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.

This combination is indicated for the treatment of external ear inflammation and infections (otitis externa) and fungal infections of the outer ear (otomycosis).

For adults and children (aged 2 years and over): The recommended dose is 2 to 3 drops twice daily for the prescribed period of time (usually not longer than 10 days). Before you apply the medication, you should warm the ear drops to body temperature by holding the bottle in the palm of your hands. Do not heat it above body temperature.

This medication is contraindicated in patients with: Punctured eardrum, Pre-existing tuberculosis of the skin, Fungal or viral infections of the skin(Chickenpox, Herpes simplex, Herpes zoster), Known hypersensitivity to corticosteroids, Iodine, Clioquinol, Flumetasone pivalate, Hydroxyquinolones or Quinolone derivatives or any of the ingredients of this formulation.

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

Overdose Effects

Application to extensive or eroded areas of skin may lead to increased PBI values within 1 week. If signs and symptoms resembling those of thyrotoxicosis occur, the preparation should be withdrawn at once.

Prior to the beginning of therapy, the ear-drum should be checked by the physician. If there is a risk that perforation of the ear-drum may occur, this ear drops should not be used. If no improvement occurs within about 1 week, the therapy should be discontinued. It is then advisable to identify the pathogens and to institute an appropriate treatment. This ear drop should not be allowed to come in contact with the conjunctiva.

Use in Special Populations

Children under 2 years of age is contraindicated.

Pregnancy & Lactation

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.

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.