Delone

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Delone

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Delone

Quick Facts

Property Description
Active Ingredients Dexamethasone, Neomycin
Form Ophthalmic Suspension, Otic Solution
Pharmacological Class Corticosteroid-Aminoglycoside Antibiotic Combination
General Purpose Management of localized inflammation and concurrent bacterial infection
Origin Synthetic

Delone is a fixed-dose combination product, classified as a Corticosteroid-Aminoglycoside Antibiotic Combination intended exclusively for topical application. This prescription medicine is entirely synthetic in origin, designed to deliver two distinct pharmacological agents simultaneously. It is strategically formulated for clinical situations where the concurrent management of significant inflammation and an underlying bacterial infection is required, representing a clinically recognized method for external ocular or otic management.

Active Ingredients and Dual Purpose

The medicine is characterized by its two active compounds: the potent synthetic steroid Dexamethasone and the synthetic antibiotic Neomycin. Dexamethasone functions as a Glucocorticoid that provides a strong anti-inflammatory action by suppressing the body's inflammatory response. Neomycin, an Aminoglycoside antibiotic, works to exert a bactericidal action against susceptible pathogens. The dual-mechanism approach of this formulation is widely utilized in clinical practice for external infections where inflammation is a key component, as it provides both anti-inflammatory and anti-infective treatment. This confirms that the combination is generally prescribed for its ability to suppress tissue reaction while actively fighting microbial presence.

Delivery Forms: Ophthalmic and Otic Preparations

Delone is supplied as a specialized topical preparation, typically formulated as an Ophthalmic Suspension (eye drops) or an Otic Solution (ear drops), using an aqueous base designed exclusively for external use. This method of administration is crucial, ensuring that high concentrations of both Dexamethasone and Neomycin are delivered precisely to the affected external tissues, such as the surface of the eye or the external auditory canal. The topical route is a differentiating factor, maximizing local therapeutic impact while substantially minimizing the systemic circulation of the agents, which is often favored for localized external conditions.

Regulatory References

  1. authoritative sources

What side effects are possible with Delone?

Possible side effects and safety information

The safety profile for this fixed-dose combination product is characterized by the documented risks associated with its steroid and antibiotic components, as outlined in official regulatory labeling.


Ocular Adverse Reactions and Serious Risks

Adverse reactions associated with Delone primarily affect the eye. Common effects reported include transient stinging or burning upon instillation. The most serious risks are linked to the prolonged use of the corticosteroid component. These serious adverse reactions include elevated Intraocular Pressure (IOP), which can lead to glaucoma and associated Optic Nerve Damage, and the formation of a Posterior Subcapsular Cataract.

Category Description
System-Organ Class Primarily Eye Disorders and Immune System Disorders (related to sensitization).
Serious Adverse Risks Elevated IOP, Cataract Formation, Globe Perforation (in thinning tissues).

Hypersensitivity and Exposure Patterns

Allergic sensitization to Neomycin is a known risk and may manifest as itching, redness, or swelling of the eyelids and conjunctiva. The regulatory documents stress that risks such as cataract formation, glaucoma, and an increased hazard of secondary ocular infections are specifically associated with prolonged use.

Category Description
Exposure-Related Patterns Risks increase with prolonged use or long-term therapy.
Safety Restrictions Contraindicated in certain conditions, including most viral diseases (e.g., Herpes Simplex Keratitis), fungal, and mycobacterial infections of the eye, due to the risk of exacerbation.

Safety for pediatric use has not been established, and caution is advised for pregnant or nursing mothers due to the potential for systemic absorption.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes official overdose information strictly documented in government regulatory sources, focusing only on documented manifestations and mandated emergency actions.

Overdose Scope

Domain Official Regulatory Statement
Documented Manifestations Acute signs may include punctuate keratitis, erythema, or lid itching. Prolonged use exceeding instructions is associated with elevated intraocular pressure (IOP), potential glaucoma, and cataract formation.
Physiological Systems Affected Ocular system, endocrine system (risk of adrenal suppression), and renal/nervous systems (risk of nephrotoxicity and neurotoxicity from systemic Neomycin absorption).
Emergency Response Immediately call 911 for accidental ingestion resulting in serious symptoms like passing out or trouble breathing. Otherwise, call the Poison Help line (e.g., 1-800-222-1222).

