TROPEX Ear drops, solution Ref.[49822] Active ingredients: Phenazone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

5.1. Pharmacodynamic properties

Pharmacotherapeutic classification (Group + ATC code): Analgesic and Antipyretic: S02DA03

Phenazone has analgesic and antipyretic properties.

Topically, solutions containing 5% of phenazone have been used locally as ear drops in disorders such as otitis media because of its local anti-inflammatory and analgesic action.

Glycerol softens wax.

5.2. Pharmacokinetic properties

Phenazone is readily absorbed from the gastro-intestinal tract and is distributed throughout the body fluids. Peak plasma concentrations are usually obtained in 1 to 2 hours. Less than 10% is bound to plasma proteins and it has a half-life of about 12 hours. Phenazone is metabolised in the liver, about 30% to 40% is metabolised to 4-hydroxyphenazone which is excreted in the urine as the glucuronide. Approximately 5% is excreted unchanged and approximately 6% is norphenazone in the urine.

5.3. Preclinical safety data

Not applicable.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.