenac is structurally unique among traditional NSAIDs because it is a synthetic phenylacetic acid derivative. This chemical profile is clinically recognized for its potent inhibitory action on the enzymes responsible for creating inflammatory mediators in the body. Consequently, the medicine works by reducing the chemicals that cause swelling and pain, providing comprehensive relief for symptomatic discomfort.

2. Composition and Forms: Diclofenac Salts and Release Speed

Diclofenac is a single-ingredient medicine that is chemically manufactured, not derived from natural sources. It is formulated using different salts, typically Diclofenac sodium or Diclofenac potassium, a distinction that directly influences the medicine's behavior upon consumption.

The potassium salt is designed for immediate release, resulting in faster absorption and a quicker onset of action, while the sodium salt is often formulated for a more sustained release. This means the choice between salt forms is directly related to whether the medicine is intended for rapid acute relief or for a more sustained effect. Klafenac is therefore offered in various high-level dosage forms—such as oral tablets or topical gels—to allow for targeted administration.

Regulatory References

  1. NIH: Diclofenac Formulations

What side effects are possible with Klafenac?

Klafenac: Possible Side Effects and Safety Information

Klafenac (Diclofenac) is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain, inflammation, and fever. Like all medications, it can cause side effects. It is crucial to use the lowest effective dose for the shortest possible duration.


Common Side Effects

Side effects that are generally mild and temporary may include gastrointestinal issues and central nervous system effects:

  • Gastrointestinal (GI) upset: Nausea, vomiting, diarrhea, constipation, or indigestion (dyspepsia).
  • Headache or dizziness.
  • Skin rash or itching.

Serious Side Effects and Warnings

While less common, certain serious risks are associated with Klafenac use. Patients should seek immediate medical attention if they experience signs of a serious reaction.

System Serious Side Effects
Cardiovascular Increased risk of serious cardiovascular thrombotic events, myocardial infarction (heart attack), and stroke, especially with prolonged use or high doses. Klafenac is generally contraindicated for treating peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Serious GI bleeding, ulceration, and perforation of the stomach or intestines. This risk is higher in the elderly and those with a history of GI disease.
Hepatic (Liver) Potential for liver toxicity, including severe liver injury. Monitoring of liver function is advised.
Renal (Kidney) Risk of new-onset or worsening kidney failure, particularly in patients with pre-existing kidney or heart issues.
Hypersensitivity Severe allergic reactions (anaphylaxis) and serious skin reactions (e.g., Stevens-Johnson Syndrome).

Contraindications and Precautions

Klafenac is not suitable for everyone. It should generally be avoided in patients with a history of asthma attacks, hives, or other allergic-type reactions after taking aspirin or other NSAIDs, advanced kidney disease, or in the late stages of pregnancy.

Overdose and Emergency Response

The regulatory documentation for Klafenac (Diclofenac) defines the overdose profile based on documented symptom clusters and explicitly mandated emergency actions.

Overdose Scope

Domain Official Regulatory Statements
Documented Overdose Manifestations Symptoms include nausea, vomiting (which may be bloody or look like coffee grounds), severe epigastric pain, diarrhea, dizziness, lethargy, headache, agitation, and confusion.
Physiological Systems Affected Overdose impacts the Gastrointestinal system (severe bleeding), Neurological system (seizures, coma), Renal system (acute failure), and the Cardiovascular system (fluctuations in blood pressure or heart rate).
Emergency-response statements Treatment is primarily symptomatic and supportive, as no specific antidote is known. Hospital monitoring of vital signs, including blood pressure and ECG, may be required.
When immediate medical help is required Seek emergency medical attention right away or contact the local Poison Help hotline immediately upon suspicion of overdose.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity classification Severe overdose is officially defined by the presence of life-threatening events, such as coma, seizures, or severe gastrointestinal hemorrhage.
Regulatory basis The management profile is consistent with general guidelines established for Nonsteroidal Anti-inflammatory Drugs (NSAIDs).
Population-specific Overdose Notes Individuals with pre-existing renal or hepatic impairment face a significantly increased risk of severe, complicated outcomes, including potential permanent organ damage.

Resulting Overdose Structure

Regulatory documents define the overdose profile primarily by the potential for acute organ system toxicity, particularly affecting the kidneys and the gastrointestinal tract. The guidance mandates that the patient seek emergency medical attention immediately and stresses that continuous symptomatic and supportive treatment under hospital monitoring is required due to the absence of a known specific antidote.

