Otic/Aural Inflammation of the external ear with suspected secondary infection
Adult: As soln containing flumetasone pivalate 0.02% and clioquinol 1%: Instill 2 or 3 drops bid directly into the auditory canal of the affected ear for 7-10 days. Patient should be seated or lying down w/ the treated ear turned upwards during application. Maintain this position for at least 1-2 min after application. Child: ≥2 yr Same as adult dose.
Contraindications
Perforation of the tympanic membrane, disorders associated w/ therapy-resistant secondary infection, iodine sensitivity, primary bacterial, viral, or fungal infection of the outer ear. Childn <2 yr.
Special Precautions
Patient w/ thyroid abnormalities. Childn. Pregnancy and lactation.
Adverse Reactions
Endocrine: Adrenal suppression (prolonged use). Ophthalmologic: Increased risk of cataract. Dermatologic: Skin atrophy, telangiectasia, purpura, striae, dermatitis, skin depigmentation, hair colour changes, hypertrichosis, application site burning or irritation, rash, pruritus, impaired healing. Immunologic:Hypersensitivity, manifestations of bacterial, viral, or fungal infection.
Patient Counseling Information
This drug may cause discolouration of skin, hair, and cloth. Avoid application to the eye.
Lab Interference
May interfere w/ thyroid function tests (e.g. PBI, radioactive iodine and butanol extractable iodine). May cause false-positive ferric chloride test for phenylketonuria.
Action
Description: Mechanism of Action: Flumetasone pivalate is a moderately potent glucocorticoid, usually used for local application. It has an anti-inflammatory, anti-allergic, vasoconstrictive and anti-proliferative effect. Clioquinol, is a halogenated hydroxyquinoline derivative which exerts its bacteriostatic action by chelating bacterial surface and trace metals needed for bacterial growth. Pharmacokinetics: Absorption: Clioquinol: Approx 1.5-4% is absorbed. Excretion: Clioquinol: Via urine, mainly as glucuronide, and as sulfate (small amounts).
Chemical Structure
Flumetasone Source: National Center for Biotechnology Information. PubChem Database. Flumethasone, CID=16490, https://pubchem.ncbi.nlm.nih.gov/compound/Flumethasone (accessed on Jan. 21, 2020)
Clioquinol Source: National Center for Biotechnology Information. PubChem Database. Clioquinol, CID=2788, https://pubchem.ncbi.nlm.nih.gov/compound/Clioquinol (accessed on Jan. 21, 2020)
Anon. Clioquinol and Flumethasone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/03/2017 .Joint Formulary Committee. Clioquinol with Flumetasone Pivalate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/03/2017 .
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