Flumetanol (Flumetasone + Clioquinol)

Therapeutic Group : Ear Drops

Presentation:

Flumetanol Ear Drops: Each ml contains Flumetasone Pivalate BP 0.2 mg and Clioquinol BP 10 mg.
Preservative: Nil. Vehicle: Polyethylene Glycol USP.

Indications:

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.

Contrainidications:

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.

Side effects:

Occasionally burning sensation, itching or skin rash may occur. Treatment should be discontinued if severe irritation or sensitization develops.

Drug interaction:

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.

Packing:

Flumetanol Ear Drops: Each plastic dropper bottle contains 5 ml ear drops.