Азидроп

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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 Азидроп

Азидроп (Azidrop) is an anti-infective medicine specifically formulated as an ophthalmic solution for targeted bacterial conditions in the eye. It is an established prescription-only medicine (POM) intended for both adult and pediatric use.

Property Description
Active ingredient Azithromycin
Form Ophthalmic Solution (Eye drops)
Pharmacological class Macrolide Antibiotic (Azalide)
General use To control bacterial growth in ocular conditions
Origin Synthetic

What Type of Medicine is Азидроп?

The active compound in Азидроп is Azithromycin (in its dihydrate form), which is classified as an azalide—a specialized subclass of macrolide antibiotics. This synthetic compound is recognized for its broad-spectrum anti-bacterial activity. Azithromycin has an established antibacterial spectrum, functioning as an anti-infective agent. Its primary role is to intervene in infections caused by susceptible bacterial strains.

Form and Composition of Азидроп Eye Drops

Азидроп is manufactured as a single-ingredient product in the form of an ophthalmic solution administered as eye drops. This prescription-only medicine is intended for topical application, meaning it must be applied directly to the surface of the eye. The formulation utilizes a clear aqueous solution base to dissolve the Azithromycin dihydrate.

This targeted, topical delivery allows for high local drug concentrations directly at the site of infection. This formulation is used for treating bacterial infections on the surface of the eye. The drug is typically positioned for managing acute, external bacterial eye conditions.

General Purpose and Anti-Bacterial Action

The general purpose of Азидроп is to control and stop the proliferation of harmful bacteria responsible for ocular infections. It achieves this by exerting a bacteriostatic effect. The drug works at a cellular level, interfering with the bacteria's ability to create the proteins necessary for growth and reproduction. By disrupting this synthesis process, the medicine helps the body resolve the underlying bacterial cause of the problem.

Regulatory References

  1. Changes to the use of antibiotic azithromycin | EMA
  2. European public assessment reports (EPARs) background and context

What side effects are possible with Азидроп?

Possible Side Effects and Safety Information

The safety profile of Azithromycin ophthalmic solution is defined by effects occurring primarily at the site of application. These effects are officially categorized by their frequency as documented in regulatory prescribing information.


Ocular Adverse Reactions and Frequency

The most frequently observed effect in clinical trials, classified as Very Common (ge 10%), is eye discomfort. This category includes temporary sensations such as burning, stinging, pruritus (itching), or other irritation experienced immediately upon instillation. Effects classified as Common (1% to <10%) include blurred vision, eyelid swelling, and the sensation of having a foreign body in the eye. Less frequently reported reactions (Uncommon <1%) affecting the eye include dry eye, eye pain, and corneal erosion.

Systemic and Serious Safety Considerations

Due to the medicine’s topical application, systemic exposure is minimal. However, official regulatory documents note the potential for non-ocular effects such as dysgeusia (change in taste), nasal congestion, rash, and urticaria to occur at an uncommon frequency. Warnings state that severe systemic allergic reactions, including anaphylaxis and severe skin conditions like Stevens-Johnson Syndrome (SJS), are risks known to be associated with the macrolide class of antibiotics and must be considered. A primary safety constraint is the potential for superinfection by non-susceptible organisms, including fungi, which can occur with prolonged use.


Special Population Safety Notes

The medicine's safety and effectiveness have not been established in children below 1 year of age. For older adults, no overall differences in safety were observed compared to younger patients. Use during pregnancy and lactation requires caution and should be undertaken only if clearly medically necessary. The product is strictly for topical ophthalmic use only and is contraindicated in individuals with known hypersensitivity to azithromycin or any macrolide antibiotic.

Overdose and Emergency Response

The official regulatory profile for Азидроп (Azithromycin Ophthalmic Solution) indicates that the risk of systemic overdose is extremely low. The total amount of Azithromycin contained within a single-use container is too small to induce the severe systemic adverse effects typically associated with high-dose macrolide antibiotics, even if the contents are accidentally swallowed. Therefore, the classic systemic overdose symptoms, such as severe nausea, vomiting, diarrhea, and reversible hearing loss, are generally not expected from this ophthalmic formulation.


When to Seek Immediate Medical Help

Treatment for any suspected overdose is symptomatic and supportive, as no specific antidote is known for Azithromycin. Regulatory authorities mandate that urgent medical attention must be sought immediately if the exposed individual exhibits life-threatening clinical signs. These signs include collapse, seizure activity, difficulty breathing, or inability to be awakened. Immediate contact with the Poison Control Center is also required for suspected gross overdose or accidental ingestion. Furthermore, a longer period of observation and treatment may be necessary if a severe allergic or hypersensitivity reaction is suspected, due to the recognized potential for recurrent symptoms.

