Otinum drops usn. 20% fl. 10g

Release form, composition and packaging

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Ear drops in the form of a transparent solution, weakly colored in yellow, with a characteristic odor.

1 ml

choline salicylate 200 mg

glycerol, ethanol, chlorobutanol hemihydrate, purified water.

10 g - polyethylene dropper bottle (1) with a screw cap - cardboard packs.

pharmachologic effect

NSAIDs.

Choline salicylate is a derivative of salicylic acid, when instilled into the ear, it has an anti-inflammatory and analgesic effect.

The action of choline salicylate is based on inhibition of the activity of cyclooxygenase, an enzyme responsible for the synthesis of prostaglandins.

Choline salicylate also inhibits the synthesis of thromboxane and prostacyclin.

It also has antimicrobial and antifungal effects (in acidic and alkaline environments).

When applied topically, it does not have a systemic effect.

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Indications for use

- Acute otitis media, myringitis, otitis externa

- before rinsing the external ear canal to soften hardened earwax before removing it.

Contraindications for use

- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history)

- violation of the integrity of the tympanic membrane

- pregnancy and lactation (due to lack of data)

- children's age (due to lack of data)

- hypersensitivity to choline salicylate and other components of the drug.

With care: allergic (hay") rhinitis, polyps of the mucous membrane of the nasal passages.

Dosage regimen

In acute otitis media, myringitis and otitis externa, 3-4 drops are instilled into the ear canal 3-4 times a day.

The course of treatment is no more than 10 days.

To soften the "sulfur plugs" before removing them, 3-4 drops are instilled into the external auditory canal 2 times a day for four days.

Before using ear drops, it is recommended to warm the bottle by holding it in your hand to avoid discomfort associated with the ingress of cold liquid into the ear.

Drops should be instilled in a patient lying on his side

after the procedure, the patient must remain in the same position for several minutes.

There is no need to change the dosage regimen for the elderly and patients with impaired liver and kidney function.

Overdose

There are no data on drug overdose.

Side effect

Possibly: allergic reactions, burning sensation.

With prolonged use, as well as in patients with perforation of the tympanic membrane, hearing impairment may occur.

Drug interactions

Strengthens the action of other anti-inflammatory, antipyretic and analgesic agents.

Application during pregnancy and lactation

Due to the lack of data, use is contraindicated during pregnancy and lactation.

Special instructions Influence on the ability to drive vehicles and control mechanisms Otinum does not affect the ability to drive vehicles and work with complex mechanisms.

Name ENG

OTINUM

Clinical and pharmacological group

NSAIDs for local use in ENT practice

ATX code

Analgesics and anesthetics

Dosage

20% x 10g

Structure

1 g of the drug contains: Active substance: choline salicylate 0.200 g. Excipients: glycerol 0.130 g, ethanol 96% 0.100 g, chlorobutanol hemihydrate 0.005 g, purified water to 1,000 g.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

choline salicylate

Specifications

Category

Ear pain

Scope of the drug

Ear, Throat, Nose

Release form

Drops

Manufacturer country

Poland

Package quantity, pcs

one

Way of introduction

Into the ear canal

Vacation conditions

Without recipe

Brand name

Meda

The amount of the dosage form in the primary package

10 g

Primary packaging type

Dropper bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

S02DA Analgesics and Anesthetics

Dosage form

Ear drops

Dosage (volume) of the substance in the preparation

1 g - choline salicylate 200 mg

Expiration date in days

1095

Package weight, g

twenty

Mode of application

:

In acute otitis media, myringitis and otitis externa, 3-4 drops are instilled into the external auditory canal 3-4 times a day.

< br> The course of treatment is no more than 10 days.

< br> To soften "sulfur plugs" before removing them < br> 3-4 drops are instilled into the external auditory canal twice a day for four days.

< br> Before using ear drops, it is recommended to warm the bottle by holding it in your hand to avoid the discomfort associated with the ingress of cold liquid into the ear.

< br> Drops should be buried in a patient lying on his side

after the procedure, the patient must remain in the same position for several minutes.

< br> There is no need to change the dosage regimen for the elderly and patients with impaired liver and kidney function.

"