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Dropleks 15 ml ear drops




Trade name
of Droplex

the International unlicensed name
Is not present

the Dosage form
of the Drop ear 15 ml

1 ml of drug contains
active agents: phenazone of 45.52 mg, lidocaine of a hydrochloride of 11.38 mg,
excipients: Natrium thiosulfuricum pentahydrate, ethanol of 96%, water purified 1M of hydroxide sodium solution, glycerin.

Transparent, colourless or slightly yellowish color solution.
Pharmacotherapeutic group
Drugs for treatment of otological diseases. Drugs for treatment of otological diseases others. Analgetics and anesthetics. The combined drugs.
The ATX S02DA30 code

the Pharmacological

Pharmacokinetics Active Ingredients properties are not soaked up in a system blood stream at the uninjured tympanic membrane.
The pharmacodynamics
of Droplex is the combined drug for topical administration. Has mestnoanesteziruyushchy and anti-inflammatory effect.
Effect of drug is caused by the active components which are a part – phenazone and lidocaine a hydrochloride.
Phenazone – analgetic – antipyretic with anti-inflammatory and analgiziruyushchy action.
Lidocaine a hydrochloride – local anesthetic.
The combination of phenazone and lidocaine of a hydrochloride promotes faster approach of anesthesia and also increases its intensity and duration.

For topical symptomatic treatment and anesthesia at:
– acute average otitis
– an aviation otitis

the Route of administration and doses
Only for topical administration.
Drops dig in in external acoustical pass 3-4 drops 2-3 times a day. In order to avoid contact of cold solution with an auricle the bottle before use should be warmed in palms. Duration of use of Droplex is no more than 7 days then it is necessary to carry out correction of the appointed therapy.

Side effects
– irritation, reddening, an itching
At emergence of these or other undesirable reactions stop use of this drug and immediately see a doctor!

– hypersensitivity to components of drug and derivatives of pyrazol
– perforation of a tympanic membrane
– the lactation period

Medicinal interactions
At topical administration of drug is not observed negative take of interaction with at the same time appointed analgetics and anti-inflammatory drugs, antiseptic agents, antibiotics for topical and system administration.

Special instructions
It is necessary to be convinced of integrity of a tympanic membrane before drug use. In case of use of drug at a perforated tympanic membrane active agents can get into a system blood stream that can lead to emergence of complications.
When using the drug Droplex in combination with other ear drops it is necessary to keep an interval at least 30 minutes between burying.
It must be kept in mind that drug contains active component which can give positive test at doping control.
Pregnancies and the period of a lactation
use of drug at pregnancy according to indications on condition of the uninjured tympanic membrane is possible.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Droplex does not affect ability of driving of the car and the performance of work demanding the high speed of psychomotor reactions.

The overdose
on condition of observance of requirements to a route of administration overdose by drug is impossible.

The form of release and packing
On 15 ml of drug spill in a white polyethylene bottle with a stopper – a dropper and the screwing-up protective cap supplied with a safety ring.
On a bottle paste the label self-adhesive.
On 1 bottle together with the instruction for medical use of drug in the state and Russian languages put in a box of cardboard.

To Store storage conditions at a temperature not above 25ºС.
After opening of a bottle to use drug within 6 months.
To store out of children’s reach!

3 years
not to apply a period of storage after an expiration date.

Prescription status
Without prescription

Rompharm Company of S.R. L., Otopen, Eroilor St. 1A, Romania.


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