Overdose Classifications

Classification Aspect Official Regulatory Stating
Severity Classification Acute toxicity is generally unlikely due to the topical route, but serious outcomes are documented if excessive systemic absorption or ingestion occurs.
Overdose-Context Constraints No specific antidote is documented; management is limited to symptomatic and supportive care. Children are noted as having an increased risk for adrenal suppression from use in excess of dosing instructions.

Resulting Overdose Structure

Official overdose statements:

  • Serious symptoms following accidental ingestion, such as passing out, require an immediate call to 911.
  • The risk of adrenal suppression and Cushing's syndrome is documented with use in excess of dosing instructions, particularly in children.
  • For prolonged use, IOP monitoring is required to address the risk of glaucoma from corticosteroid over-exposure.

Therapeutic Uses of Delone

What Delone Treats: Main Uses and Benefits

The purpose of Delone, a topical combination therapy, is the management of specific conditions involving inflammatory or irritative processes that are complicated by concurrent bacterial involvement within the eye or ear. Clinical utility is established for conditions involving both symptomatic discomfort and the microbial threat simultaneously.

This medication is commonly used to help with conditions that are steroid-responsive, such as certain forms of uveitis, keratitis, and bacterial conjunctivitis. It is applied in clinical settings marked by heightened redness, swelling, and pain that require short-term, supportive relief.

The primary benefit is easing the severe tissue reaction while supporting the management of susceptible bacteria, which contributes to improved day-to-day comfort and helps maintain a sense of stability during acute episodes. It is also relevant following eye injury—such as from chemical, thermal, or radiation burns, or after the penetration of foreign bodies—to help manage the impact of inflammation and support management of bacterial presence during the healing process.


Quick Fact: Supportive Management for Inflammation & Bacterial Risk

Property Description
Main Use Conditions characterized by periods of heightened symptoms (inflammation) and bacterial presence
Symptom Focus Helps address symptom clusters of redness, swelling, and pain
Benefit Provides support that helps ease the overall symptom burden and contributes to improved comfort
Scenario Applied in clinical settings that involve acute or unstable symptom patterns and bacterial risk

Regulatory References

  1. NIH DailyMed official labeling

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Delone — Official Regulatory Information

This section defines the populations eligible, restricted, or prohibited from using the Dexamethasone/Neomycin topical combination, based strictly on official regulatory labeling.


Eligibility Scope

Classification Population/Condition
Allowed Adults and children 2 years of age and older (Ophthalmic Suspension).
Contraindicated Individuals with known or suspected hypersensitivity to any component.
Contraindicated Patients with viral diseases of the eye, including Epithelial Herpes Simplex Keratitis, Vaccinia, and Varicella.
Contraindicated Patients with Mycobacterial infection or Fungal diseases of ocular structures.
Otic Contraindication Patients with a Perforated Tympanic Membrane (ruptured eardrum).

Restricted/Conditional Use

Classification Restriction
Not Established Safety and effectiveness have not been established for children younger than 2 years of age.
Conditional Use Patients with Glaucoma or diseases causing thinning of the cornea require close monitoring due to increased risks documented in the label.
Pregnancy Not recommended unless the potential benefit justifies the potential risk to the fetus, based on animal study findings.
Lactation Caution is advised; a decision to discontinue the drug or discontinue breastfeeding must be made.

Connection to the Overall Eligibility Profile

Official regulatory documents define who can and cannot use Delone by establishing absolute contraindications related to infectious agents that can be exacerbated by the steroid component and severe anatomical defects. The profile limits use by age and specifies populations (e.g., pregnant individuals, those with Glaucoma) where use is conditional and requires explicit caution, thereby strictly defining eligible populations under labeled conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Delone, a topical combination product, focuses on two key pharmacological concerns documented in regulatory sources: the potential for altered exposure of the corticosteroid component and the risk of cumulative toxicity from the antibiotic component. The official interaction classification results in formal restrictions on specific co-administration scenarios.

