Otinum ear drops 2g, 10ml

Composition

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of 1 g of the drug contains:

Active ingredient:

Choline salicylate – 0.200 g

Auxiliary substances:

Glycerol – 0.130 g

Ethanol 96% – 0.100 g

Chlorobutanol hemihydrate-0.005 g

Purified water up to 1,000 g

Pharmacological action

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

The action of choline salicylate is based on the inhibition 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.

Indications

For symptomatic relief of ear pain in acute otitis media, chronic otitis media, external otitis, and myringitis.

Softening of hardened earwax before removing it from the ear.

Recommendations for use

In acute and chronic otitis media, miringitis and otitis externa

,3-4 drops are instilled into the external ear canal 3-4 times a day.

The course of treatment should not exceed 3 days.

To soften the “sulfur plugs” before removing them

,3-4 drops are instilled into the external ear canal twice a day for 4 days.

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

Drops should be instilled in the patient lying on his side so that his ear is directed upwards. 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, children and patients with impaired liver and kidney function.

If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of use and in the doses indicated in the instructions for use.

Contraindications

Hypersensitivity to choline salicylate or other components of the drug.

Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis).

Violation of the integrity of the eardrum.

Pregnancy and lactation period (due to lack of data).

Children under 1 year of age.

With caution

Allergic (“hay”) runny nose, polyps of the nasal mucosa.

Side effects

The frequency of development is not established.

Local hypersensitivity reactions: itching, redness of the skin.

Ear diseases: the use of the drug in patients with perforation of the eardrum can lead to hearing impairment.

If you experience any of the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

There are no data indicating the interaction of choline salicylate with other drugs when instilled in the ear.

Overdose

Overdose of the drug when instilled in the ear is impossible.

One bottle of the drug contains 2 grams of choline salicylate. If accidentally swallowed, this amount of the drug can only be dangerous for newborns.

Symptoms

Symptoms that may occur with an overdose if swallowed: confusion, dizziness, increased sweating, vomiting, tinnitus, and hyperventilation. After ingesting very large amounts of the drug, symptoms of CNS depression may appear, such as drowsiness, lethargy, convulsions, and coma.

Treatment

Oral overdose management:

– removal of choline salicylate from the body (to induce vomiting, gastric lavage, intake of activated carbon);

– control of the patient’s condition (primarily water and electrolyte balance);

– symptomatic treatment (including correction of water and electrolyte balance; in cases where the concentration exceeds salicylate 300 mg in a liter – forced diuresis).

Description

Clear solution from colorless to slightly colored yellow with a characteristic odor, free from foreign particles.

Functional features

There are no data on the pharmacokinetics of choline salicylate when instilled in the ear.

Special instructions

In children under 1 year of age, the drug can only be used under the close supervision of a doctor.

Salicylic acid derivatives can cause hearing loss or deafness if they enter the middle ear through a damaged eardrum. In this regard, the drug should not be used without a preliminary examination by an otorhinolaryngologist and without instructions from a doctor.

Effect of the drug on the ability to drive vehicles, mechanisms

The drug does not affect the ability to drive vehicles or engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Ear drops 20%.

10 g each in a plastic dropper bottle with a capacity of 10 ml with a screw-on lid. 1 bottle with instructions for use is placed in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ° C. Keep out of reach of children.

Shelf

life is 3 years.

Do not use after the expiration date.

Active ingredient

Choline salicylate

Dosage form

ear drops

Description

For adults

Indications

Dissolving Sulfur Plugs, Otitis media