Dicloftil

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Medically reviewed

Rosario Oropesa

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 Dicloftil

Property Description
Active Ingredient Diclofenac
Form Varies (e.g., tablet, gel, solution for injection)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General Purpose Relieves pain, inflammation, and fever
Origin Synthetic, derived from phenylacetic acid

What Type of Medicine is Dicloftil?

Dicloftil is the medicinal entity containing the active compound Diclofenac, a potent, synthetic drug classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This classification identifies it as a non-narcotic agent whose primary function is to interfere with the body's processes that cause inflammation and pain. Diclofenac's status as an NSAID distinguishes it from analgesics like acetaminophen, as it possesses significant anti-inflammatory power in addition to pain relief. It is recognized as a well-established agent for general symptom management.


Composition and Available Forms of Diclofenac

The core active ingredient in Dicloftil is Diclofenac, typically prepared using various salt forms, such as Diclofenac sodium or Diclofenac potassium, to optimize its stability and absorption within the body. This medicine is prepared for both systemic and local routes of administration, a key feature that enhances its utility across various patient needs. Available high-level forms include oral delivery as tablets and capsules, solutions for injection, rectal suppositories, and preparations designed for topical use such as gels, patches, and ophthalmic solutions (eye drops). The availability of multiple formulations emphasizes the versatility of Diclofenac for addressing localized discomfort.


The General Purpose of Dicloftil

The general purpose of Dicloftil is to provide relief by addressing the symptoms associated with the body’s inflammatory response, primarily pain, inflammation, and fever. Its foundational mechanism is its role as a cyclooxygenase inhibitor, meaning it blocks the chemical pathways that produce pain- and swelling-inducing substances called prostaglandins. By interrupting this process, the medication effectively mitigates the inflammatory cycle, offering the general benefit of reducing swelling and restoring comfort.

Regulatory References

  1. NCBI Review of Diclofenac
  2. local
  3. cyclooxygenase inhibitor

What side effects are possible with Dicloftil?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety information for Dicloftil (diclofenac ophthalmic solution), strictly based on governmental regulatory documents.


Adverse Reactions

Adverse reactions are classified by frequency as reported in clinical data and regulatory documentation:

  • Common Reactions: The most frequently reported adverse event is transient mild to moderate burning and stinging upon eye instillation.
  • Rare/Uncommon Reactions: These include less frequent ocular events such as irritation, itching, redness, or corneal changes. Systemic events such as headache may also occur.

Clinically Significant and Serious Safety Concerns

Corneal Risks: Serious and clinically significant adverse reactions involve the cornea (the eye's surface). These can include corneal thinning, erosion, ulceration, and perforation. The risk of these serious events is heightened in patients with pre-existing conditions like diabetes mellitus, rheumatoid arthritis, or dry eye syndrome, or following complex or repeat eye surgeries.

Bleeding Risk: As an NSAID, Dicloftil has the potential to interfere with platelet function, which may lead to increased bleeding time. This general NSAID class characteristic is noted in the drug's safety profile.

Restrictions and Limitations

Contraindications (Must Not Be Used): The medicine is strictly contraindicated in patients with a known history of hypersensitivity to diclofenac or any of its components, or in individuals who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs).

Population Safety: Due to the known effects of this class of drugs on the fetal cardiovascular system, its use must be avoided during late pregnancy.

Overdose and Emergency Response

Dicloftil Overdose and When to Seek Help

The information in this section is based solely on official government regulatory documents (e.g., FDA, EMA, NIH) regarding acute overexposure to diclofenac.

Documented Overdose Manifestations

Symptoms following an acute Dicloftil overdose typically include nausea, vomiting, epigastric pain, and diarrhea. Less common, but documented, manifestations may involve the central nervous system, such as dizziness, drowsiness, headache, or ringing in the ears (tinnitus).

Serious Outcomes and Immediate Actions

In cases of severe poisoning, more critical complications can arise, including gastrointestinal bleeding, acute renal failure, hepatic damage, seizures, or coma. A large overdose can be particularly harmful to both children and adults.

If an overdose is suspected, immediate medical attention must be sought. Contact your local emergency services or a poison control center right away. The management of acute overdose is primarily supportive and symptomatic, as no specific antidote exists. Treatment protocols focus on reducing the absorption of the drug (e.g., activated charcoal, gastric lavage, if indicated) and addressing specific complications (e.g., managing convulsions or hypotension) while monitoring vital signs and laboratory parameters.

