Dicloabak 0,1%

Quick links to important sections

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 Dicloabak 0,1%

Dicloabak 0,1% is a medication strictly designed for use in the eye, known as an ophthalmic solution. It is a specialized, prescription-only intervention whose core identity is that of an Ophthalmic Non-Steroidal Anti-Inflammatory Drug (NSAID). Its fundamental therapeutic purpose is controlling localized inflammation and associated discomfort within the eye structures.

Property Description
Active ingredient Diclofenac Sodium
Form Sterile Eye Drops (Solution)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common use Management of localized ocular inflammation
Origin Synthetic (Phenylacetic acid derivative)

What Type of Medicine is Dicloabak 0,1%?

Dicloabak 0,1% is classified as an Ophthalmic Non-Steroidal Anti-Inflammatory Drug (NSAID), placing it in the family of phenylacetic acid derivatives, which are synthesized compounds. As an ophthalmic product, its use is topical ocular, designed for direct application to the eye, ensuring a highly concentrated local effect for managing inflammation and pain while limiting systemic absorption. Diclofenac ophthalmic solution is a topical NSAID used to address pain or swelling of the eye, reinforcing its role as a localized anti-inflammatory agent. Its usage is clinically recognized for supporting comfort, particularly in scenarios where ocular inflammation is present.

Dicloabak 0,1% Composition and Formulation

The composition of this medicine is based on the single active substance, Diclofenac Sodium, which is presented in the solution at a concentration of 0.1% in a sterile, aqueous vehicle. Distinctively, the Dicloabak formulation is often delivered using a preservative-free system, a feature designed to reduce irritation on the delicate ocular surface. This attribute differentiates it from traditional multidose eye drops that contain common chemical preservatives.

How Does Dicloabak Manage Inflammation?

The primary action of Dicloabak is achieved through its mechanism as a prostaglandin synthesis inhibitor. The active ingredient, Diclofenac, works by blocking the enzyme cyclooxygenase (COX), which is essential for producing prostaglandins, the chemical mediators that trigger swelling, redness, and pain. By inhibiting this synthesis pathway, the solution provides the benefit of mitigating localized ocular discomfort and controlling the intensity of the inflammatory reaction within the eye structures.

Regulatory References

  1. NIH DailyMed: Diclofenac Sodium Ophthalmic Solution

What side effects are possible with Dicloabak 0,1%?

Possible Side Effects and Safety Information

The safety profile of Dicloabak 0.1% (Diclofenac Ophthalmic Solution) is classified by regulatory authorities based on the frequency and the physiological systems affected. Adverse reactions are primarily localized to the eye structures.


Frequency Classification of Adverse Reactions

Adverse effects are categorized by incidence according to regulatory standards:

Frequency Classification Associated Adverse Reactions
Very Common (ge 1/10) Transient mild to moderate stinging and burning upon application.
Common (ge 1/100 to < 1/10) Ocular hyperemia (redness), eye pain, punctate keratitis, eye pruritus, and blurred vision.
Rare (ge 1/10,000 to < 1/1,000) Corneal erosion, corneal thinning, and ulcerative keratitis.
Not Known Asthma exacerbation, severe hypersensitivity reactions.

Serious Adverse Reactions and Systemic Considerations

Potential serious adverse reactions documented in official labeling include corneal ulceration and, rarely, corneal perforation, particularly when used for prolonged durations. While the primary system affected is the Eye Disorders class, the label notes the potential for Immune System Disorders (hypersensitivity) and Respiratory Disorders, especially in individuals with known cross-sensitivity to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).


Safety Restrictions and Context of Use

Diclofenac ophthalmic solution is formally contraindicated in patients who have previously experienced asthma, urticaria, or acute rhinitis after taking aspirin or other NSAIDs, due to the risk of cross-sensitivity. Furthermore, the risk of serious corneal events, such as thinning and erosion, is noted to be increased with prolonged use and in patients with pre-existing conditions like diabetes, rheumatoid arthritis, or underlying corneal epithelial defects. These safety restrictions define the specific populations and conditions where the medicine's use is limited.

Overdose and Emergency Response

Overdose and when to seek help

The official overdose profile for Dicloabak 0.1% (Diclofenac Sodium Ophthalmic Solution) is shaped by its topical application and minimal systemic absorption, as documented by regulatory authorities.


