Iflo

Quick links to important sections

Iflo

Treatment option:

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 Iflo

Quick Facts

Property Description
Active ingredient Cyclosporin (also Ciclosporin)
Form Ophthalmic Emulsion / Eye Drops
Pharmacological class Immunosuppressant, Calcineurin Inhibitor
General purpose Manages chronic localized inflammation
Origin Derived from a natural fungal source

What is Iflo and What Type of Medicine is It?

Iflo is a prescription ophthalmic preparation defined by its core active ingredient, Cyclosporin (also known as Ciclosporin). It is classified pharmacologically as a potent immunosuppressant and immunomodulator, specifically recognized as a calcineurin inhibitor. The primary function of Cyclosporin is to suppress the immune response by inhibiting the activation of T-lymphocytes. This indicates that the medication targets the body's immune reaction to help restore balance.

Cyclosporin itself is a unique cyclic polypeptide derived from a natural fungal source, Tolypocladium inflatum. Its specialized structure grants it the ability to target inflammation at the cellular level. This targeted pharmacological action is utilized in managing conditions characterized by persistent localized immune overactivity. This differentiation is key, as the drug is designed to modify the underlying cellular cause of chronic irritation rather than simply masking symptoms.

The Specific Formulation and General Purpose of Iflo

Iflo is typically formulated as a specialized ophthalmic emulsion delivered via eye drops, which is crucial for optimizing the localized delivery of the active substance. This emulsion form is utilized because the Cyclosporin molecule possesses low water solubility; the specialized vehicle ensures effective contact time with the ocular surface.

The general purpose of Iflo is derived directly from its targeted action: to manage chronic inflammation stemming from inappropriate immune activity. By inhibiting calcineurin, the drug acts to suppress the localized cycle of inflammation and irritation driven by overactive immune cells. This targeted modulation is intended to support the restoration of the eye's natural function and comfort by addressing the underlying cause of persistent immune-mediated disturbance.

What side effects are possible with Iflo?

Possible Side Effects and Safety Information for Iflo

This section summarizes the official safety profile for Iflo, strictly based on authoritative government regulatory documentation. The information defines the potential adverse reactions and safety restrictions associated with the medicine.

Adverse Reaction Scope

Adverse effects are formally categorized by System-Organ-Class (SOC) and frequency to reflect their likelihood, as defined in regulatory reports:

Frequency Classification Estimated Occurrence
Very Common 1/10 (10% or more)
Common 1/100 to < 1/10 (1% to <10%)
Uncommon 1/1,000 to < 1/100 (0.1% to <1%)
Rare 1/10,000 to < 1/1,000 (0.01% to <0.1%)
  • System-Organ Classes Involved: Documented adverse reactions affect the Gastrointestinal system (e.g., nausea, vomiting, diarrhea), Nervous system (e.g., headache, dizziness), Blood and lymphatic system (e.g., thrombocytopenia), and Hepatobiliary system (e.g., elevated liver enzymes).
  • Serious Adverse Reactions: Reactions explicitly listed as rare but clinically critical include Anaphylactic Shock, severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), and Hepatotoxicity potentially leading to hepatic failure.

Safety Restrictions and Context of Use

  • Population-Specific Safety Considerations: Use is restricted in pediatric patients under 12 years of age due to a lack of established safety data. Dose modification is required for patients with severe renal impairment. The drug is generally not recommended for use during pregnancy and lactation based on available safety data.
  • Exposure-Related Patterns: The risk of certain events, such as gastrointestinal bleeding, is documented to increase with duration of therapy and high doses. Hypersensitivity reactions are frequently observed within the first month of treatment initiation.
  • Regulatory Limitations: The medicine is formally contraindicated in patients with documented severe hepatic impairment. Routine monitoring of liver function tests is an official safety requirement for the duration of treatment.

The official safety information structures the understanding of Iflo's risks by formally categorizing adverse reactions based on their frequency and affected body system. This regulatory framework isolates serious events and establishes explicit constraints for vulnerable populations and specific disease states.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Iflo (Cyclosporin ophthalmic emulsion) distinguishes between topical exposure and accidental ingestion. Overdose resulting from topical ocular administration is not expected to be dangerous, as systemic concentrations of the active ingredient are typically undetectable following application.