Therapeutic Uses of Dicloftil

What Dicloftil Treats: Main Uses and Benefits

Dicloftil (Diclofenac) is commonly used to help with the symptoms related to inflammatory or irritative states, which often include pain and fever. It offers supportive therapeutic benefit in clinical settings marked by increased discomfort or tension, which may temporarily create noticeable physiological strain. The medication is used to provide relief from symptoms associated with a range of conditions, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute migraine attacks, renal or biliary colic, and painful manifestations like primary dysmenorrhea. It is utilized to relieve symptomatic discomfort across multiple conditions.

It is relevant in contexts where additional symptomatic support is needed to help ease discomfort. As a result, the medication is often applied during phases when symptoms become more noticeable.

“It provides supportive relief when symptoms interfere with routine activities, helping patients cope more steadily with symptom fluctuations by easing distress.”


Quick Fact: Relief for Inflammation, Pain, and Stiffness

Dicloftil plays a role in managing acute and chronic symptoms that interfere with daily functioning in situations involving:

  • Chronic Disease: Easing joint pain and stiffness in long-term conditions.
  • Episodic Pain: Controlling intense manifestations like colic or acute migraine.
  • Acute Recovery: Managing pain and swelling following soft tissue injuries or post-operative procedures.

The use of Dicloftil assists with maintaining functional stability and contributes to improved comfort during periods of heightened symptoms.

Regulatory References

  1. NIH MedlinePlus overview of Diclofenac

Eligibility and Restrictions for Use

Who can and cannot use Dicloftil? — Official Regulatory Information

Eligibility for Dicloftil (diclofenac sodium ophthalmic solution) is defined by official regulatory bodies based on documented contraindications, age restrictions, and patient health status.

Category Eligibility Rule Classification
Hypersensitivity Patients with known allergy to diclofenac, any component, or with a history of asthma/acute rhinitis precipitated by aspirin or other NSAIDs must not use this medication. Contraindicated
Age Restriction Safety and effectiveness have not been established in pediatric patients (children under 18 years of age). Not Established
Pregnancy Use must be avoided during late pregnancy (third trimester) due to the risk of premature closure of the fetal ductus arteriosus. Avoid/Not Recommended
Comorbidities Patients with corneal epithelial defects, diabetes mellitus, rheumatoid arthritis, or known bleeding tendencies require caution and monitoring. Use with Caution

These rules establish absolute exclusions for individuals with known NSAID cross-sensitivity. They also set conditional eligibility for certain patients whose ocular or systemic health status requires special consideration, and they restrict use in children and during late pregnancy where safety is either unproven or associated with fetal risk.

What should I know about interactions with other medicines?

Dicloftil (Diclofenac) can interact with a variety of other medicines, potentially altering the effect of Dicloftil or the other medication, or increasing the risk of adverse reactions. It is crucial to inform your healthcare provider about all prescription, over-the-counter, and herbal products you are currently taking.

Increased Risk of Bleeding and Gastrointestinal Issues

Concurrent use with other medications that increase the risk of bleeding or stomach issues should be avoided or closely monitored. This includes:

  • Other Non-Steroidal Anti-inflammatory Drugs (NSAIDs): Such as aspirin, ibuprofen, or naproxen. Combining these significantly raises the risk of serious gastrointestinal problems and bleeding.
  • Anticoagulants and Antiplatelet Agents: Medicines like warfarin, apixaban, or clopidogrel increase the risk of serious bleeding.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Certain antidepressants in these classes can increase the risk of bleeding.
  • Corticosteroids: Such as prednisone, which increase the risk of gastrointestinal ulcers or bleeding.

Potential for Altered Drug Levels or Reduced Effectiveness

Dicloftil can affect the blood levels and effectiveness of several drug classes, including:

  • Blood Pressure Medications: Angiotensin-Converting Enzyme (ACE) inhibitors, Angiotensin II Receptor Blockers (ARBs), and diuretics (water pills) may become less effective. Combining Dicloftil with these can also increase the risk of kidney problems.
  • Lithium and Methotrexate: Dicloftil can elevate the blood levels of lithium and methotrexate, which may lead to increased toxicity and side effects. Close monitoring is essential.
  • Cyclosporine and Tacrolimus: Combining with these immunosuppressants may increase the risk of kidney toxicity.