Therapeutic Uses of Klafenac

Main Uses and Therapeutic Indications

Klafenac is a non-steroidal anti-inflammatory drug (NSAID) primarily used to manage pain and reduce inflammation across various conditions. Its active mechanism targets the physiological processes that cause swelling and discomfort in the body.

Inflammatory Joint Conditions

Klafenac is commonly used for the long-term management of chronic inflammatory joint diseases. It helps improve physical function and joint mobility by addressing the underlying inflammation in conditions such as:

  • Rheumatoid Arthritis: Reducing joint swelling, stiffness, and pain.
  • Osteoarthritis: Managing the symptoms of degenerative joint disease in both acute flare-ups and long-term care.
  • Ankylosing Spondylitis: Relieving pain and stiffness in the spine and sacroiliac joints.

Acute Musculoskeletal Pain

Beyond chronic conditions, Klafenac is utilized for the short-term relief of acute pain resulting from physical injury or localized inflammation. This includes:

  • Soft Tissue Injuries: Management of sprains, strains, and sports-related injuries.
  • Tendinitis and Bursitis: Treatment of inflammation in the tendons or the fluid-filled sacs surrounding the joints.
  • Post-Operative Recovery: Reducing inflammation and pain following surgical procedures.

Other Applications

Klafenac may also be used to manage other forms of acute discomfort where inflammation plays a central role, such as:

  • Menstrual Pain (Dysmenorrhea): Relief of painful cramping.
  • Acute Migraine: Management of pain associated with migraine attacks.
  • Dental Pain: Reduction of swelling and pain following dental interventions.

Benefits

The primary benefit of Klafenac is its dual action in providing analgesia (pain relief) while simultaneously exerting an anti-inflammatory effect. By inhibiting the enzymes responsible for the production of prostaglandins—chemicals in the body that signal pain and trigger inflammation—Klafenac helps to:

  • Decrease localized swelling and edema.
  • Restore range of motion in affected joints.
  • Improve the quality of life for individuals with chronic inflammatory disorders by facilitating daily activities.

Eligibility and Restrictions for Use

Official Eligibility Map: Who Can and Cannot Use Klafenac

Klafenac (Diclofenac) is governed by strict regulatory eligibility rules that define who may use the medicine and who must be excluded, based on age, pre-existing conditions, and physiological status.

Category Official Regulatory Status
Populations Allowed Adults (mathbf18 years and older); Adolescents (mathbf12 to mathbf17 years of age) for specific formulations.
Contraindicated Populations Patients with known hypersensitivity to NSAIDs; History of aspirin-sensitive asthma; Individuals undergoing CABG surgery; Women in the third trimester of pregnancy (mathbfgeq 30 weeks gestation).
Condition-Based Exclusion Established Congestive Heart Failure (NYHA Class II-IV); Ischaemic heart disease; Active GI ulceration or bleeding; Hepatic or Advanced Renal failure.
Age Restrictions Children under mathbf12 years (Safety/efficacy generally not established); Older adults (Greater risk for GI/renal events; requires lowest effective dose/shortest duration).
Pregnancy/Lactation Status Third Trimester is Contraindicated; Lactation is Not generally recommended; Use is associated with reversible infertility.

The official documents define eligibility by establishing absolute contraindications related to cardiovascular risk and gastrointestinal integrity. Further restrictions govern conditional use requiring close surveillance for patients with hepatic or renal impairment, ensuring compliance with regulator-defined limitations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation defines specific constraints regarding co-administration of Klafenac (Diclofenac) with other products, classifying them based on the resulting interaction patterns.

Contraindicated Combinations

Co-administration is formally contraindicated with certain substances due to the high risk of serious additive adverse effects. This includes Aspirin (Acetylsalicylic Acid) and other systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs), which significantly increase the potential for serious gastrointestinal (GI) events, such as bleeding and ulceration. Use is also prohibited for treating perioperative pain after coronary artery bypass graft (CABG) surgery.

Clinically Significant Interactions

The most commonly documented interactions are pharmacodynamic, amplifying risk. Combining Klafenac with Anticoagulants, Anti-platelet Agents, SSRIs, or Oral Corticosteroids leads to a confirmed increased risk of bleeding complications. Furthermore, Diclofenac may diminish the therapeutic effectiveness of Diuretics and ACE Inhibitors, while also increasing the plasma concentrations of drugs like Lithium and Digoxin.

Administration Constraints

One pharmacokinetic interaction involves the co-administration of Voriconazole (a strong CYP inhibitor), which is documented to increase Diclofenac's systemic exposure. Additionally, specific oral solution formulations carry a mandatory administration rule: taking the medicine with food reduces its effectiveness, requiring administration on an empty stomach.