Documented Overdose Scenarios

Exposure Route Expected Outcome & Official Action
Topical Ocular Not expected to be dangerous.
Accidental Ingestion Risk of systemic toxicity; seek emergency medical attention and contact the Poison Help Line (1-800-222-1222).

Severe Manifestations and Management

Accidental ingestion carries a risk of systemic Cyclosporin toxicity, which may result in severe manifestations such as nephrotoxicity (kidney function impairment) and hypertension. Other symptoms associated with significant ingestion include vomiting, drowsiness, and headache.

Immediate medical help is also required for severe systemic reactions, such as angioedema, face swelling, tongue swelling, or difficulty breathing, even though these are classified as post-marketing events, not typical overdose signs. The official management approach for systemic exposure is symptomatic and supportive treatment, with mandated monitoring of renal function and overall clinical status. No specific antidote is known for Cyclosporin overdose.

Therapeutic Uses of Iflo

What Iflo Treats: Main Uses and Benefits

Iflo is commonly used to help with conditions characterized by periods of heightened symptoms related to dry eye disease (Keratoconjunctivitis Sicca). The medication is applied in clinical settings to manage conditions where reduced tear production is a key factor, such as persistent irritation, burning, stinging, and the sensation of a foreign body in the eye.

This therapy helps address symptom clusters that may become intense or disruptive.

The medicine is relevant when supportive symptom management is appropriate for keratitis (corneal inflammation) associated with chronic dryness, and in situations involving recurrent or episodic manifestations. This approach may assist with maintaining functional stability and contributes to easing the overall symptom load, which supports the patient during episodes of heightened discomfort.


Quick Fact: Focus on Symptoms Related to Dryness

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Iflo — Official Regulatory Information

The eligibility profile for Iflo (Cyclosporine Ophthalmic Emulsion) is determined by official governmental regulatory sources and defines the specific population allowed to use the medicine.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults and adolescents 16 years of age and older.
Populations for whom use is contraindicated Patients with known or suspected hypersensitivity to any ingredient in the formulation.
Age-related eligibility rules Safety and effectiveness have not been established in pediatric patients below the age of 16.
Pregnancy and lactation eligibility status Pregnancy: Administer only if clearly needed. Lactation: Caution should be exercised when administered to a nursing woman.
Eligibility-related restrictions Must not be administered while wearing contact lenses; lenses may be reinserted 15 minutes following administration.

Eligibility Classifications (High-Level)

Classification Official Regulatory Wording
Eligibility severity classification: Contraindicated (Hypersensitivity), Use Not Established (Pediatrics)
Regulatory basis: U.S. Food and Drug Administration / Health Canada Product Monographs
Eligibility-context constraints: Contact Lens Wear (Must be removed prior to administration)

Resulting Eligibility Structure

Official eligibility statements:

  • The medicine is contraindicated in patients with a known allergy to the drug or any of its ingredients.
  • The established use population is adults and adolescents 16 years of age and older.
  • Safety and efficacy have not been established in children under 16 years old.
  • Administration is prohibited while wearing contact lenses.

Connection to the overall eligibility profile: Regulatory documents define who can and cannot use the medicine by establishing an absolute contraindication for hypersensitivity and setting a minimum age of 16 years for established use. Eligibility is also constrained by an explicit requirement to remove contact lenses during administration and the need for caution in pregnant or breastfeeding populations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Iflo (Cyclosporin ophthalmic emulsion) is governed by the official finding of negligible systemic absorption following topical application. This core pharmacokinetic fact dictates that the drug does not reach measurable concentrations in the bloodstream, which in turn limits the potential for most drug-drug interactions.


