Product Data
Composition:
Active ingredients: Flumethasone pivalate 0.02% w/v Clioquinol BP 1.0% w/v Inactive ingredients: Polyethylene Glycol 300
Indications And Usage:
Clinical particulars - Therapeutic indications Inflammatory conditions of the external ear where a secondary infection is suspected. Otorrhoea. - Posology and method of administration Instil 2 or 3 drops twice daily directly into the auditory canal of the affected ear. Treatment should be limited to 7-10 days. If there is little improvement after 7 days treatment with Viotic, appropriate microbiological investigations should be carried out and local or systemic antibiotic treatment given. Use in the elderly: There is no evidence to suggest that dosage should be different in the elderly. Use in children: VioticEar Drops are contra-indicated in children below the age of two years. Route of administration: Auricular use
Contraindications:
Hypersensitivity to any component of the formulation or iodine. Primary bacterial, viral or fungal infections of the outer ear. Perforation of the tympanic membrane. Use in children below the age of two years.
Drug Interactions:
Interaction with other medicinal products and other forms of interaction None known via this topical route.
Precautions:
use Long-term continuous topical therapy should be avoided since this can lead to adrenal suppression. Topical application of clioquinol-containing preparations may lead to a marked increase in protein-bound iodine (PBI). The results of thyroid function tests, such as PBI, radioactive iodine and butanol extractable iodine, may be affected. However, other thyroid function tests, such as the T3 resin sponge test or T4 determination, are unaffected. The ferric chloride test of phenylketonuria may yield a false-positive result when clioquinol is present in the urine. Vioticshould not be allowed to come into contact with the conjunctiva. Effects on ability to drive and use machines None known.
Pharmacological Properties:
Pharmacodynamic properties Viotic Ear Drops combine the anti-fungal and anti-bacterial properties of clioquinol with the anti-inflammatory activity of flumetasone pivalate.
Pregnancy & Lactation:
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus. It is not known whether the active substances of Viotic and/or their metabolite(s) pass into breast milk after topical administration. Use in lactating mothers should only be at the doctor's discretion.
Overdosage:
Vioticis for topical (external) use only. If accidental ingestion of large quantities occurs, there is no specific antidote and general measures to eliminate the drug and reduce its absorption should be undertaken. Symptomatic treatment should be administered as appropriate.
Adverse Effects:
Vioticis generally well tolerated, but occasionally at the site of application, there may be signs of irritation such as a burning sensation, itching or skin rash. Hypersensitivity reactions may also occasionally occur. Treatment should be discontinued if ptients experience severe irritation or sensitisation. Viotic may cause hair discoloration.
