A-Cerumen

A-Cerumen

Manufacturer:

Gilbert Laboratoires

Distributor:

PHarMed
Full Prescribing Info
Contents
Sodium acyl sarcosinate, sucrose ester (preservative-free).
Description
A-Cerumen also contains the following excipient: Humectant agent.
Action
Pharmacology: Fixation of the surfactants to the earwax plug. Fragmentation of the earwax plug (cerumenolytic action). Solubilisation of the excess earwax.
In vitro evaluation of the cerumenolytic activity of A-Cerumen on human cerumen plugs. (See Figure 1.)

Click on icon to see table/diagram/image

The activity was assessed by measuring the mass lost by the cerumen plugs. The test product, A-Cerumen, provoked the dissolution of 61% of the cerumen after 1 hr of incubation.
Conclusion: The results of the study demonstrate that A-Cerumen has a significant effect on the dissolution of cerumen plugs. (See Figure 2.)

Click on icon to see table/diagram/image

Conclusion: Hierarchy of Efficacy: 1/A-Cerumen, 2/Distilled Water, 3/Solution of Seawater.
In Vivo Study: Tolerance, efficacy and acceptability of the test product, A-Cerumen, on the prevention of the appearance of cerumen; tested under ENT control.
Under the study protocol, A-Cerumen was tested under ENT-specialist control for 21 days in 59 patients. (See Figure 3.)

Click on icon to see table/diagram/image

Conclusion: The product was deemed effective by the physician for: Softening the cerumen in 96% of patients. Regulation of cerumen production in 94% of patients. Prevention of cerumen production in 90% of patients. (See Figure 4.)

Click on icon to see table/diagram/image

Conclusion: A-Cerumen was perceived effective by: Eighty-six percent (86%) of the volunteers on the softness of cleaning. Eighty-two percent (82%) on the elimination of cerumen. Seventy-seven percent (77%) on the prevention of the appearance of cerumen and the regulation of cerumen.
Indications/Uses
Ensures proper cleaning of ears especially those who suffer frequently from earwax plugs. Treats earwax plugs and make patients autonomous, thus ensures patients' comfort.
Dosage/Direction for Use
Regular Ear Hygiene: Use 2 times a week. In Presence of Ear Plug: Use 3-4 consecutive days, morning and evening.
Contraindications
Do not introduce the tip of the single-dose container or spray too deeply into the auditory canal in order to avoid irritating the latter. Do not use A-Cerumen in case of perforation of the eardrum, ear infections and in carriers of transtympanic aerator. Avoid contact with eyes. Do not swallow.
ATC Classification
S02D - OTHER OTOLOGICALS ; Used in otologic preparations.
Presentation/Packing
Ear drops (single-use vial) 2 mL x 10's. Ear spray 40 mL.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in