Always consult your doctor or pharmacist for a complete review of your medication regimen to manage potential interactions safely.

Mechanism of Action

How Dicloftil Works: Mechanism of Action

Dicloftil (diclofenac) exerts its effects by engaging mechanisms that modulate overactive signaling at the molecular level. It operates primarily within the domain of lipid-mediated signaling, which is integral to localized inflammatory responses. The drug modifies molecular steps that shape downstream physiological outcomes, contributing to altered signaling dynamics within targeted pathways.


Primary Inhibition of Cyclooxygenase (COX) Enzymes

This domain describes the drug's activity in suppressing the initial synthesis of inflammatory mediators. Dicloftil acts as an inhibitor of the Cyclooxygenase (COX) enzyme system (both COX-1 and COX-2), which is essential for converting arachidonic acid into prostaglandins. This action modifies the early molecular steps of the arachidonic acid cascade, resulting in the modulation of localized mediator activity.

Modulation of Prostaglandin-Driven Signaling Cascades

This domain addresses the resulting biochemical consequences of the initial enzyme blockade. Prostaglandins are lipid mediators that influence local vascular dynamics and neuronal sensitivity; consequently, the mechanism restricts the available concentration of these compounds. This sequence modification alters the signaling dynamics within the affected tissue by influencing the concentration of key signaling mediators.

Targeted Pathway Interference in Ophthalmic Tissue

This domain highlights the localized application of the drug's mechanism. In the eye, Dicloftil's activity influences systems where specific mediators dominate, particularly by suppressing prostaglandin levels following surgical trauma. This specialized, targeted pathway interference influences local activity patterns relevant to surgically induced pupillary constriction (miosis).

Dosage and Administration Information

How to Use Dicloftil: Official Administration Guidelines

Proper use of Dicloftil (Diclofenac) is defined by official regulatory instructions, which specify the approved routes of administration, standard adult dosing ranges, and specific requirements for handling the medication. Use is governed by the principle of administering the lowest effective dose for the shortest duration.


Approved Administration Routes

Dicloftil is approved for both systemic and local use. Official routes include:

  • Oral: Tablets (delayed-release, extended-release), capsules, and powder for solution.
  • Parenteral: Intramuscular (IM) injection and Intravenous (IV) infusion.
  • Local/Topical: Gels, solutions, patches, and ophthalmic preparations.

Standard Adult Dosing and Frequency

The standard adult daily dose for chronic conditions like osteoarthritis typically ranges from 100 mg to 150 mg in divided doses, or 100 mg once daily for extended-release forms. The maximum daily dose for most oral forms should not exceed 150 mg to 200 mg, depending on the specific product and indication. Acute pain management often uses lower doses (e.g., 25 mg to 50 mg) taken up to three or four times per day.


Administration Requirements

Specific instructions must be followed to ensure correct drug absorption and timing:

  • Tablets: Delayed-release and extended-release tablets must be swallowed whole and must not be crushed, split, or chewed, as this compromises the intended release mechanism.
  • Timing: Certain fast-acting forms, such as the oral solution powder used for migraines, should be taken on an empty stomach with 1 to 2 ounces of water to ensure rapid absorption.
  • Population Adjustments: For older adults and patients with underlying hepatic or renal impairment, the official protocol advises using the lowest effective dose and exercising caution.
  • Parenteral: Intravenous administration is generally required to be slow, typically via infusion over 30 minutes or longer, and may require dilution using specified solutions.

Recent Clinical Evidence

Research evidence / Overview of studies for Dicloftil

Evidence for Symptom Management in Chronic Joint Conditions

The research base for Dicloftil (Diclofenac) in chronic joint conditions is well-established and includes both Randomized Controlled Trials (RCTs) and various observational studies. Research examined Dicloftil's role in research exploring symptoms associated with chronic joint pain and inflammation in conditions marked by functional limitations, such as Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS). These studies were used in research exploring how symptoms change over time, and were designed to track changes in patient-reported experiences related to stiffness and pain.

For conditions like OA, research explored outcomes related to short-term symptom changes, primarily in adults diagnosed with mild-to-moderate joint involvement. Findings describe patterns observed in the studies related to scores measured for pain and stiffness, typically monitored for durations up to 12 weeks. To examine the measurements related to the medicine in these chronic conditions, researchers used established tools like the WOMAC Pain Subscale for OA and the BASDAI and BASFI for AS.

