Otic Products


Dropleks (Ear Drops)
(Phenazone/Lidocaine)

TRADE NAME

Dropleks

INTERNATIONAL NONPROPRIETARY NAME
Phenazone
Lidocaine hydrochloride

CHEMICAL NAME
Phenazone
1,5-dimethyl-2-phenyl-1,2-dihydro-3Н-pyrazol-3-one

Lidocaine hydrochloride
2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide

PHARMACEUTICAL FORM
Ear drops, solution of 4% phenazone and 1% lidocaine hydrochloride.
Description: clear, colorless or slightly yellowish solution.

COMPOSITION
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, glycerol.

АТC CODE S02DA30

PHARMACOTHERAPEUTIC GROUP
Combined drugs with antiinflammatory and local anesthetic action for treatment of ear diseases.

PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
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 anesthetic action.
Lidocaine hydrochloride is topical anesthetic.
The combination of phenazone and lidocaine hydrochloride promotes faster anesthesia begin-ning, and also increases its intensiveness and duration.

PHARMACOKINETICS
Active ingredients are not absorbed into systemic circulation, if tympanic membrane is not injured.

THERAPEUTIC INDICATIONS
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.

CONTRAINDICATIONS
- hypersensitivity to drug components and pyrazole derivatives;
- perforation of tympanic membrane.

ADVERSE EFFECTS
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 conducted.

OVERDOSAGE
Overdosage data are not reported.

DRUG INTERACTIONS
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.

PARTICULAR INDICATIONS
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.

PACKAGING
Dropleks, ear drops, solution of 4% phenazone and 1% lidocaine hydrochloride, in 15 ml white polyethylene drop dispenser closed by polyethylene cap with protective ring.
1 vial in a carton box with enclosed leaflet.

STORAGE CONDITIONS
Store at temperature not exceeding 25°С.
Keep out of reach of children.

SHELF LIFE
3 years from the date of manufacture.
Use within 6 months after first opening the vial.
Do not use after the expiry date.

SALES TERMS
Sold without prescription.

MANUFACTURER
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.


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