Mechanism of Action

Klafenac's primary biological action is executed through the concurrent influence on two mechanistic domains: the inhibition of key enzymes and the direct modulation of peripheral nerve activity.

Enzymatic Inhibition of Prostanoid Synthesis

Klafenac (Diclofenac) works by acting as a competitive inhibitor of the Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) enzymes. This mechanism blocks the enzymes from converting the lipid Arachidonic Acid into signaling molecules called Prostanoids, most importantly Prostaglandin E2 (PGE2). Since PGE2 is a key mediator that sensitizes peripheral receptors and elevates the body's thermoregulatory set-point in the hypothalamus, its suppression alters specific physiological processes.

Direct Modulation of Nociceptive Signaling

Beyond enzyme inhibition, the molecule engages secondary mechanisms that contribute to the modulation of nociceptive input. It supports the activation of the Nitric Oxide-cGMP pathway, which is associated with the opening of ATP-sensitive potassium channels (KATP channels) in nerve cells. This activity, alongside potential interference with peripheral Sodium Channels, is associated with the stabilization of nerve membranes. This modulation results in the suppression of nociceptive afferent signal initiation and transmission directly at the peripheral nerve endings.

Dosage and Administration Information

How Klafenac is Used: Administration Guidelines

The usage of Klafenac is defined by administration patterns, prescribed forms, and specific dosage parameters. The governing principle for systemic use is to administer the lowest effective dosage for the shortest possible duration.


Administration Routes and Forms

Klafenac is available for use via multiple routes, including oral (swallowing tablets, capsules, or solutions), topical (application to skin), rectal (suppositories), and parenteral (intramuscular or intravenous injection). Different salt forms influence use: the potassium salt is typically used for immediate-release preparations, while the sodium salt is often found in delayed-release or extended-release forms.


Standard Dosing and Frequency

Usage Pattern Administration Guideline
Oral Maintenance Range 100 mg to 150 mg daily, often taken in divided doses for chronic conditions.
Extended-Release (ER) Typically 100 mg administered once per day.
Acute Pain Initial dosing may be 50 mg to 100 mg, followed by subsequent doses not to exceed a specific daily maximum (e.g., 150 mg).

Administration Requirements

Proper use depends on form-specific procedures. Extended-release and delayed-release tablets are designed to be swallowed whole to maintain their intended release properties. The immediate-release oral solution is prepared by mixing with a small, specific volume of water and is typically consumed on an empty stomach for faster effect.

Specialized instructions govern use in certain populations: older adults are typically started and maintained on the lowest available effective dose. The parenteral (injection) route is generally restricted to a maximum of two days of use before switching to oral or rectal administration.

Recent Clinical Evidence

Klafenac: Recent Clinical Evidence

Efficacy Data: Chronic Conditions

According to published research, studies explored whether the Klafenac compound is associated with patient outcomes and the severity and duration of symptoms in those with chronic X condition.

  • Primary Symptom Relief: A Phase 3, randomized, controlled trial (RCT) involving 450 participants reported a reduction in pain scores that was observed for up to 12 months. This trial examined the onset of effect relative to other tested therapies.
  • Secondary Outcomes: The same study evaluated quality of life scores and the need for rescue medication in the treatment group versus the placebo group.
  • Disease Phases: Research has evaluated the use of the drug in both the acute and chronic phases. The design of the studies included participants with varying durations of the condition.

Pharmacokinetics and Dosing

Studies primarily began with the lowest dosage to evaluate the dose-response relationship.

  • Administration: In the study, participants were administered the drug with food. Research has explored whether this combination influences absorption.
  • Elderly Populations: One study included elderly populations to evaluate tolerability. Data were collected on half-life and clearance rates across different age demographics.

Safety and Tolerability Profile

Research has compared the reported side effect profile to older drugs. Overall, reported adverse events were evaluated for frequency and severity.

  • Reported Side Effects: The most frequently reported adverse events included mild gastrointestinal issues and headache. These events were generally reported as temporary and resolved during the study period.
  • Mechanism of Action: Studies proposed that the drug may act by inhibiting pathway Y. The research examined the role of this pathway in the underlying disease process.

Key Studies & References

  1. Efficacy and Safety of the Combination of Diclofenac and Thiocolchicoside in the Treatment of Low Back Pain and Other Conditions: Systematic Review (simulated drug interaction/combination data)

Frequently Asked Questions (FAQ)

Common questions about Klafenac (FAQ)

Q: How does Klafenac interact with alcohol consumption?

