Viotic
Ear Drops
1. Name of the medicinal product :
vote Ear Drops
2. Qualitative and quantitative composition:
Active ingredients:
flumetasone pivalate 0.2% W/V
Clioquinol BP 1.0% w/v
inactive ingredients :
Polyethylene Glycol 300
3. Pharmaceutical form :
Ear drops, solution
4. Clinical particulars :
4.1 Therapeutic indications :
Inflammatory conditions of the external ear where a secondary infection is suspected Otorrhoea .
4.2 Posology and method of administration :
Instil 2 or 3 drops twice daily directly inlo the auditory canal of the affected car. Treatment should be limited 10 7-10 days
If there is little improvement after 7 days treatment with Viotic, appropriate microbiological investigations should be earned out and local Of svsternk antibiotic treatment given.
Use in the elderly
There is no evidence to suggest that dosage should be. different in the elderly.
Use in children
vionctar Drops art contra-indicated in children below the age of two years.
Route of administration: Auricular use
4.3 Contraindications :
Hypersensitivity to any component of the formulation or iodine. Primary bacterial, viral or fungal infections of the outer ear. Perforation of the t)’IT’lpanic membrane. Use in children below the age or two years.
4.4 Special warnings and precautions for use :
long-term continuos topical therapy should be avoided since this can lead 10 adrenal suppression
Topical application of dioquinol-mntdining preparations may lead 10 a marked increase in protein-bound iodine (PBI). The results of thyroid function tests. such as PRI, 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 lest of phenytketonuria may yield a false-positive result when dioquinol is
present in the urine. votcsboutd not be allowed to come into contact with the conjunctiva.
4.5 Interaction with other medicinal products and other forms of interaction :
None known via this topical route.
4.6. Pregnancy and lactation :
Then’ is inadequate evidence of safet} in human pregnancy Topical administration of corlicosleroids to pregnant animals can cause abnormahties of foetal development, including deft palate and intra-uterine growth retardation. There may, therefore, be a vel’)’ small risk of such effects in the human foetus.
It is not know!! whether the active substances of Viotic and/or thetr metabolite(s) pass into breast milk erte- topical administration use In lactating mothers should only be at the doctor’s discretion.
4.7 Effects on ability to drive and use machines :
None known.
4.8 Undesirable effects :
vcuos generally well tolerated, but occasionally at the site of application, there mdY be signs of irritation such as a bumillg sensation itching or skin rash. Hypersensitivity reecuoos may also
occasionally occur. Treatment should be drsconurued if patients experience severe irritation or sensibsation.
Viotic may cause hair discoloration.
4.9 Overdose :
viotic is for topical {extemaij use only. If ecooental ingestion of large quantilies 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.
5. Pharmacological properties :
5.1 Pharmacodynamic properties :
Viotic Ear Drops combine the anti-fungal and anti -bacterial properties of dioquinol with the anti-inflammdtory activity of flurnetasone pivalate.
5.2 Pharmacokinetic properties :
No pharmacokinetic data on Viotic Ear Drops are available.
5.3 Preclinical safety data :
Not apphcebe,
6. Pharmaceutical particulars :
6.1 list of excipients :
Polyethylene glycol
6.2 Incompatibilities:
None known.
6.3 Shelf life:
36 months
6.4 Special precautions for storage :
Do not store above 30″C.
6.5 Nature and contents of container :
Carton box containing yellcw. opaque plastic bottle contains 10 ml
viscous liquid with yellow opaque dropper & yellow screw cap.
6.6 special precautions for disposal and other handling :
Medidnes should be kepi out of the reach of duldren
Keep all medicaments out of reach of children
Product of:
AMOUN PHARMACEUTICAL CO. SAE.
