Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Flumethasone pivalate; Clioquinol
LOCACORTEN ® -VIOFORM ® V 4.0 1 LOCACORTEN®-VIOFORM® _flumethasone pivalate / clioquinol _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Locacorten-Vioform ear drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LOCACORTEN- VIOFORM IS USED FOR Locacorten-Vioform ear drops contain flumethasone pivalate and clioquinol. Flumethasone pivalate belongs to a group of medicines called corticosteroids. It is used to relieve symptoms of ear infection such as itching, redness and swelling. Clioquinol is an anti-infective medicine. It is used to fight the germs which are causing the ear infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. Locacorten-Vioform is only available with a doctor's prescription. It is not addictive. BEFORE YOU USE LOCACORTEN- VIOFORM _WHEN YOU MUST NOT USE IT _ DO NOT USE LOCACORTEN-VIOFORM IF YOU HAVE AN ALLERGY TO: • flumethasone or clioquinol, the active ingredients of Locacorten- Vioform • macrogol, the other ingredient of Locacorten- Vioform • other quinoline medicines which are similar to clioquinol • iodine or other medicines that contain iodine IF YOU ARE NOT SURE ABOUT ANY OF THE ABOVE MEDICIN Read the complete document
LOCACORTEN-VIOFORM EAR DROPS DESCRIPTION Locacorten-Vioform ear drops are presented in polyethylene bottles containing 7.5 mL solution containing 0.02% Flumethasone pivalate and 1% Clioquinol. Flumethasone pivalate Chemical Formula: C 27 H 36 F 2 O 6 ( 6 α, 9-Difluouro-11ß,17,21-trihydroxy-16α-methyl- pregna-1,4- diene-3,20-dione 21-pivalate) MW: 494.571 CAS Number: 2002-29-1 Flumethasone is a synthetic difluorinated glucocorticoid. Clioquinol Chemical Formula: C 9 H 5 ClINO (5-chloro-7-iodo-8-quinolinol) MW: 305.5 CAS Number: _130-26-7_ Clioquinol is an halogenated hydroxyquinoline derivative. Polyethylene glycol 300 ACTIONS PHARMACOLOGY Flumethasone pivalate is a moderately potent 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 while at the same time reducing swelling. Clioquinol, the antimicrobial component of Locacorten-Vioform ear drops, 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 moderate inhibitory effect on Gram-negative bacteria. Clioquinol exerts a bacteriostatic, rather than a bactericidal action. PHARMACOKINETICS No pharmacokinetic data on Locacorten-Vioform ear-drops are available. Trials (including treatment under occlusive dressings) with different formulations of Locacorten- Vioform for topical application have shown that no demonstrable percutaneous absorption of flumethasone pivalate occurs, while clioquinol was absorbed to an extent of about 1.5% to 4%, as judged by the urinary excretion. Read the complete document