1 ml Otrelax ear drops contains:
The pharmacokinetics of phenazone solutions with lidocaine has not been studied. Based on the fact that the solution is intended for topical use, as well as the morphological features of the middle ear, it can be assumed that there is no systemic absorption, respectively, entering the systemic circulation, excluding patients with trauma to the eardrum.
Phenazone is a pyrazolone derivative with anti-inflammatory and analgesic effects.
Lidocaine is an amide-type local anesthetic.
Combined preparation for local use in otology with analgesic and anti-inflammatory effects due to the synergism of the action of its components. Lidocaine has a local anesthetic effect, and phenazone has an anti-inflammatory effect. Phenazone enhances the local anesthetic effect of lidocaine. The combined use of phenazone and lidocaine reduces the time of onset of the anesthetic effect, while increasing its severity and duration, which allows you to quickly eliminate pain in otitis media.
Reduction of pain and inflammation of the eardrum begins about five minutes after instillation. The pain syndrome almost completely disappears within 15–30 minutes.
As an adjuvant for earache in otitis media in patients with an intact tympanic membrane.
Instill into the external auditory canal. The recommended dose for adults is 4 drops 2-3 times a day.
The duration of treatment should not exceed 10 days.
If symptoms do not improve after 2-3 days of treatment, a reassessment of the therapeutic approach is required.
To avoid discomfort caused by the introduction of a cold solution into the ear canal, it is recommended to warm the vial to body temperature before administering the drug.
Rarely
- local allergic reactions, irritation or redness of the ear canal
- hypersensitivity to phenazone, lidocaine hydrochloride or any of the excipients
- hypersensitivity to pyrazolone derivatives (metamizol, isopropylaminophenazone, propyphenazone)
- perforation of the tympanic membrane of infectious or traumatic origin
Data on the interaction of the drug were not reported. The possibility of interaction arises with the simultaneous administration of active substances by another route or with systemic absorption of active substances, due to perforation of the tympanic membrane.
It is recommended to check the integrity of the eardrum before using Otirelax. The use of ear drops in patients with a perforated tympanic membrane may cause side effects due to the action at the level of the middle ear structures.
The drug contains an active substance that can give a positive test in doping control.
Pregnancy and lactation
If necessary, this medicine can be used by pregnant women or nursing mothers after consulting a doctor, in the absence of cracks in the eardrum.
Use in children
The safety and efficacy of Otirelax in children has not been established.
Features of the influence of the drug on the ability to drive vehicles or potentially dangerous mechanisms
Does not affect
Store at a temperature not exceeding 25 ºС, in the original packaging.
Keep out of the reach of children!
Shelf life 3 years
The period of application after opening the vial is not more than 4 weeks.
Do not use after expiration date
- Active ingredients: Phenazone 45.52 mg, Lidocaine hydrochloride 11.38 mg,
- Excipients: sodium thiosulfate, ethyl alcohol 96%, 0.1 M sodium hydroxide solution, glycerol, purified water.
Pharmacological properties
Pharmacokinetics
The pharmacokinetics of phenazone solutions with lidocaine has not been studied. Based on the fact that the solution is intended for topical use, as well as the morphological features of the middle ear, it can be assumed that there is no systemic absorption, respectively, entering the systemic circulation, excluding patients with trauma to the eardrum.
Pharmacodynamics
Phenazone is a pyrazolone derivative with anti-inflammatory and analgesic effects.
Lidocaine is an amide-type local anesthetic.
Combined preparation for local use in otology with analgesic and anti-inflammatory effects due to the synergism of the action of its components. Lidocaine has a local anesthetic effect, and phenazone has an anti-inflammatory effect. Phenazone enhances the local anesthetic effect of lidocaine. The combined use of phenazone and lidocaine reduces the time of onset of the anesthetic effect, while increasing its severity and duration, which allows you to quickly eliminate pain in otitis media.
Reduction of pain and inflammation of the eardrum begins about five minutes after instillation. The pain syndrome almost completely disappears within 15–30 minutes.
Indications for use
As an adjuvant for earache in otitis media in patients with an intact tympanic membrane.
Dosage and administration
Instill into the external auditory canal. The recommended dose for adults is 4 drops 2-3 times a day.
The duration of treatment should not exceed 10 days.
If symptoms do not improve after 2-3 days of treatment, a reassessment of the therapeutic approach is required.
To avoid discomfort caused by the introduction of a cold solution into the ear canal, it is recommended to warm the vial to body temperature before administering the drug.
Possible side effects
Rarely
- local allergic reactions, irritation or redness of the ear canal
Contraindications
- hypersensitivity to phenazone, lidocaine hydrochloride or any of the excipients
- hypersensitivity to pyrazolone derivatives (metamizol, isopropylaminophenazone, propyphenazone)
- perforation of the tympanic membrane of infectious or traumatic origin
Drug Interactions
Data on the interaction of the drug were not reported. The possibility of interaction arises with the simultaneous administration of active substances by another route or with systemic absorption of active substances, due to perforation of the tympanic membrane.
Special instructions
It is recommended to check the integrity of the eardrum before using Otirelax. The use of ear drops in patients with a perforated tympanic membrane may cause side effects due to the action at the level of the middle ear structures.
The drug contains an active substance that can give a positive test in doping control.
Pregnancy and lactation
If necessary, this medicine can be used by pregnant women or nursing mothers after consulting a doctor, in the absence of cracks in the eardrum.
Use in children
The safety and efficacy of Otirelax in children has not been established.
Features of the influence of the drug on the ability to drive vehicles or potentially dangerous mechanisms
Does not affect
How to store Otirelax?
Store at a temperature not exceeding 25 ºС, in the original packaging.
Keep out of the reach of children!
Shelf life 3 years
The period of application after opening the vial is not more than 4 weeks.
Do not use after expiration date
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