Universal reference book for medicines
Product name: OTINUM (OTINUM)

Active substance: choline salicylate

Type: NSAIDs for topical application in ENT practice

Manufacturer: ICN POLFA RZESZOW (Poland)
Composition, form of production and packaging
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Drops of ear in the form of a transparent solution, slightly dyed yellow, with a characteristic odor.
1 ml

choline salicylate 200 mg

Excipients: glycerol, ethanol, chlorobutanol, hemihydrate, purified water.

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

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

NSAIDs.
Choline Salicylate is a derivative of salicylic acid, when instilled in the ear it has anti-inflammatory and anelgesic effect. The effect of choline salicylate is based on inhibition of cyclooxygenase activity - the enzyme responsible for the synthesis prostaglandins. Choline salicylate also inhibits the synthesis of thromboxane and prostacyclin.
It also has antimicrobial and antifungal action (in acidic and alkaline medium).

When topical application does not have a systemic effect.

INDICATIONS

- Acute otitis media, myringitis, otitis externa;

- before washing the external ear canal to soften the hardened earwax before the procedure for its removal.

DOSING MODE

In acute otitis media, myringitis and external otitis are instilled into the external auditory meatus 3-4 drops 3-4 times a day.
The course of treatment is no more than 10 days.
To soften the "sulfur plugs" before they are removed, drop 3-4 drops into the external auditory meatus twice a day for four days.

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

Droplets should be instilled in the patient lying on his side;
After the procedure, the patient should 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 .

SIDE EFFECT

Possible: allergic reactions, burning sensation.

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

CONTRAINDICATIONS

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis);

- 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 caution: allergic ("hay") runny nose, polyps of the nasal mucosa.

PREGNANCY AND LACTATION

In connection with the lack of data, use during pregnancy and lactation is contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

There is no need to change the dosing regimen for those with impaired renal function .

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

There is no need to change the dosing regimen for patients with impaired hepatic function


APPLICATION FOR CHILDREN

Due to lack of data, use in children is contraindicated


APPLICATION IN ELDERLY PATIENTS

There is no need to change the dosage regimen for the elderly.

SPECIAL INSTRUCTIONS

Impact on the ability to drive vehicles and manage mechanisms

The otinum does not affect the ability to drive vehicles and work with complex machinery.

OVERDOSE

Data on drug overdose are absent.

DRUG INTERACTION

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

TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children. Shelf life - 3 years.
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