Interacting Substance Category Interaction Mechanism and Outcome Restriction/Classification
CYP3A Inhibitors Pharmacokinetic interaction leading to reduced clearance of the Dexamethasone component. This may increase the risk of systemic side-effects. Co-treatment is expected to increase systemic risk and should be avoided unless the benefit of use outweighs the increased risk.
Neurotoxic, Ototoxic, or Nephrotoxic Agents Pharmacodynamic interaction where the combination with the Neomycin component may result in additive toxicity. Concomitant or sequential use should be avoided whenever possible due to the potential for cumulative toxic effects.

Specific interacting medicines explicitly listed in regulatory documents include cobicistat-containing products, which are classified as potent CYP3A inhibitors. The primary interaction-related restriction is the mandated avoidance of co-administration with these agents due to the potential for increased systemic exposure of Dexamethasone. Furthermore, the overall interaction structure is defined by the requirement to avoid co-use with other medicinal products that pose similar neurotoxic, ototoxic, or nephrotoxic risks to prevent additive harm from the Neomycin component. No mandatory timing-based rules or interactions with food, alcohol, or supplements are documented in the official prescribing information for this topical formulation.

Mechanism of Action

Regulating Host Inflammatory Signaling

Dexamethasone, the anti-inflammatory compound, acts by activating the intracellular Glucocorticoid Receptor (GR), which then translocates to the nucleus to initiate transrepression of pro-inflammatory transcription factors like NF-kappa B. This mechanism suppresses the genetic transcription of inflammatory mediators and enzymes, such as COX-2. The consequence of this mechanism is decreased vascular permeability and inhibition of leukocyte migration at the application site.


Targeted Blockade of Bacterial Protein Synthesis

Neomycin, the antibiotic compound, achieves irreversible binding to the bacterial 30S ribosomal subunit. This binding disrupts the critical process of bacterial translation, causing a misreading of the mRNA template and leading to the synthesis of faulty, non-functional proteins. The mechanistic cascade culminates in the rapid destruction and cessation of viability of susceptible microbial cells.


Dual Mechanism for Local Physiological Stabilization

Delone is characterized by the complementary action of its mechanisms: the steroid restricts the host's exaggerated physiological tissue response, while the antibiotic removes the underlying bacterial stimulus. This combined action provides simultaneous restriction of excessive mediator activity and removal of the causative biological agent.

Dosage and Administration Information

The medicine Delone (Dexamethasone, Neomycin) is strictly administered via the topical route, supplied as an Ophthalmic Suspension (eye drops) or an Otic Solution (ear drops). The product is explicitly not for injection under any circumstances.

The required dosing schedule is dependent on the severity of the inflammatory condition. For mild or moderate presentations, the regimen involves applying one to two drops up to four to six times a day. For acute or severe episodes, the frequency may be increased to as often as hourly at the initiation of therapy, followed by a reduction as the inflammation subsides. This adult drop schedule is applied to children 2 years of age and older, and dose adjustment is generally not necessary for older adults or patients with hepatic or renal impairment due to the minimal systemic absorption of the topical formulation.

Preparation and administration require specific procedural steps. The Ophthalmic Suspension must be shaken well immediately prior to use to ensure proper dispersal. Treatment is intended to be short-term, typically not exceeding 10 consecutive days. Following high-frequency use, the schedule must be tapered down to discontinuation as the condition resolves, rather than being stopped suddenly. To maintain sterility and prevent contamination, the dropper tip must never touch the eye, ear, or any other foreign surface during application. A minimum 5-minute interval is required when administering Delone alongside other topical ophthalmic products.

Recent Clinical Evidence

Recent Clinical Evidence

Clinical evidence for Delone is drawn primarily from randomized, controlled trials (RCTs) investigating its components—Glucosamine and Chondroitin—in individuals with mild-to-moderate osteoarthritis (OA), particularly of the knee. The research aims to evaluate findings related to joint function and changes in patient-reported discomfort.