Evidence for Short-Term Acute Pain and Inflammation

The research involved a high volume of Randomized Controlled Trials covering various acute scenarios. Research explored rapid, short-term symptom patterns in conditions associated with acute or disruptive episodes, such as acute musculoskeletal injuries and Primary Dysmenorrhea. For severe, acute events like renal or biliary colic, studies monitored how pain scores evolved in patients and the subsequent tracking of secondary analgesic interventions.

Durability and Long-Term Follow-Up in Studies and Limitations

Long-term effects are not fully established through controlled studies. Research often relies on observational settings which track patient-reported outcomes over months or years. This data contributes to understanding how patients reported their experience, but comparative evidence to control groups is lacking over these long durations. Research indicates data for certain groups remain insufficient regarding long-term outcomes or daily functioning, and follow-up durations were limited across many of the definitive controlled trials.

Key Studies & References

  1. Diclofenac - NCBI Bookshelf Review (Focus on mechanism and established use)
  2. Diclofenac: MedlinePlus Drug Information (General overview of uses)

Frequently Asked Questions (FAQ)

Common questions about Dicloftil (FAQ)


Q: Is Dicloftil the same as other diclofenac eye drops?

The active compound, diclofenac sodium at a 0.1% strength, is the key ingredient used in all generic and branded versions of this ophthalmic solution. However, official information indicates that different manufacturers may use slightly different inactive ingredients, such as various preservatives, in their specific product formulations.


Q: What are the typical uses for Dicloftil besides surgery?

According to official regulatory documents, Dicloftil is primarily indicated for use around eye surgery. Its uses include treating postoperative inflammation following cataract extraction and providing temporary relief from pain and light sensitivity (photophobia) after corneal refractive surgery.


Q: How quickly should I expect to feel relief after using Dicloftil?

Regulatory studies suggest that the medication reaches peak concentrations in the cornea and conjunctiva (the eye's surface tissues) approximately 30 minutes after the drops are applied, indicating a rapid onset of local activity.


Q: Does Dicloftil help with general eye redness or irritation?

Official labeling states that the drug is indicated for specific types of inflammation and pain related to surgery. It is not listed as a treatment for general eye redness or irritation. In fact, official safety information notes that eye irritation and redness are common side effects of using the drops.


Q: Can Dicloftil be used for long-term dry eye symptoms?

Official product information notes that this ophthalmic solution is not intended for long-term use. The drug should also be used with caution in patients who have pre-existing ocular surface diseases, such as severe dry eye syndrome, as this may increase the risk of serious corneal complications.


Q: Are there any common over-the-counter medicines that interact with Dicloftil?

As Dicloftil belongs to the NSAID class, there is a risk of increased bleeding. Official warnings mention that caution is recommended when the drug is used with other over-the-counter NSAIDs, such as aspirin or ibuprofen, or any medication that could affect blood clotting.


Q: Is it okay to wear contact lenses when I'm supposed to use Dicloftil?

Official precautions recommend that soft contact lenses be removed from the eye before the drops are instilled. Patients are generally advised to wait a minimum of 15 minutes after using the medication before reinserting their lenses.


Q: What happens if you miss one dose of Dicloftil?

Guidance on missed doses indicates that if a dose is forgotten, it is typically applied as soon as the patient remembers. If it is nearly time for the next scheduled dose, the missed dose is generally skipped. It is advised not to instill extra drops to compensate for a missed dose.


Q: Is Dicloftil commonly prescribed for people with glaucoma?

Official information does not list glaucoma as an indication for this medicine. Studies have shown that Dicloftil itself typically does not have a significant effect on the pressure within the eye.


Q: How long does the anti-inflammatory effect of one drop of Dicloftil last?

The typical recommended dosing is four times a day, which is roughly every six hours. This frequency is established to consistently maintain the drug's intended anti-inflammatory and pain-relieving effects in the eye.


Q: Is it normal to feel a slight stinging right after putting in Dicloftil?

Official safety documents indicate that transient, mild to moderate burning and stinging is a frequently reported adverse event immediately following eye instillation.


Q: Is it normal for my vision to be slightly blurry after using the drops?

Official safety information notes that transient blurred vision may occur. Regulatory advice notes that patients who experience visual disturbances, such as blurred vision, should avoid driving or operating machinery until their vision returns to normal.


