flumetasone pivalate/ clioquinol

Action and Spectrum

Actions and spectrum: 

Flumetasone Pivalate is a member of the corticosteroid class. It possesses vasoconstrictive, anti-inflammatory, and anti-pruritic abilities. It also reduces the migration of polymorphonuclear leukocytes and reverses capillary permeability to inhibit the inflammatory response. Clioquinol exhibits both antibacterial and antifungal abilities. It kills microorganisms by interfering with their ability to divide and function. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Burning 

Irritation of the skin 

Atrophy of skin 

Difficulty breathing 

Swelling of throat, face, or lips 

Hypertrichosis 

Skin pigmentation 

Telangiectasia 

Changes in hair color 

Adrenal suppression on prolonged use 

Raised risk of cataract 

Black Box Warning

Black Box Warning  

Contact the doctor immediately if ear drops are swallowed accidentally 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

Hypersensitivity 

Anti-infective therapy 

Iodine sensitivity 

Kaposi’s sarcoma 

Peripheral neuropathy 

Optic atrophy 

Pregnancy / Lactation

Pregnancy consideration:  

Caution is recommended 

Lactation:  

It is not recommended. If necessary, take the advice of the physician before using it.  

Pregnancy category:  

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 a lack of studies on pregnant women and no evidence of risk to the fetus 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 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: 

Pharmacodynamics: 

Flumetasone pivalate is a moderately potent glucocorticoid. It has anti-allergic, anti-inflammatory, vasoconstrictive, and anti-proliferative properties. Clioquinol is a derivative of halogenated hydroxyquinoline that functions as a bacteriostatic agent by chelating trace metals and bacterial surfaces that are necessary for bacterial growth. 

Pharmacokinetics:  

Absorption 

Approximately 1.5-4% of clioquinol is absorbed 

Distribution  

Metabolism  

Elimination and excretion 

Clioquinol is mainly excreted through urine as glucuronide and as sulfates in smaller amounts  

Half-life: 

Adminstartion

Administration: 

With the affected ear up top, sit or lie down. 

Squeeze the middle of the bottle with your fingers after placing the bottle’s nozzle close to the ear opening.  

Keep your head tilted for a few minutes. To prevent any drops from running out, briefly insert a piece of loose cotton wool into the ear opening. 

Take great care to avoid getting ear drops in or close to the eyes. 

Once the ear drop has been applied, wash your hands. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: flumetasone pivalate/ clioquinol 

Why do we use flumetasone pivalate/ clioquinol? 

Flumetasone pivalate/ clioquinol is used in the treatment of infection and inflammation of the external ear. The combination of flumetasone pivalate/clioquinol possesses antifungal and antibacterial activity.