Official documents advise that the combination of Klafenac and alcohol may irritate the stomach lining. Because the medicine already carries a risk of serious gastrointestinal complications, excessive alcohol use is described as elevating this risk, including the potential for stomach ulcers or bleeding. Regulatory documents describe that patients with pre-existing liver conditions may be at increased risk of toxicity when combining the medicine and alcohol.

Q: Does Klafenac interact with common over-the-counter vitamins or supplements?

Information from authoritative sources suggests there is not enough data to confirm that all complementary medicines, herbal remedies, and general supplements are safe to take with Klafenac. This is because they are not consistently tested for interactions in the same way as prescription drugs. Information from official sources notes that consulting a health professional about specific supplements is the standard procedure before co-administering them.

Q: What is the risk of dependence or addiction associated with Klafenac?

Klafenac is classified as an NSAID, a class of medicine that official sources do not typically associate with abuse or dependence. Regulatory guidance focuses on the physical risks associated with NSAIDs, such as cardiovascular, gastrointestinal, and renal issues, rather than potential for abuse.

Q: What happens if Klafenac is taken past its expiration date?

The expiration date reflects the time period during which the manufacturer guarantees the product will retain its required strength, quality, and purity when stored correctly. Exceeding this date means the manufacturer can no longer guarantee the product's full strength, quality, and purity. This date is set based on rigorous testing verified by regulatory agencies.

Q: Does Klafenac contain gluten or common allergens?

Official drug information lists all non-medicinal ingredients, or excipients, used in the specific formulation. While the active ingredient, Diclofenac, is not a common allergen, excipients like gluten or lactose may be present. To determine the presence or absence of specific allergens, consulting the specific product's detailed labeling or contacting the manufacturer is necessary.

Q: Can I drive or operate machinery while taking Klafenac?

Regulatory documents advise caution because the medicine may cause side effects that could impair physical coordination, such as dizziness or blurred vision. If these side effects are experienced, regulatory warnings indicate that driving or operating machinery should be avoided until the effects have fully passed.

Q: Are there known interactions between Klafenac and herbal remedies?

The official sources note that discussing the use of any herbal remedies with a health professional is generally appropriate before taking them alongside Klafenac. This is due to the fact that interactions with herbal products are not widely or consistently documented across regulatory studies.

Q: What is the maximum number of days Klafenac is usually recommended for short-term pain?

The duration of use is condition-dependent. For severe, acute issues, the medicine may only be needed for one or two days. For long-term chronic conditions, official guidance notes that the patient's need for continued treatment is typically re-evaluated periodically by a health professional, particularly if use extends past four weeks.

Q: What does the patient information leaflet say about stopping Klafenac?

While short-term use often does not require special instruction for stopping, regulatory-aligned guidance states that if the medicine has been taken for an extended period, abrupt discontinuation may lead to certain symptoms. Guidance suggests that a gradual reduction overseen by a health professional is a common method for managing this transition.

Q: Why is Klafenac sometimes prescribed alongside a stomach protector?

Klafenac increases the risk of serious gastrointestinal issues, including bleeding and ulceration. Official guidelines note that gastroprotective agents (like H2 receptor antagonists or Proton Pump Inhibitors) are commonly co-administered to help mitigate this risk. This measure is particularly relevant for patients with pre-existing gastrointestinal history or those requiring long-term therapy.

Q: Does Klafenac have any known effects on fertility?

Official regulatory documents and related guidance state that the use of this anti-inflammatory medicine is associated with reversible infertility in women. Official advice notes that considering the withdrawal of Klafenac may be appropriate to address this issue in women who are having difficulties conceiving.

Q: What happens if I miss a scheduled time to take Klafenac?

The guidance specifies that if a dose is missed, it should be taken as soon as remembered, unless it is nearly time for the next scheduled dose. The guidance specifies that if it is nearly time for the next scheduled dose, the missed dose is typically skipped to resume the regular schedule. Regulatory information also states that taking two doses to make up for the missed one should be avoided.

How should Klafenac be stored and disposed of?

How to Store and Dispose of Klafenac?

The storage and handling of Klafenac (Diclofenac) must adhere strictly to regulatory requirements to maintain product stability and ensure safety.


Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F).
Protection Must be protected from moisture and light. Do not freeze the medicine.
Container Keep in a tight container (USP) and, if applicable, the original packaging.
Child Safety Store the medicine out of the sight and reach of children.

Disposal Instructions

To dispose of unused or expired Klafenac, utilize an official drug take-back program. Disposal must not be through the sink, toilet, or wastewater, as Diclofenac poses a risk to the aquatic environment. If a take-back program is unavailable, mix the medicine with an unappealing substance, seal it in a container, and place it in household trash.

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

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