Q: Does Dicloftil contain preservatives?

Official product descriptions indicate that the multi-dose ophthalmic solution typically contains a preservative. Examples include sorbic acid or benzalkonium chloride, though the specific type may vary by manufacturer.


Q: Can older people use Dicloftil without special precautions?

The regulatory label does not specify special precautions based on age alone for the ophthalmic solution. However, extra caution and monitoring are required for any patient who has pre-existing conditions that affect the eye, such as rheumatoid arthritis or diabetes.


Q: Can Dicloftil be used for pain from an eye injury?

Official documentation indicates that the drug is specifically for pain and inflammation related to eye surgeries. It is not approved or labeled for the treatment of general eye injuries.


Q: Do people typically experience eye discomfort as a side effect of Dicloftil?

Official safety records indicate that mild to moderate discomfort is a frequently reported event. These include transient burning, stinging, eye irritation, and mild pain.


Q: Is Dicloftil used to prevent swelling as well as treat it?

Official documentation indicates that the drug is approved for the treatment of postoperative inflammation. This use covers both managing existing swelling and reducing the onset of inflammation following surgery.


Q: Are headaches a known side effect of Dicloftil eye drops?

Official safety information lists headache as a systemic adverse reaction. It was reported in a small percentage of patients during clinical trials.


Q: What is the percentage strength of diclofenac in Dicloftil?

The standard strength of the ophthalmic solution is 0.1% of the active ingredient. This means that one milliliter of the solution contains 1 milligram of diclofenac sodium.


Q: Has Dicloftil been tested on people with severe dry eyes?

Official post-marketing reports indicate that patients with underlying ocular surface disease, which includes conditions like dry eye syndrome, may face an increased risk of severe corneal adverse events. Close monitoring is indicated for these individuals.


Q: Are there any restrictions on driving while using Dicloftil?

Official safety instructions note that if visual disturbances, such as blurred vision, are experienced after using the drops, patients are advised to refrain from driving a vehicle or operating machinery.


Q: Can Dicloftil be used after laser eye surgery (LASIK)?

Official indications list the temporary relief of pain and light sensitivity in patients undergoing corneal refractive surgery, which covers procedures like LASIK.


Q: Are there generic versions of Dicloftil available?

The active ingredient, diclofenac sodium, is available in generic ophthalmic solutions; the inactive ingredients may differ between generic and branded products.


Q: Does Dicloftil affect blood pressure if absorbed systemically?

While systemic absorption is limited from eye drops, the drug belongs to the NSAID class, which has been shown to reduce the effectiveness of blood pressure medications. This is noted as a potential interaction.


Q: Can Dicloftil affect the healing process of the eye?

Official safety precautions state that the use of this drug may slow or delay the general healing process of the eye.


Q: What are the signs of an allergic reaction to Dicloftil?

Official health information advises that severe, rare side effects may be signs of an allergic reaction. These can include swelling of the eye or face, red or bloody eyes, and eye pain.


Q: Is Dicloftil effective for treating postoperative inflammation in diabetic patients?

The medication is indicated for postoperative inflammation. However, official warnings state that patients with diabetes mellitus are at an increased risk for corneal adverse effects and must be monitored closely during use.


Q: Why is proper instillation technique important for Dicloftil drops?

Official use instructions emphasize the importance of proper technique. The purpose of proper technique is to prevent contamination by not touching the dropper tip and to minimize the amount of medication that is absorbed systemically.

How should Dicloftil be stored and disposed of?

How to Store and Dispose of Dicloftil?

The storage and disposal requirements for Dicloftil (Diclofenac) are based strictly on official regulatory labeling to ensure product stability and public safety.


Official Storage Requirements

  • Temperature and Protection: The medicine must be stored at room temperature, generally below 25 C or 30 C, and protected from excessive heat, light, and moisture. Specific formulations must not be frozen.
  • Packaging: Keep the product in its original, tightly closed container.
  • Child Safety: It is mandatory to keep Dicloftil out of the sight and reach of children and pets at all times.

Official Disposal Rules

Expired or unused Dicloftil should be disposed of using a drug take-back program when available. If a take-back program is not feasible, the product must be mixed with an undesirable substance (e.g., dirt or used coffee grounds), placed in a sealed bag, and then thrown in the household trash. Do not flush the medicine down the toilet or pour it down the sink due to the risk to the aquatic environment.

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

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