fluocinolone acetonide, otic

Action and Spectrum

Actions and Spectrum: 

When fluocinolone acetonide binds to glucocorticoid receptors in the ear, less inflammatory mediators, including prostaglandins and leukotrienes, are produced and released. 

Drug Interaction

Adverse Reaction

Frequency not defined  

Miliaria 

Burning 

Perioral dermatitis 

Hypopigmentation 

Allergic contact dermatitis 

Striae 

Acneiform eruption 

Secondary infection 

Itching 

Skin atrophy 

Ear infection 

Irritation dryness 

Folliculitis 

Black Box Warning

Black Box Warning 

According to the warning, patients with viral infections of the external ear canal, such as herpes simplex virus and varicella zoster virus, should not use fluocinolone acetonide, otic solution since it may make these illnesses worse. 

Patients with ruptured eardrums should not take fluocinolone acetonide, otic solution since the drug might harm the inner ear. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Those who are known to be allergic or hypersensitive to fluocinolone acetonide or any of the other substances in the formulation should not use fluocinolone acetonide, otic solution. 
• It should not be used on those who have viral infections of the external ear canal, such as varicella zoster or herpes simplex, since it might make them worse. 

Caution: 

• fluocinolone acetonide, otic solution should be used with caution in individuals who have ruptured eardrums since the medicine may harm the inner ear. 
• Moreover, immunocompromised persons should utilise it with caution since they may be more susceptible to infections. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: C 

Lactation: Excretion into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology 

A synthetic glucocorticoid with anti-inflammatory and immunosuppressive effects is fluocinolone acetonide. It works locally in the ear canal to reduce swelling and inflammation as well as symptoms including discomfort, itching, and discharge when given as an otic (ear) treatment. 

Pharmacodynamics 

The anti-inflammatory and immunosuppressive characteristics of fluocinolone acetonide, otic medication is mostly connected to its pharmacodynamics. It reduces the generation and release of inflammatory mediators including prostaglandins and leukotrienes when given topically to the ear canal because it binds to glucocorticoid receptors in the cytoplasm of target cells. 

It also contains immunosuppressive qualities that might lessen the immune response in the ear and lower the risk of additional swelling and inflammation. 

Pharmacokinetics 

Absorption   

The ear canal is treated topically with fluocinolone acetonide, otic solution, which is then locally absorbed. The state of the ear canal, such as the presence of inflammation or infection, as well as the dosage and frequency of administration, can have an impact on the degree of absorption. 

Distribution 

fluocinolone acetonide is present throughout the body, however after local administration, the concentration is greatest in the ear tissue. During repeated usage, the substance doesn’t seem to build in the body. 

Metabolism 

The liver’s cytochrome P450 (CYP) 3A4 enzyme is principally responsible for the metabolism of fluocinolone acetonide. The metabolites are eliminated by feces and urine. 

Elimination and excretion 

A lower quantity of fluocinolone acetonide and its metabolites are eliminated in the feces as well as urine. The drug’s half-life for elimination is 8 to 9 hours. 

Adminstartion

Administration:  

It is topically applying fluocinolone acetonide, otic solution in the ear canal. 

The illness being treated, the patient’s age, and medical history may all affect the recommended dose and frequency of administration. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: fluocinolone acetonide, otic 

Why do we use fluocinolone acetonide, otic? 

The most common problems of the ear canal treated with fluocinolone acetonide, otic solution include: 

Bacterial or fungal ear infection that hurts, itches, and inflames the ear canal. 

A skin condition that is inflammatory and can lead to redness, scaling, and itching. 

An immune-mediated reaction known as an allergic reaction in the ear canal can result in itching, redness, and swelling.