Interaction scope

Category Official Regulatory Statement
Medicinal product categories with documented interactions: Topical ophthalmic products (e.g., lubricant eye drops, artificial tears).
Specific interacting medicines (if explicitly listed): None are specifically listed as having systemic pharmacokinetic interactions.
Mechanistic basis of interactions (only if stated in label): Systemic interaction: None expected due to undetectable systemic absorption. Local interaction: Physical interference/washout risk with co-administered topical eye products.
Timing-based interaction rules (if applicable): A mandatory 15-minute interval separation is required when co-administering any other topical ophthalmic product.
Population-specific interaction notes (if applicable): None documented. Systemic concentration is below the limit of quantitation, negating the need for population-specific adjustments related to systemic interactions.

Interaction classifications (high-level)

Classification Type Official Regulatory Statement
Interaction severity classification (as defined in official documents): Systemic interactions: Not applicable (not expected). Local administration interaction: Required procedural constraint (timing rule).
Regulatory basis (EMA / FDA / etc.): The statements are based on pharmacokinetic data found in FDA Prescribing Information and other government product monographs.
Interaction-context constraints (as defined in official documents): The 15-minute separation rule applies only to co-administration with other locally applied eye products.

Official interaction statements: Regulatory labeling specifies that no interaction with systemic drugs is expected to occur because the active ingredient does not reach measurable plasma levels. Consequently, no systemic interactions are established with enzyme-mediated pathways or drug transporters. No interactions with food, alcohol, or herbal products are documented for this ophthalmic emulsion. The only mandatory interaction-related restriction is the procedural requirement for a 15-minute time separation when using other topical eye products.

Mechanism of Action

The action of Iflo (Cyclosporin) is rooted in its highly selective ability to modulate the immune response by interfering with a critical enzyme pathway within T-lymphocytes (T-cells). This targeted action gradually alters the cellular microenvironment by shifting the tissue toward a less immunologically active state.

Targeted Inhibition of the Calcineurin-NFAT Signaling Axis

Cyclosporin initiates its action by forming a complex with the intracellular protein Cyclophilin-A, which then inhibits the Calcineurin enzyme. This inhibition interferes with the activation of the NFAT transcription factor, thereby blocking the early signaling events required for T-cell activation.

Downstream Modulation of Cytokine Gene Expression

By preventing NFAT from entering the nucleus, the drug acts to limit the gene transcription of key pro-inflammatory cytokines, especially Interleukin-2 (IL-2). This mechanism reduces the growth and persistence of pathogenic T-cell populations, leading to a reduction of T-cell proliferation and the activity of localized immune cell populations at the cellular level.

Mechanism of Epithelial Cell Stabilization

Beyond immunosuppression, Cyclosporin engages a secondary cytoprotective mechanism by acting on mitochondrial pathways to inhibit apoptosis (programmed cell death). This effect contributes to reduced apoptosis in superficial epithelial cells, which maintains cellular viability at the site of action against inflammatory stress.

Dosage and Administration Information

How Iflo is Used: Official Administration Guidelines

Iflo, a preparation containing Cyclosporin, is administered according to established clinical protocols.


Administration Scope

Feature Standard Clinical Guidelines
Route of administration Topical Ophthalmic Use only. The preparation is instilled directly into the affected eye(s).
Dosing schedule The standard unit dose is one drop per affected eye. Frequencies vary: a Twice Daily schedule (BID, 12 hours apart) is common for 0.05% and 0.1% strengths for dry eye disease, while a Once Daily schedule (QD, at bedtime) is used for the 1 mg/mL strength in severe keratitis.
Preparation requirements Vials or bottles containing the emulsion must be gently shaken immediately prior to use to ensure the contents are properly mixed.
Age-group administration rules No dose adjustment is required for older adult patients. The medication is used for specific inflammatory conditions (e.g., Vernal Keratoconjunctivitis) in children 4 years of age and older, following a specific protocol.
Missed-dose rules If a scheduled dose is missed, patients are instructed to continue with the next scheduled dose; a double dose should not be taken to compensate.

Special Procedural Conditions

Administration involves precise timing and handling constraints to optimize delivery. Contact lenses must be removed before instillation and can be reinserted after a waiting period, typically 15 minutes. When using other topical eye drops, a minimum interval of 15 minutes must separate the application of the products. Furthermore, the contents of single-use containers must be used immediately, and the container must be discarded immediately after use, even if solution remains.

