Locacorten (Flumethasone Pivalate – Clioquinol)



Flumethasone Pivalate – Clioquinol

Topical Aural Corticosteroid – Antibacterial – Antifungal

Action And Clinical Pharmacology: Flumethasone pivalate is a moderately potent difluorinated glucocorticoid with anti-inflammatory, antipruritic, and vasoconstrictive properties. As it is a pivalate, its action is concentrated at the site of application. This local effect on diseased areas results in a prompt decrease in inflammation, exudation and itching.

Clioquinol, the antimicrobial component of Locacorten Vioform Eardrops, is active against a broad spectrum of pathogenic micro-organisms, including fungi (e.g., Candida, Microsporum, Trichophyton) and gram-positive bacteria (e.g., Staphylococci). Clioquinol has only a slight inhibitory effect on gram-negative bacteria. Clioquinol exerts a bacteriostatic rather than a bactericidal action.

The polyethylene glycol vehicle is inert, non-irritant and viscous. This vehicle softens the cerumen and ensures prolonged contact of the active ingredients with the surface of the ear canal.

Indications And Clinical Uses: Otitis externa; otomycosis including that due to aspergillus niger.

Contra-Indications: Perforation of the eardrum (suspected or verified).

Viral (e.g., chicken pox) or syphilitic skin infections; tuberculosis of the skin; skin eruptions following vaccination.

Known hypersensitivity to flumethasone pivalate or to corticosteroids in general, to hydroxyquinolines, clioquinol, or other quinoline derivatives, iodine, as well as to any other components of Locacorten Vioform eardrops (see Supplied).

Application to the eye.

Children: Use is contraindicated in children under 2 years of age.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: Safety during pregnancy or lactation has not been established. Studies have shown that corticosteroids may induce fetal abnormalities in pregnant animals. The relevance of this finding to human use has not been elucidated. It is not known whether the active substances pass into breast milk when applied topically. Therefore, the potential benefit of this product during pregnancy (particularly during the first 3 months) or lactation, should be weighed against possible hazard to the fetus or the nursing infant.

Precautions: Prior to beginning therapy, the eardrum should be checked by the physician. Locacorten Vioform should not be used if there is a risk that perforation of the eardrum may occur or has occurred.

Topical use of clioquinol-containing preparations may lead to a marked increase in protein-bound iodine (PBI) (see Overdose: Symptoms and Treatment).

Provided the preparation is used as recommended unwanted systemic effects are unlikely to occur. On basic medical grounds, the possibility of a clinically important effect on adrenocortical function should nevertheless be borne in mind, particularly in pediatric use and in patients undergoing prolonged therapy.

If no improvement occurs within 1 week, therapy should be discontinued; the pathogens should then be identified and treated.

Patients should, as a general rule, be advised to inform subsequent physicians of the prior use of corticosteroids.

Locacorten Vioform eardrops should not be allowed to come into contact with the conjunctiva (see Contraindications).

Locacorten Vioform may turn yellow when exposed to air and may cause staining of the skin, nails, hair or fabrics.

Drug Interactions: Topical use of clioquinol, as well as other iodine-containing compounds, may increase the amount of protein-bound iodine (PBI) in patients with normal thyroid function and therefore may interfere with some thyroid function tests (such as PBI, radioactive iodine and butanol-extractable iodine). These tests should not be performed within 1 month of Locacorten Vioform eardrops use. Other thyroid function tests, such as the T3 resin sponge test or the T4 determination, are unaffected by clioquinol.

The ferric chloride test for phenylketonuria may yield a false-positive result when clioquinol is present in the urine.

Adverse Reactions: Occasionally: signs of irritation such as burning sensation, itching or skin rash at the site of application; hypersensitivity reactions.

If an exacerbation or allergic type reaction occurs, treatment with Locacorten Vioform eardrops should be discontinued.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Poisoning due to accidental ingestion is not expected since a bottle of Locacorten Vioform eardrops contains far less active ingredients than the upper safe limit of a single oral dose for either component.

Application of clioquinol-containing preparations to extensive or eroded areas of skin may lead to increased PBI values within 1 week. Elevated PBI values may also occur where relatively small areas of skin are treated for more than 1 week. If signs and symptoms resembling those of thyrotoxicosis occur, the preparation should be withdrawn at once.

Dosage And Administration: Thorough cleansing of the external ear is essential for successful treatment. If a copious and offensive discharge is present, the meatus may initially require gentle syringing. Thereafter the passage may be kept clean by wiping as necessary.

Two to 3 drops should be instilled twice daily.

The solution may be warmed to body temperature prior to application by holding the bottle in the hands. Heating above body temperature should be avoided.

To ensure correct administration of the drug, the patient or another person should be instructed both on how to clean the outer ear and apply the ear drops. The patient should be either sitting or lying down with the treated ear turned upwards during application. This position should be maintained for 1 to 2 minutes following the application.

Free drainage of the ear encourages healing; however, in severe cases it may be desirable to pack the ear lightly with a gauze strip moistened with the solution, replacing this dressing as necessary, at least once every 24 hours.

To avoid contamination of the ear drops, contact of the dropper with any surface (including the ear) should be avoided.

Treatment should normally not exceed 10 days.

Availability And Storage: Each dispenser of clear solution contains: flumethasone pivalate 0.02% and clioquinol 1%. Nonmedicinal ingredients: polyethylene glycol. Parabens- and tartrazine-free. Plastic controlled-drop dispenser of 10 mL, cartons of 1. Protect from heat (store between 15 and 30°C) and light. The eardrops may turn yellow when exposed to air and may cause staining of the skin, nails, hair or fabrics.

LOCACORTEN® VIOFORM® Eardrops Novartis Flumethasone Pivalate – Clioquinol Topical Aural Corticosteroid – Antibacterial – Antifungal

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