Dropleks (Ear Drops)
INTERNATIONAL NONPROPRIETARY NAME
Ear drops, solution of 4% phenazone and 1% lidocaine hydrochloride.
Description: clear, colorless or slightly yellowish solution.
1 ml of the medicine contains
Active ingredients: phenazone 35 mg,
lidocaine hydrochloride 8.8 mg.
Excipients: sodium thiosulphate, ethanol 96%, purified water, sodium hydroxide,
АТC CODE S02DA30
Combined drugs with antiinflammatory and local anesthetic action for treatment
of ear diseases.
Dropleks is a combined drug for local use. It possesses antiinflammatory and
local anesthetic action.
Drug action is conditioned by active ingredients, phenazone and lidocaine
hydrochloride, con-taining in the composition.
Phenazone is analgesic and antipyretic with antiinflammatory and local
Lidocaine hydrochloride is topical anesthetic.
The combination of phenazone and lidocaine hydrochloride promotes faster
anesthesia begin-ning, and also increases its intensiveness and duration.
Active ingredients are not absorbed into systemic circulation, if tympanic
membrane is not injured.
For topical symptomatic treatment and anesthetization in grown-ups and children
(including infants) with:
- acute otitis media;
- otitis, as complication after flu;
- barotraumatic otitis;
- posttraumatic otitis.
- hypersensitivity to drug components and pyrazole derivatives;
- perforation of tympanic membrane.
The drug is usually well tolerated.
The symptoms, associated with hypersensitivity to drug, are rarely reported.
DOSAGE AND ADMINISTRATION
Only for topical application.
The drops are instilled into external auditory canal by 3-4 drops 2-3 times a
day. In order to avoid the contact of cold solution with auricle, the vial
should be warmed in hands before use. The duration of Dropleks application
should not exceed 10 days, then the correction of prescribed therapy should be
Overdosage data are not reported.
During topical drug administration there is no negative result of interaction
with concurrently prescribed analgesics and anti inflammatory drugs, antiseptics,
antibiotics for topical and systemic application.
It is necessary to be sure in integrity of tympanic membrane before drug use. In
case of drug application with tympanic membrane the active ingredients can
penetrate into systemic circulation, it can lead to complication appearance.
It is necessary to maintain the interval minimum 30 minutes between
instillations during Dropleks use in combination with other ear drops.
It should be noted, that the drug contains active ingredient, which can give
positive result during drug test.
PREGNANCY AND LACTATION
The drug can possibly be used during pregnancy and lactation by indications, if
tympanic membrane is not injured.
EFFECTS ON ABILTY TO DRIVE AND USE MACHINES
Dropleks does not influence the ability for driving and work efficiency,
requiring high rate of psychomotor reactions.
Dropleks, ear drops, solution of 4% phenazone and 1% lidocaine hydrochloride, in
15 ml white polyethylene drop dispenser closed by polyethylene cap with
1 vial in a carton box with enclosed leaflet.
Store at temperature not exceeding 25°С.
Keep out of reach of children.
3 years from the date of manufacture.
Use within 6 months after first opening the vial.
Do not use after the expiry date.
Sold without prescription.
The Holder of Trade Mark and Marketing Authorization is
"WORLD MEDICINE OPHTHALMICS, UNITED KINGDOM.
Manufactured by “Rompharm Company S.R.L.”, Otopeni, Eroilor street 1A, Romania.