Universal reference book for medicines
Product name: OTIRELAX

Active substance: lidocaine, phenazone

Type: The drug with anti-inflammatory and local anesthetic action for topical application in ENT practice

Manufacturer: SC ROMPHARM Company (Romania)
Composition, form of production and packaging
Ear drops
in the form of a clear, colorless or slightly yellowish solution.

1 g

phenazone 40 mg

lidocaine hydrochloride 10 mg

Excipients: sodium thiosulfate pentahydrate, ethanol 96%, glycerol, sodium hydroxide (1M solution), purified water.

15 ml (17.1 g) - a bottle of droppers, polyethylene (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Combination drug for topical application.
Has a local anesthetic and anti-inflammatory effect.
Phenazone is an analgetic-antipyretic with an anti-inflammatory and analgesic effect.
Lidocaine is a local anesthetic. The combination of phenazone and lidocaine promotes a faster onset of anesthesia, and also increases its intensity and duration.
PHARMACOKINETICS

The active substances are not absorbed into the systemic blood stream with an intact tympanic membrane.

INDICATIONS

For local symptomatic treatment and analgesia in adults and children (including newborns) with:

- external otitis;

- in the complex therapy of otitis media with an intact tympanic membrane;

- barotraumatic otitis media.

DOSING MODE

Drops are instilled into the external auditory meatus by 3-4 drops 2-3 times / day.
To avoid contact of the cold solution with the auricle, the bottle should be warmed in the palms before use.
The course of treatment should not exceed 10 days.

SIDE EFFECT

Probably: local allergic reactions, irritation and hyperemia of the auditory canal, insignificant pain during application.

CONTRAINDICATIONS

perforation of the tympanic membrane;

- hypersensitivity to the components of the drug;

- hypersensitivity to pyrazolone derivatives.

PREGNANCY AND LACTATION

Use in pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

If it is necessary to use during the lactation period, the question of stopping breastfeeding should be solved.

APPLICATION FOR CHILDREN

Possible use in children (including newborns)

SPECIAL INSTRUCTIONS

It is necessary to make sure the integrity of the tympanic membrane before applying the drug.
If the drug is used with a perforated eardrum, the active substances can enter the systemic circulation, which can lead to complications.
The duration of application of Otirelax is not more than 10 days, after which it is necessary to correct the prescribed therapy.

When using Otirelaks in combination with other ear drops, it is necessary to keep an interval of at least 30 minutes between instillations.

It should be borne in mind that the drug contains an active ingredient that can give a positive test for doping control.

OVERDOSE

Data on the overdose of Otirelaks were not provided.

DRUG INTERACTION

At present, there is no information on the interaction of the drug Otirelax with other drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
After opening the vial, the drug should be used within 6 months.

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