Therapeutic Uses of Азидроп

What Азидроп Treats: Main Uses and Benefits

This ophthalmic solution is commonly used for the management of external bacterial eye conditions, and is applied in conditions such as bacterial conjunctivitis (often known as 'pink eye') caused by susceptible microorganisms. Its application is relevant where symptoms are associated with the acute presence of bacteria.

This medication is commonly used across conditions presenting with acute episodes, relevant for conditions such as acute bacterial conjunctivitis and other susceptible ocular surface infections. It is relevant for managing symptom clusters that may become intense or disruptive, including the presence of purulent discharge, redness related to inflammatory states, and the resulting eyelid crusting that interferes with daily comfort. This support helps ease the overall symptom burden of these pronounced manifestations.

It supports the management of bacterial conjunctivitis in both adults and children (from a specific age threshold). This broad relevance may assist with maintaining functional stability and provides supportive relief for acute eye problems across typical patient groups.


Quick Fact: Relief for Ocular Discharge The medicine is commonly used in clinical settings that involve acute symptom patterns, helping to address the visible signs of infection, particularly the sticky, purulent discharge that causes symptoms related to physical discomfort.

Regulatory References

  1. DailyMed NLM/NIH Azithromycin Ophthalmic Label

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The official regulatory profile for Азидроп (Azithromycin Ophthalmic Solution) establishes clear rules defining its eligible user population.

Populations For Whom Use Is Contraindicated

Use of this medicine is absolutely prohibited (contraindicated) for any patient with a known history of hypersensitivity or allergic reaction to the active ingredient, Azithromycin, or to any other macrolide antibiotic, such as Erythromycin.

Age-Related Eligibility

Age Group Regulatory Status
Adults and Geriatric Patients Use is established and permitted.
Pediatric Patients (1 year and older) Safety and efficacy have been established.
Infants (Below 1 year of age) Safety and effectiveness have not been established.

Pregnancy and Lactation Status

  • Pregnancy: Use is considered acceptable; regulatory data have not identified drug-associated risks, as systemic exposure is negligible.
  • Lactation: Use is generally acceptable. Though the drug passes into breast milk, the amount transferred is considered negligible.

Eligibility-Related Restrictions

Patients exhibiting signs of bacterial conjunctivitis must not wear contact lenses during the treatment period, as specified in regulatory labeling. Restrictions related to severe hepatic or renal impairment are typically not documented for this ophthalmic formulation due to its minimal systemic absorption.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Азидроп (Azithromycin Ophthalmic Solution) is notably restricted due to its formulation as a topical eye drop and the resulting negligible systemic absorption of the active ingredient, Azithromycin. This means that the drug concentrations in the body are insufficient to cause the clinically significant systemic drug-drug interactions associated with oral forms of macrolide antibiotics.


Systemic Interaction Assessment

Regulatory documents confirm that this ophthalmic solution does not typically interfere with the systemic metabolism of other medicines. This includes the absence of documented interactions related to CYP450 enzymes, drug transporters, food, alcohol, or herbal products. Consequently, official labeling lists no formal contraindications based on metabolic or pharmacokinetic interactions with other systemic medicinal products.


Local Administration-Timing Constraint

Interaction Type Requirement as per Official Labeling
Topical Ophthalmic Products Co-administration requires strict time separation.

When co-administering any other topical ophthalmic solution, a mandatory interval of at least 15 minutes must be observed between the applications. This requirement is a procedural constraint intended to prevent the wash-out of the ophthalmic solution from the eye, ensuring adequate local exposure to the active substance. To adhere to this rule, Азидроп is specified to be the last eye product instilled.

Mechanism of Action

Blocking the Bacterial Protein Factory

The core mechanism involves Azithromycin binding specifically to the 50S ribosomal subunit inside susceptible bacteria, particularly the 23S rRNA. By physically blocking the peptide chain elongation step during protein synthesis, the drug functionally stops the bacteria from creating the essential proteins needed for growth and reproduction. This action results in the suppression of microbial proliferation, which is the primary physiological consequence of inhibiting protein synthesis.


️ Immunomodulation and Anti-Inflammatory Action

Beyond its direct effect on bacteria, the drug acts as an immunomodulator on host cells, influencing the inflammatory response. It helps suppress the activation of transcription factors (like NF-kappaB) in immune cells, leading to a decreased synthesis and release of pro-inflammatory mediators (e.g., IL-8). This mechanism reduces the over-recruitment of inflammatory cells to the site of infection, contributing to the physiological effect of attenuating local tissue inflammation.


⏳ Sustained Local Delivery

A unique feature of this mechanism is the drug's ability to be actively concentrated and transported by host phagocytic immune cells (macrophages and neutrophils) and then released slowly at the infection site. This cell-mediated delivery facilitates sustained, high local concentrations of Azithromycin within the ocular tissue for an extended period, increasing the duration of the antibacterial and immunomodulatory physiological activity.

Dosage and Administration Information

How to Use Азидроп (Azithromycin Ophthalmic Solution)

The administration of Azithromycin ophthalmic solution, such as Азидроп, is performed according to a specific protocol for the management of susceptible ocular infections. This medicine is strictly for topical ocular use and is instilled directly onto the surface of the affected eye(s). It is not for systemic use or injection.


Administration Protocol Summary

The usage of the solution is structured as a short-term, seven-day course, which involves a change in frequency after the initial phase. The dose is one drop per affected eye for every administration time, a unit dose that remains fixed throughout the treatment period.

Treatment Phase Duration Dosing Frequency
Initial Phase First 2 Days One drop twice daily (BID)
Continuation Phase Next 5 Days One drop once daily (QD)

Procedural and Population Rules

Before administration, the closed bottle must be inverted and shaken once to ensure the contents are properly mixed. To maintain sterility, care is taken to prevent the dropper tip from touching the eye or any other surface.

This seven-day regimen is used for both adults and children across the clinical age range (which includes children from six months of age). No dose adjustment is required for elderly patients. If a dose is missed, it is administered as soon as possible, provided it does not coincide with the time for the next scheduled dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Азидроп


Evidence for Use in Acute Bacterial Conjunctivitis

The research base was evaluated through randomized, double-masked, vehicle-controlled (placebo) clinical trials. These studies were conducted during periods of increased symptom activity to assess short-term changes.

In these trials, research examined two key outcomes. The first was Clinical Resolution, which tracked outcomes related to physical discomfort such as the presence of eye discharge and redness. The second key outcome was Microbiological Eradication, defined as the absence of bacteria growth or reduction below pathogenic thresholds in cultures. Studies observed patient responses over short-term observation intervals, typically focusing on endpoints assessed around one week after starting treatment.

Findings describe patterns observed in the studies related to the resolution of ocular signs and the reduction of bacterial presence. Comparative trials were evaluated against other marketed antibiotic eye drops. These data show patterns related to non-inferiority endpoints when compared to the standard treatment for the same outcomes. However, it is important to note that these findings describe group patterns, not personal outcomes, and results apply only to the populations studied within the trial setting.


Research Evaluating Trachomatous Conjunctivitis

The topical solution was studied for the management of trachomatous conjunctivitis, a condition characterized by fluctuating or episodic manifestations caused by the Chlamydia trachomatis bacterium. This research often involved large, community-based randomized trials conducted in specific geographic areas where the condition is common.


Long-Term Evidence and Observation Periods

The core research was studied for acute management, meaning the follow-up durations were limited. Most key clinical trials assessed the condition during the initial acute phase, with primary results reported around one week after treatment initiation.

Due to the study design, there is limited information for long-term outcomes or the durability of the effects of the topical solution beyond this short-term window. Long-term effects are not fully established, and certainty remains low regarding whether the medication may influence the frequency of future infectious episodes. The evidence landscape primarily describes the short-term response observed during the defined observation interval.

Key Studies & References

  1. Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis
  2. Elimination of Active Trachoma after Two Topical Mass Treatments with Azithromycin 1.5% Eye Drops

Frequently Asked Questions (FAQ)

Common questions about Азидроп (FAQ)

Q: Is Азидроп effective against viral infections like the common cold or flu?

According to the official product information, Азидроп is an anti-infective medicine specifically indicated for the treatment of bacterial eye infections. The official description of its mechanism states its role is to interfere with the growth of susceptible bacteria, meaning it is not used for infections caused by viruses.


Q: Why is the typical course of Азидроп sometimes shorter than other antibiotics?

Official information indicates that the topical solution is specially formulated for sustained local delivery. This prolonged presence is cited as the factor that supports a shorter overall treatment course compared to some other antibiotic eye drops.


Q: Are headaches a recognized side effect of taking Азидроп?

