Flumetanol Ear Drops: Each ml contains Flumetasone Pivalate BP 0.2 mg and Clioquinol BP 10 mg.
Preservative: Nil. Vehicle: Polyethylene Glycol USP.
Flumetasone Pivalate is a potent difluorinated glucocorticoid designed for local application. It exerts an anti-inflammatory, anti-allergic, vasoconstrictive and anti-proliferative effect. In inflammatory skin diseases of the external auditory meatus it affords prompt relief and eliminates symptoms such as pruritus and also reduces swelling. Clioquinol is a halogenated hydroxyquinoline derivative which exerts bacteriostatic action. It is active against a broad spectrum of microorganisms including fungi (e.g., Candida, Microsporum, Trichophyton) and Gram-positive bacteria (e.g. Staphylococci). It is also effective against Gram-negative bacteria.
Flumetanol is indicated for the treatment of eczema of the external auditory meatus in which secondary infection has occurred, such as otitis externa & otomycosis. It is effective in otitis media when given in combination with oral antibiotic.
Dosage & Administration
Instill 2-3 drops of Flumetanol into the auditory meatus twice daily for 7-10 days.
Contraindicated in perforation of the ear-drum (suspected or verified); application to the eye; viral infections of the skin; known hypersensitivity to iodine, Flumetasone Pivalate, Clioquinol, hydroxyquinolines and other quinoline derivatives or to any other component of this product.
Warning & Precautions
Prior to the beginning of therapy, the ear-drum should be examined by the physician. If there is a risk that perforation of the ear-drum may occur, this product should not be used. Should not be allowed to come into contact with the conjunctiva.
Occasionally burning sensation, itching or skin rash may occur. Treatment should be discontinued if severe irritation or sensitization develops.
Topical use of Clioquinol-containing preparations may lead to a marked increase in protein-bound iodine (PBI).
Use in special groups
Use in pregnancy: No reports of adverse effects in human pregnancy have been received to date. However, when using this product in pregnancy, the risk-benefit relationship should be carefully considered.
Use in lactation: It is not known whether Flumetasone Pivalate or Clioquinol passes into breast milk. Caution should be exercised when Flumetanol is administered to a nursing mother.
Use in children: Safety and efficacy in children below the age of 2 years have not been established.
Flumetanol Ear Drops: Each plastic dropper bottle contains 5 ml ear drops.