Overdose Scope and Manifestations

Feature Official Regulatory Statement
Documented Overdose Presentations Overdosage from ocular administration will not ordinarily cause acute problems; low risk due to limited systemic absorption.
Physiological Systems Affected Primary concern is the risk of systemic effects following accidental oral ingestion of the solution.
Dose-Related Factors Risk is mainly associated with the circumstance of accidental swallowing of the contents.

Required Emergency Actions

Official overdose guidance focuses on accidental ingestion, which necessitates immediate action and help-seeking:

  • In the event of accidental ingestion, fluids should be taken to dilute the medication, as specifically stated in the FDA prescribing information.
  • Contact a Poison Control Center or seek emergency medical attention immediately after accidental ingestion.
  • If the individual has collapsed or is not breathing, local emergency services must be called without delay.
  • No specific antidote is listed in the official regulatory documentation for this overdose scenario, directing management toward supportive care.

Connection to the Overdose Profile

Regulatory documents define the overdose profile by establishing a low acute risk for ocular overexposure while emphasizing the need for an urgent response to accidental oral ingestion. This framework strictly mandates procedural steps and triggers the requirement to seek immediate medical attention if the event occurs or if severe clinical signs manifest, ensuring that management remains supportive.

Therapeutic Uses of Dicloabak 0,1%

Quick Facts: Dicloabak 0,1% Uses

  • Post-Cataract Care: May support the management of inflammation following cataract removal surgery.
  • Corneal Surgery: Used for the temporary relief of pain and sensitivity to light (photophobia) following corneal refractive procedures.

Dicloabak 0,1% is an ophthalmic solution indicated for specific therapeutic domains related to eye surgery. Its primary use is in providing support for the management of inflammation following the extraction of a cataract. This usage aims to help minimize the post-operative inflammatory response in the eye.

Additionally, this medication is used to provide temporary relief of ocular pain and light sensitivity in adult patients who have undergone corneal refractive surgery. By addressing these symptoms, the drug may contribute to patient comfort during the recovery period following these procedures. It is an option that may be considered by physicians for appropriate post-surgical management.

Eligibility and Restrictions for Use

This information is based on official regulatory documentation and outlines the populations for whom use of Dicloabak 0,1% (diclofenac eye drops) is either prohibited or restricted.

Populations Who Must Not Use Dicloabak (Contraindications)

Use of this medicine is strictly contraindicated for individuals with:

  • Known hypersensitivity or allergy to diclofenac, or to any of the ingredients in the eye drop formulation.
  • Known hypersensitivity to other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as aspirin (acetylsalicylic acid), where this sensitivity has led to an allergic reaction such as asthma, acute rhinitis, or urticaria (hives).

Eligibility-Related Restrictions

Use is subject to specific restrictions for certain populations and conditions, requiring careful consideration by a healthcare professional:

  • Soft Contact Lenses: The use of Dicloabak 0,1% is not recommended while wearing soft contact lenses. Patients must remove contact lenses before application and wait at least fifteen minutes before reinserting them.
  • Pregnancy and Lactation: Eligibility status in these populations is not typically defined as a formal contraindication but falls under safety and risk considerations. Consult a healthcare provider.
  • Age: No specific age-related prohibitions are cited in the core eligibility criteria, though safety in the pediatric population may not be fully established. Consult a healthcare provider.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Dicloabak 0,1% (Diclofenac Sodium ophthalmic solution) is primarily based on pharmacodynamic effects and administration timing rules rather than systemic metabolic interactions, due to its localized topical use.


Drug–Drug Interaction Patterns

Classification Interacting Agent Category Official Restriction or Caution
Contraindicated Aspirin and Other Prostaglandin Synthesis Inhibitors (e.g., NSAIDs) Restricted in patients where these agents precipitate asthma, rhinitis, or urticaria, due to potential for cross-sensitivity.
Caution Required Topical Ophthalmic Corticosteroids Co-administration may increase the potential for delay in corneal wound healing.
Caution Required Systemic Medications that Prolong Bleeding Time Caution is noted for use in surgical patients receiving agents that affect hemostasis (e.g., anticoagulants), due to the diclofenac component's potential to interfere with thrombocyte aggregation.

Administration and Timing Rules

A mandatory separation window is officially required when this solution is used with other topical eye medications. To ensure the intended localized effect and prevent washout, administration of Dicloabak 0,1% and other eye drops or ophthalmic ointments must be separated by an interval of at least 5 to 10 minutes.

No specific interactions with food, alcohol, or herbal products are explicitly documented in the official regulatory labeling for the ophthalmic solution.

