OTALGAN ® is a drug based on phenazone and procaine.
THERAPEUTIC GROUP: Other otologists.
Indications OTALGAN ® Phenazone and Procaine
OTALGAN ® is indicated in the treatment of painful manifestations of the ear.
Mechanism of action OTALGAN ® Phenazone and Procaine
The pain-relieving and anti-inflammatory properties of OTALGAN ® are evidently associated with its active ingredients, which have different but complementary therapeutic activities.
More precisely, Fenazone ® is an active ingredient with anti-inflammatory and antipyretic activity, probably due to the ability to inhibit the synthesis of inflammatory mediators such as prostaglandins, prostacyclines and thromboxanes by blocking the activity of cyclooxygenase enzymes.
Procaine, on the other hand, is a typical local anesthetic with a short duration of action, which by blocking the opening of the sodium channels of excitable cells, including those involved in the transmission of pain, inhibits depolarization and the consequent transmission of the pain signal.
The typical use of the aforesaid active principles, limiting their systemic absorption, allows to effectively control all the potential side effects.
Studies carried out and clinical efficacy
CLINICAL EFFECTIVENESS OF OTALGAN
Arzneimittelforschung. 2009; 59: 504-12. doi: 10.1055 / s-0031-1296434.
Therapeutic properties and tolerance of procaine and phenazone containing ear drops in infants and very young children.
Adam D, Federspil P, Lukes M, Petrowicz O.
Large German clinical trial confirming the clinical efficacy of OTALGAN in improving pain and inflammation of the ear canal in over 400 pediatric patients.
PHARMACOGENOMICS OF THE PHENAZONE
Bull Exp Biol Med. 2011 Aug; 151: 445-8.
Effects of CYP1A2 gene polymorphisms on antipyrine CYP1A2-dependent metabolism.
Chernyak YI, Itskovich VB, Kolesnikov SI.
Interesting genomic drug study that demonstrates how the pharmacokinetics of active ingredients such as Phenazone can vary significantly from patient to patient based on their genetic makeup, mainly referred to that of cytochromial enzymes.
EFFECTIVENESS AND SAFETY OF EARPHONE DROPS BASED ON PHENAZONE
Ann Pediatr (Paris). 1993 Sep; 40: 481-4.
[Efficacy and tolerance of a local application of phenazone and chlorhydrate lidocaine (Otipax) in infants and children with congestive otitis].
Francois M.
Yet another study that demonstrates the efficacy and excellent tolerability of ear drops based on anti-inflammatories such as Fenazone and anesthetics such as lidocaine in the treatment of congestive otitis in pediatric patients.
Method of use and dosage
OTALGAN ®
Otological solution of 5 g of phenazone and 1 g of Procaine hydrochloride per 100 g of product.
The definition of the dosage schedule is up to the doctor following a careful evaluation of the patient's clinical condition.
Generally, in adults 2-4 instillations of 5-8 drops per day are recommended; dosages must obviously be reviewed in pediatric patients.
OTALGAN ® Phenazone and Procaine warnings
As with any product intended for otological use, it is advisable to first evaluate the integrity of the tympanic membrane in order to avoid the onset of unpleasant side effects, also taking care to warm the vial before use.
Prolonged use of OTALGAN ® over time could cause the onset of sometimes annoying sensitization phenomena.
PREGNANCY AND BREASTFEEDING
The use of OTALGAN ® is compatible with pregnancy and with the subsequent period of breastfeeding, as long as this therapy takes place under the supervision of your doctor.
Interactions
No drug interactions worthy of clinical note are currently known.
Contraindications OTALGAN ® Phenazone and Procaine
The use of OTALGAN ® is contraindicated in patients with hypersensitivity to the drug or in case of perforation of the tympanic membrane.
Undesirable Effects - Side Effects
The use of OTALGAN ®, especially if prolonged over time, could determine the appearance of sensitization or irritation phenomena.
Note
OTALGAN ® is a non-prescription drug
The information on OTALGAN ® Fenazone and Procaine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