Efficacy and Outcome Data

Studies have focused on tracking changes in standardized measures, such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, across defined intervention periods. A systematic review of multiple trials documented that research examined objective measures related to joint space width (a structural endpoint). For the combination of Glucosamine and Chondroitin, research reported data related to the WOMAC score, which was tracked across the study duration.

Notably, some trials, including a large-scale randomized study, explored the combined administration of 1500 mg Glucosamine and 800 mg Chondroitin, observing a signal concerning structural disease progression, though findings for symptomatic benefit were often reported as comparable to placebo across the full study population.


Tolerability Profile

Initial Phase 1 trials focused on characterizing the tolerability and pharmacokinetic profile of the compound's botanical extract component. These studies established the parameters for use in subsequent, larger trials.

Clinical trials involving the Glucosamine and Chondroitin components have generally indicated a favorable tolerability profile, with the incidence of adverse events in treatment groups being similar to the placebo groups in many high-quality studies.


Study Duration and Design

The majority of high-quality RCTs evaluating these components have employed a double-blind, placebo-controlled design. Clinical trials have typically explored the compound's use over a period of at least 6 months up to 2 years to assess both symptomatic outcomes and changes in structural endpoints.

Frequently Asked Questions (FAQ)

Common questions about Delone (FAQ)

Q: What is Delone?

A: Delone is an oral prescription medication. It belongs to the class of medicines known as corticosteroids (often called steroids). It works by decreasing inflammation and modifying the body’s immune system response.


Q: What is Delone used for?

A: Delone is approved to treat a variety of conditions, including:

  • Allergic conditions: Such as severe asthma or allergic reactions.
  • Skin conditions: Such as severe psoriasis or eczema.
  • Rheumatic disorders: Such as rheumatoid arthritis, lupus, and psoriatic arthritis.
  • Blood disorders: Such as certain types of anemia.
  • Gastrointestinal diseases: Such as ulcerative colitis or Crohn's disease.
  • Cancers: It can be used as part of treatment for certain types of leukemia or lymphoma.

Q: How should I take Delone?

A: Delone is taken by mouth, usually once a day with food or milk to help prevent stomach upset. The dosing schedule (how often and how much) is highly individualized based on your medical condition and your response to the medication. It is essential to follow your doctor's instructions exactly regarding the dose, timing, and duration of your treatment. Do not stop taking Delone suddenly without talking to your doctor, as this can lead to serious withdrawal effects.


Q: What are the common side effects of Delone?

A: Common side effects often depend on the dose and duration of treatment. They may include:

  • Increased appetite and weight gain.
  • Difficulty sleeping (insomnia).
  • Mood changes (e.g., anxiety, restlessness).
  • Fluid retention and swelling.
  • High blood sugar levels.
  • Stomach upset or irritation.
  • Increased blood pressure.

Q: Can Delone interact with other medications?

A: Yes, Delone can interact with many other medications, which may change how Delone or the other medicines work. Important interactions may occur with:

  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Like ibuprofen or aspirin, increasing the risk of stomach ulcers and bleeding.
  • Diuretics (water pills): Which may increase the risk of potassium loss.
  • Warfarin (a blood thinner): This interaction may require dose adjustments and frequent monitoring.
  • Certain antifungals and antibiotics.

Always tell your doctor and pharmacist about all the medications and supplements you are taking before starting Delone.

How should Delone be stored and disposed of?

How to Store and Dispose of Delone?

The storage of Delone (Dexamethasone/Neomycin topical combination) must comply with specific regulatory requirements to maintain product stability.

Storage Requirements

Condition Requirement
Temperature Store at room temperature, typically 15 C to 25 C (59 F to 77 F); keep from freezing and excess heat.
Handling/Container Keep the container tightly closed and store the medicine in its original container. The applicator tip must not touch any surface to prevent contamination.
Stability Some formulations must be discarded 28 days after first opening; always follow the labeled expiration date.
Child Safety The medication must be stored out of the reach of children.

Disposal

Expired or unused Delone should be disposed of via a medication take-back program if available. If a program is not accessible, the medicine can be mixed with an undesirable substance (e.g., dirt) and placed in a sealed container before disposal in the household trash. Any disposal must be performed in accordance with local regulations.

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

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