Mechanism of Action

How Dicloabak 0.1% Works

Dicloabak 0.1% functions as an inhibitor of specific biochemical signaling within the eye, leveraging the drug's classification as a Non-Steroidal Anti-Inflammatory Drug (NSAID) to modulate physiological responses.

Molecular Blockade of Prostaglandin Synthesis

The core mechanism involves the active ingredient, Diclofenac Sodium, acting as a non-selective, reversible inhibitor of the Cyclooxygenase (COX) enzymes, specifically targeting both COX-1 and COX-2. By blocking these enzymes, the drug prevents the conversion of arachidonic acid into prostaglandins—chemical mediators that drive inflammatory responses. This modification of the early molecular steps within the Arachidonic Acid Cascade is a key mechanistic action.

Dampening Nociceptor and Vascular Signaling

The suppression of prostaglandin synthesis initiates a mechanistic cascade that results in two primary physiological effects. First, it reduces the sensitization of local nociceptors, which is characterized by diminished signal transmission. Second, the absence of high prostaglandin levels allows for reduced vasodilation and limits increased vascular permeability. This combined physiological adjustment results in reduced activity of inflammatory pathways within the targeted ocular tissues.

Dosage and Administration Information

How to Use Dicloabak 0,1% — Administration Guidelines

This section describes the standard administration of Diclofenac Sodium 0.1% Ophthalmic Solution.

The medicine is designed for topical ocular instillation, meaning it is applied directly as eye drops into the conjunctival sac of the affected eye(s). It is strictly prohibited from being injected subconjunctivally or into the anterior chamber.

Standard Dosage and Duration

Administration follows a short-term, specialized protocol, typically involving the instillation of one drop per dose.

Indication Standard Frequency Typical Duration
Post-Cataract Extraction Four times daily (QID) Up to two weeks
Post-Corneal Refractive Surgery Four times daily (QID)* Up to three days

*The regimen for corneal refractive procedures includes initial pre- and immediate post-surgical doses of one to two drops, followed by the four-times-daily maintenance schedule.

Procedural Context

Proper use requires adherence to specific administration rules. If other topical ophthalmic medications are used concurrently, a minimum interval of five minutes must be observed between the instillation of each product. Users must avoid contact between the dropper tip and the eye or any surrounding structures to preserve the sterility of the solution. Furthermore, soft contact lenses must be removed prior to instillation and should not be reinserted until at least 15 minutes after the medicine has been applied. The safety and effectiveness of this formulation have not been established in pediatric patients.

Recent Clinical Evidence

Dicloabak 0,1%: Recent Clinical Evidence

Dicloabak is an ophthalmic solution containing diclofenac sodium (0.1%), a non-steroidal anti-inflammatory drug (NSAID). Research focuses on its role in managing ocular inflammation and pain, particularly in the perioperative period.


Efficacy in Postoperative Management

Clinical trials have primarily investigated the use of diclofenac 0.1% for ophthalmic indications related to surgery. Studies have evaluated its use in the prevention of miosis (pupil constriction) during cataract surgery and for the management of postoperative inflammation in the eye's anterior segment.

Evidence from randomized studies suggests the agent is associated with a reduction in measures of anterior chamber inflammation following cataract surgery. The solution is also studied for providing temporary relief of ocular pain associated with procedures such as photorefractive keratectomy (PRK) in the initial 24 hours after surgery. Comparative studies have examined its effect on inflammation and pain outcomes relative to other topical NSAIDs, with findings generally suggesting comparable efficacy in these endpoints.


Safety and Tolerability Profile

The formulation used in Dicloabak is preservative-free (ABAK system), which has been a key focus of recent tolerability research. Studies comparing preservative-free diclofenac to preserved formulations have suggested improved subjective tolerability and less ocular discomfort for patients using the preservative-free version. This formulation has been shown to maintain anti-inflammatory efficacy similar to preserved versions.

The most commonly reported adverse effects associated with diclofenac ophthalmic solution include transient burning or stinging upon instillation and visual disturbances. Rarely, topical NSAIDs have been associated with corneal complications, such as epithelial defects, thinning, and ulceration. Patients with pre-existing ocular surface disease, diabetes, or those who have had repeated ocular surgeries may be at an increased risk for these adverse events.

Frequently Asked Questions (FAQ)

Common questions about Dicloabak 0,1% (FAQ)


Q: What is the difference between Dicloabak 0,1% and other diclofenac eye drops like Voltaren Ophtha?