Recent Clinical Evidence

Research evidence / Overview of studies for Iflo (Cyclosporin Ophthalmic Emulsion)

This overview describes the types of research and study findings related to Cyclosporin ophthalmic emulsion (Iflo), drawing only from official regulatory and peer-reviewed scientific sources.


Evidence Base for Chronic Dry Eye Disease

The core body of evidence for Cyclosporin ophthalmic emulsion was studied for conditions characterized by fluctuating or episodic manifestations of chronic dry eye disease, specifically Keratoconjunctivitis Sicca. Research focused on cases where reduced tear production was observed, which regulatory documents link to underlying causes. The primary research approach involved multiple Randomized Controlled Trials (RCTs), where a defined group of adults was observed using the active emulsion, alongside a comparison group using a non-active eye drop (called the vehicle). Studies primarily monitored two main kinds of outcomes: objective signs and patient-reported outcomes describing perceived discomfort. Objective measurements included the Schirmer wetting value (tear production) and checks of the ocular surface status using staining scores.

Findings describe patterns observed in the studies over the six-month trial period. The key trials reported data showing a larger proportion of people using the active emulsion reaching a specific increase in tear production compared to those using the vehicle. However, studies report how symptoms evolved in the observed populations with findings were mixed regarding the consistency of change in subjective symptoms across all collected data.


Long-Term Evidence and Durability of Study Findings

The primary evaluation of the medicine was evaluated in trials lasting for approximately six months. Evidence extending beyond this period is limited primarily to observational studies and long-term extensions of the initial trials, which monitored responses for up to one year. Long-term patterns of change are not fully established beyond the one-year mark, particularly concerning the durability of findings.


Consistency, Variability, and Research Gaps

Overall, the research data show patterns related to changes in key objective measures of dry eye over a six-month period when compared to the vehicle. A significant gap is the variability in symptom findings; while objective physical measurements show a pattern of change, the corresponding patient-reported outcomes related to physical discomfort often demonstrated findings were mixed. Additionally, comparative evidence is lacking to fully define the medicine’s role when used alongside other topical anti-inflammatory treatments or punctal plugs, as these were typically excluded from the initial trials.

Key Studies & References

  1. An Updated Systematic Review With Meta-Analysis Of Randomized Trials On Topical Cyclosporin A For Dry-Eye Disease
  2. Efficacy of topical 0.05% cyclosporine treatment in children with severe vernal keratoconjunctivitis

Frequently Asked Questions (FAQ)

Common questions about Iflo (FAQ)

Q: Is Iflo used for long-term or short-term treatment?

A: Regulatory documentation suggests that this medication is generally intended for continuous, long-term use. The maximum recommended dose is designed for this ongoing treatment. Clinical study data for certain formulations have been gathered for administration lasting up to 40 months.

Q: How often do people typically report mild side effects from Iflo?

A: Official information derived from clinical trials indicates the most commonly reported adverse reaction was ocular burning, which occurred in approximately 17% of patients. Other reactions like conjunctival redness, discharge, eye pain, and blurred vision were reported in a lower percentage of patients (1% to 5%).

Q: How quickly does Iflo usually start working after the first dose?

A: Because this medication works by modulating the immune response at the cellular level, its intended effects are gradual. Clinical studies for dry eye disease observed changes in tear production over the course of treatment, with significant changes typically noted after about six months, reflecting the gradual nature of its mechanism.

Q: Can Iflo be used in children, and if so, at what age?

A: The established age of use varies depending on the specific condition being treated. For dry eye disease, one FDA-approved formulation is indicated for children 16 years of age and older. However, a different formulation used for vernal keratoconjunctivitis (VKC) is approved for children 4 years of age and older in the US and Europe.

Q: What is the risk classification for Iflo during pregnancy?

A: Official prescribing information states there are no adequate and well-controlled studies of the eye drops in pregnant women. Given the medication’s undetectable systemic exposure, official documentation states that the medication should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as determined by a healthcare professional.