Yes, regulatory documents list headache as a non-ocular side effect that may occur at an uncommon frequency when using the ophthalmic solution. This is not one of the most frequently observed effects, which usually involve temporary eye discomfort.


Q: Are there any specific vitamins or mineral supplements that may interact with Азидроп?

Due to its topical application, Азидроп has negligible systemic absorption, making significant systemic interactions unlikely. However, official prescribing information for this medicine and class of drugs typically suggests reviewing all substances used, including vitamins, mineral supplements, and herbal products, with a healthcare professional.


Q: Can patients with a history of liver impairment safely use Азидроп?

The solution is an eye drop, and official information notes that the risk associated with severe systemic liver conditions is described as generally negligible for this topical use due to minimal systemic absorption into the bloodstream.


Q: Is it necessary to take Азидроп with food or on an empty stomach?

Official instructions for the administration of the ophthalmic solution describe the physical process of instilling the drops into the eye. These regulatory guidelines do not specify any requirement regarding the timing of application in relation to food or empty stomach intake.


Q: Can Азидроп be used to help prevent certain types of infections?

The official therapeutic indications for the solution are for the local antibacterial curative treatment of specific ocular infections. The official labeling does not include a general preventative indication.


Q: What are the described signs of a potentially serious liver issue related to taking Азидроп?

Serious hepatic injury is a rare warning linked to the macrolide class of antibiotics. These signs, which are linked to the macrolide class warnings, may include changes such as dark urine, jaundice (yellowing of the skin or eyes), fatigue, weakness, or nausea.


Q: What should be monitored if a person experiences ringing in the ears (tinnitus) while using Азидроп?

Tinnitus (ringing in the ears) and hearing loss are described in regulatory documents as possible side effects associated with the macrolide class of antibiotics. These effects are typically observed with long-term systemic (oral or injected) exposure.


Q: Can Азидроп affect the effectiveness of oral contraceptive pills?

The Centers for Disease Control and Prevention (CDC) does not generally consider this class of antibiotics to significantly interfere with the effectiveness of combined hormonal contraception. Due to the minimal systemic absorption of the eye drop formulation, the potential for interference is noted as negligible.


Q: What condition relating to muscle weakness (Myasthenia Gravis) is a concern for using Азидроп?

Regulatory warnings for the azithromycin class mention that the drug may exacerbate symptoms in patients with myasthenia gravis, a chronic condition causing muscle weakness. This is a key consideration mentioned in the labeling.


Q: Why is it described as important to complete the full prescribed course of Азидроп?

Official patient instructions state that finishing the full course, even if symptoms improve, is noted as important to help prevent incomplete treatment of the infection. Stopping the medicine too soon increases the chance of the bacteria potentially becoming resistant to antibiotics.


Q: Are there any known interactions with vaccines while taking Азидроп?

Official drug interaction checkers generally report no known interaction between the systemic Azithromycin and common viral vaccines. Since the ophthalmic solution is minimally absorbed, the overall potential for interaction is noted as low.


Q: Does Азидроп affect energy levels or cause fatigue?

While fatigue and weakness are reported as possible signs of rare, serious systemic issues related to the macrolide class, as detailed in regulatory documents, fatigue is not listed as a common or frequently observed side effect of the topical ophthalmic solution itself.


Q: How soon does a person typically feel symptom relief after starting Азидроп?

Studies included in the European regulatory documents indicate that symptomatic relief from the ocular infection is generally observed within three days of beginning the treatment course. These findings reflect patterns seen in the population studied in clinical trials.


Q: Can Азидроп be used to treat infections in the eye or the ear?

Regulatory indications for this specific solution specify that it is for the local antibacterial treatment of certain forms of conjunctivitis and trachomatous conjunctivitis. The product is formulated and labeled strictly for ocular (eye) use.

How should Азидроп be stored and disposed of?

Storage and Disposal Conditions for Azithromycin Ophthalmic Solution

The storage of this medicine is strictly defined by regulatory labeling to maintain product stability.

Storage Condition Requirement
Unopened Product Must be stored under refrigeration at mathbf2 C to mathbf8 C (mathbf36 F to mathbf46 F).
Post-Opening Storage Store between mathbf2 C and mathbf25 C (mathbf36 F to mathbf77 F). Do not freeze.
In-Use Stability The solution must be discarded 14 days after opening.

All medicine must be kept out of the sight and reach of children and stored in the original container. Unused or expired product must be disposed of according to local pharmaceutical waste regulations; do not discard the product into wastewater (sinks or toilets).

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

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