A: Dicloabak 0,1% is often distinguished by its preservative-free formulation, utilizing the ABAK system. Some other diclofenac ophthalmic solutions may contain a preservative, such as benzalkonium chloride. The preservative-free formulation is linked in studies to improved subjective tolerability and less ocular discomfort, which can be a key difference for patients.


Q: Can Dicloabak 0,1% be used for common eye irritation not related to surgery?

A: According to official product information, this medication is primarily indicated for the treatment of pain and inflammation that occurs following specific eye surgeries, such as cataract extraction or corneal refractive procedures. While some regulatory documents reference non-infected inflammatory conditions of the anterior segment of the eye, the main indications listed are typically for managing pain and inflammation related to specific surgical procedures.


Q: Can Dicloabak 0,1% be used by children, or is it only for adults?

A: Official prescribing information states that the safety and effectiveness of this ophthalmic solution have not been established in pediatric patients (children). Therefore, the product is not indicated for this population.


Q: Is Dicloabak 0,1% safe to use during pregnancy or while breastfeeding?

A: Diclofenac ophthalmic solution is strictly contraindicated (prohibited) during the third trimester of pregnancy due to risks to the fetus. Use during the first two trimesters is not generally recommended unless a healthcare professional determines the benefit outweighs the potential risk. For breastfeeding, caution is advised and use requires a benefit-risk assessment by a healthcare professional due to the possibility of drug presence in breast milk, despite low systemic absorption.


Q: Can Dicloabak 0,1% cause issues for people who have dry eyes?

A: Regulatory warnings suggest that patients with pre-existing ocular surface diseases, such as dry eye syndrome, may be at an increased risk for serious corneal adverse events, including corneal thinning or erosion, when using topical NSAIDs.


Q: Does Dicloabak 0,1% interact with common oral medications, such as blood thinners?

A: Caution is noted in official labeling for patients who are taking oral systemic medications that prolong bleeding time, such as certain blood thinners (anticoagulants). Since diclofenac can interfere with platelet aggregation, a theoretical possibility of increased bleeding risk in ocular tissues exists, particularly during or after surgery.


Q: What happens if I accidentally miss a dose of the eye drops?

A: If a dose is missed, it can be applied as soon as it is remembered. However, if it is nearly time for the next scheduled dose, regulatory patient information typically advises that the missed dose be skipped, and the patient return to the regular dosing schedule. Extra doses should not be used to compensate for a missed dose.


Q: Can Dicloabak 0,1% be used alongside antibiotic eye drops?

A: Yes, if an ocular infection is present or suspected, appropriate concurrent therapy, such as antibiotic eye drops, should be given alongside Dicloabak 0,1%. However, to ensure proper absorption and effectiveness, a mandatory separation window of at least five minutes must be observed between the instillation of the different eye drop products.


Q: Is Dicloabak 0,1% ever prescribed for conditions like conjunctivitis or pink eye?

A: The primary approved indications for this medicine are to manage inflammation and pain related to specific types of eye surgery. While it addresses ocular inflammation, its use for common conditions like viral or bacterial conjunctivitis (pink eye) is not a specified primary indication in the product labeling.


Q: Can Dicloabak 0,1% be used to treat swelling in the eyelid?

A: This medication is designed to treat localized inflammation and discomfort within the internal structures of the eye. Swelling of the external eyelid is not listed as a condition the medication is indicated to treat.


Q: Does the 'Abak' container system offer any benefits compared to standard dropper bottles?

A: The ABAK system is designed to dispense a preservative-free solution. Studies evaluating preservative-free formulations have linked them to improved subjective tolerability and less ocular discomfort compared to products that contain common chemical preservatives.


Q: What does it mean if Dicloabak 0,1% is 'indicated for temporary relief' of pain?

A: This means the medication is indicated for short-term use during a recovery period, not for indefinite or chronic pain management. For example, the indication for pain relief after corneal refractive surgery is typically limited to the initial three days following the procedure.


Q: Could Dicloabak 0,1% interact with herbal supplements commonly taken for inflammation?

A: Official regulatory labeling does not contain explicit documentation of specific interactions between this ophthalmic solution and food, alcohol, or herbal products.


Q: Does the efficacy of Dicloabak 0,1% differ between older and younger adult patients?

A: According to official dosing recommendations, no adjustment to the standard dosage is typically needed for elderly patients. The safety and effectiveness are considered comparable to the general adult population.


Q: Could Dicloabak 0,1% potentially affect the pressure inside the eye (intraocular pressure)?

A: Clinical studies generally indicate that the drug itself has no significant effect on intraocular pressure (IOP). However, it is noted that IOP elevations are a possibility following cataract surgery, a primary condition for which the drops are prescribed.


Q: What should I do if the burning sensation from the drops does not go away quickly?

A: A mild, transient stinging or burning sensation is a very common side effect upon application, which should subside rapidly. If this sensation or any other side effect persists or worsens, official patient guidelines recommend that the patient discontinue use and promptly contact a healthcare professional or eye doctor.


Q: Are there any systemic (non-eye related) side effects to be aware of since it's an NSAID?

A: While the drug is localized to the eye and systemic absorption is low, official documents report some non-eye related side effects. These have included headache, nausea, vomiting, dizziness, abdominal pain, fever, chills, and insomnia.


Q: Can an allergic reaction to Dicloabak 0,1% cause swelling of the eye or face?

A: Yes, regulatory information indicates that severe allergic reactions (hypersensitivity) are a potential serious side effect. Symptoms of a serious allergic reaction can include swelling of the face, lips, mouth, tongue, or throat, as well as swelling of the eyes or eyelids.


Q: How long does it usually take to feel the pain relief from Dicloabak 0,1% drops?

A: The drug's mechanism involves blocking the chemical mediators of pain and inflammation (prostaglandins) directly at the site of application. While clinical documents do not provide a specific time-to-onset, the medicine is designed for rapid local action to manage pain, especially in the immediate postoperative period.


Q: Is Dicloabak 0,1% preservative-free, and why is that important for eye drops?

A: Dicloabak is formulated to be preservative-free using the ABAK system. This is important because studies suggest preservative-free eye drops are associated with reduced irritation and discomfort on the ocular surface compared to products that contain common chemical preservatives.


Q: What is the typical length of treatment with Dicloabak 0,1%?

A: The length of treatment is short-term and specialized, depending on the indication. For instance, the duration is typically up to two weeks after cataract surgery, or up to three days following corneal refractive surgery, as outlined in official prescribing guidelines.


Q: Are there any long-term side effects associated with using Dicloabak 0,1%?

A: The medication is approved for short-term, specific use. Regulatory documents note that the risk of serious corneal adverse events, such as thinning or erosion, is increased when the medication is used for prolonged durations beyond the recommended treatment period.


Q: Is it normal to experience increased light sensitivity (photophobia) while using this medication?

A: Increased light sensitivity (photophobia) is a common symptom associated with the inflammation this drug treats. While visual disturbances are a commonly reported side effect, photophobia is not explicitly classified in the most frequent side effect lists of the product label.


Q: Is it possible for Dicloabak 0,1% to affect the eye's healing process after surgery?

A: Official warnings note that when this medication is used concurrently with topical ophthalmic corticosteroids (steroid drops), there is a potential for increased risk of delayed corneal wound healing. The risk when used alone is generally low, but patients with pre-existing conditions that affect the cornea are monitored closely.


Q: Is there a maximum number of days or weeks Dicloabak 0,1% should be used for a single treatment?

A: Yes, there is a maximum duration linked to the specific indication. For a single course of treatment, usage is limited, such as a maximum of two weeks after cataract extraction or a maximum of three days after corneal refractive surgery, as defined in the official dosage guidelines.


Q: What is the role of diclofenac in preventing miosis during eye surgery?

A: Clinical trials have evaluated the use of diclofenac 0.1% drops specifically for the prevention of miosis, which is the undesirable constriction of the pupil, during surgical procedures like cataract surgery. Its anti-inflammatory action helps maintain the pupil's dilation during the operation.

How should Dicloabak 0,1% be stored and disposed of?

Official Storage Conditions for Dicloabak 0.1% Eye Drops

The ophthalmic solution must be stored at controlled room temperature, generally between 15 C and 30 C. It is mandatory to keep the medicine from freezing and to store it away from excess heat and moisture. The product requires protection from light and must be kept in the original container with the cap tightly closed to maintain sterility.

Handling and Child Safety

To prevent contamination, the applicator tip should not touch any surface. As with all medicines, Dicloabak 0.1% must be stored safely, out of the sight and reach of children.

Disposal of Unused Medicine

Expired or unused eye drops should not be kept. Patients are instructed to ask a healthcare professional, such as a pharmacist, for guidance on how to properly dispose of any medicine that is no longer needed.

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

Available in countries:

Equivalent of Dicloabak 0,1% found in:

A-Z Index: