Otinum ushn drop. 20% 10ml vial

Description

Composition
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
Description:
The clear solution from colorless to weakly yellow-colored with a characteristic odor, free from foreign particles.
Product form:
Ear drops 20%.
10 g in a plastic bottle – a drip capacity of 10 ml with a screw cap. 1 bottle with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to choline salicylate or other components of the formulation.
Full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history).
Violation of the integrity of the eardrum.
Pregnancy and lactation (due to lack of data).
Children under 1 year.
Carefully
Allergic ( “senny”) runny nose, polyps, nasal mucosa.
Dosage
20 %
Indications
For the symptomatic relief of ear pain in acute otitis media, chronic otitis media, otitis externa, miringite.
Softening wax solidified before the procedure of its removal from the ear.
Interaction with other drugs
No data indicating choline salicylate interaction with other drugs with instillation of his ear.
Overdose
Drug overdose when instilled into the ear is not possible.
One vial formulation contains 2 grams of choline salicylate. If accidentally swallowed a quantity of the drug may be dangerous for infants only.
symptoms
Symptoms that may occur with an overdose ingestion: confusion, dizziness, sweating, vomiting, tinnitus and hyperventilation. After ingestion of very large amounts of the drug may occur CNS depression symptoms, such as drowsiness, lethargy, convulsions and coma.
Treatment
Help overdose after oral administration:
– removal from the body of choline salicylate (cause vomiting, gastric lavage, take activated charcoal);
– monitoring the patient’s condition (particularly – water and electrolyte balance);
– symptomatic therapy (including correction fluid and electrolyte balance, in cases where the salicylate concentration exceeds 300 mg per liter – diuresis).
pharmachologic effect
Pharmacological group:
NSAIDs
ATC code: [S02DA]
Pharmacodynamics:
Choline salicylate is a salicylic acid derivative, when instilled in the ear anti-inflammatory and anelgeziruyuschee action. Action choline salicylate based on the inhibition of cyclooxygenase activity – an enzyme responsible for prostaglandin synthesis. Choline salicylate also inhibits the synthesis of thromboxane and prostacyclin.
Also possesses antimicrobial and antifungal activity (in acidic and alkaline medium).
The local application has no systemic action.
Pharmacokinetics:
Data on the pharmacokinetics of choline salicylate when instilled into the ear missing.
Pregnancy and breast-feeding
Use of the drug during pregnancy and in nursing mothers is contraindicated due to a lack of relevant studies.
Conditions of supply of pharmacies
Without a prescription.
side effects
the incidence has not been established.
Local hypersensitivity reactions: itching, redness of the skin.
Diseases of the ear: the use of the drug in patients with perforation of the eardrum can lead to hearing loss.
If you have marked side effects listed in the instructions, or they are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
In children younger than 1 year of a drug can only be used under close medical supervision.
Salicylic acid derivatives in contact with the middle ear through a damaged ear drum can cause hearing loss or deafness. In connection with this drug should not be applied without preliminary inspection and without otorinolaringologa physician instructions.
Effect of the drug on the ability to drive, the mechanisms
The drug does not affect the ability to drive vehicles or to engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
At a temperature of not higher than 25 degrees. Keep out of the reach of children.
Dosing and Administration
In acute and chronic otitis media, and otitis externa miringite
Buried in the external auditory canal of 3-4 drops 3-4 times a day.
The course of treatment should not exceed 3 days.
Softening “cerumen” before deleting them
Instill 3-4 drops into the ear canal twice a day for 4 days.
Before use, ear drops recommended to warm the bottle by holding it in hand, to avoid unpleasant sensations associated with hitting a cold fluid in the ear.
Drops Bury patient lying on the side so that his ear was directed upward. After the procedure, the patient should be within a few minutes to remain in the same position.
No need to modify the dosing regimen for the elderly, children and patients with impaired liver and kidney function.
If after treatment there is no improvement or symptoms are aggravated, or there are new symptoms, you should consult with your doctor. Use according to the drug only indications that the application and in the doses indicated in the instructions for use.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist