Instructions for use Droplex ear drops solution dropper bottle 15 ml
Composition
active ingredients: phenazone, lidocaine hydrochloride;
1 ml of solution contains phenazone 45.52 mg and lidocaine hydrochloride 11.38 mg;
excipients: sodium thiosulfate, ethanol 96%, purified water, sodium hydroxide solution, glycerin.
Dosage form
Ear drops, solution.
Main physicochemical properties: transparent colorless or slightly brownish-yellow solution.
Pharmacotherapeutic group
Means used in otology. ATX code S02D A30.
Pharmacological properties
Pharmacodynamics
The drug is a combination of two active ingredients: phenazone and lidocaine.
Phenazone is a pyrazolone derivative with analgesic and anti-inflammatory properties. Lidocaine is a local anesthetic of the amide group. The combination of phenazone with lidocaine provides a synergistic analgesic/anti-inflammatory effect.
Pharmacokinetics
The absorption of any component of the drug through the skin has not been studied. Absorption is almost non-existent. Systemic absorption of this solution is not expected (in the absence of damage to the eardrum).
The drug's effect (reducing eardrum pain and reducing inflammation) begins five minutes after instillation. The pain syndrome almost completely disappears after 15–30 minutes.
Indication
Local symptomatic treatment of certain painful conditions of the middle ear with an intact tympanic membrane in children from 1 month of age and adults with:
otitis media in the acute period; phlyctenulous viral otitis (post-influenza); barotraumatic otitis.
Contraindication
Hypersensitivity to the active substances, to other components of the drug or to amide local anesthetic drugs.
Perforation of the eardrum of traumatic or infectious origin (see section "Special instructions for use").
Interaction with other medicinal products and other types of interactions
There are currently no data on the possibility of clinically significant interactions.
Application features
Before using the drug, the integrity of the eardrum should be checked (as a precaution). If there is destruction of the eardrum, administration of the drug into the ear may result in contact of the drug with the structures of the middle ear, causing adverse reactions in these tissues.
The drug contains an active ingredient that may show a positive result in an anti-doping test.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving vehicles or other mechanisms.
Use during pregnancy or breastfeeding
No consequences of using the drug during pregnancy are expected, since systemic exposure to phenazone and lidocaine is insignificant.
When used correctly, phenazone and lidocaine do not pass into breast milk. If necessary, the drug can be used during pregnancy or breastfeeding after consulting a doctor.
Method of administration and doses
The drug is intended for use in the external auditory canal.
For children aged 1 month and older and adults, instill 4 drops of the solution 2–3 times a day into the external auditory canal of the ear in which pain is felt. The course of treatment should not exceed 10 days. After that, the treatment should be reviewed.
To prevent unpleasant sensations resulting from contact of the skin of the ear canal with the cold solution, you should warm the bottle in your hands before using it.
Children
There are no data on the safety and efficacy of the drug in children under 1 month of age.
The drug can be used in children from 1 month of age after consultation and on the recommendation of a doctor.
Overdose
When using the drug at the recommended dosage, no overdose was observed.
Adverse reactions
Reported adverse reactions are listed according to system organ class.
From the organs of hearing and balance: local reactions: allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rashes.
Expiration date
3 years.
After opening the bottle, the drug can be used within 28 days.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Packaging
15 ml in polymer dropper bottles; 1 dropper bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
WORLD MEDICINE ILACH SAN. VE TIJ. A.Sh./ WORLD MEDICINE ILAC SAN. VE TIC. AS
Location of the manufacturer and its business address
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey/ 15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.