Q: Is it normal to feel a mild headache after starting Iflo?

A: Headache is listed as a systemic adverse reaction in the official product labeling and was reported in a small percentage (up to 7%) of patients in clinical trials. Any concerns about ongoing headaches should be directed to a healthcare professional.

Q: Do the side effects of Iflo usually go away over time?

A: Adverse reactions reported for the eye drops are generally expected to be localized (in the eye), transitory, and mild to moderate in severity. This means that symptoms like burning or stinging are typically temporary.

Q: How long does Iflo stay in the system after the last dose?

A: Because this medication is applied topically to the eye, its systemic exposure is negligible. Blood concentrations of the active ingredient were not detectable in human subjects after using the product for up to 12 months. This indicates that the drug does not build up or stay in the bloodstream.

Q: What is the maximum amount of time a person should be on Iflo, according to official documents?

A: The maximum recommended dose is intended for continuous long-term treatment. Regulatory documents state that clinical study data exists for administration of the product for up to 40 months.

Q: Is Iflo part of a larger treatment plan, or is it used alone?

A: Official guidance confirms that Iflo can be used at the same time as artificial tears (lubricant eye drops). A 15-minute interval must be observed between the application of the two products to prevent one from washing out the other.

Q: Is it true that Iflo can cause joint pain?

A: Joint pain is not listed among the adverse reactions commonly reported or otherwise cited in the clinical trials for this ophthalmic product. Official information does not confirm this as an expected effect.

Q: Does Iflo have a specific classification regarding driving or operating machinery?

A: Yes, official guidance warns that the eye drops may cause transient blurred vision or other temporary vision problems. The official warning states that operating machinery or driving should be avoided until any temporary visual disturbance has resolved.

Q: Does Iflo have any ingredients that people with common food allergies should be aware of?

A: The inactive ingredients are explicitly listed in the official product description. These typically include components such as castor oil, polysorbate 80, and glycerin, among others.

Q: What should be done if I feel dizzy after taking Iflo?

A: Official patient counseling information advises that if you experience blurred vision or any other vision problem after applying the drops, you should not drive or do anything that requires clear vision until the effect passes. Any concerns or adverse effects should be addressed by consulting a healthcare professional.

Q: Does Iflo contain lactose or gluten?

A: No, the inactive ingredients listed in the official product description for the ophthalmic emulsion or solution do not include lactose or gluten.

Q: What is the purpose of the 'inactive ingredients' listed in Iflo?

A: Inactive ingredients are components that are essential for the physical properties of the medicine. They are used to formulate the product as a sterile emulsion or solution, giving it the correct consistency (viscosity), pH, and other characteristics needed for safe and effective use in the eye.

Q: Does Iflo cause drowsiness?

A: The official product information does not list drowsiness as an adverse reaction. However, a warning is included regarding the potential for transient blurred vision or other vision problems that may temporarily affect your ability to operate machinery.

Q: Does Iflo affect fertility?

A: Nonclinical animal studies using high oral doses of the active ingredient found no adverse effects on fertility in male and female rats. Because human systemic exposure is undetectable and animal studies showed no adverse effects on fertility, no specific risk to human fertility is established.

How should Iflo be stored and disposed of?

How to Store and Dispose of Iflo (Cyclosporine Ophthalmic Emulsion)

Official regulatory documents define strict storage and disposal requirements for cyclosporine ophthalmic emulsion.

Storage Conditions

Requirement Official Instruction
Temperature Store at controlled room temperature, typically 15 C to 25 C (59 F to 77 F). Do not freeze.
Protection Keep away from excessive heat, moisture, and direct light.
Child Safety The medicine must be kept out of the sight and reach of children and pets.

Handling and Disposal

Requirement Official Instruction
Container Rule Keep the container tightly closed when not in use, and do not allow the dropper tip to touch any surface.
Stability Single-use vials must be discarded immediately after one use, even if residual solution remains.
Disposal Dispose of outdated or unused medicine in accordance with local regulations, avoiding disposal via wastewater or household trash.

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

Equivalent of Iflo found in:

A-Z Index: