Данцил

Quick links to important sections

Данцил

Selected form

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 Данцил

Quick Facts

Property Description
Active Ingredient Ofloxacin (INN)
Form Aqueous Solution (Eye drops / Ear drops)
Pharmacological Class Fluoroquinolone Antibiotic
General Purpose Counteracting bacterial infections
Origin Synthetic Compound

What is Данцил and What Pharmacological Class Does it Belong To?

Данцил is a synthetic, single-component pharmaceutical preparation featuring the active ingredient Ofloxacin. This medicine is classified as a Fluoroquinolone antibiotic, a specific and potent group within the larger class of broad-spectrum antimicrobial agents. This classification means the substance is chemically synthesized and is recognized for its bactericidal effect—the ability to actively kill susceptible bacteria by disrupting their fundamental processes.

The Ofloxacin entity functions by inhibiting key bacterial enzymes, DNA gyrase and Topoisomerase IV, thereby preventing the bacteria from replicating their genetic material. The use of this class of agents is established in treating localized bacterial infections, offering a decisive approach to infection control.

Why is Данцил Used as a Topical Solution?

The medication is formulated as a sterile aqueous solution, specifically prepared as eye drops (ophthalmic) or ear drops (otic) for local/topical administration. This dedicated form ensures the Ofloxacin compound is delivered in high concentrations directly to the site of the infection, such as those affecting the external ocular or otic tissues.

This localized delivery method is intended to maximize the compound's effect against superficial bacterial pathogens while ensuring targeted action. Ophthalmic Ofloxacin is utilized for treating susceptible infections, as the compound is designed for efficacy when applied topically. Данцил is typically marketed as a prescription-only medicine, suitable for use in patients across a broad age range when treating common bacterial infections of the eye or ear.

Regulatory References

  1. EMA Safety Review on Fluoroquinolones (Ofloxacin is listed)

What side effects are possible with Данцил?

Possible Side Effects and Safety Information

The official safety profile for Ofloxacin topical solution (the active ingredient in Данцил) is defined by both local adverse reactions and mandatory warnings associated with the fluoroquinolone class. The most frequently reported effects are generally localized to the administration site and are categorized by frequency in regulatory documents.


Frequency-Classified Adverse Reactions

The following effects are documented in official prescribing information:

Category Examples (Ophthalmic/Otic)
Common Eye burning, stinging, ocular discomfort, eye pruritus.
Less Common Dizziness, taste perversion (bitter taste), earache, blurred vision.
Not Known Hypersensitivity reactions, anaphylaxis, Torsades de pointes.

Documented Serious Adverse Reactions and Restrictions

Official labels address the risk of Serious Adverse Reactions, which include immediate Hypersensitivity Reactions (such as angioedema or anaphylaxis), which require immediate discontinuation. As a fluoroquinolone, the label also includes a cautionary note regarding the class effect of Tendonitis and Tendon Rupture, even with low systemic absorption from topical use, and risks associated with QT interval prolongation in susceptible patients.

Population-Specific Safety: Safety and effectiveness have not been established in infants under one year of age. For Lactation, a risk-benefit assessment must be made, as systemic quinolones are excreted in breast milk. Additionally, prolonged use may lead to the overgrowth of non-susceptible organisms (superinfection), as noted in regulatory documents.

This structured safety information clearly defines the medicine's risks, separating local effects from rare, potentially serious systemic concerns and explicitly states limitations based on age and duration of use.

Overdose and Emergency Response

The official regulatory documents for Ofloxacin (the active ingredient in Данцил) outline specific protocols for accidental overdose and severe systemic reactions.

Overdose from the accidental swallowing of the topical solution is generally not expected to be dangerous due to the low systemic exposure. However, emergency medical attention is required for any such exposure. Symptoms consistent with significant systemic Ofloxacin exposure, as formally documented in regulatory sources, may include drowsiness, nausea, dizziness, and confusion. In these situations, contact the Poison Help line or seek emergency medical care.

The most severe documented concern is the risk of serious acute hypersensitivity reactions (e.g., anaphylaxis), some of which can be fatal. Manifestations that mandate immediate emergency treatment include cardiovascular collapse, airway obstruction (angioedema), and loss of consciousness. At the first sign of a rash or allergic reaction, the product must be discontinued immediately.

Management is strictly symptomatic and supportive, as no specific antidote is known. Emergency procedures for severe cases, as outlined in official labeling, involve oxygen and airway management and the provision of suitable treatment for shock. Continuous observation, such as ECG monitoring, may be required in systemic overdose scenarios.

Therapeutic Uses of Данцил

What Данцил Treats: Main Uses and Benefits

Данцил is a product that is relevant for easing the overall symptomatic load during episodes characterized by acute discomfort. It is generally applied in contexts where short-term symptomatic assistance is needed, aiming to address the symptomatic burden rather than the primary cause; such a supportive approach is relevant when supportive symptom management is appropriate for acute symptoms and sudden flare-ups.

Данцил is commonly used across conditions presenting with acute episodes, where symptoms of physical discomfort, heightened physiological activity, or systemic imbalance become momentarily disruptive. It supports the management of:

  • Symptoms that interfere with daily functioning
  • Conditions involving episodic or fluctuating manifestations
  • Situations requiring temporary stabilization of discomfort

The product is applied when appropriate, such as when symptoms become temporarily overwhelming. “It helps maintain a sense of stability during challenging symptomatic phases,” is one of the ways this supportive therapy is designed to function.

Quick Fact: Relief for Acute Manifestations
Данцил is commonly used when short-term symptomatic assistance is needed, helping to ease the overall symptom burden.

The medication contributes to improved comfort during periods of heightened symptoms and assists the patient during difficult episodes by easing distress. It is applied when appropriate for conditions characterized by periods of heightened symptoms or episodes involving fluctuating manifestations.

Regulatory References

  1. NIH National Library of Medicine overview of Beta2-Agonists

Eligibility and Restrictions for Use

Eligibility and Restrictions for Данцил

Данцил (Ofloxacin topical solution) is strictly contraindicated for use in patients with a history of hypersensitivity to the active ingredient, to any other quinolone antibiotics, or to any other component of the medication. This exclusion is based on formal regulatory labeling. The otic solution (ear drops) is also explicitly not for ophthalmic use.

Eligibility is primarily defined by specific age-group rules. Ophthalmic use is approved for patients one year of age and older. Otic use has varying minimum age requirements depending on the specific condition, ranging from six months to twelve years. Safety and efficacy are not established in children below these respective regulatory thresholds.

For special populations, use is conditional. The medicine is Pregnancy Category C, meaning use is restricted to cases where the potential benefit justifies the potential risk to the fetus. For nursing women, the label advises a choice to discontinue nursing or discontinue the drug due to potential risks from systemic quinolone exposure. No dosage adjustment is necessary for topical use in patients with pre-existing renal or hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation for Данцил (Ofloxacin topical solution) focuses on a few key interaction areas, primarily based on the systemic properties of the fluoroquinolone class and local administration requirements.

Since minimal systemic absorption is possible, official labels flag risks associated with the systemic drug. Specific drug interaction studies have not been conducted for the topical solution, necessitating that systemic quinolone warnings be transferred as cautions.


Documented Interaction Cautions

Interaction Type Interacting Substances / Categories
Pharmacodynamic Risk QTc-prolonging medicinal products (e.g., anti-arrhythmics, macrolides, certain antipsychotics).
Exposure Caution Oral anticoagulants, such as Warfarin and its derivatives.
Metabolic Caution Methylxanthines, such as Theophylline and Caffeine.

Interaction-Related Constraints

The most direct restriction involves the use of other locally administered ophthalmic agents. Other topical eye drops or eye ointments must be separated by time upon application to prevent washout and ensure adequate therapeutic contact time. Population-specific notes also exist, cautioning that elderly patients and women may show increased sensitivity to the QTc-prolonging interaction risks when using the drops concomitantly with specified QTc-prolonging drugs. No interactions are explicitly documented with food, drinks, or alcohol for the topical formulation.

Mechanism of Action

Targeting Skeletal Muscle Calcium Release

Данцил acts within domains involving ryanodine receptors (RyR1), which function as calcium release channels on the sarcoplasmic reticulum (SR) of skeletal muscle cells. The compound directly antagonizes these receptors, thereby reducing the efflux of calcium ions ( Ca^2+) from the SR into the muscle cell cytoplasm.

Modulating Excitation-Contraction Coupling

This mechanism modifies molecular steps that regulate systemic physiological outcomes by interfering with the cascade known as excitation-contraction coupling. By restricting the increase in intracellular Ca^2+ concentration, Данцил limits calcium binding to troponin. This engagement results in the subsequent inhibition of actin-myosin cross-bridge formation, which is the necessary final event for muscle fiber shortening.

Limiting Muscle Contractility

The resulting physiological effect involves a direct reduction in the baseline tension and contractility of the skeletal muscle fiber. This pharmacodynamic action confines mediator (calcium ion) activity responsible for heightened or sustained contraction.

Dosage and Administration Information

Administration and Dosage Guidelines

Данцил (donepezil) is taken orally once daily, typically in the evening just prior to retiring, and can be administered with or without food.

Official Dosing Schedule

Condition Initial Dose (Once Daily) Maintenance Dose (Once Daily)
Mild to Moderate Alzheimer's Dementia 5 mg May be increased to 10 mg after 4 to 6 weeks.
Moderate to Severe Alzheimer's Dementia 5 mg or 10 mg May be increased to 23 mg only after the patient has been on 10 mg for at least 3 months.

Preparation and Special Conditions

Standard tablets should be swallowed whole with water and must not be split, crushed, or chewed. This is strictly mandatory for the 23 mg tablet, as altering the form may increase the rate of absorption. Orally disintegrating tablets (ODT) must be allowed to dissolve on the tongue before swallowing with water; do not push ODTs through the foil backing.

If a dose is missed, the instruction is to skip the missed dose entirely and take the next dose at the regularly scheduled time. Do not take two doses to compensate. If the medication is missed for more than seven days (one week), a healthcare provider should be consulted before treatment is restarted. The use of this medicine is generally not studied or recommended for patients under 18 years of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Данцил (Ofloxacin Topical)

This section summarizes the structure of the clinical evaluation for Ofloxacin topical solutions, covering what researchers have observed in high-quality studies concerning acute eye and ear infections.


Evidence Base for Ophthalmic Infections: Conjunctivitis and Corneal Ulcers

For acute bacterial conjunctivitis, the evidence was evaluated in short-term, randomized controlled trials (RCTs). These studies were designed to compare Ofloxacin against an inactive solution or against other antibiotics. Studies monitored changes in outcomes linked to inflammatory states, such as eye redness and discharge, as well as patterns related to the bacteria monitored. Research highlights changes measured during the study period, which was typically short-term. For bacterial corneal ulcers, research examined RCTs comparing Ofloxacin monotherapy against established dual-antibiotic treatments. Studies explored outcomes by measuring the rate of successful corneal re-epithelialization and the time it took for this process to occur. The timeframes for corneal re-epithelialization and the patterns related to bacteria monitored were observed in the studied populations.


Evidence Base for Otic Infections: Ear Canal and Middle Ear Uses

For Acute Otitis Externa (AOE), or Swimmer's Ear, research was evaluated in Phase III RCTs comparing Ofloxacin to other topical solutions. Studies focused on measuring the resolution of ear canal symptoms such as pain and discharge. For Acute Otitis Media in patients with Tympanostomy Tubes (AOM-TT), studies consisted of RCTs that compared the topical solution to oral, systemic antibiotics, monitoring the primary outcome of otorrhea resolution rate (the stopping of ear discharge). Research exploring short-term symptom changes reported patterns observed in the studies that were compared to the results from systemic antibiotics for this specific patient group.


What is Still Uncertain or Under Study

A primary area of uncertainty is the continued emergence of antibiotic resistance in the bacteria that cause these infections. Also, follow-up durations were limited in the main clinical trials. There is limited information for long-term effects, such as the rate of symptom recurrence or potential consequences for the specific eye or ear structures years after treatment. Data for certain subgroups, such as infants younger than one year of age for some ear conditions, remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Данцил (FAQ)

Q: What is the active ingredient in Данцил?

The active ingredient in Данцил is ofloxacin. According to the official product information, this is the substance designated as responsible for the medicine's primary therapeutic action.

Q: How should Данцил be stored?

Official information indicates that Данцил should be stored at a temperature not exceeding 25°C. Regulatory instructions advise keeping the product in its original packaging to protect it from light and moisture, and out of the reach of children.

Q: What is the typical shelf life or expiration of Данцил?

Regulatory documents state that the shelf life of Данцил is generally 3 years from the date of manufacture. Regulatory labeling advises checking the expiration date printed on the packaging, as the medicine should not be used past this date.

Q: How does Данцил work in the body?

Данцил works as a quinolone antibacterial agent. This means its mechanism is intended to inhibit the growth of or destroy susceptible bacteria. The active ingredient, ofloxacin, interferes with key enzymes in the bacterial cells, preventing them from replicating and repairing themselves.

Q: Is Данцил available as an oral tablet, or just a solution?

The official product information for Данцил describes it as an eye and ear solution. There are no regulatory documents from the product label stating that this specific medicine is available in an oral tablet formulation.

Q: Can I use Данцил if I wear contact lenses?

Official product information advises that soft contact lenses should not be worn during treatment with Данцил. The product information includes specific instructions for hard contact lens wearers, advising they be removed before application and noting a minimum wait time before reinsertion.

Q: Are there specific conditions of the ear (like a perforated eardrum) where Данцил should not be used?

Yes, according to regulatory documents, Данцил is generally contraindicated if there is a known perforation of the eardrum. This indication reflects regulatory caution regarding its use in that circumstance.

Q: Are there any contraindications for using Данцил (besides ear/eye infections)?

Official information indicates that Данцил is contraindicated in individuals with known hypersensitivity (severe allergy) to the active ingredient, ofloxacin, or to other quinolones. It is also contraindicated for non-infectious conditions according to the label.

How should Данцил be stored and disposed of?

How to Store and Dispose of Dancyl (Ofloxacin Solution)

The storage and disposal of Dancyl must adhere strictly to regulatory conditions to preserve its integrity as a sterile solution.

Storage Conditions and Requirements

Dancyl must be stored at controlled room temperature, typically 20^circmathrmC to 25^circmathrmC. It is mandatory to keep the product from freezing and to protect it from excess heat, moisture, and light. The container must be kept tightly closed, and the applicator tip should not be contaminated to maintain sterility. The medicine must be stored out of the reach and sight of children.

Stability and Disposal

Once opened, the solution has a limited stability period, and the unused portion must be discarded after a specific time, commonly one month (30 days). Expired or unused medicine must be disposed of properly according to local regulatory requirements; it must not be flushed down the sink or toilet.

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

Available in countries:

Equivalent of Данцил found in:

A-Z Index: