Otirelax (Lidocaine + Phenazone) 15ml ear drops

The composition and form of issue: 

Ear drops. 1 g contains:

active substances: 

phenazone 40 mg

lidocaine hydrochloride 10 mg

excipients: sodium thiosulfate pentahydrate, ethanol 96% glycerol purified water sodium hydroxide solution 1M 

in vials-droppers of PE white color, closed PE caps with safety rings, for 17, 1 g (15 ml) in the paper cartons 1 a bottle.

Description pharmaceutical form:

Transparent colorless or slightly yellowish solution.

Pharmacokinetics:

The drug does not penetrate into the systemic circulation in the intact eardrum.

Description pharmacological action:

Phenazone has anti-inflammatory and analgesic effect. Lidocaine has a local analgesic effect.

Indications:

Local symptomatic treatment and analgesia in children and adults:

• for external otitis
• in the treatment of otitis media with intact eardrum
• when barotraumatic otitis media.

Contraindications:

• hypersensitivity to the drug
• perforation of the tympanic membrane
• hypersensitivity to the pyrazolone derivative (drugs containing Metamizole sodium, phenylbutazone).

Caution: you must verify the integrity of the eardrum before using the drug. In the case of drugs in a perforated eardrum, the drug may enter the systemic circulation and lead to complications.

Application of pregnancy and breast-feeding:

Application of pregnancy is possible only in the case when expected benefit for mother exceeds the potential risk to the fetus.

If necessary, use during lactation should decide the issue of termination of breastfeeding.

Side effects:

There is a risk of local allergic reactions, irritation and redness of the ear canal, mild pain during application.

Drug interactions:

Currently, information about interaction with other drugs missing.

Method of application and dose:

Local.

Instilled into the ear canal adults and children 2-3 times a day 3-4 drops. In order to avoid the contact of cold solution with auricle, the bottle before use to keep them warm in the palms.

The course of treatment should not exceed 10 days.

Precautions:

The duration of the application Tirerack not more than 10 days, and then should review the prescribed treatment.

After first opening the bottle the drug should be used within 6 months. Do not use after the expiry date printed on the package.

When using the drug Tireless in combination with other ear drops, you should keep the interval at least 30 min between drops.

Information for athletes: the drug contains an active component that can give a positive reaction in doping control.